[Federal Register Volume 85, Number 248 (Monday, December 28, 2020)]
[Rules and Regulations]
[Pages 84472-85377]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26815]



[[Page 84471]]

Vol. 85

Monday,

No. 248

December 28, 2020

Part II





Department of Health and Human Services





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Centers for Medicare & Medicaid Services





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42 CFR Parts 400, 410, 414, et al.





Medicare Program; CY 2021 Payment Policies Under the Physician Fee 
Schedule and Other Changes to Part B Payment Policies; Medicare Shared 
Savings Program Requirements; Medicaid Promoting Interoperability 
Program Requirements for Eligible Professionals; Quality Payment 
Program; Coverage of Opioid Use Disorder Services Furnished by Opioid 
Treatment Programs; Medicare Enrollment of Opioid Treatment Programs; 
Electronic Prescribing for Controlled Substances for a Covered Part D 
Drug; Payment for Office/Outpatient Evaluation and Management Services; 
Hospital IQR Program; Establish New Code Categories; Medicare Diabetes 
Prevention Program (MDPP) Expanded Model Emergency Policy; Coding and 
Payment for Virtual Check-in; Final Rule

  Federal Register / Vol. 85 , No. 248 / Monday, December 28, 2020 / 
Rules and Regulations  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 400, 410, 414, 415, 423, 424, and 425

[CMS-1734-F, CMS-1734-IFC, CMS-1744-F, CMS-5531-F and CMS-3401-IFC]
RIN 0938-AU10, 0938-AU31, 0938-AU32, and 0938-AU33


Medicare Program; CY 2021 Payment Policies Under the Physician 
Fee Schedule and Other Changes to Part B Payment Policies; Medicare 
Shared Savings Program Requirements; Medicaid Promoting 
Interoperability Program Requirements for Eligible Professionals; 
Quality Payment Program; Coverage of Opioid Use Disorder Services 
Furnished by Opioid Treatment Programs; Medicare Enrollment of Opioid 
Treatment Programs; Electronic Prescribing for Controlled Substances 
for a Covered Part D Drug; Payment for Office/Outpatient Evaluation and 
Management Services; Hospital IQR Program; Establish New Code 
Categories; Medicare Diabetes Prevention Program (MDPP) Expanded Model 
Emergency Policy; Coding and Payment for Virtual Check-in Services 
Interim Final Rule Policy; Coding and Payment for Personal Protective 
Equipment (PPE) Interim Final Rule Policy; Regulatory Revisions in 
Response to the Public Health Emergency (PHE) for COVID-19; and 
Finalization of Certain Provisions from the March 31st, May 8th and 
September 2nd Interim Final Rules in Response to the PHE for COVID-19

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

ACTION: Final rule and interim final rule.

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SUMMARY: This major final rule addresses: Changes to the physician fee 
schedule (PFS); other changes to Medicare Part B payment policies to 
ensure that payment systems are updated to reflect changes in medical 
practice, relative value of services, and changes in the statute; 
Medicare Shared Savings Program requirements; Medicaid Promoting 
Interoperability Program requirements for Eligible Professionals; 
updates to the Quality Payment Program; Medicare coverage of opioid use 
disorder services furnished by opioid treatment programs; Medicare 
enrollment of Opioid Treatment Programs; payment for office/outpatient 
evaluation and management services; Requirement for Electronic 
Prescribing for Controlled Substances for a Covered Part D drug under a 
prescription drug plan or an MA-PD plan and Medicare Diabetes 
Prevention Program (MDPP) expanded model Emergency Policy. This final 
rule also finalizes certain provisions of the interim final rules with 
comment period that CMS issued on March 31, 2020, May 8, 2020\,\ and 
September 2, 2020 in response to the Public Health Emergency (PHE) for 
the Coronavirus Disease 2019 (COVID-19). This rule also establishes 
coding and payment for virtual check-in services and for personal 
protective equipment (PPE) on an interim final basis.

DATES: Effective Date: The regulations in the final rule are effective 
on January 1, 2021.
    Applicability date: The policies in this final rule are applicable 
on January 1, 2021, except as follows:
    (1) The revisions to 42 CFR 400.200 and 425.611(b)(1)(ii) are 
applicable retroactively to the start of the PHE for COVID-19 on 
January 27, 2020. (See discussions in sections II.J. and III.G.5.d.(2) 
of this final rule, respectively.)
    (2) The revisions to 42 CFR 425.400(c)(2) are applicable 
retroactively for the performance year starting on January 1, 2020. 
(See discussion in section III.G.5.e.(3) of this final rule.)
    Comment date: Comments will be accepted/considered ONLY on the 
``Interim Final Rule with Comment Period for Coding and Payment of 
Virtual Check-in Services'' contained in section II.D. of the preamble 
of this document and ``Interim Final Rule with Comment Period for 
Coding and Payment for Personal Protective Equipment (PPE)'' contained 
in section II.H. of the preamble of this document. To be assured 
consideration, comments must be received at one of the addresses 
provided below, no later than 5 p.m. on February 1, 2021.

ADDRESSES: In commenting, please refer to file code CMS-1734-IFC.
    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 http://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-1734-IFC,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-1734-IFC, Mail Stop C4-26-05, 7500 
Security Boulevard, Baltimore, MD 21244-1850.

FOR FURTHER INFORMATION CONTACT: Jamie Hermansen, (410) 786-2064, for 
any issues not identified below.
    Michael Soracoe, (410) 786-6312, for issues related to practice 
expense, work RVUs, conversion factor, PFS specialty-specific impacts, 
and the interim final rule with comment period for coding and payment 
for PPE.
    Larry Chan, (410) 786-6864, for issues related to potentially 
misvalued services under the PFS.
    Emily Yoder, (410) 786-1804, Donta Henson, (410) 786-1947, and 
Patrick Sartini, (410) 786-9252, for issues related to telehealth, 
other services involving communications technology, and interim final 
rule with comment period for coding and payment of virtual check-in 
services.
    Liane Grayson, (410) 786-6583, for issues related to care 
management services and remote physiologic monitoring services.
    Emily Yoder, (410) 786-1804, Christiane LaBonte, (410) 786-7237, 
Ann Marshall, (410) 786-3059, and Patrick Sartini, (410) 786-9252, for 
issues related to payment for office/outpatient evaluation and 
management visits.
    Christiane LaBonte, (410) 786-7237, and Cindy Bergin, (401) 786-
1176, for issues related to teaching physician services.
    Roberta Epps, (410) 786-4503, and Regina Walker-Wren, (410) 786-
9160, for issues related to supervision of diagnostic tests.
    Ann Marshall, (410) 786-3059, for issues related to incident to 
pharmacist services.
    Gift Tee, (410) 786-9316, for issues related to therapy services.
    Sarah Leipnik, (410) 786-3933, for issues related to medical record 
documentation.
    Lindsey Baldwin, (410) 786-1694 and Terry Simananda, (410) 786-
8144, for issues related to Medicare coverage of opioid use disorder 
treatment services furnished by opioid treatment programs.
    Laura Ashbaugh, (410) 786-1113, for issues related to Clinical 
Laboratory Fee

[[Page 84473]]

Schedule: Revised Data Reporting Period and Phase-in of Payment 
Reductions
    Joseph Schultz, (410) 786-2656, for issues related to opioid 
treatment program provider enrollment regulation updates for 
institutional claim submissions.
    Lisa Parker, (410) 786-4949, for issues related to RHCs and FQHCs, 
primary care management services, and the FQHC market basket.
    Rachel Katonak, (410) 786-8564, or JoAnna Baldwin (410) 786-7205, 
for issues related to comprehensive screenings for seniors: Section 
2002 of the Substance Use-Disorder Prevention that Promote Opioid 
Recovery and Treatment for Patients and Communities Act (SUPPORT Act).
    David Koppel, (303) 844-2883, or Elizabeth LeBreton (202) 615-3816 
for issues related to the Medicaid Promoting Interoperability Program.
    Fiona Larbi, (410) 786-7224, or Sabrina Ahmed, (410) 786-7499, for 
issues related to the Medicare Shared Savings Program (Shared Savings 
Program) Quality performance standard, quality reporting requirements 
and finalization of Shared Savings Program provisions from the March 
31st COVID-19 IFC.
    Janae James, (410) 786-0801, or Elizabeth November, (410) 786-4518, 
or [email protected], for issues related to Shared 
Savings Program beneficiary assignment, repayment mechanism 
requirements, and finalization of Shared Savings Program provisions 
from the May 8th COVID-19 IFC.
    Cheryl Gilbreath, (410) 786-5919, for issues related to home 
infusion therapy benefit.
    Heather Hostetler, (410) 786-4515 for issues related to removal of 
selected national coverage determinations.
    Joella Roland, (410) 786-7638, for issues related to requirement 
for electronic prescribing for controlled substances for a covered Part 
D drug under a prescription drug plan or an MA-PD plan.
    Edmund Kasaitis, (410) 786-0477, for issues related to Part B drug 
payment and Food Drug & Cosmetic Act section 505(b)(2) drug products.
    Elizabeth Holland, (410) 786-1309, for issues related to updates to 
certified electronic health record technology due to the 21st Century 
Cures Act.
    Julia Venanzi, (410) 786-1471, for issues related to the Hospital 
Inpatient Quality Reporting (IQR) Program.
    Cynthia Hake, (410) 786-3404, for issues related to HCPCS Level II 
codes.
    Amanda Rhee, (410) 786-3888, for the Medicare Diabetes Prevention 
Program (MDPP) expanded model emergency policy.
    Molly MacHarris, (410) 786-4461, for inquiries related to Merit-
based Incentive Payment System (MIPS).
    Brittany LaCouture, (410), 786-0481, for inquiries related to 
Alternative Payment Models (APMs).
    Patricia Taft, (410) 786-4561, for issues related to the Physician 
Self-Referral Law: Annual Update to the List of CPT/HCPCS Codes.

SUPPLEMENTARY INFORMATION:
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. We post all comments 
received before the close of the comment period on the following 
website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to 
view public comments. CMS will not post on Regulations.gov public 
comments that make threats to individuals or institutions or suggest 
that the individual will take actions to harm the individual. CMS 
continues to encourage individuals not to submit duplicative comments. 
We will post acceptable comments from multiple unique commenters even 
if the content is identical or nearly identical to other comments.
    Addenda Available Only Through the internet on the CMS website: The 
PFS Addenda along with other supporting documents and tables referenced 
in this final rule are available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.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 
2021 PFS final rule, refer to item CMS-1734-F. Readers with questions 
related to accessing any of the Addenda or other supporting documents 
referenced in this final 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 final rule, we use CPT codes and descriptions to refer to a 
variety of services. We note that CPT codes and descriptions are 
copyright 2019 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 final rule revises payment polices under the Medicare 
PFS and makes other policy changes, including to the implementation of 
certain provisions of the Bipartisan Budget Act of 2018 (BBA of 2018) 
(Pub. L. 115-123, February 9, 2018) and the Substance Use-Disorder 
Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for 
Patients and Communities Act (the SUPPORT Act) (Pub. L. 115-271, 
October 24, 2018), related to Medicare Part B payment. In addition, 
this final rule includes provisions related to other payment policy 
changes that are addressed in sections III. and IV. of this final rule.
    We are issuing an interim final rule with comment period (IFC) to 
establish coding and payment for virtual check-in services to support 
the continuing need for coding and payment to reflect the provision of 
lengthier audio-only services outside of the PHE for COVID-19, if not 
as substitutes for in-person services, then as a tool to determine 
whether an in-person visit is needed, particularly as beneficiaries may 
still be cautious about exposure risks associated with in-person 
services. We are also issuing an interim final rule with comment period 
to establish coding and payment for PPE as a bundled service and 
certain supply pricing increases in recognition of the increased 
market-based costs for certain types of PPE.
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 final rule, we are establishing RVUs for CY 2021 for 
the PFS 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 final rule also includes

[[Page 84474]]

discussions and provisions regarding several other Medicare Part B 
payment policies.
    Specifically, this final rule addresses:
 Practice Expense RVUs (section II.B.)
 Potentially Misvalued Services Under the PFS (section II.C.)
 Telehealth and Other Services Involving Communications 
Technology, and the Interim Final Rule with Comment Period for Coding 
and Payment for Virtual Check-in Services (section II.D.)
 Care Management Services and Remote Physiologic Monitoring 
Services (section II.E.)
 Refinements to Values for Certain Services to Reflect 
Revisions to Payment for Office/Outpatient Evaluation and Management 
(E/M) Visits and Promote Payment Stability during the PHE for COVID-19 
(section II.F.)
 Scopes of Practice and Related Issues (section II.G.)
 Valuation of Specific Codes, and the Interim Final rule with 
Comment Period for Coding and Payment for Personal Protective Equipment 
(PPE) (section II.H.)
 Modifications related to Medicare Coverage for Opioid Use 
Disorder (OUD) Services Furnished by Opioid Treatment Programs (OTPs) 
(section II.I.)
 Technical Correction to the Definition of Public Health 
Emergency (section II.J.)
 Clinical Laboratory Fee Schedule (section III.A.)
 Opioid Treatment Program Provider Enrollment Regulation 
Updates for Institutional Claim Submissions (section III.B.)
 Payment for Primary Care Management Services in RHCs and FQHCs 
(section III.C.)
 Changes to the Federally Qualified Health Center Prospective 
Payment System (FQHC PPS) for CY 2021: Rebasing and Revising of the 
FQHC Market Basket (section III.D.)
 Comprehensive Screenings for Seniors: Section 2002 of the 
Substance Use-Disorder Prevention that Promote Opioid Recovery and 
Treatment for Patients and Communities Act (SUPPORT Act) (section 
III.E.)
 Medicaid Promoting Interoperability Program Requirements for 
Eligible Professionals (EPs) (section III.F.)
 Medicare Shared Savings Program (section III.G.)
 Notification of Infusion Therapy Options Available Prior to 
Furnishing Home Infusion Therapy Services (section III.H.)
 Modifications to Quality Reporting Requirements and Comment 
Solicitation on Modifications to the Extreme and Uncontrollable 
Circumstances Policy for Performance Year 2020 (section III.I.)
 Removal of Selected National Coverage Determinations (section 
III.J.)
 Requirement for Electronic Prescribing for Controlled 
Substances for a Covered Part D drug under a prescription drug plan or 
an MA-PD plan (section III.K.)
 Medicare Part B Drug Payment for Drugs Approved Through the 
Pathway Established Under Section 505(b)(2) of the Food, Drug, and 
Cosmetic Act (section III.L.)
 Updates to Certified Electronic Health Record Technology 
Requirements in the Promoting Interoperability Program, Quality Payment 
Program, and Hospital Inpatient Quality Reporting Program due to the 
21st Century Cures Act (section III.M.)
 Establishing New Code Categories (section III.N.)
 Medicare Diabetes Prevention Program (MDPP) expanded model 
emergency policy (section III.O.)
 Updates to the Quality Payment Program (section IV.)
 Physician Self-Referral Law: Annual Update to the List of CPT/
HCPCS Codes (section V.)
 Waiver of Delay in Effective Date for this Final Rule (section 
VI.)
 Collection of Information Requirements (section VII.)
 Regulatory Impact Analysis (section VIII.)
2. Provisions Related to the PHE for COVID-19
    The United States is currently responding to an outbreak of 
respiratory disease caused by a novel (new) coronavirus. This virus has 
been named ``severe acute respiratory syndrome coronavirus 2'' (``SARS-
CoV-2''), and the disease it causes has been named ``coronavirus 
disease 2019'' (``COVID-19''). On January 31, 2020, the Secretary 
determined that a PHE existed nationwide as a result of the 
consequences of the COVID-19 pandemic (hereafter referred to as the PHE 
for COVID-19). On March 13, 2020, President Trump declared the COVID-19 
pandemic a national emergency. Effective, October 23, 2020, the 
Secretary renewed the January 31, 2020 determination that a PHE exists 
and has existed since January 27, 2020. (Note: This declaration was 
previously renewed on April 21, 2020 and July 25, 2020.)
    As the healthcare community continues to establish and implement 
recommended infection prevention and control practices, regulatory 
agencies operating under appropriate waiver authority during the PHE 
for COVID-19 are also working to revise and implement regulations that 
support these healthcare community infection prevention and treatment 
practices. We addressed some of these regulations in three previous 
interim final rules with comment period (IFCs):
     The ``Medicare and Medicaid Programs; Policy and 
Regulatory Revisions in Response to the COVID-19 Public Health 
Emergency'' IFC appeared in the April 6, 2020 Federal Register (85 FR 
19230) with an effective date of March 31, 2020 (hereafter referred to 
as the ``March 31st COVID-19 IFC'');
     The ``Medicare and Medicaid Programs, Basic Health 
Program, and Exchanges; Additional Policy and Regulatory Revisions in 
Response to the COVID-19 Public Health Emergency and Delay of Certain 
Reporting Requirements for the Skilled Nursing Facility Quality 
Reporting Program'' IFC appeared in the May 8, 2020 Federal Register 
(85 FR 27550) with an effective date of May 8, 2020 (hereafter referred 
to as the ``May 8th COVID-19 IFC''); and
     The ``Medicare and Medicaid Programs, Clinical Laboratory 
Improvement Amendments (CLIA), and Patient Protection and Affordable 
Care Act; Additional Policy and Regulatory Revisions in Response to the 
COVID-19 Public Health Emergency'' IFC appeared in the September 2, 
2020 Federal Register (85 FR 54820) with an effective date of September 
2, 2020 (hereinafter referred to as the ``September 2nd COVID-19 IFC).
    In this final rule, we are finalizing certain provisions of the 
March 31st, May 8th, and September 2nd COVID-19 IFCs.
    We indicated in the CY 2021 PFS proposed rule (85 FR 50140 and 
50147) our intent that for certain provisions of the March 31st, May 
8th, and September 2nd COVID-19 IFCs, we would respond to comments 
received in this final rule. In this final rule, we are responding to 
public comments and finalizing certain provisions of the March 31st, 
May 8th, and September 2nd COVID-19 IFCs.
3. Summary of Costs and Benefits
    We have determined that this final rule is economically 
significant. For a detailed discussion of the economic impacts, see 
section VIII. of this final rule.
    4. Waiver of the 60-Day Delay in Effective Date for the Final Rule
    The United States is responding to an outbreak of respiratory 
disease caused by a novel (new) coronavirus that has now been detected 
in more than 190

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locations internationally, including in all 50 States and the District 
of Columbia. The virus has been named ``SARS CoV 2'' and the disease it 
causes has been named ``Coronavirus disease 2019'' (abbreviated 
``COVID-19'').
    Due to the significant devotion of resources to the COVID-19 
response, as discussed in section VI. of the preamble of this final 
rule, we are hereby waiving the 60-day delay in the effective date for 
this final rule as proposed, and replacing it with a 30-day delay in 
the effective date for this final rule.

II. Summary of the Proposed Provisions, Analysis of and Response to 
Public Comments, and the Provisions of the Final Rule for the PFS

A. Background

    Since January 1, 1992, Medicare has paid for physicians' services 
under section 1848 of the Social Security Act (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 in the November 25, 1991 Federal Register (56 FR 59502) 
set forth the first fee schedule used for payment for physicians' 
services.
    We note that throughout this final 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 RVUs
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 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 by 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 `97) delayed implementation of 
the resource-based PE RVU system until January 1, 1999. In addition, 
section 4505(b) of the BBA `97 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 resource 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 specific facility resource costs 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

[[Page 84476]]

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 `97 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.
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 VIII. of this final rule, the Regulatory 
Impact Analysis, 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 
component. Please refer to the CY 2020 PFS final rule for a discussion 
of the last GPCI update (84 FR 62615 through 62623).

    RVUs are converted to dollar amounts through the application of a 
CF, which is calculated based on a statutory formula by CMS' 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 PE 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 5-year review of work RVUs under the 
PFS and proposed changes to the PE 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

[[Page 84477]]

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 titled ``CY 2021 PFS Final Rule PE/HR'' on the 
CMS website under downloads for the CY 2021 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    As noted above, we have established PE/HR values for various 
specialties without SMS or PPIS survey data by crosswalking them to 
other similar specialties to estimate a proxy PE/HR. On this note, 
stakeholders have raised concerns regarding the appropriate specialty 
crosswalk used for home PT/INR monitoring services. These services are 
currently classified under the independent diagnostic testing 
facilities (IDTF) specialty for PE/HR purposes, due to a lack of survey 
data for these services, and stakeholders have suggested to CMS that 
this specialty does not reflect the indirect costs associated with 
furnishing these services. Stakeholders have raised concerns that the 
practice pattern of PT/INR monitoring services are markedly different 
from that of the dominant parent specialty as most of the services are 
furnished remotely and require long-term relationship with 
beneficiaries similar to chronic therapy. Stakeholders also stated that 
this is a unique request due to the lack of home PT/INR monitoring 
supplier involvement in the last PPIS, and that payments for these 
services are derived from previously used supplemental survey data from 
the Association for Quality Imaging (AQI), blended with supplementary 
survey data from the American College of Radiology (ACR)--neither of 
which reflect indirect cost inputs for home PT/INR monitoring.
    Therefore, we are solicited comment from the public regarding the 
most accurate specialty crosswalk to use for indirect PE when it comes 
to home PT/INR monitoring services. We sought information on any 
additional costs associated with these services that are not reflected 
in our currently assigned PE/HR for independent diagnostic testing 
facilities, as well as which specialties would best capture these costs 
through the use of a crosswalk.
    We received public comments on our comment solicitation regarding 
the most accurate specialty crosswalk to use for indirect PE for home 
PT/INR monitoring services. The following is a summary of the comments 
we received and our responses.
    Comment: Several commenters stated that they had numerous concerns 
about the labor, supplies, equipment, and utilization associated with 
home PT/INR monitoring services. Commenters questioned why the typical 
clinical staff type for these services is an RN when 95 percent of 
Medicare claims for HCPCS code G0248 indicate that the service is 
instead furnished by the IDTF provider specialty. Commenters also 
questioned the clinical staff labor associated with HCPCS code G0249, 
as the commenters stated that they did not believe that an 
electrodiagnostic technologist is the appropriate clinical staff type 
since these technologists furnish cardiac event monitoring (CEM)-
related services, not PT/INR monitoring services. Commenters stated 
that they believed a patient education booklet is likely a duplicative 
supply item for HCPCS code G0248, as the patient is expected to have 
already received booklet(s) related to anticoagulation at previous 
physician visits, and a free booklet is also supplied with INR meters. 
Commenters also questioned the discrepancy between the description and 
billing rules for this code, which state that four tests are performed, 
and the supply details for this code, which include supplies for six 
tests. Commenters stated that CMS should decrease the minutes assigned 
to the home INR monitor (EQ031) equipment and questioned whether this 
frequency of physician review meets Medicare medical necessity criteria 
for all patients receiving such services. One commenter submitted a 
shipping invoice for the INR test strip (SJ055) supply.
    Response: We appreciate the additional information provided by the 
commenters regarding the direct PE inputs and claims data utilization 
for home PT/INR monitoring services. However, our comment solicitation

[[Page 84478]]

sought information regarding the most accurate specialty crosswalk to 
use for indirect PE as well as which specialties would best capture 
these costs through the use of a crosswalk. We did not propose to make 
revisions to the direct PE inputs or conduct a review of the Medicare 
claims data. Although we appreciate the information provided by the 
commenters, we are not finalizing any changes to the direct PE inputs 
for home PT/INR monitoring services. With regard to the shipping 
invoice for the INR test strip supply, we welcome the submission of 
invoices or other pricing information as part of our ongoing market-
based supply and equipment pricing update. However, this invoice listed 
the transportation costs of shipping the test strips and not the price 
of the test strips themselves, and as a result we were unable to make 
use of it.
    Comment: Many commenters stated that there were inherent 
differences between home PT/INR monitoring services and independent 
diagnostic testing facilities. Several commenters stated that given the 
significant changes to technology and associated decrease in costs 
since the IDTF PE/HR value was first developed, they believed that many 
of the indirect PE inputs originally recognized for IDTFs in 2007 no 
longer apply in 2020 and home PT/INR monitoring services should no 
longer be crosswalked to them. Several commenters stated that typical 
IDTF services include the use of large, capital-intensive equipment 
while home PT/INR monitoring services typically involve the use of 
equipment by a patient in his/her home, frequently intended for use for 
the remainder of the patient's life--more like a therapeutic device 
than a diagnostic one. Several commenters emphasized that PT/INR 
monitoring services are very different from typical imaging and 
scanning services provided by IDTFs, and because there are so few 
suppliers of home PT/INR monitoring services, the distribution of 
direct and indirect costs and the indirect practice cost index (IPCI) 
applied to IDTFs do not accurately reflect indirect resources expended 
by the specialty suppliers of home PT/INR monitoring.
    Several commenters provided feedback regarding the most accurate 
specialty crosswalk to use for indirect PE when it comes to home PT/INR 
monitoring services. Several commenters submitted data indicating that 
the direct to indirect cost percentages used to furnish home PT/INR 
monitoring are in the range of 31:69 rather than the approximately 
50:50 currently considered in determining the PE RVUs for these 
services as IDTFs. These commenters recommended a crosswalk to the 
Pathology or All Physicians specialty type based on the submitted data. 
One commenter stated that they were not equipped to say which specific 
indirect factors may be optimal for crosswalk due to a lack of 
information on direct and indirect cost data from the suppliers but did 
wish to highlight the importance of ensuring sure that home PT/INR 
monitoring rates are adequate to assure access. Several commenters 
stated that the payment rates for these services have fallen 
dramatically over the past several years and they were very concerned 
about the impact of these cuts on patient access to these critically 
important services.
    Response: We appreciate the detailed feedback from the commenters 
regarding home PT/INR monitoring services and especially the submission 
of data associated with the direct to indirect cost percentages. We 
also share the concerns of the commenters regarding maintaining access 
to care for these services. After consideration of the comments, we are 
finalizing a crosswalk to the General Practice specialty to use for 
indirect PE when it comes to home PT/INR monitoring services (HCPCS 
codes G0248, G0249, and G0250). The data submitted by the commenters 
indicated that the direct to indirect cost percentages to furnish home 
PT/INR monitoring are in the range of 31:69, similar to the ratio 
associated with the General Practice specialty. We also share the 
concerns of the commenters who were uncertain which specific indirect 
factors may be optimal for crosswalking due to a lack of information, 
and we believe that the broad nature of the General Practice specialty 
will serve as a more accurate proxy for home PT/INR monitoring services 
as opposed to trying to select a more specific specialty designation.
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 at 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. 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.
     Then, we incorporate the specialty-specific indirect PE/HR 
data into the calculation. In our example, if, based on the survey 
data, the average indirect

[[Page 84479]]

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 titled ``Calculation 
of PE RVUs under Methodology for Selected Codes'' which is available on 
our website under downloads for the CY 2021 PFS final rule at http://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 final 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.
    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 projected 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 
policy 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 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 
policy to apply these service-level overrides for both PE and MP, 
rather than one or the other category.
    We received public comments on the proposed list of expected 
specialty assignments for CY 2021. The following is a summary of the 
comments we received and our responses.
    Comment: One commenter stated that the 2021 expected specialty 
assignment for the low volume services code list included a number of 
services that were reassigned from cardiac surgery to thoracic surgery 
in CY 2020. The commenter identified these services and stated that 
they had concerns that CMS had erroneously assigned them as thoracic 
surgery procedures instead of cardiac surgery procedures. The commenter 
requested that CMS to correct the list and permanently assign the 
identified codes to the requested thoracic surgery specialty 
assignment.
    Response: We finalized a proposal in CY 2020 to update the expected 
specialty list to accurately reflect a previously finalized crosswalk 
to thoracic surgery for the services in question. As we stated at the 
time, we did not finalize a proposal to assign the codes in question to 
the cardiac surgery specialty. Instead, we finalized a proposal to 
update the incorrect

[[Page 84480]]

documentation in our expected specialty list to accurately reflect a 
previously finalized crosswalk to thoracic surgery for these services. 
The previously finalized assignment of the cardiac specialty to these 
services has been in place since the CY 2012 rule cycle, and we believe 
that the expected specialty list should be updated to reflect the 
correct specialty assignment. We did not propose to make further 
changes to the anticipated specialty assignment of these codes for CY 
2021 and we are not finalizing any changes. We direct readers to the 
discussion of this topic in the CY 2020 PFS final rule (84 FR 62574 
through 62578) and we reiterate again that we do not anticipate this 
finalized proposal having a discernible effect on the valuation of the 
affected codes due to the similarity between the cardiac surgery and 
thoracic surgery specialties.
    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 
titled ``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 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 and MP 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 1.

[[Page 84481]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.000

     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 2 details the manner in which the 
modifiers are applied.

[[Page 84482]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.001

    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 
final 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 below in this final 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 below in this final 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.
    We received public comments on equipment utilization rate 
assumptions. The following is a summary of the comments we received and 
our responses.
    Comment: Several commenters requested that CMS review the 
utilization assumptions for equipment due to decreased practice 
capacity during the public health emergency (PHE) for COVID-19. 
Commenters stated that equipment was used less frequently than normal 
and that this should be reflected in the equipment utilization rate. 
Commenters stated that any modifications to the equipment utilization 
during the public health emergency also should not be subject to budget 
neutrality.
    Response: We disagree with the commenters that utilization 
assumptions for equipment should be revisited as part of the public 
health emergency. While we agree that many services had a reduced 
volume of Medicare beneficiaries at times during the 2020 calendar 
year, we note that equipment costs under the PFS are amortized across 
the full useful life of the equipment which in the vast majority of 
cases is 5-10 years. We believe that it would distort relativity to 
apply a temporary decrease in utilization caused by the public health 
emergency to the pricing structure of the equipment's full useful life 
duration. We also note that we do not have statutory authority to 
exempt any modifications to the equipment utilization assumptions from 
budget neutrality calculations.
    Useful Life: In the CY 2005 PFS final rule we stated that we 
updated the useful life for equipment items primarily based on the 
AHA's ``Estimated Useful Lives of Depreciable Hospital Assets'' 
guidelines (69 FR 66246). The most recent edition of these guidelines 
was published in 2018. This reference material provides an estimated 
useful life for hundreds of different types of equipment, the vast 
majority of which fall in the range of 5 to 10 years, and none of which 
are lower than 2 years in duration. We believe that the updated 
editions of this reference material remain the most accurate source for 
estimating the useful life of depreciable medical equipment.
    In the CY 2021 PFS proposed rule, we noted that stakeholders 
including the RUC, specialty societies, and other commenters suggested 
a useful life of less than 1 year for several of the new equipment 
items for CY 2021, and as low as 3 months in one case. We have rarely, 
if ever, received requests for equipment useful life of less than one

[[Page 84483]]

year in duration and note that these very short useful life durations 
are significantly lower than anything in our current equipment 
database, and if finalized would represent major outliers when compared 
to the rest of the equipment. Table 3 details the distribution of 
useful life durations of the equipment currently in our database:
[GRAPHIC] [TIFF OMITTED] TR28DE20.002

    As Table 3 demonstrates, the vast majority of equipment items have 
a useful life duration of 5 to 10 years, and only 4 out of the 777 
equipment codes have a useful life duration of less than 3 years. We 
also noted that due to the formula used to calculate the equipment cost 
per minute, decreasing the useful life of any equipment item from 5 
years to 3 months has the same effect as increasing the price of the 
equipment 20 times over. In other words, decreasing the useful life 
from 5 years to 0.25 years has the same multiplicative effect as 
increasing the price of the equipment from $5,000 to 100,000 due to the 
formula listed above. Since we currently do not have any equipment 
items in our database with a useful life of less than one year, we 
proposed a clarification on how to address these cases.
    We disagreed that assigning a useful life at these very short 
durations would be typical for new equipment, especially in light of 
the data provided by the AHA's ``Estimated Useful Lives of Depreciable 
Hospital Assets'' reference. The equipment life durations listed in 
Table 3 were finalized over the last 15 years through the use of this 
reference material. We noted concerns that assigning very low useful 
life durations to equipment items would fail to maintain relativity 
with other equipment on the PFS, effectively assigning a much higher 
price than other equipment items with more typical useful life 
durations. We noted that we believe that equipment items with very low 
useful life durations represent outlier cases that are not handled 
appropriately by the current equipment methodology and which we 
clarified through this rulemaking. We also noted that the equipment 
cost per minute formula was designed under the assumption that each 
equipment item would remain in use for a period of several years and 
depreciate over that span of time. Our current equipment formula is not 
designed to address cases in which equipment is replaced multiple times 
per year, and we believe that applying a multi-year depreciation in 
these situations would not be reflective of market pricing. We noted 
that we did not believe that items which are replaced on a monthly 
basis can be accurately priced using a formula which assumes they will 
be in use for years at a time, and that the use of such a formula would 
distort relativity with the overwhelming majority of equipment items 
which are in use for 5-10 years.
    Therefore, we proposed to treat equipment life durations of less 
than 1 year as having a duration of 1 year for the purpose of our 
equipment price per minute formula. We noted that we believe that this 
is the most accurate way to incorporate these short equipment life 
durations within the framework of our current methodology. In the rare 
cases where items are replaced every few months, we noted that we 
believe that it is more accurate to treat these items as disposable 
supplies with a fractional supply quantity as opposed to equipment 
items with very short equipment life durations. For example, we 
proposed to establish the EECP compression equipment package (SD341) 
and the EECP electrical equipment package (SD342) as disposable 
supplies instead of equipment items as described in the Valuation of 
Specific Codes (section II.H. of this final rule) portion of the 
preamble. We noted that we expect these situations to occur only 
rarely, and we will evaluate them on an individual case-by-case basis. 
Our criteria will be based on whether or not the item in question could 
be more accurately classified as a disposable supply while maintaining 
overall relativity within our PE methodology. We welcomed additional 
comments from stakeholders regarding the subject of useful life 
durations for new equipment items with unique useful life durations as 
described above and any additional suggestions on alternative ways to 
incorporate these items into our methodology or potential wider changes 
to the equipment cost per minute formula more broadly.
    We received public comments on our proposals associated with 
equipment life duration. The following is a summary of the comments we 
received and our responses.
    Comment: A commenter stated that although they had asked CMS to use 
0.75 years as the useful life duration for the radionuclide rod source 
set (ER044) equipment, the commenter recognized that one year was in 
accordance with the CMS policy to treat equipment useful life durations 
of less than one year as having a duration of one year.
    Response: We appreciate the feedback from the commenter and the 
acknowledgment of our proposed policy.
    After consideration of the public comments, we are finalizing our 
proposal to treat equipment life durations of less than 1 year as 
having a duration of 1 year for the purpose of our equipment price per 
minute formula. In the rare cases where items are replaced every few 
months, we noted that we believe that it is more accurate to treat 
these items as disposable supplies with a fractional supply quantity as 
opposed to equipment items with very short equipment life durations.
     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 PFS 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

[[Page 84484]]

noted that we 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 noted that we did 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 a different maintenance factor, we did not 
propose a variable maintenance factor for equipment cost per minute 
pricing as we did not believe that we have sufficient information at 
present. We noted that we would 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). The Interest rates are listed in Table 4.
[GRAPHIC] [TIFF OMITTED] TR28DE20.003

    We did not propose any changes to the equipment interest rates for 
CY 2021.
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 2021 direct PE input public use files, which are 
available on the CMS website under downloads for the CY 2021 PFS final 
rule at http://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 through 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 post service 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 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'' and ``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 policy 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 policy 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 a series of clinical labor tasks associated with 
pathology services in the CY 2016 PFS final rule with comment period 
(80 FR 70902). We do not believe these activities would be dependent on 
number of blocks or batch size, and we believe that the finalized 
standard values accurately reflect the typical time it takes to perform 
these clinical labor tasks.

[[Page 84485]]

    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. We proposed 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. Commenters explained 
in response that when the new version of the PE worksheet introduced 
the activity codes for clinical labor, there was a need to translate 
old clinical labor tasks into the new activity codes, and that a prior 
clinical labor task was split into two of the new clinical labor 
activity codes: CA007 (Review patient clinical extant information and 
questionnaire) in the preservice period, and CA014 (Confirm order, 
protocol exam) in the service period. Commenters stated that the same 
clinical labor from the old PE worksheet was now divided into the CA007 
and CA014 activity codes, with a standard of 1 minute for each 
activity. We agreed with commenters that we would finalize the RUC-
recommended 2 minutes of clinical labor time for the CA007 activity 
code and 1 minute for the CA014 activity code in situations where this 
was the case. However, when reviewing the clinical labor for the 
reviewed codes affected by this issue, we found that several of the 
codes did not include this old clinical labor task, and we also noted 
that several of the reviewed codes that contained the CA014 clinical 
labor activity code did not contain any clinical labor for the CA007 
activity. In these situations, we continue to believe that in these 
cases the 3 total minutes of clinical staff time would be more 
accurately described by the CA013 ``Prepare room, equipment and 
supplies'' activity code, and we finalized these clinical labor 
refinements. For additional details, we direct readers to the 
discussion in the CY 2019 PFS final rule (83 FR 59463 and 59464).
    Following the publication of the CY 2020 PFS proposed rule, a 
commenter expressed concern with the published list of common 
refinements to equipment time. The commenter stated that these 
refinements were the formulaic result of the applying refinements to 
the clinical labor time and did not constitute separate refinements; 
the commenter requested that CMS no longer include these refinements in 
the table published each year. In the CY 2020 PFS final rule, we agreed 
with the commenter that that these equipment time refinements did not 
reflect errors in the equipment recommendations or policy discrepancies 
with the RUC's equipment time recommendations. However, we believed 
that it was important to publish the specific equipment times that we 
were proposing (or finalizing in the case of the final rule) when they 
differed from the recommended values due to the effect that these 
changes can have on the direct costs associated with equipment time. 
Therefore, we finalized the separation of the equipment time 
refinements associated with changes in clinical labor into a separate 
table of refinements. For additional details, we direct readers to the 
discussion in the CY 2020 PFS final rule (84 FR 62584).
    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 in previous calendar years, to facilitate 
rulemaking for CY 2021, 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 crosswalked to the 
new listing of clinical labor activity codes. These lists are available 
on the CMS website under downloads for the CY 2021 PFS final rule at 
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
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 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 PFS 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

[[Page 84486]]

prices for the equipment items related to scopes utilized by these 
services. 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 noted 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 the CY 2018 PFS proposed rule (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 PFS 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 was to create an 
administratively simple scheme that would be easier to maintain and 
help to reduce administrative burden. In 2018, the RUC convened a Scope 
Equipment Reorganization Workgroup to incorporate 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 delayed proposals for any further changes to scope 
equipment until CY 2020 in order to incorporate the feedback from the 
aforementioned workgroup.
(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, but we did propose and finalize the updated pricing for CY 
2019 to $36,306 along with changing the name of the ES031 equipment 
item 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.
(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 2020
    The Scope Equipment Reorganization Workgroup organized by the RUC 
submitted detailed recommendations to CMS for consideration in the CY 
2020 rule cycle, describing 23 different types of scope equipment, the 
HCPCS codes associated with each scope type, and a series of invoices 
for scope pricing. Based on the recommendations from the workgroup, we 
proposed to establish 23 new scope equipment codes. For the eight new 
scope equipment items where we received submitted invoices for pricing, 
we proposed to replace the existing scopes with the new scope equipment 
at the same amount of equipment time. This scope replacement involved 
approximately 100 HCPCS codes in total and was detailed in a table 
published in the CY 2020 PFS proposed rule (84 FR 40495 through 40498). 
We noted that we did not receive pricing information along with the 
workgroup recommendations for the other 15 new scope equipment items. 
Therefore, although we proposed to establish new equipment codes for 
these scopes, we did not propose to replace existing scope equipment 
with the new equipment items as we did for the other eight new scope 
equipment items for CY 2020.
    Following the publication of the CY 2020 PFS proposed rule, 
commenters provided additional information regarding pricing for the 
new scope equipment and their associated HCPCS

[[Page 84487]]

codes. Based on this information provided by the commenters, we 
finalized a price for eight additional new scope equipment items and 
finalized the replacement of the existing scopes with the new scope 
equipment at the same amount of equipment time for approximately two 
dozen additional HCPCS codes (84 FR 62593 through 62595). Table 5 lists 
the CY 2020 finalized price for the new scope equipment codes:
[GRAPHIC] [TIFF OMITTED] TR28DE20.004

    We noted that although we updated the scope equipment pricing for 
CY 2020 such that the ES087 and ES089 scopes shared the same price with 
the ES088 scope, and the ES090 scope shared the same price with the 
ES085 scope, we did not mean to suggest that these scopes that shared 
pricing were identical with one another. We assigned the same price to 
these scopes because they replaced the same current scope equipment 
codes, and because we did not have individual pricing information for 
them. We noted in the CY 2021 PFS proposed rule (85 FR 50087) that we 
remain open to the submission of additional invoices to establish 
individual pricing for these scopes, and we welcomed more data to help 
identify pricing for the remaining seven scope equipment codes that 
still lack invoices.
(5) Scope Proposals for CY 2021
    We did not receive further recommendations from the Scope Equipment 
Reorganization Workgroup organized by the RUC following the publication 
of the CY 2020 PFS final rule. However, we did receive invoices 
associated with the pricing of the scope video system (monitor, 
processor, digital capture, cart, printer, LED light) (ES031) equipment 
item as part of the review of the Esophagogastroduodenoscopy (EGD) with 
Biopsy and the Colonoscopy code families. We previously finalized a 
price of $36,306 for the ES031 equipment based on the sum of 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, $1,750 for the 
cart, $1,915 for the LED light, and $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.) We 
received 37 invoices associated with the components of the ES031 scope 
video system, which averaged out to prices of $21,988.89 for the 
processor, $16,175.87 for the digital capture device, $6,987.56 for the 
monitor, $7,922.80 for the printer, $4,945.45 for the cart, and 
$12,652.82 for the LED light. Based on the sum of these component 
prices, we proposed to update the price the ES031 scope video system 
equipment to $70,673.38. We did not propose to include an additional 
$1,000 to cover the expense of miscellaneous small equipment as the 
products listed on the component invoices indicated that cost of cables 
were already included in this significantly higher equipment pricing. 
We solicited additional comments from stakeholders regarding the 
pricing of the full ES031 scope equipment system as well as its 
components.
    As part of our market-based supply and equipment pricing 
transition, we finalized a policy in CY 2019 to phase in any updated 
pricing established during the 4-year transition period for very 
commonly used supplies and equipment that are included in 100 or more 
codes, even if invoices are provided as part of the formal review of a 
code family (83 FR 59473 through 59475). Because the ES031 scope 
equipment system is utilized by more than 250 HCPCS codes, we proposed 
to transition this pricing increase over the remaining 2 years of the 
pricing update,

[[Page 84488]]

such that the CY 2021 equipment price will be $53,489.69 before moving 
to its destination price of $70,673.38 in CY 2022. We noted that this 
transition policy also applies to the price of the suction machine 
(Gomco) (EQ235) equipment, which, although it is not a scope, is 
utilized by approximately 360 HCPCS codes, and therefore, is another 
example of this pricing transition policy. We proposed to transition 
the EQ235 pricing increase over the remaining 2 years of the pricing 
update, such that the CY 2021 equipment price would be $1,981.66 before 
moving to its destination price of $ $3,195.85 in CY 2022. As we stated 
previously, this policy was intended to minimize any potential 
disruptive effects during the pricing transition period due to the high 
number of services that make use of these very common supply and 
equipment items included in 100 or more HCPCS codes.
    We also received invoices for the colonoscopy videoscope (ES033) 
and gastroscopy videoscopy (ES034) as part of the review of the 
Esophagogastroduodenoscopy (EGD) with Biopsy and the Colonoscopy code 
families. We finalized the replacement of both of these scope equipment 
items in the CY 2020 PFS final rule (84 FR 62588 through 62590), 
replacing the colonoscopy videoscope (ES033) with the multi-channeled 
flexible digital scope, colonoscopy (ES086) equipment item and the 
gastroscopy videoscopy (ES034) with the multi-channeled flexible 
digital scope, esophagoscopy gastroscopy duodenoscopy (EGD) (ES087) 
equipment item. In both cases, the submitted invoices were nearly 
identical to the finalized prices for the ES086 ($38,058.81) and ES087 
($34,585.35) equipment. We believe that these invoices reinforce the 
prices finalized through rulemaking last year, and therefore, we did 
not propose to further update the prices of these scopes.
    We noted that we remain open to further comments regarding the 
pricing of the remaining seven scope equipment codes that still lack 
invoices, as well as additional data regarding the pricing of the scope 
equipment codes that currently share the same price.
    We received public comments on our proposals associated with 
equipment recommendations for scope systems. The following is a summary 
of the comments we received and our responses.
    Comment: Several commenters thanked CMS for updating the prices of 
the scope video system (ES031) and Gomco suction machine (EQ235) to 
reflect the submitted invoices. Commenters stated that they supported 
the proposed transition in price increase for both pieces of equipment 
over the remaining 2 years of the pricing update and supported the 
ES031 price update to correctly account for the cost of the various 
components included in this scope video system.
    Response: We appreciate the support for our proposals from the 
commenters.
    Comment: A commenter stated that although they appreciated CMS's 
efforts to ensure the accuracy of the inputs for scope equipment, the 
price inputs for scope video systems do not capture all of the costs 
needed for near infrared fluorescence visualization with 4K monitors. 
The commenter stated that the actual cost of these processor, monitor, 
and digital capture device components are 45 to 97 percent higher than 
current CMS prices. The commenter encouraged CMS to seek additional 
price inputs for this newer technology and planned to submit invoices 
to demonstrate the costs related to the near infrared fluorescence 
scope video price inputs.
    Response: We appreciate the feedback from the commenter regarding 
the costs associated with new technology being incorporated into scope 
video systems and we look forward to the submission of invoices or 
other data sources with additional pricing information. However, in the 
absence of information demonstrating these additional costs, we will 
continue to maintain our current scope pricing.
    Comment: A commenter submitted invoices associated with three of 
the eight scope equipment items that still lacked a price: The 
cystoscopy rigid scope (ES070), the cystoscopy channeled flexible 
digital scope (ES081), and the hysteroscopy channeled flexible digital 
scope (ES082). The commenter stated that these invoices were 
representative of national pricing for these scopes and compiled a list 
of procedures associated with these scopes. This procedure list 
submitted by the commenter also included the hysteroscopy rigid scope, 
channeled (ES071) equipment item which was previously priced in CY 
2020.
    Response: We appreciate the additional pricing information 
submitted by the commenter in helping us assign a price to the 
remaining scope equipment codes. Based on this information, we are 
finalizing a price of $7,270.00 for the rigid scope, cystoscopy (ES070) 
equipment, a price of $22,274.36 for the channeled flexible digital 
scope, cystoscopy (ES081) equipment, and a price of $19,081.82 for the 
channeled flexible digital scope, hysteroscopy (ES082) equipment. When 
added to the previously finalized prices for the other scope equipment 
items from CY 2020, the total list is shown in Table 6.

[[Page 84489]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.005

    With regard to the procedure list submitted by the commenter, we 
are not finalizing the replacement of any current scope equipment with 
the new scope equipment codes. We did not propose to make any such 
replacements in the proposed rule and we had reservations about some of 
the procedures on the submitted list, which included CPT codes that 
currently do not contain scopes or any direct PE inputs at all in some 
cases. We appreciate the submission of this additional information from 
the commenter and we will consider the procedure list for potential use 
in future rulemaking.
    After consideration of the public comments, we are finalizing our 
proposal to update the price the ES031 scope video system equipment to 
$70,673.38 along with our proposed update to the price of the suction 
machine (Gomco) (EQ235) equipment. We are also finalizing the price for 
the three new scope equipment items as detailed above.
c. Technical Corrections to Direct PE Input Database and Supporting 
Files
    For CY 2021, we proposed to address the following inconsistencies:
     Following the publication of the CY 2020 PFS final rule, 
stakeholders contacted CMS and clarified that CPT code 0466T (Insertion 
of chest wall respiratory sensor electrode or electrode array, 
including connection to pulse generator) is always performed on an add-
on basis and would never be used as a standalone code. Therefore, we 
proposed to update the global period for CPT code 0466T to add-on 
status (ZZZ) to more accurately reflect the way in which this service 
is performed.
    We received public comments on the technical corrections to direct 
PE input database and supporting files. The following is a summary of 
the comments we received and our responses.
    Comment: A commenter stated that they supported the proposed change 
to the global period of CPT code 0466T and agreed that this technical 
correction was appropriate.
    Response: We appreciate the support for our proposal from the 
commenter.
    Comment: Several commenters stated that in the direct PE inputs for 
CPT code 33202 (Insertion of epicardial electrode(s); open incision 
(e.g., thoracotomy, median sternotomy, subxiphoid approach)), there are 
two tables listed under the equipment inputs: An exam table (EF023) and 
a power table (EF031). Commenters stated that spreadsheet information 
from CPT 2007 listed a power table and an exam light for this service, 
not an exam table. Commenters stated that it seemed likely that this 
was an accidental data entry error and requested that the equipment 
inputs for CPT code 33202 be corrected in the CMS equipment database to 
include a power table and exam light.
    Response: We agree with the commenters that this was likely a data 
entry error confusing the exam light with the exam table. Based on the 
information supplied by the commenters, we are finalizing the 
replacement of the exam table with an exam light (EQ168) at the same 
equipment time of 36 minutes for CPT code 33202.
    Comment: Several commenters stated that in the 2020 CMS direct PE 
inputs supplies listing, the ``unit'' type is missing for the skin prep 
barrier wipes (SM029) supply. Commenters stated that although this 
omission does not affect pricing, it makes it ambiguous what the units 
mean and could have an unintended impact if there are multiple 
different possible unit types, such as a liquid, where it would be 
unclear if it were ounces, milliliters, or something else. Commenters 
recommended that each supply item in the CMS database should have a 
unit type and provided a list of the supply items in the CY 2020 PFS 
final rule that were missing a unit type, with potential unit type 
suggestions for each item.

[[Page 84490]]

    Response: We agree with the commenters that each supply item in the 
CMS database should include a unit type in order to avoid potential 
confusion regarding pricing. We are finalizing the addition of the unit 
types as listed in Table 7.
[GRAPHIC] [TIFF OMITTED] TR28DE20.006

    All of the supply items in the CMS database should now include a 
unit type with the additions from this list. We note that we did not 
add a unit type for the ``No Supplies'' (SX007) category as the 
commenter requested since this is not a supply item.
    Comment: Several commenters questioned the proposed RVUs associated 
with several occupational therapy evaluation procedures (CPT codes 
97165-97167). Commenters stated that the PE valuation for these codes 
appeared to be illogical, with the proposed valuation of the codes 
demonstrating an inverse relationship between PE value and complexity. 
Commenters stated that it was counterintuitive for the PE RVU to go 
down as the level of complexity increased. Commenters stated that the 
distribution of code usage has not changed in any manner to justify a 
reduction in the code values and that all three evaluation codes should 
reimburse at the same rate.
    Response: We appreciate the commenters bringing this issue to our 
attention. However, although we agree with the commenters that the 
proposed valuation of these services is somewhat illogical, we do not 
agree that their proposed valuation represents a technical error. 
Although the three codes in question share the same work RVU and the 
same direct PE inputs, they do not share the same specialty 
distribution in the claims data and therefore will not necessarily 
receive the same allocation of indirect PE. In response to the 
comments, we are implementing a technical change which should ensure 
that these three services receive the same allocation of indirect PE.
    Following the publication of the proposed rule, we also discovered 
a technical error in the published RVUs for three HCPCS codes. Code 
G0102 (Prostate cancer screening; digital rectal examination) was 
assigned the same value as CPT code 99211, the lowest level E/M 
service, in the CY 2000 PFS final rule (64 FR 59414). Code G0102 was 
assigned a work RVU of 0.17 which matched the work RVU of CPT code 
99211 at the time. However, when we increased the work RVU for CPT code 
99211 to 0.18 in CY 2010 as part of the last E/M revalution, the work 
RVU for HCPCS code G0102 was not increased to match. We are correcting 
this technical oversight by finalizing an increase in the work RVU of 
code G0102 from 0.17 to 0.18 to match the previously finalized 
crosswalk to CPT code 99211.
    We also previously finalized and valued in the CY 1998 PFS final 
rule (62 FR 59082) the following two G codes for use when a barium 
enema is being substituted for either a screening sigmoidoscopy or 
screening colonoscopy: HCPCS codes G0106 (Colorectal cancer screening; 
alternative to G0104, screening sigmoidoscopy, barium enema) and G0120 
(Colorectal cancer screening; alternative to G0105, screening 
colonoscopy, barium enema). We established the same RVUs for these 
screening G codes as for the diagnostic barium enema procedure, CPT 
code 74280 (Radiologic examination, colon, including scout abdominal 
radiograph(s) and delayed image(s), when performed; double-contrast 
(e.g., high density barium and air) study, including glucagon, when 
administered). The work RVU for codes G0106 and G0120 has matched the 
work RVU for CPT code 74280 for the last two decades; however, we 
reviewed CPT code 74280 last year and, in the CY 2020 PFS final rule, 
increased the work RVU for CPT code 74280 to 1.26. Through an 
oversight, we did not make corresponding changes in the work RVUs for 
HCPCS codes G0106 and G0120. We are therefore correcting this technical 
oversight by finalizing an increase in the work RVU for HCPCS codes 
G0106 and G0120 to match the previously finalized crosswalk to CPT code 
74280.
    After consideration of the public comments, we are finalizing our 
proposals along with the additions as detailed above.

[[Page 84491]]

d. 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 2021, 
we proposed to update the price of one supply and four equipment items 
in response to the public submission of invoices. As these pricing 
updates were each part of the formal review for a code family, we 
proposed that the new pricing take effect for CY 2021 for these items 
instead of being phased in over 4 years. These supply and equipment 
items with updated prices associated with the formal review of a code 
family are listed in the valuation of specific codes section of the 
preamble under Table 31: CY 2021 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) (Pub. L. 113-93, enacted April 1, 2014) 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, 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 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 final rule at http://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).
     The Federal Register, current DPEI data, historical 
proposed and final rules prior to CY 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 no data were available for commercial products, the current 
CMS prices were used as the RP.
    GSA prices were not used to calculate the StrategyGen recommended 
prices, due to our concern that the GSA system curtails the number and 
type of suppliers whose products may be accessed on the GSA Advantage 
website, and that the GSA prices may often be lower than prices that 
are available to non-governmental purchasers. After reviewing the 
StrategyGen report, we proposed to adopt the updated direct PE input 
prices for supplies and equipment as recommended by StrategyGen.
    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 indicated 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 would experience increases or 
decreases in their Medicare payments if we 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 RVU reduction for codes that are not new or revised to 19 
percent in any individual calendar year.
    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, in the CY 2019 PFS proposed rule we proposed 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-

[[Page 84492]]

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 proposed 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 proposed 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 transition from the current 
to the fully-implemented new pricing is provided in Table 8.
[GRAPHIC] [TIFF OMITTED] TR28DE20.007

    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 proposed 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 also 
proposed 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 proposed 
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 proposed 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 also proposed to phase in any 
updated pricing we establish during the 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 was 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 believed that implementing the proposed updated prices with a 4-
year phase-in would 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 timeframe will allow more opportunities for public 
comment and submission of additional, applicable data. We welcomed 
feedback from stakeholders on the proposed updated supply and equipment 
pricing, including the submission of additional invoices for 
consideration.
    We received many comments regarding the market-based supply and 
equipment pricing proposal following the publication of the CY 2019 PFS 
proposed rule. For a full discussion of these comments, we direct 
readers to the CY 2019 PFS final rule (83 FR 59475 through 59480). In 
each instance in which a commenter raised questions about the accuracy 
of a supply or equipment code's recommended price, the StrategyGen 
contractor conducted further research on the item and its price with 
special attention to ensuring that the recommended price was based on 
the correct item in question and the clarified unit of measure. Based 
on the commenters' requests, the StrategyGen contractor conducted an 
extensive examination of the pricing of any supply or equipment items 
that any commenter identified as requiring additional review. Invoices 
submitted by multiple commenters were greatly appreciated and ensured 
that medical equipment and supplies were re-examined and clarified. 
Multiple researchers reviewed these specified supply and equipment 
codes for accuracy and proper pricing. In most cases, the contractor 
also reached out to a team of nurses and their physician panel to 
further validate the accuracy of the data and pricing information. In 
some cases, the pricing for individual items needed further 
clarification due to a lack of information or due to significant 
variation in packaged items. After consideration of the comments and 
this additional price research, we updated the recommended prices for 
approximately 70 supply and equipment codes identified by the 
commenters. Table 9 in the CY 2019 PFS final rule lists the supply and 
equipment codes with price changes based on feedback from the 
commenters and the resulting additional research into pricing (83 FR 
59479 through 59480).
    After consideration of the public comments, we finalized our 
proposals

[[Page 84493]]

associated with the market research study to update the PFS direct PE 
inputs for supply and equipment pricing. We continue to 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. We continue to welcome 
feedback from stakeholders on the proposed updated supply and equipment 
pricing, including the submission of additional invoices for 
consideration.
    For CY 2021, we received invoice submissions for approximately a 
dozen supply and equipment codes from stakeholders as part of the third 
year of the market-based supply and equipment pricing update. The 
submitted invoices were used in many cases to supplement the pricing 
originally proposed for the CY 2019 PFS rule cycle. We reviewed the 
invoices, as well as prior data for the relevant supply/equipment codes 
to make sure the item in the invoice was representative of the supply/
equipment item in question and aligned with past research. Based on 
this research, we proposed to update the prices of the supply and 
equipment items listed in Table 7 of the CY 2021 PFS proposed rule.
    We finalized a policy in CY 2019 to phase in the new supply and 
equipment pricing over 4 years so that supply and equipment values 
transition smoothly from their current prices to the final updated 
prices in CY 2022. We finalized our proposal to implement this pricing 
transition such that one quarter of the difference between the current 
price and the fully phased in price was 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 
transition from the current to the fully-implemented new pricing is 
provided in Table 8. For CY 2021, one half of the difference between 
the CY 2020 price and the final price will be implemented as per the 
previously finalized policy. Table 9 contains the list of proposed CY 
2021 market-based supply and equipment pricing updates:
[GRAPHIC] [TIFF OMITTED] TR28DE20.008

    The prices for the supply and equipment items listed in Table 9 
were calculated based on averaging together the prices on the submitted 
invoices. In the case of the vascular sheath (SD136) and RF endovenous 
occlusion catheter (SD155) supplies, the price was determined by 
removing the sheath or catheter from the eight submitted kit invoices 
and then averaging the resulting price together with the single 
standalone sheath/catheter invoice.
    In addition to submitting invoices with information updating the 
price of the ``Vmax 22d and 62j (PFT equip, autobox, computer system)'' 
(EQ041) equipment, stakeholders also clarified that the ``Vmax 229 
(spirometry testing equip, computer system)'' (EQ040) and ``Vmax 29s 
(spirometry testing equip, computer system)'' (EQ043) equipment items 
have become obsolete and are no longer typically used in any HCPCS 
codes. Based on the information supplied by the stakeholders, we 
proposed to remove the EQ040 and EQ043 equipment items, replacing them 
with the EQ041 equipment at the same number of minutes in the six HCPCS 
codes where they are utilized.
    We did not propose to update the price of additional supply and 
equipment items for which invoices were submitted following the 
publication of the CY 2020 PFS final rule. We did not propose to update 
the price for the ``pipette, transfer 23ml'' (SL109), ``slide specimen 
mailer (1-5 microscope slides)'' (SL121), ``stain, hematoxylin'' 
(SL135), ``stain, eosin'' (SL201), and ``stain, PAP OG-6'' (SL491) 
supplies. In each case we received a single invoice for these five 
supplies detailing price increases ranging from 82 percent to 160 
percent above the current pricing. These supplies are commonly used in 
cytopathology procedures and we disagree that the typical price for 
these supplies has more than doubled since being reviewed by the 
StrategyGen contractor 2 years ago for CY 2019.
    We also did not propose to update the price for the ``embedding 
mold'' (SL060) supply or the ``microscope, compound'' (EP060) equipment 
based on the same rationale. The submitted invoices represent pricing 
increases of 339 percent for the compound microscope and 7800 percent 
for the embedding mold and, based on the recent review of the pricing 
of these items by our contractor, we do not believe that the submitted 
invoices reflect typical market-based pricing. The same stakeholder 
also submitted an invoice to update the price of the surgical mask 
(SB033) supply by 617 percent over the current price. However, the 
invoice in question contains the price for a surgical mask with face 
shield, which is described by the SB034 supply code, not the SB033 
supply code. Therefore, we did not propose to update the price of the 
surgical mask (SB033) supply based on this invoice. Finally, we 
received an invoice for a ClosureFast Procedure Pack (CFP) but it was 
unclear

[[Page 84494]]

what supply or equipment item this invoice was intended to update. As a 
result, we noted in the CY 2021 PFS proposed rule that we were unable 
to use this invoice to make a pricing proposal.
    We received public comments on the market-based supply and 
equipment pricing update. The following is a summary of the comments we 
received and our responses.
    Comment: Several commenters stated that they continued to support 
the engagement from the agency to work with CMS contractors and 
stakeholders to incorporate current pricing data based on invoices into 
the calculation of direct PE cost. Commenters stated that bringing in 
an outside vendor in addition to accepting invoices from stakeholders 
was a reasonable approach, and that the incorporation of this new data 
and the process for determining what is accepted and what is rejected 
should be done in a transparent manner. Several different commenters 
urged CMS to be more deliberate and transparent about this decision-
making process regarding supply and equipment pricing.
    Response: We appreciate the feedback from the commenters and share 
the desire for transparency in pricing. We continue to believe that it 
is important to make use of the most current information available for 
supply and equipment pricing through the use of market-based research, 
and we agree with the need to explain the rationale behind the adoption 
or rejection of invoices submitted by stakeholders. We routinely accept 
public submission of invoices as part of our process for developing 
payment rates for new, revised, and potentially misvalued codes. We 
consider invoices submitted as public comments during the comment 
period following the publication of the PFS proposed rule, and would 
consider any invoices received after February 10th or outside of the 
public comment process as part of our established annual process for 
requests to update supply and equipment prices. Stakeholders are 
encouraged to submit invoices as part of their public comments or, if 
outside the public comment process, via email at 
[email protected].
    Comment: A commenter stated that they supported the proposed 
pricing for the UroVysion test kit (SA105) supply. The commenter stated 
that establishing a price that is in line with invoice pricing ensures 
that reimbursement for the service reflects accurately the cost of 
resources involved in providing the service.
    Response: We appreciate the support for our proposed pricing from 
the commenter.
    Comment: A commenter disagreed with the proposed pricing of the 
lysing reagent (FACS) (SL089) supply. The commenter submitted six 
invoices for the supply and requested that CMS use them to update the 
pricing.
    Response: We appreciate the submission of these additional invoices 
for use in pricing the SL089 supply. Therefore, we are finalizing an 
update in the price of this supply to $3.645 as indicated on the 
submitted invoices. As part of our ongoing pricing transition, the CY 
2021 price of the supply will be $3.764 before reaching the finalized 
price of $3.645 in CY 2022.
    Comment: One commenter disagreed with the proposed pricing of the 
radiofrequency introducer kit (SA026). The commenter stated that 
although some vendors now include this supply in an overall catheter 
pack, it is still common that many practices purchase this item 
separately. The commenter submitted two invoices for the supply and 
requested that CMS use them to update the pricing.
    Response: We appreciate the submission of these additional invoices 
for use in pricing the SA026 supply. Therefore, we are finalizing an 
update in the price of this supply to $28.575 based on an average of 
the prices on the two submitted invoices. As part of our ongoing 
pricing transition, the CY 2021 price of the SA026 supply will be 
$32.83 before reaching the finalized price of $28.575 in CY 2022.
    Comment: Several commenters disagreed with the proposed pricing of 
the hydrophilic guidewire (SD089) supply. Commenters stated that $27.76 
would be a more appropriate reimbursement rate and submitted an invoice 
in support of their suggested pricing.
    Response: We appreciate the submission of these additional invoices 
for use in pricing the SD089 supply. We noted that the guidewire on the 
newly submitted invoice was a different size than the guidewire on the 
invoice that we previously used for pricing the SD089 supply. Since we 
do not have information currently available as to which of these 
guidewires would be more typical, we are averaging together the two 
submitted invoices for a price of $20.555. As part of our ongoing 
pricing transition, the CY 2021 price of the SD089 supply will be 
$29.995 before reaching the finalized price of 20.555 in CY 2022.
    Comment: A commenter disagreed with the proposed pricing of the 
endovascular laser treatment kit (SA074). The commenter stated that 
they were not sure that the proposed pricing was typical for the 
average clinic due to the economy of scale advantages available for 
larger providers. The commenter submitted three invoices for the supply 
and requested that CMS use them to update the pricing.
    Response: We appreciate the submission of these additional invoices 
for use in pricing the SA074 supply. The unit prices on the three 
submitted invoices were $431.08 (for a pack of five), $438.60 (for a 
pack of two), and $535.60 for an individual supply. The price for the 
individual endovascular laser treatment kit was significantly higher 
than the other invoice prices and we believe that this price would not 
be typical in light of the other pricing data that we have available. 
Therefore, we are finalizing an update in the price of this supply to 
$438.60 based on taking the median of the submitted invoices which we 
believe to be more representative of typical pricing. As part of our 
ongoing pricing transition, the CY 2021 price of the SA074 supply will 
be $429.88 before reaching the finalized price of $438.60 in CY 2022.
    Comment: A commenter disagreed with the proposed pricing of the 
tubing set (Liposorber) (SC083) and plasma separator (Liposorber) 
(SD188) supplies. The commenter stated that the proposed prices did not 
accurately reflect the actual average prices paid by their U.S. 
provider customers. The commenter submitted 45 invoices for the two 
supplies and requested that CMS use them to update the pricing.
    Response: We appreciate the submission of this large quantity of 
additional invoices for use in pricing the SC083 and SD188 supplies. 
After reviewing the invoices, we agree with the commenter that the 
average sales price matches the numbers listed in their comment letter. 
Therefore, we are finalizing an update in the price of the SC083 supply 
to $75.71 and an update in the price of the SD188 supply to $131.42 as 
indicated on the submitted invoices. As part of our ongoing pricing 
transition, the CY 2021 price of the SC083 supply will be $62.28 and 
the CY 2021 price of the SD188 supply will be $113.04 before reaching 
their finalized prices in CY 2022.
    Comment: Several commenters disagreed with the proposed pricing for 
the RF endovenous ablation catheter (SD 155) and the vascular sheath 
(SD 136) supplies. Commenters stated that the proposed prices did not 
reflect the reality of their practice's economics and expressed concern 
that such reductions could encourage office-based physicians to curtail 
or cease performing these

[[Page 84495]]

procedures. Commenters stated that the proposed pricing for RF 
catheters and sheaths represented the price being paid by high-volume 
or large multi-location practices and did not reflect the prices paid 
by smaller providers who are more typical. Due to the greater 
negotiating power and high volume discounts available to larger 
practices, commenters stated that the proposed supply pricing did not 
seem be to what typical providers pay and that the current pricing of 
$52.80 was more representative for the vascular sheath. One commenter 
requested a more thorough review of the data CMS used to determine the 
updated pricing for the SD136 and SD155 supplies as well as the 
opportunity to provide additional data to validate their pricing. 
Several commenters submitted a series of invoices for the RF endovenous 
occlusion catheter (SD155) that they stated were more typical of 
pricing and urged CMS to update the supply pricing accordingly.
    Response: We appreciate the additional information provided by the 
commenters regarding the pricing of these supplies, especially the 
invoices with additional pricing data for the SD155 catheter. The 
commenters are correct that the proposed pricing for the SD155 supply 
was based in part on a bulk order and that ordering the catheters on an 
individual basis resulted in higher prices. However, we do not agree 
that it would be accurate to base the pricing of the SD155 supply 
solely on the basis of individual orders with no discounts included, as 
it is clear from the submitted invoices that there exists a variety of 
discounts available for providers. Therefore, we are averaging together 
the newly submitted invoices together with our previous invoices for 
the SD155 supply and finalizing the resulting price of $487.92. As part 
of our ongoing pricing transition, the CY 2021 price of the supply will 
be $562.71 before reaching the finalized price of $487.92 in CY 2022.
    We did not receive any invoices with updated pricing information 
for the vascular sheath (SD136) supply. In the absence of additional 
information, we believe that the proposed price for the vascular sheath 
accurately reflects the cost of this supply and we are finalizing the 
proposed price of $24.44. We continue to welcome the submission of 
invoices with additional information regarding the pricing of these two 
or any other supply items.
    Comment: Several commenters stated that they believe the HDR 
Afterload System, Nucletron--Oldelft (ER003) and the SRS System, SBRT, 
Six Systems (ER083) equipment items remain significantly undervalued 
relative to fair market pricing. The commenters stated that it was 
imperative for CMS equipment pricing to accurately reflect marketplace 
pricing given the high cost of these items and their substantial 
utilization in certain radiation oncology delivery codes. One commenter 
stated that the pricing for this equipment may represent a less costly 
electronic brachytherapy system used to treat skin cancer or an 
equipment upgrade or refurbished equipment. The commenters requested 
that CMS conduct additional research regarding fair and accurate market 
pricing for these two equipment items and accept newly submitted 
invoices during the 60-day comment period. One commenter requested a 
one-year moratorium on phasing in the StrategyGen revised pricing 
inputs and maintain all direct PE inputs at 2020 levels.
    Response: We share the desire of the commenter for fair and 
accurate market-based pricing for these two equipment items. However, 
both of these equipment items were priced based on research conducted 
by our StrategyGen contractor and then were updated in response to 
additional information supplied by commenters in the CY 2019 PFS final 
rule (83 FR 59478-59479). In the absence of additional information, we 
believe that the current prices accurately reflect the cost of these 
equipment items. We continue to welcome the submission of invoices with 
additional information regarding the pricing of these two or any other 
equipment items. We also note that the ongoing market-based supply and 
equipment pricing update was previously finalized in CY 2019 rulemaking 
and we do not agree that a one-year moratorium on the continuing 
pricing transition would facilitate our goal of ensuring current 
pricing.
    After consideration of the public comments, we are finalizing our 
proposals associated with the market-based supply and equipment pricing 
update as detailed above. Table 10 contains the list of finalized CY 
2021 market-based supply and equipment pricing updates:

[[Page 84496]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.009

(2) Invoice Submission
    The full list of updated supply and equipment pricing as it will be 
implemented over the 4-year transition period will be made available as 
a public use file displayed on the CMS website under downloads for the 
CY 2021 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    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. 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 will consider invoices submitted as public 
comments during the comment period following the publication of the PFS 
proposed rule, and would consider any invoices received after February 
10th or outside of the public comment process as part of our 
established annual process for requests to update supply and equipment 
prices. Stakeholders are encouraged to submit invoices as part of their 
public comments or, if outside the public comment process, via email at 
[email protected].
(3) Updated Supply Pricing for Venous and Arterial Stenting Services
    Following the publication of the CY 2020 PFS final rule, 
stakeholders contacted CMS and presented additional information 
regarding supply pricing for certain venous and arterial stenting 
services. These stakeholders stated that the use of the ``stent, 
vascular, deployment system, Cordis SMART'' (SA103) supply was no 
longer typical in CPT codes 37238 (Transcatheter placement of an 
intravascular stent(s), open or percutaneous, including radiological 
supervision and interpretation and including angioplasty within the 
same vessel, when performed; initial vein) and 37239 (Transcatheter 
placement of an intravascular stent(s), open or percutaneous, including 
radiological supervision and interpretation and including angioplasty 
within the same vessel, when performed; each additional vein). The 
stakeholders stated that a new venous stent system had become the 
typical standard of care for these services, and they supplied ten 
invoices for use in pricing this supply.
    The stakeholders also requested additional information regarding 
the nature of the ``stent, balloon, implantable'' (SD299) supply 
included in CPT codes 37236 (Transcatheter placement of an 
intravascular stent(s) (except lower extremity artery(s) for occlusive 
disease, cervical carotid, extracranial vertebral or intrathoracic 
carotid, intracranial, or coronary), open or percutaneous, including 
radiological supervision and interpretation and including all 
angioplasty within the same vessel, when performed; initial artery) and 
37237 (Transcatheter placement of an intravascular stent(s) (except 
lower extremity artery(s) for occlusive disease, cervical carotid, 
extracranial vertebral or intrathoracic carotid, intracranial, or 
coronary), open or percutaneous, including radiological supervision and 
interpretation and including all angioplasty within the same vessel, 
when performed; each additional artery). The stakeholders specifically 
were unclear what the implantable stent balloon represented and sought 
guidance on whether pricing involved a stent, a balloon, or a 
combination of both.
    In response to the additional information provided by the 
stakeholders, we proposed to remove the SA103 supply item from CPT 
codes 37238 and 37239. We proposed to replace it with a newly created 
``venous stent system'' (SD340) supply at the same supply quantity. We 
proposed a price of $1,750.00 for the venous stent system based on the 
median price of the ten invoices supplied by the stakeholders. We 
proposed the use of the median price due to the presence of several 
invoices that appear to be outliers, which are not reflective of

[[Page 84497]]

market pricing for the venous stent system. With regards to the request 
for additional information regarding the nature of the ``stent, 
balloon, implantable'' (SD299) supply, the original invoice used to 
price this supply during the CY 2015 rule cycle listed an item named 
``Renal and Biliary Stent System 7.0 mm x 15 mm x 135 cm''. We welcomed 
additional information from stakeholders regarding the nature and 
pricing of this supply item.
    We received public comments on our proposals associated with 
updated supply pricing for venous and arterial stenting services. The 
following is a summary of the comments we received and our responses.
    Comment: Several commenters stated that they supported the proposed 
change to replace the stent for CPT codes 37238 and 37239. One 
commenter stated that they appreciated the additional information on 
the two CPT codes and looked forward to researching this issue further.
    Response: We appreciate the support for our proposals from the 
commenters.
    After consideration of the public comments, we are finalizing our 
proposals associated with updated supply pricing for venous and 
arterial stenting services.
(4) Myocardial PET Equipment Inputs
    Following the publication of the CY 2020 PFS final rule, 
stakeholders contacted CMS and presented additional information 
regarding the direct PE inputs for several codes associated with 
Myocardial PET services. The stakeholders stated that the nuclide rod 
source set (ER044) equipment was inadvertently excluded from the direct 
PE recommendations for CPT codes 78432 (Myocardial imaging, positron 
emission tomography (PET), combined perfusion with metabolic evaluation 
study (including ventricular wall motion[s] and/or ejection 
fraction[s], when performed), dual radiotracer (eg, myocardial 
viability)), 78459 (Myocardial imaging, positron emission tomography 
(PET), metabolic evaluation study (including ventricular wall motion[s] 
and/or ejection fraction[s], when performed), single study)), 78491 
(Myocardial imaging, positron emission tomography (PET), perfusion 
study (including ventricular wall motion[s] and/or ejection 
fraction[s], when performed); single study, at rest or stress (exercise 
or pharmacologic)), and 78492 (Myocardial imaging, positron emission 
tomography (PET), perfusion study (including ventricular wall motion[s] 
and/or ejection fraction[s], when performed); multiple studies at rest 
and stress (exercise or pharmacologic)), and requested that CMS add 
this equipment to the direct inputs for this group of CPT codes. The 
stakeholders also stated that the current useful life of 5 years for 
the ER044 equipment was incorrect as these sources are replaced every 9 
months to 1 year. The stakeholders requested that CMS update the useful 
life of ER044 to 0.75 years. Finally, the stakeholders stated that the 
costs for the purchase of the Rubidium PET Generator (ER114) equipment 
are captured elsewhere through the billing of HCPCS supply code A9555, 
and the stakeholders recommended that we remove equipment item ER114 to 
avoid incorrect billing duplication.
    We noted that we appreciate the additional information submitted by 
the stakeholders regarding the direct PE inputs for these Myocardial 
PET services. In response to this new information, we proposed to 
update the price for the nuclide rod source set (ER044) equipment to 
$2,081.17 based on averaging together the price of the three submitted 
invoices after removing the shipping and delivery costs according to 
our standard pricing methodology. We also proposed to add the ER044 
equipment to CPT codes 78432, 78459, 78491, and 78492 as requested, 
assigning the same equipment time utilized by the ``PET Refurbished 
Imaging Cardiac Configuration'' (ER110) equipment in each service. We 
proposed to update the useful life of the ER044 equipment to one year 
in accordance with our proposed policy to treat equipment useful life 
durations of less than 1 year as having a duration of one year. As we 
stated previously in section II.B, we have concerns that assigning very 
low useful life durations of less than 1 year would fail to maintain 
relativity with other equipment on the PFS, and the equipment cost per 
minute formula was designed under the assumption that each equipment 
item would remain in use for a period of several years and depreciate 
over that span of time. We direct readers to the previous discussion 
regarding equipment cost per minute methodology earlier in section 
II.B. of this final rule. Finally, we are removing the ``PET Generator 
(Rubidium)'' (ER114) equipment from our database as requested by the 
stakeholders. We noted that since the technical components for CPT 
codes 78432, 78459, 78491, and 78492 are all contractor-priced, there 
will be no change to the national pricing of these codes.
    We received public comments on our proposals associated with 
Myocardial PET equipment inputs. The following is a summary of the 
comments we received and our responses.
    Comment: Several commenters stated that they agreed with and 
supported all four of the CMS proposals associated with Myocardial PET 
equipment inputs. Commenters also stated that they supported the 
decision to maintain contractor pricing for the technical components 
for all the new and revised Myocardial PET codes. Commenters stated 
that the standard CMS formula and RUC PE inputs do not allow for 
certain high-cost expenses that are generally part of overhead to be 
factored into the RVUs and requested that contractor pricing continue 
to be maintained for these services.
    Response: We appreciate the support for our proposals from the 
commenters.
    After consideration of the public comments, we are finalizing our 
proposals associated with Myocardial PET equipment inputs.
(5) Autologous Platelet-Rich Plasma (HCPCS Code G0460) Supply Inputs
    We did not make any proposals associated with HCPCS code G0460 
(Autologous platelet rich plasma for chronic wounds/ulcers, including 
phlebotomy, centrifugation, and all other preparatory procedures, 
administration and dressings, per treatment) in the CY 2021 PFS 
proposed rule. Following the publication of the rule, stakeholders 
contacted CMS regarding the creation of a new 3C patch system supply 
which is topically applied for the management of exuding cutaneous 
wounds, such as leg ulcers, pressure ulcers, and diabetic ulcers and 
mechanically or surgically-debrided wounds. Stakeholders first sought 
clarification on how CMS calculated the underlying nonfacility PE RVUs 
for HCPCS code G0460. Stakeholders also stated that autologous platelet 
rich plasma administration procedures furnished in clinical trials 
(including the new 3C patch system) are reported using HCPCS code G0460 
and requested that CMS revalue the service to reflect the PEs 
associated with the new patch system supply. The stakeholders stated 
that the use of the new 3C patch system will represent the typical case 
for HCPCS code G0460 and the therefore the cost inputs for this supply 
should be used to establish the RVUs for this code as the current MPFS 
rate is substantially less than the amount it costs to furnish the 3C 
patch.
    We clarify for stakeholders that the valuation of the direct PE 
inputs increased for HCPCS code G0460 as a result of the ongoing 
market-based supply and equipment pricing update. However, there was 
also a minor

[[Page 84498]]

decrease in the indirect PE allocation associated with this service, 
with the net result that the proposed PE RVU coincidentally ended up 
remaining the same as in the previous year. We also clarify for 
stakeholders that HCPCS code G0460 is not included in the Anticipated 
Specialty Assignment for Low Volume Services list, and therefore, was 
unaffected by low utilization in the claims data.
    We understand that the stakeholders originally believed that the 
new 3C patch system would be reported using new HCPCS coding before CMS 
issued a clarification that the clinical trials associated with this 
supply would be reported under HCPCS code G0460. We share the concerns 
of the stakeholders that patient access to the 3C patch will be 
materially impacted if CMS maintains reimbursement for HCPCS G0460 at 
the current rate. However, we note that we did not propose to increase 
the price of HCPCS code G0460 in the PFS proposed rule, and we have 
concerns about finalizing a fivefold increase in the pricing of this 
service without going through notice and comment rulemaking. Therefore, 
we are finalizing contractor pricing for HCPCS code G0460 for CY 2021 
to allow for increased pricing for this service when it includes the 3C 
patch system without establishing a new national price. We believe that 
the use of contractor pricing will allow additional time to determine 
the most accurate pricing for HCPCS code G0460. We are also adding the 
3C patch system to our supply database under supply code SD343 at a 
price of $625.00 based on an average of the submitted invoices.
(6) 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 2021, we proposed to continue with the fourth and final year 
of the transition of this adjustment to the standard process for 
allocating indirect PE.
    We did not receive public comments on this provision, and 
therefore, we are finalizing as proposed.
e. Update on Technical Expert Panel Related to Practice Expense
    The RAND Corporation is currently studying potential improvements 
to CMS' PE allocation methodology and the data that underlie it. As we 
noted earlier in this section, our current system for setting PE RVUs 
relies in part on data collected in the Physician Practice Information 
Survey (PPIS), which was administered by the AMA in CY 2007 and 2008.
    RAND, in its first phase of research, available at https://www.rand.org/pubs/research_reports/RR2166.html, found that the PPIS 
data are outdated and may no longer reflect the resource allocation, 
staffing arrangements, and cost structures that describe practitioners' 
resource requirements in furnishing services to Medicare beneficiaries, 
and consequently may not accurately capture the indirect PE resources 
required to furnish services to Medicare FFS beneficiaries. For 
example, the PPIS preceded the widespread adoption of electronic health 
records, quality reporting programs, billing codes that promote team-
based care, and hospital acquisition of physician practices. Notably, 
RAND found that practice ownership was strongly associated with 
indirect PE, with physician-owned practices requiring 190% higher 
indirect PE compared to facility-owned practices, suggesting a need to 
potentially update demographic information. Additionally, RAND found 
that aggregating Medicare provider specialties into broader categories 
resulted in small specialty-level impacts relative to the current 
system, suggesting that specialty-specific inputs may not be required 
to accurately reflect resource costs.
    To follow up on these and other issues raised in the first phase of 
RAND's research, in the CY 2020 PFS, we announced that RAND was 
convening a technical expert panel (TEP) to obtain input from 
stakeholders including physicians, practice and health system managers, 
health care accountants, and health policy experts. The TEP occurred on 
January 10, 2020 and its report is available at https://www.rand.org/pubs/working_papers/WR1334.html. Topics discussed included identifying 
issues with the current system; changes in medicine that have affected 
PE; how PE inputs could be updated, including through a potential new 
survey instrument; how best to aggregate PE categories if there were to 
be new survey instrument; ways to maximize response rates in a 
potential new survey; and using existing data to inform PFS PE rates. 
In addition, RAND has issued the results of its subsequent phase of 
research, available at www.rand.org/t/RR3248. This report is also 
available as a public use file displayed on the CMS website under 
downloads for the CY 2021 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    Based on the results of the TEP and RAND's other ongoing research, 
we are interested in potentially refining the PE methodology and 
updating the data used to make payments under the PFS. We believe that 
potential refinements could improve payment accuracy and strengthen 
Medicare. Our goals are to balance obtaining the data as soon as 
practicable and in a way that would allow stakeholders and CMS to 
collectively examine many of the issues the TEP and RAND's research 
identified. We noted that we were considering several questions, 
including how to best incorporate market-based information, which could 
be similar to the market research that we recently conducted to update 
supply and equipment pricing used to determine direct PE inputs under 
the PFS payment methodology. For example, stakeholders have expressed 
an interest in updating the clinical labor data that we use for direct 
PE inputs based on current salaries and compensation for the health 
care workforce. We solicited comment regarding how we might update the 
clinical labor data. We noted that historically we have used data from 
the Bureau of Labor Statistics and sought comment to determine if this 
is the best data source or if there is an alternative. We also noted 
that we are interested in hosting a Town Hall meeting at a date to be 
determined to provide an open forum for discussion with stakeholders on 
our ongoing research to potentially update the PE methodology and the 
underlying inputs. Finally, we welcomed feedback from all interested 
parties regarding RAND's report and clarified that we were not making 
any proposals based on this report for this rulemaking cycle We 
encouraged stakeholders to submit feedback as part

[[Page 84499]]

of their public comments or, if outside the public comment process, via 
email at [email protected].
    We received public comments on the update on technical expert panel 
related to PE. The following is a summary of the comments we received 
and our responses.
    Comment: In response to the RAND report, commenters encouraged CMS 
to work with stakeholders on any new PE data collection effort.
    Response: We agree that we would want to engage with stakeholders 
as part of any new PE data collection effort. Our public notice and 
comment rulemaking process is the venue we would use for any potential 
future proposals.
    Comment: Commenters were supportive of CMS convening a Town Hall 
meeting.
    Response: We appreciate and are encouraged by commenters' support. 
We continue to believe that a Town Hall would provide open forum for 
discussions with stakeholders. We remain interested in hosting this 
meeting at a date to be determined.

C. 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 relative 
value units (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 final rule, Valuation of 
Specific Codes, each year we develop appropriate adjustments to the 
RVUs taking into account recommendations provided by the American 
Medical Association (AMA) Resource-Based Relative Value Scale (RVS) 
Update Committee (RUC), the Medicare Payment Advisory Commission 
(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 Merit-based Incentive 
Payment System (MIPS) data. 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 (http://www.medpac.gov/docs/default-source/reports/Mar06_Ch03.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 costs decline. 
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 costs rises.
    As MedPAC noted in its March 2009 Report to Congress (http://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 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

[[Page 84500]]

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. Individuals and stakeholder groups may submit codes for review 
under the potentially misvalued codes initiative to CMS in one of two 
ways. Nominations may be submitted to CMS via email or through postal 
mail. Email submissions should be sent to the CMS emailbox 
[email protected], with the phrase ``Potentially 
Misvalued Codes'' and the referencing CPT code number(s) and/or the CPT 
descriptor(s) in the subject line. Physical letters for nominations 
should be sent via the U.S. Postal Service to the Centers for Medicare 
& Medicaid Services, Mail Stop: C4-01-26, 7500 Security Blvd., 
Baltimore, Maryland 21244. Envelopes containing the nomination letters 
must be labeled ``Attention: Division of Practitioner Services, 
Potentially Misvalued Codes''. Nominations for consideration in our 
next annual rule cycle should be received by our February 10th 
deadline. Since CY 2009, as a part of the annual potentially misvalued 
code review and Five-Year Review process, we have reviewed over 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 Medicare Program; Payment Policies Under the Physician Fee 
Schedule, Five-Year Review of Work Relative Value Units, Clinical 
Laboratory Fee Schedule: Signature on Requisition, and Other Revisions 
to Part B for CY 2012; final rule (76 FR 73052 through 73055) 
(hereinafter referred to as the ``CY 2012 PFS final rule with comment 
period''). 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 Medicare Program; Revisions to Payment Policies Under the 
Physician Fee Schedule, DME Face-to-Face Encounters, Elimination of the 
Requirement for Termination of Non-Random Prepayment Complex Medical 
Review and Other Revisions to Part B for CY 2013 (77 FR 68892) 
(hereinafter referred to as 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 the 
Medicare Program; Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Part B for CY 2009; and Revisions to 
the Amendment of the E-Prescribing Exemption for Computer Generated 
Facsimile Transmissions; Proposed Rule (73 FR 38589) (hereinafter 
referred to as the ``CY 2009 PFS proposed rule''), 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). We continue 
each year to consider and finalize a list of potentially misvalued 
codes that have or will be reviewed and revised as appropriate in 
future rulemaking.
3. CY 2021 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. In the CY 2015 PFS final rule with comment period (79 FR 67606 
through 67608), we modified this process whereby the public and 
stakeholders may nominate potentially misvalued codes for review by 
submitting the code with supporting documentation by February 10th of 
each year. Supporting documentation for codes nominated for the annual 
review of potentially misvalued codes may include the following:
     Documentation in peer reviewed medical literature or other 
reliable data that demonstrate 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 MIPS data).
     National surveys of work time and intensity from 
professional and management societies and

[[Page 84501]]

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 for each nominated code whether we 
agree with its inclusion 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 submissions nominating codes for review under the 
potentially misvalued code initiative, and several requests for review 
of PE related inputs prior to our February 10, 2020 deadline. We refer 
readers to section II.B. of this final rule, Determination of Practice 
Expense RVUs, for further discussion on the PE-related submissions. The 
summary of the submissions reviewed under the potentially misvalued 
code initiative is discussed below.
    We received multiple submissions requesting that CMS consider CPT 
code 22867 (Insertion of interlaminar/interspinous process 
stabilization/distraction device, without fusion, including image 
guidance when performed, with open decompression, lumbar; single level) 
for nomination as potentially misvalued. In their request, the 
submitters suggested that the physician work assigned to this code 
significantly undervalues the procedure relative to the value of CPT 
code 63047 (Laminectomy, facetectomy and foraminotomy (unilateral or 
bilateral with decompression of spinal cord, cauda equina and/or nerve 
root[s], [e.g., spinal or lateral recess stenosis]), single vertebral 
segment; lumbar). The submitters stated that the work performed during 
the surgical steps to perform a laminectomy for both procedures is 
generally similar except for the additional intensity and complexity 
involved in CPT code 22867 to implant the interspinous stabilization 
device. The submitters also requested that the malpractice RVUs 
assigned to this code be increased to better align with similar spine 
procedures, in terms of specialty-level and service-level risk factors, 
in addition to the intensity and complexity of the procedure. After 
considering the information provided by the submitter, which suggests 
that the current valuation for the service may not reflect the level of 
intensity inherent in furnishing the service relative to other similar 
services with inputs that exceed those for the nominated service, we 
proposed to nominate CPT code 22867 as potentially misvalued and 
welcomed public comment on this code.
    We received public comments on the CY 2021 identification and 
review of potentially misvalued services. The following is a summary of 
the comments we received and our responses.
    Comment: The AMA RUC has indicated that CPT code 22867 will be 
placed on a list they call the ``next Level of Interest for review.''
    Response: We acknowledge and thank the AMA RUC's placement of CPT 
code 22867 on their ``next Level of Interest for review'' list and look 
forward to their input, as well as input from the initial submitters of 
CPT code 22867 and all other parties.
    Comment: Some commenters expressed support for the nomination of 
CPT code 22867 as a potentially misvalued code, but disagreed with the 
comparison to CPT code 63047. Some commenters stated that CPT code 
22867 was misvalued from its last review in 2016, when CMS determined a 
work RVU of 13.50 over the AMA RUC recommended work RVU of 15.00. 
Commenters stated that CMS already has the necessary survey data from 
the specialties who perform this service--which had been surveyed and 
reviewed twice by the AMA RUC with the same outcome, and that the 
procedure's technology has not changed since the last survey. One 
commenter also highlighted differences between CPT code 63047 and CPT 
code 22867, noting that CPT code 63047 involves more postoperative work 
(as an inpatient service), spends more time with intense imaging 
services and device sizing, and that the decompression performed is 
more extensive than CPT code 22867, all of which supports the relative 
greater RVU amount for CPT code 63047.
    Response: We acknowledge and appreciate comments and feedback from 
CPT code 22867 stakeholders who have expressed their reasons both for 
and against the nomination of this code as potentially misvalued.
    Comment: Some commenters requested that CMS nominate HCPCS codes 
G0442 (Annual alcohol misuse screening, 15 minutes) and G0444 (Annual 
depression screening, 15 minutes) as potentially misvalued due to the 
possible misinterpretation of their descriptors. These commenters 
highlighted that the descriptors may appear to convey that the 
physician providing the service must provide a full 15 minutes of 
screening to report either of these services. The commenters stated 
their understanding of the descriptor to mean ``up to 15 minutes'' to 
perform the screenings, and suggested that CMS adjust the official 
descriptors to say G0442 (Annual alcohol misuse screening, up to 15 
minutes) and G0444 (Annual depression screening, up to 15 minutes), and 
for CMS to provide an educational announcement to clarify the proposed 
change.
    Response: We thank the commenters for these suggestions for 
clarifications on HCPCS codes G0442 and G0444 descriptors and welcome 
comments and continued engagement with stakeholders on all aspects of 
coding that improves accuracy and promotes clarity.
    Comment: Several commenters nominated CPT code 49436 (Delayed 
creation of exit site from embedded subcutaneous segment of 
intraperitoneal cannula or catheter) as being potentially misvalued, 
due to the PFS presently only making payment for this service in the 
facility setting and not in the office setting. Commenters requested 
that CMS review this code, and value the required resources for correct 
payment in the office setting. They contend that the procedure can be 
performed in the office, just as safely as it is done in an ASC or 
outpatient setting, and that it might be a more convenient site of 
service for the physician and for the patient. CPT code 49436 helps 
promote home peritoneal dialysis, which falls in line with the 
President's Executive Order (E.O.) on Advancing American Kidney Health 
and keeps patients at home during the PHE for COVID-19 rather than 
having to travel to a dialysis center three times a week.
    Response: While CMS had decided not to nominate CPT code 49436 in 
the proposed rule as being potentially misvalued, commenters 
resubmitted their nomination during this comment period. We appreciate 
all of the comments and feedback that we have received for nominating 
CPT code 49436 as potentially misvalued and further to consider valuing 
CPT code 49436 in the office setting. We intend to research the 
information provided and understand more about the potential impact of 
valuing CPT code 49436 in the office setting and may consider for 
future rulemaking.
    Comment: Commenters referenced codes that were publicly nominated 
in CY 2019 as misvalued by a national commercial insurer. The commenter 
expressed disappointment that CMS accepted these public nominations 
from a private national commercial insurer, as they could potentially 
represent a possible conflict of interest in their role

[[Page 84502]]

as a private commercial medical insurance and Medicare Advantage payer 
to the providers of physician services. The commenter urged CMS to 
evaluate how it considers public nominations from parties with possible 
conflicts in payment determinations.
    Response: CMS will accept and review all public nomination of 
services that may be potentially misvalued, as appropriate. As we had 
stated in our CY 2019 PFS final rule, we also reiterate that we 
continue to be open to reviewing additional and supplemental sources of 
data furnished by stakeholders, and providing such information to CMS 
is not limited to the public nomination process for potentially 
misvalued codes. We encourage stakeholders to continue to provide such 
information for our consideration, as this information may support CMS' 
review and refinement of work RVUs that are the basis for payment for 
many services under the PFS.
    Comment: One commenter urged CMS to use its authority to adjust CY 
2018 Medicare payments for physicians' services to increase the current 
rate for managing home patients (CPT code 90966 (End-stage renal 
disease (ESRD) related services for home dialysis per full month, for 
patients 20 years of age and older) 6.77 RVU) and to the maximum 
payment amount for managing in-center patients (CPT code 90960 (End-
stage renal disease (ESRD) related services monthly, for patients 20 
years of age and older; with 4 or more face-to-face visits by a 
physician or other qualified health care professional per month) 8.07 
RVU); however, no supporting documentation was included with this 
nomination request.
    Response: Should there be compelling evidence of substantial change 
in the nature of CPT codes 90966 and 90960 and their relationship to 
each other since their 2018 review, the commenter is free to nominate 
these codes as potentially misvalued and lend support and evidence to 
that effect for the next proposed rule.
    After consideration of the public comments, we are finalizing our 
proposal to nominate CPT code 22867 as potentially misvalued. We 
appreciate all of the comments and information we have received from 
stakeholders about services that they believe to be potentially 
misvalued and look forward to receiving new and additional information 
prior to our February 10th deadline for our next round of rulemaking.

D. Telehealth and Other Services Involving Communications Technology, 
and Interim Final Rule With Comment Period for Coding and Payment of 
Virtual Check-In Services

1. Payment for Medicare Telehealth Services Under Section 1834(m) of 
the Act
    As discussed in the CY 2021 PFS proposed rule (85 FR 50095) and 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) and in 42 CFR 410.78 and 414.65.
a. Adding Services to the Medicare Telehealth Services List
    In the CY 2003 PFS final rule with comment period (67 FR 79988), we 
established a regulatory process for adding services to or deleting 
services from the Medicare telehealth services list in accordance with 
section 1834(m)(4)(F)(ii) of the Act (Sec.  410.78(f)). This process 
provides the public with an ongoing opportunity to submit requests for 
adding services, which are then reviewed by us and assigned to 
categories established through notice and comment rulemaking. 
Specifically, we assign any submitted request to add to the Medicare 
telehealth services list 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 Medicare telehealth services list. 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 Medicare telehealth services list. 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 Medicare telehealth services list, including the additions 
described later in this section, is available on the CMS website at 
https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
    For CY 2021, requests to add services to the Medicare telehealth 
services list must have been submitted and received by February 10, 
2020. Each request to add a service to the Medicare telehealth services 
list must have included 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 
Medicare telehealth services list, requesters are 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 in the future to add services to the Medicare telehealth 
services list, including where to mail these requests, see our website 
at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
b. Requests To Add Services to the Medicare Telehealth Services List 
for CY 2021
    Under our current policy, we add services to the Medicare 
telehealth services list on a Category 1 basis when we determine that 
they are similar to

[[Page 84503]]

services on the existing Medicare telehealth services 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 
Medicare telehealth services list that resemble those services already 
on the Medicare telehealth services list. We received several requests 
to add various services as Medicare telehealth services effective for 
CY 2021. We also conducted an internal review of potential services to 
add to the Medicare telehealth services list.
    In response to the public health emergency (PHE) for Coronavirus 
Disease 2019 (COVID-19), CMS undertook emergency rulemaking to add a 
number of services to the Medicare telehealth services list on an 
interim final basis. In the ``Medicare and Medicaid Programs; Policy 
and Regulatory Revisions in Response to the COVID-19 Public Health 
Emergency'' interim final rule with comment period (IFC), (which was 
issued on March 31, 2020 and appeared in the April 6, 2020 Federal 
Register (85 FR 19230, 19234 through 19241) (hereinafter referred to as 
the ``March 31st COVID-19 IFC''), on an interim final basis for the 
duration of the PHE for COVID-19, we also finalized the addition of a 
number of services to the Medicare telehealth services list on a 
Category 2 basis. The following is a list of those services:
     Emergency Department (ED) Visits, Levels 1-5 (CPT codes 
99281-99285).
     Initial and Subsequent Observation and Observation 
Discharge Day Management (CPT codes 99217-99220; CPT codes 99224-99226; 
CPT codes 99234-99236).
     Initial Hospital Care and Hospital Discharge Day 
Management (CPT codes 99221-99223; CPT codes 99238-99239).
     Initial nursing facility visits, All levels (Low, 
Moderate, and High Complexity) and nursing facility discharge day 
management (CPT codes 99304-99306; CPT codes 99315-99316).
     Critical Care Services (CPT codes 99291-99292).
     Domiciliary, Rest Home, or Custodial Care services, New 
and Established patients (CPT codes 99327-99328; CPT codes 99334-
99337).
     Home Visits, New and Established Patient, All levels (CPT 
codes 99341-99345; CPT codes 99347-99350).
     Inpatient Neonatal and Pediatric Critical Care, Initial 
and Subsequent (CPT codes 99468-99472; CPT codes 99475-99476).
     Initial and Continuing Intensive Care Services (CPT code 
99477-994780).
     Assessment and Care Planning for Patients with Cognitive 
Impairment (CPT code 99483).
     Group Psychotherapy (CPT code 90853).
     End-Stage Renal Disease (ESRD) Services (CPT codes 90952, 
90953, 90959, and 90962).
     Psychological and Neuropsychological Testing (CPT codes 
96130-96133; CPT codes 96136-96139).
     Therapy Services, Physical and Occupational Therapy, All 
levels (CPT codes 97161-97168; CPT codes 97110, 97112, 97116, 97535, 
97750, 97755, 97760, 97761, 92521-92524, 92507).
     Radiation Treatment Management Services (CPT codes 77427).
    When we previously considered adding these services to the Medicare 
telehealth services list, either through a public request or through 
our own internal review, we considered whether these services met the 
Category 1 or Category 2 criteria. In many cases, we reviewed requests 
to add these services on a Category 1 basis, but did not receive or 
identify information that allowed us to review the services on a 
Category 2 basis. While we stated in the March 31st COVID-19 IFC that 
we did not believe the context of the PHE for COVID-19 would change the 
assessment of these services as Category 1, we did reassess all of 
these services on a Category 2 basis in the context of the widespread 
presence of COVID-19 in the community.
    Given the exposure risks for beneficiaries, the health care work 
force, and the community at large, we stated that in-person 
interactions between professionals and patients posed an immediate 
potential risk that would not have been present when we previously 
reviewed these services. We were concerned that this new risk created a 
unique circumstance where health care professionals might have to 
choose between mitigating exposure risk for themselves and for their 
patients or seeking Medicare payment for the service. For example, 
certain persons, especially older adults who are particularly 
vulnerable to complications from this specific viral infection; those 
considered at risk because of underlying health conditions; and those 
known to be recently exposed or diagnosed, and therefore, likely to 
spread the virus to others, were often being directed by local public 
health officials to self-isolate as much as possible. At the same time, 
we noted that the risk to medical professionals treating patients is 
high and we considered it likely that medical professionals would try 
to treat patients as effectively as possible without exposing 
themselves or their patients unnecessarily. We explained that, in some 
cases, the use of telecommunications technology could mitigate the 
exposure risk; and in such cases, there is a clear clinical benefit of 
using such technology in furnishing the service. In other words, 
patients who should not be seen by a professional in-person due to the 
exposure risk were highly likely to be without access to clinically 
appropriate treatment or diagnostic options unless they have access to 
services furnished through interactive communication technology.
    Therefore, in the context of the PHE for COVID-19, we believed that 
all of the services we added met the Category 2 criteria to be added to 
the Medicare telehealth services list on the basis that there was a 
patient population that would otherwise not have access to clinically 
appropriate treatment. We noted that, as with other services on the 
Medicare telehealth services list, it may not be clinically appropriate 
or possible to use telecommunications technology to furnish these 
particular services to every person or in every circumstance. In the 
context of the PHE for COVID-19, with specific regard to the exposure 
risks noted above, we recognized the clinical benefit of access to 
medically reasonable and necessary services furnished using 
telecommunications technology as opposed to the potential lack of 
access that could occur to mitigate the risk of disease exposure.
    The following presents a discussion of these services and the 
related proposals.
    After reviewing the requests we received and the services we 
identified for consideration, we identified the services listed in 
Table 11 as being sufficiently similar to services currently on the 
Medicare telehealth services list to be added on a Category 1 basis. 
Therefore, we proposed to add the services in Table 11 to the Medicare 
telehealth services list on a Category 1 basis for CY 2021.

[[Page 84504]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.010


[[Page 84505]]


[GRAPHIC] [TIFF OMITTED] TR28DE20.011

    We noted that we believe the services described by the HCPCS codes 
in Table 11 are similar to services currently on the Medicare 
telehealth services list. The HCPCS codes G2211 and G2212 are add-on 
codes to the office/outpatient evaluation and management (O/O E/M) 
services and are, by definition, part of the O/O E/M services with 
which they are billed; they cannot be billed with any other codes. 
These codes were previously described by placeholder HCPCS codes GPC1X 
and 99XXX (for G2211 and G2212, respectively). For further discussion 
of these codes, please see section II.F.2.c of this rule. The 
Assessment of and Care Planning for Patients with Cognitive Impairment 
was defined as a service meant to be billed in specific clinical 
scenarios in lieu of a level 5 O/O E/M visit. As such, these services 
fall within the Category 1 criteria, because they are similar to the 
office visits that are already on the Medicare telehealth services 
list. As it describes group therapy, CPT code 90853 is similar to the 
other group therapy services currently on the Medicare telehealth 
services list.
    While the patient's home cannot serve as an originating site (where 
the patient is located) for purposes of most Medicare telehealth 
services, the SUPPORT for Patients and Communities Act amended section 
1834(m)(4)(C) of the Act and added a new paragraph at section 
1834(m)(7) of the Act to remove geographic limitations and authorize 
the patient's home to serve as a telehealth originating site for 
purposes of treatment of a substance use disorder (SUD) or a co-
occurring mental health disorder, furnished on or after July 1, 2019, 
to an individual with a SUD diagnosis. These domiciliary/home visits 
contain the same elements and similar descriptors to the O/O E/M 
visits, and therefore, we noted that there is sufficient justification 
to add them to the Medicare telehealth services list on a Category 1 
basis. Additionally, we noted that, due to the vulnerability of this 
particular patient population that are receiving treatment for a 
diagnosed SUD or co-occurring mental health disorder, we should 
maximize the availability of telehealth services for the treatment of 
SUDs and co-occurring mental health disorders. We also noted that, 
because the home is not generally a permissible telehealth originating 
site, these services could be billed when furnished as telehealth 
services only for treatment of a SUD or co-occurring mental health 
disorder.
    Finally, we received a request to add CPT code 96121 
(Neurobehavioral 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 (List separately in addition 
to code for primary procedure)) on the basis that this is an add-on 
code to CPT code 96116 (Neurobehavioral 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), which 
is currently on the Medicare telehealth services list. In the past, we 
have added services to the Medicare telehealth services list that are 
add-on codes that describe a continuation or additional elements of 
services currently on the Medicare telehealth services list since the 
services would only be considered telehealth services when billed as an 
add-on to codes already on the Medicare telehealth services list (82 FR 
53008). Therefore, we proposed to add CPT code 96121 to the Medicare 
telehealth services list.
    We also received a request to add services to the Medicare 
telehealth services list that do not meet our criteria for addition to 
the Medicare telehealth services list. We did not propose to add the 
services listed in Table 12 to the Medicare telehealth services list.
[GRAPHIC] [TIFF OMITTED] TR28DE20.012

    We received a request to add Medical Genetics services to the 
Medicare telehealth services list. We note that CPT code 96040 is 
considered bundled into O/O E/M visits, which are already on the 
Medicare telehealth services list. Therefore, we do not believe it is 
necessary to add CPT code 96040. As we stated in the CY 2012 PFS final 
rule

[[Page 84506]]

with comment period (76 FR 73096 through 73097), physicians and NPPs 
who may independently bill Medicare for their services and who are 
counseling individuals would generally report office or other 
outpatient E/M CPT codes for office visits that involve significant 
counseling, including genetic counseling, and these office visit CPT 
codes are already on the Medicare telehealth services list. CPT code 
96040 would only be reported by genetic counselors for genetic 
counseling services. Genetic counselors are not among the practitioners 
who can bill Medicare directly for their professional services, and 
they are also not practitioners who can furnish telehealth services as 
specified in section 1834(m)(4)(E) of the Act. As such, we noted that 
we do not believe that it would be necessary or appropriate to add CPT 
code 96040 to the Medicare telehealth services list.
    HCPCS code S0265 is a Medication, Supplies, and Services code. 
There is no separate payment under the PFS for this category of codes. 
Therefore, we did not propose to add this service to the Medicare 
telehealth services list.
    We received public comments on the requests to add services to the 
Medicare telehealth services list for CY 2021. The following is a 
summary of the comments we received and our responses.
    Comment: Commenters broadly supported our proposal to add HCPCS 
codes and CPT codes 90853, 96121, G2212, 99483, 99334, 99335, 99347, 
and 99348 to the Medicare telehealth list on a Category 1 basis.
    Response: We thank the commenters for their support and feedback.
    Comment: One commenter opposed the addition of G2211 to the 
Medicare telehealth list on the basis they do not agree the creation of 
the code.
    Response: We thank the commenter for their feedback and refer them 
to section II.F.2.c. of this final rule for further discussion of 
payment policies for HCPCS code G2211. We note that HCPCS codes G2211 
and G2212 replace GPC1X and 99XXX respectively, please see section 
II.F.2.c in this final rule.
    Comment: One commenter requested clarification on the addition of 
CPT codes 99347 and 99348 (Home visit for the evaluation and management 
of an established patient). Specifically, the commenter requested 
clarification from CMS on the situations in which a home visit after 
the end of the PHE for COVID-19 would be allowed via telehealth.
    Response: While the patient's home cannot serve as an originating 
site (where the patient is located) for purposes of most Medicare 
telehealth services, the SUPPORT for Patients and Communities Act 
amended section 1834(m)(4)(C) of the Act and added a new paragraph at 
section 1834(m)(7) of the Act to remove geographic limitations and 
authorize the patient's home to serve as a telehealth originating site 
for purposes of treatment of a SUD or a co-occurring mental health 
disorder, furnished on or after July 1, 2019, to an individual with a 
SUD diagnosis. These domiciliary/home visits contain the same elements 
and similar descriptors to the O/O E/M visits, and therefore, we 
believe there is sufficient justification to add them to the Medicare 
telehealth services list on a Category 1 basis. We are adding these to 
the telehealth services list because an office/outpatient visit might 
not always most accurately or specifically describe the type of visit 
furnished to treat an individual in their home for an SUD or co-
occuring mental health disorder; and that sometimes one of the 
domiciliary/home visit codes would more accurately describe the 
service.
    Comment: One commenter stated that Assessment and Care Planning for 
Patients with Cognitive Impairment (CPT Code 99483) should not be added 
at this time until more study can be done to assess the appropriateness 
of this service being delivered in the telehealth context given that 
many cognitive impairments and symptoms may require in-person 
assessment.
    Response: We continue to believe that CPT code 99483 is 
sufficiently similar to an office visit to warrant addition to the 
Medicare telehealth list on a permanent basis in that it involves 
evaluating and managing a patient's cognitive impairment in an office/
outpatient setting. When the AMA CPT Editorial Panel created this code, 
they assumed that the work associated with assessment and care planning 
for patients with cognitive impairment had been reported with 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; 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), which is currently on the Medicare telehealth list.
    After considering the public comments received, we are finalizing 
our proposal and adding HCPCS codes G2211 and CPT codes 90853, 96121, 
G2212, 99483, 99334, 99335, 99347, and 99348 to the Medicare telehealth 
list for CY 2021.
    Comment: Commenters expressed opposition to CMS' decision not to 
propose to add Medical Genetics services (CPT code 96040) to the 
Medicare telehealth services list.
    Response: We note that CPT code 96040 is not separately billable 
under the PFS; it is considered bundled into O/O E/M visits, which are 
already on the Medicare telehealth services list. Therefore, we believe 
it is unnecessary, and could potentially be confusing, to add CPT code 
96040 to the list. Only codes that are separately billable can be added 
to the Medicare telehealth list. As we stated in the CY 2012 PFS final 
rule with comment period (76 FR 73096 through 73097), physicians and 
NPPs who furnish and bill Medicare for these services would generally 
report office or other outpatient E/M CPT codes for office visits that 
involve significant counseling, including genetic counseling; and the 
office visit CPT codes are already on the Medicare telehealth services 
list. CPT code 96040 would only be reported by genetic counselors for 
genetic counseling services. Genetic counselors are not among the 
practitioners who can bill Medicare directly for their professional 
services, and they are also not practitioners who can furnish 
telehealth services as specified in section 1834(m)(4)(E) of the Act. 
As such, we do not believe that it would be necessary or appropriate to 
add CPT code 96040 to the Medicare telehealth services list.
c. Proposed Temporary Addition of a Category 3 Basis for Adding to or 
Deleting Services From the Medicare Telehealth Services List
    Legislation enacted to address the PHE for COVID-19 provided the 
Secretary with new authorities under section 1135(b)(8) of the Act, as 
added by section 102 of the Coronavirus Preparedness and Response 
Supplemental Appropriations Act, 2020 (Pub. L. 116-123, March 6, 2020) 
and subsequently amended by section 6010 of the Families First 
Coronavirus Response Act (Pub. L. 116-127, March 18, 2020) and section 
3703 of the Coronavirus Aid, Relief, and Economic Security Act (CARES 
Act) (Pub. L. 116-136, March 27, 2020)), to waive or modify Medicare 
telehealth payment requirements during the PHE for COVID-19. We 
established several flexibilities to accommodate these

[[Page 84507]]

changes in the delivery of care. Through waiver authority under section 
1135(b)(8) of the Act, in response to the PHE for COVID-19, we removed 
the geographic and site of service originating site restrictions in 
section 1834(m)(4)(C) of the Act, as well as the restrictions in 
section 1834(m)(4)(E) of the Act on the types of practitioners who may 
furnish telehealth services, for the duration of the PHE for COVID-
19.\1\ We also used waiver authority to allow certain telehealth 
services to be furnished via audio-only communication technology. In 
the March 31st COVID-19 IFC, we added 89 services to the Medicare 
telehealth services list on an interim basis. Through the ``Medicare 
and Medicaid Programs; Additional Policy and Regulatory Revisions in 
Response to the COVID-19 Public Health Emergency'' interim final rule 
with comment period (IFC), (which was issued on May 1, 2020, and was 
effective upon publication in the May 8, 2020 Federal Register (85 FR 
27550 through 27649)) (hereinafter referred to as the ``May 8th COVID-
19 IFC''), on an interim basis for the duration of the PHE for COVID-
19, we removed the requirement in our regulations that we undertake 
rulemaking to add or delete services on the Medicare telehealth 
services list so that we could consider the addition of services on a 
subregulatory basis as they were recommended by the public or 
identified internally. On a subregulatory basis, we simultaneously 
added 46 more services to the Medicare telehealth services list on an 
interim basis when we issued the May 8th COVID-19 IFC. Finally, on 
October 14, 2020 we added 11 more services to the Medicare telehealth 
list on a subregulatory basis. For a full list of Medicare telehealth 
services please see the CMS website: https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Telehealth-Codes.
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    \1\ https://www.cms.gov/files/document/summary-covid-19-emergency-declaration-waivers.pdf.
---------------------------------------------------------------------------

    At the conclusion of the PHE for COVID-19, these waivers and 
interim policies will expire, payment for Medicare telehealth services 
will once again be limited by the requirements of section 1834(m) of 
the Act, and we will return to the policies established through the 
regular notice and comment rulemaking process, including the previously 
established Medicare telehealth services list, as modified by 
subsequent changes in policies and additions to the telehealth services 
list adopted through rulemaking, including in this final rule. We 
believe that the experiences of clinicians who are furnishing 
telehealth services during the PHE for COVID-19 will be useful to 
inform decisions about which of the services we added temporarily to 
the Medicare telehealth services list might be appropriate to add on a 
permanent basis. However, we also recognize that the annual PFS 
rulemaking schedule may not align perfectly with the expiration of the 
PHE for COVID-19, and that the clinicians providing services via 
telehealth during the PHE may not have the opportunity to conduct the 
kinds of review or develop the kind of evidence we usually consider 
when adding services to the Medicare telehealth services list on a 
permanent basis. In the event that the PHE for COVID-19 ends prior to 
the end of CY 2021, stakeholders might not have the opportunity to use 
our current consideration process for telehealth services to request 
permanent additions to the Medicare telehealth services list prior to 
those services being removed from the Medicare telehealth services 
list. This is especially true for those services that might need to be 
considered on a Category 2 basis, which involves providing supporting 
documentation to illustrate the clinical benefit of such services. 
Recognizing the extent to which practice patterns are shifting as a 
result of the PHE for COVID-19 from a model of care based on in-person 
services to one that relies on a combination of in-person services and 
virtual care, we noted that we believe that it would be disruptive to 
both clinical practice and beneficiary access to abruptly eliminate 
Medicare payment for these services when furnished via telehealth as 
soon as the PHE for COVID-19 ends without first providing an 
opportunity to use information developed during the PHE to support 
requests for permanent changes to the Medicare telehealth services 
list.
    As previously noted, in response to the PHE for COVID-19, we added 
a broad range of services to the Medicare telehealth services list. 
Before eliminating the full range of these services from the Medicare 
telehealth services list and potentially jeopardizing beneficiary 
access to those services that have been clinically beneficial, based 
primarily on the timing of annual rulemaking, we noted that we believe 
it would be prudent to collect information from the public regarding 
which, where, and how various telehealth services have been in use in 
various communities during the COVID-19 response. Feedback from 
patients and clinicians is essential to helping CMS understand how the 
use of telehealth services may have contributed positively to, or 
negatively affected, the quality of care provided to beneficiaries 
during the PHE for COVID-19, enabling us to better determine which 
services should be retained on the Medicare telehealth services list 
until we can give them full consideration under our established 
rulemaking process.
    Therefore, we proposed to create a third category of criteria for 
adding services to the Medicare telehealth services list on a temporary 
basis. This new category would describe services that would be included 
on the Medicare telehealth services list on a temporary basis. We would 
include in this category the services that were added during the PHE 
for COVID-19 for which there is likely to be clinical benefit when 
furnished via telehealth, but for which there is not yet sufficient 
evidence available to consider the services as permanent additions 
under Category 1 or Category 2 criteria. Recognizing that the services 
we would add on a temporary basis under Category 3 would ultimately 
need to meet the criteria under categories 1 or 2 in order to be 
permanently added to the Medicare telehealth services list, and the 
potential for evidence development that could continue through the 
Category 3 temporary addition period, we considered each of the 
services we added on an interim final basis during the PHE for COVID-
19.
    In developing the proposal to add specific services on a Category 3 
basis, we conducted a clinical assessment to identify those services 
for which we could foresee a reasonable potential likelihood of 
clinical benefit when furnished via telehealth outside the 
circumstances of the PHE for COVID-19 and that we anticipate would be 
able to demonstrate that clinical benefit in such a way as to meet our 
Category 2 criteria in full. Any service added under the proposed 
Category 3 would remain on the Medicare telehealth services list 
through the calendar year in which the PHE for COVID-19 ends. When 
assessing whether there was a potential likelihood of clinical benefit 
for a service such that it should be added to the Medicare telehealth 
services list on a Category 3 basis, we considered the following 
factors:
     Whether, outside of the circumstances of the PHE for 
COVID-19, there are increased concerns for patient safety if the 
service is furnished as a telehealth service.
     Whether, outside of the circumstances of the PHE for 
COVID-19, there are concerns about whether the provision of the service 
via telehealth is likely to jeopardize quality of care.

[[Page 84508]]

     Whether all elements of the service could fully and 
effectively be performed by a remotely located clinician using two-way, 
audio/video telecommunications technology.
    We recognized that the circumstances of the PHE for COVID-19 have 
provided clinicians with the opportunity to use telecommunications 
technology in health care delivery in a scope and manner far surpassing 
the telehealth services described under section 1834(m) of the Act, 
particularly as a result of the removal of geographic and site of 
service restrictions, and the addition of many services to the Medicare 
telehealth services list. When adding services to the Medicare 
telehealth services list on an interim basis during the PHE for COVID-
19, we reassessed services on a Category 2 basis in the context of the 
widespread presence of COVID-19 in the community. We recognized that 
healthcare access issues could arise due to the immediate potential 
exposure risks to patients and healthcare workers, and that the use of 
telecommunication technology could mitigate risk and facilitate 
clinically appropriate treatment. In the context of the PHE for COVID-
19. We found that all of the added services met the Category 2 criteria 
on the basis that there is a patient population who would otherwise not 
have access to clinically appropriate care (85 FR 19234). While the 
interim addition of a broad swath of services to the Medicare 
telehealth services list is responsive to critical needs during the PHE 
for COVID-19, the impact of adding these services to the Medicare 
telehealth services list on a permanent basis is currently unknown. 
Specifically, although it is possible to assess the uptake among health 
care practitioners of the added telehealth services, the extent to 
which service delivery via telehealth demonstrates clinical benefit 
outside the conditions of the PHE for COVID-19 is not known. Adding 
services to the Medicare telehealth services list on a Category 3 basis 
will give the public the opportunity to gather data and generate 
requests to add certain services to the Medicare telehealth services 
list permanently, which would be adjudicated on a Category 1 or 
Category 2 basis during future PFS annual rulemaking, while maintaining 
access to telehealth services with potential likelihood of clinical 
benefit. We proposed that the Category 3 criteria and the basis for 
considering additions to the Medicare telehealth services list would be 
temporary, to expire at the end of the calendar year in which the PHE 
for COVID-19 expires.
    We identified a number of services that we believe, based on our 
clinical assessment, fit the Category 3 criteria enumerated above in 
that we did not identify significant concerns over patient safety, 
quality of care, or the ability of clinicians to provide all elements 
of the service remotely if these services were to remain on the 
Medicare telehealth services list for an additional period beyond the 
PHE for COVID-19. Therefore, we proposed to continue including the 
services listed in Table 13 on the Medicare telehealth services list 
through the calendar year in which the PHE for COVID-19 ends. We 
solicited public comment on the services we identified for temporary 
addition to the Medicare telehealth services list through the Category 
3 criteria, including whether some should not be considered as Category 
3 temporary additions to the Medicare telehealth services list, or 
whether services currently not proposed as Category 3 additions to the 
Medicare telehealth services list should be considered as such. We 
noted that while our clinical assessment indicated that the services in 
Table 13 demonstrate potential likelihood of clinical benefit when 
furnished as telehealth services and, as such, the potential to meet 
the Category 1 or Category 2 criteria for permanent addition to the 
Medicare telehealth services list with the development of additional 
evidence, we solicited information from the public that would 
supplement our clinical assessment and assist us in consideration of 
our proposals regarding the Category 3 addition of services, even 
though we recognize that formal analyses may not yet be available. The 
following are examples of the types of information we sought from the 
public to help inform our decisions about proposed additions under 
Category 3:
     By whom and for whom are the services being delivered via 
telehealth during the PHE;
     What practical safeguards are being employed to maintain 
safety and clinical effectiveness of services delivered via telehealth; 
and how are practices quickly and efficiently transitioning patients 
from telehealth to in-person care as needed;
     What specific health outcomes data are being or are 
capable of being gathered to demonstrate clinical benefit;
     How is technology being used to facilitate the acquisition 
of clinical information that would otherwise be obtained by a hands-on 
physical examination if the service was furnished in person. Certain 
services on the Medicare telehealth services list prior to the PHE, 
specifically the O/O E/M code set, involve a physical exam. With the 
telehealth expansions during the PHE, clinicians may have had valuable 
experience providing other telehealth services to patients in higher 
acuity settings of care, such as an emergency department, that involve 
a hands-on physical examination when furnished in person.
     Whether patient outcomes are improved by the addition of 
one or more services to the Medicare telehealth services list, 
including whether inclusion on the Medicare telehealth services list 
increases access, safety, patient satisfaction, and overall quality of 
care;
     Whether furnishing this service or services via 
telecommunication technology promotes prudent use of resources;
     Whether the permanent addition of specific, individual 
services or categories of services to the Medicare telehealth services 
list supports quick responses to the spread of infectious disease or 
other emergent circumstances that may require widespread use of 
telehealth; and
     What is the impact on the health care workforce of the 
inclusion of one or more services or categories of services on the 
Medicare telehealth services list (for example, whether the health care 
workforce and its capabilities to provide care are expanded).
    In addition, we noted that CMS is committed to the following broad 
goals, and these weigh heavily in our decision-making around the 
addition, whether temporary or permanent, of a service or services to 
the Medicare telehealth services list. We requested that commenters 
consider these goals in conjunction with their comments on the 
proposals for the treatment of the telehealth services we added on an 
interim basis during the PHE for COVID-19:
     Maintaining the capacity to enable rapid assessment of 
patterns of care, safety, and outcomes in the Medicare, Medicaid, CHIP, 
and Marketplace populations;
     Establishing system safeguards to detect and avert 
unintended patient harms that result from policy adjustments;
     Ensuring high quality care is maintained;
     Demonstrating ongoing quality improvement efforts by 
Medicare participating providers, while maintaining access to necessary 
care;
     Establishing protections for vulnerable beneficiary 
populations (those with multiple chronic conditions, functional 
limitations, heart failure,

[[Page 84509]]

COPD, diabetes, dementia), and sites of heightened vulnerability (such 
as nursing homes, rural communities) with high risk of adverse 
outcomes;
     Ensuring appropriate resource utilization and supporting 
cost efficiency;
     Supporting emergency preparedness and maintaining capacity 
to surge for potential coronavirus resurgence or other healthcare 
issues; and
     Considering timing and pace of policy corrections in light 
of local and regional variations in systems of care and the impact of 
the PHE for COVID-19.
BILLING CODE 4120-01-P

[[Page 84510]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.013


[[Page 84511]]


[GRAPHIC] [TIFF OMITTED] TR28DE20.014


[[Page 84512]]


[GRAPHIC] [TIFF OMITTED] TR28DE20.015


[[Page 84513]]


[GRAPHIC] [TIFF OMITTED] TR28DE20.016


[[Page 84514]]


[GRAPHIC] [TIFF OMITTED] TR28DE20.017


[[Page 84515]]


[GRAPHIC] [TIFF OMITTED] TR28DE20.018


[[Page 84516]]


[GRAPHIC] [TIFF OMITTED] TR28DE20.019

BILLING CODE 4120-01-C
    We received public comments on the proposed temporary addition of a 
category 3 basis for adding to or deleting services from the Medicare 
telehealth services list. The following is a summary of the comments we 
received and our responses.
    Comment: Many commenters supported our proposal to use a third, 
temporary category of criteria for adding services to the Medicare 
telehealth list on a provisional basis. Commenters agreed that keeping 
certain services added on an interim basis during the PHE for COVID-19 
on the Medicare telehealth list on a temporary basis after the end of 
the PHE will give the medical community time to gather much needed data 
on services in this category to support Category 2 requests through the 
regular process for considering additions to the telehealth services 
list, while maintaining beneficiary access and allowing practitioners 
to transition back to models of care focused primarily on in-person, 
rather than virtual, services. The majority of commenters also 
supported adding the services CMS proposed to add to the Medicare 
telehealth list on a Category 3 basis.
    Response: We appreciate commenters' support for these proposals.
    Comment: Most commenters supported the proposed timeframe for 
services added on a Category 3 basis to remain on the Medicare 
telehealth list; however, a few commenters stated that adding services 
to the Medicare telehealth list on a temporary basis would create 
unnecessary burden for clinicians who are attempting to both treat 
patients in the midst of a pandemic and develop an evidence base to

[[Page 84517]]

support adding these services to the Medicare telehealth list 
permanently. In addition, by stipulating that certain codes would 
remain on the list through the year in which the PHE ends, commenters 
suggested that CMS was creating ambiguity as to when services added to 
the list on a Category 3 basis would expire. The commenters stated that 
this would be an impediment to investing in the infrastructure 
necessary to furnish these services. Some commenters requested that CMS 
fund the studies necessary to demonstrate whether a given service 
should be added permanently to the Medicare telehealth list, or at 
least articulate clear standards CMS would use to assess efficacy.
    Response: While we understand commenters' concerns that adding 
services temporarily to the Medicare telehealth list without a fixed 
end date would create ambiguity that could serve as a disincentive to 
providing the services as telehealth services, we would note that the 
PHE for COVID-19 has now been extended into CY 2021.\2\ The extension 
of the PHE into CY 2021 ensures that clinicians will have at least the 
entirety of 2021 to collect evidence to support a request to add these 
services permanently to the Medicare telehealth list.
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    \2\ https://www.phe.gov/emergency/news/healthactions/phe/Pages/covid19-2Oct2020.aspx.
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    Comment: Some commenters also expressed concern with the timeframe 
for which services added on a Category 3 basis will be on the Medicare 
telehealth list after the conclusion of the PHE. Some commenters 
suggested alternative timeframes, ranging between 90 days and 2 years 
after the end of the PHE. Some commenters suggested that CMS should 
specify a year in which the category 3 additions to the telehealth list 
will expire, such as 2022.
    Response: As stated above, the PHE for COVID-19 has been extended 
into CY 2021, allowing for services added to the Medicare telehealth 
list on a Category 3 basis to remain there for at least the entirety of 
2021. Any potential extension of this timeframe would be proposed in 
future rulemaking.
    After considering the public comments, we are finalizing the 
additions in Table 14 to the telehealth list on a Category 3 basis 
through the later of the end of the year in which the PHE ends or 
December 31, 2021, as proposed.
d. Comment Solicitation on Medicare Telehealth Services Added on an 
Interim Basis During the PHE for COVID-19 That CMS Did Not Propose To 
Retain After the PHE Ends
    In the March 31st COVID-19 IFC and the May 8th COVID-19 IFC, we 
finalized on an interim basis during the PHE for COVID-19 the addition 
of a number of services to the Medicare telehealth services list. While 
a number of these services were previously requested by external 
stakeholders and reviewed for addition as part of our standard process 
for updating the Medicare telehealth services list, a few were 
identified through internal review. As discussed above, we conducted a 
clinical assessment of each of the services added on an interim basis 
during the PHE for COVID-19 to the Medicare telehealth services list to 
identify those for which we could foresee a reasonable potential 
likelihood of clinical benefit when furnished via telehealth outside 
the circumstances of the PHE for COVID-19. In our clinical review of 
these services, we did not identify sufficient information to suggest 
there is a potential likelihood of clinical benefit for the services 
described below such that they could meet the Category 1 or Category 2 
criteria outside the circumstances of the PHE for COVID-19. We 
specifically considered the potential for these services to be 
furnished, outside the circumstances of the PHE for COVID-19, without 
increased concerns for patient safety or jeopardizing quality of care; 
and furnished fully and effectively, including all elements of the 
service, by a remotely located clinician via two-way, audio/video 
telecommunications technology. After assessing these factors, we did 
not find a potential likelihood that the services could meet Category 2 
criteria even with development of additional evidence. As such, we 
proposed not to extend them on the Medicare telehealth services list 
beyond the end of the PHE for COVID-19. However, we solicited public 
comment on whether any service added to the Medicare telehealth 
services list on an interim basis for the duration of the PHE for 
COVID-19 should be added to the Medicare telehealth services list on a 
temporary, Category 3 basis, based on the criteria outlined above. We 
welcomed additional information from commenters about these services.
    We also sought comment on the following considerations associated 
with particular services. We noted that comments on these specific 
concerns would inform our final decisions on whether these services 
should be added to the Medicare telehealth services list on a 
temporary, Category 3 basis:
     Initial and final/discharge interactions (CPT codes 99234-
99236 and 99238-99239): We noted that we believe that the potential 
acuity of the patient described by these codes would require an in-
person physical exam in order to fulfill the requirements of the 
service. We expressed concerns that, without an in-person physical 
examination, the need for the physician or health care provider to 
fully understand the health status of the person with whom they are 
establishing a clinical relationship would be compromised. We noted 
that we believe the need for an in-person interaction would rise beyond 
any specific diagnosis, and serves as the foundation upon which any and 
all clinical decisions are based for these services. We noted that, 
without an in-person interaction, care planning that includes risk-
benefit considerations and clinical decision-making will be less well-
informed and create risk of patient harm.
     Higher level emergency department visits (CPT codes 99284-
99285): We expressed concern that the full scope of service elements of 
these codes cannot be met via two-way, audio/video telecommunications 
technology as higher levels are indicated by patient characteristics, 
clinical complexity, urgency for care, and require complex decision-
making. We also noted that we believe, due to the acuity of the patient 
described by these codes, that an in-person physical examination is 
necessary to fulfill the service requirements.
     Hospital, Intensive Care Unit, Emergency care, Observation 
stays (CPT codes 99217-99220; 99221-99226; 99484-99485, 99468-99472, 
99475-99476, and 99477-99480): These codes describe visits that are 
furnished to patients who are ill enough to require hospital evaluation 
and care. We noted that we believe that the codes describe an 
evaluation for these potentially high acuity patients that is 
comprehensive and includes an in-person physical examination. Our view 
that in-person care is necessary to fulfill the requirements of the 
code is driven by the need for the physician or health provider to 
fully understand the health status of the person with whom they are 
establishing a clinical and therapeutic relationship. We also noted 
that we believe that the need for an in-person interaction would rise 
above any specific diagnosis, and serves as the foundation upon which 
any and all clinical decisions are based for these services. We noted 
that, without an in-

[[Page 84518]]

person interaction, care planning that includes risk-benefit 
considerations and clinical decision-making would be less well-informed 
and create risk of patient harm. With regard to the physical therapy, 
occupational therapy, and speech-language pathology services in Table 
13, we have received a number of requests that we add therapy services 
to the Medicare telehealth services list. In the CY 2017 PFS final 
rule, we noted that section 1834(m)(4)(E) of the Act specifies the 
types of practitioners who may furnish and bill for Medicare telehealth 
services as those practitioners under section 1842(b)(18)(C) of the 
Act. Physical therapists (PTs), occupational therapists (OTs) and 
speech-language pathologists (SLPs) are not among the practitioners 
identified in section 1842(b)(18)(C) of the Act. We stated in the CY 
2017 PFS final rule (81 FR 80198) that because these services are 
predominantly furnished by PTs, OTs, and SLPs, we did not believe it 
would be appropriate to add them to the Medicare telehealth services 
list at that time. In a subsequent request to consider adding these 
services for 2018, the original requester suggested that we might 
propose these services to be added to the Medicare telehealth services 
list so that payment can be made for them when furnished via telehealth 
by physicians or practitioners who can serve as distant site 
practitioners. We stated that since the majority of the codes are 
furnished over 90 percent of the time by therapy professionals who are 
not included on the statutory list of eligible distant site 
practitioners, we believed that adding therapy services to the Medicare 
telehealth services list could result in confusion about who is 
authorized to furnish and bill for these services when furnished via 
telehealth.
    In the proposed rule, we noted that we continue to believe this is 
generally the case, and we did not propose to add these services 
permanently to the Medicare telehealth services list. We solicited 
comment on whether these services should be added to the Medicare 
telehealth services list so that, in instances when a practitioner who 
is eligible to bill for telehealth services furnishes these services 
via telehealth, they could bill and receive payment for them. We also 
solicited comment on whether all aspects of these services can be fully 
and effectively furnished via two-way, audio/video telecommunications 
technology. We noted that given our clarification regarding telehealth 
services furnished incident to the professional services of a physician 
or practitioner (85 FR 27562), if these services were added to the 
Medicare telehealth services list, they could be furnished by a 
therapist and billed by a physician or practitioner who can furnish and 
bill for telehealth services provided that all of the ``incident to'' 
requirements are met.
    Comment: Commenters expressed concern that we did not propose to 
add the vast majority of the interim PHE telehealth services to the 
telehealth list on a Category 3 basis. Commenters stated that, by 
limiting the availability of these interim PHE telehealth services to 
the duration of the PHE, CMS would jeopardize access to care for 
beneficiaries who have come to rely on the provision of these services 
virtually, and would disrupt practice patterns for those clinicians who 
were accustomed to furnishing a broader array of telehealth services 
than included in the proposed permanent and temporary Category 3 
additions to the Medicare telehealth list.
    Response: We appreciate commenters' concerns. In response, we are 
finalizing the addition of a broader array of services to the Medicare 
telehealth list on a Category 3 basis, as described below.
    Comment: Many commenters requested that CMS add specific interim 
PHE telehealth services that we did not propose to the Medicare 
telehealth list on a Category 3 basis. Most commenters did not provide 
sufficient (or in some cases, any) evidence to support their requests 
to be considered under Category 3 criteria. Other commenters did 
provide additional evidence sufficient to consider certain services on 
a Category 3 basis. Table 15 includes the complete list of services 
commenters requested for addition to the CMS Medicare telehealth list 
on a Category 3 basis.
BILLING CODE 4120-01-P

[[Page 84519]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.020


[[Page 84520]]


[GRAPHIC] [TIFF OMITTED] TR28DE20.021


[[Page 84521]]


[GRAPHIC] [TIFF OMITTED] TR28DE20.022


[[Page 84522]]


[GRAPHIC] [TIFF OMITTED] TR28DE20.023


[[Page 84523]]


[GRAPHIC] [TIFF OMITTED] TR28DE20.024


[[Page 84524]]


[GRAPHIC] [TIFF OMITTED] TR28DE20.025


[[Page 84525]]


[GRAPHIC] [TIFF OMITTED] TR28DE20.026

BILLING CODE 4120-01-C
    The following is a summary of these comments and our responses.
    Comment: Some commenters requested that we consider adding

[[Page 84526]]

initial nursing facility visits, which are currently interim PHE 
telehealth services, to the telehealth list on a Category 3 basis. 
Commenters did provide information regarding how telehealth is used in 
long-term care facilities; however, they did not provide information 
indicating how the full scope of service elements of an initial nursing 
facility visit could be furnished via two-way, audio/telecommunications 
technology.
    Response: We continue to believe that there are components of the 
initial visit, such as the physical exam, that in the vast majority of 
circumstances can only be properly performed in person given the 
vulnerability and frailty of this particular patient population. 
Commenters did not provide evidence to indicate otherwise. We note that 
patients in a nursing facility may still receive subsequent visits as 
telehealth services; however, we are not persuaded that these services, 
in general, could be furnished via telehealth as described by the CPT 
codes based upon information provided by commenters.
    Comment: Many commenters requested that we add physical therapy, 
occupational therapy, and speech language pathology services to the 
Medicare telehealth list on a category 3 basis. Commenters provided 
extensive information on how they furnish these services via two-way, 
audio/video telecommunications technology. In response to CMS's 
longstanding concerns that the practitioners who furnish and bill for 
the overwhelming majority of these services are, outside of the 
circumstances of the PHE for COVID-19, not among the statutorily 
authorized practitioners who may independently bill Medicare for 
telehealth services, commenters pointed to our proposed clarification 
that telehealth services could be furnished by a therapist incident to 
the professional services of a billing clinician in accordance with our 
regulations at Sec.  410.26.
    Response: We appreciate the additional information commenters 
provided suggesting a possible scenario whereby services furnished by 
therapists may be provided and billed incident to the professional 
services of a physician or practitioner who is authorized to furnish 
and bill for telehealth services. While we continue to have concerns as 
to whether certain elements of therapy services, particularly when 
provided to new patients, could be furnished in total via two-way, 
audio/video telecommunications technology, we recognize that the 
clarification of billing requirements for these services may allow for 
additional information to be collected and submitted for consideration 
by CMS. We are therefore finalizing addition of these services to the 
Medicare telehealth list on a Category 3 basis.
    Comment: Some commenters requested that we add several audiology 
services to the Medicare telehealth list on a Category 3 basis. These 
codes are currently interim PHE telehealth services. Commenters 
explained that including CPT codes for device evaluation and 
therapeutic services with a device is necessary to support access for 
patients in needs of these assistive technologies, and that not 
including them would inhibit the ability of speech language 
pathologists to perform the evaluation and therapeutic services via 
telehealth.
    Response: We note that, outside of the circumstances of the PHE, 
speech language pathologists are not eligible to independently bill for 
Medicare telehealth services, although these services could possibly be 
furnished by a therapist incident to an eligible billing practitioner. 
Furthermore, we do not agree that the information provided by 
commenters demonstrates that, under most circumstances, these services 
can be furnished, in full, via two-way audio/video communication 
technology given that these codes describe a new patient interaction 
which would likely require hands-on, clinical assessment and direct, 
one-on-one interaction/observation.
    Comment: Some commenters requested that we add ESRD MCP services 
with 1 monthly visit to the Medicare telehealth list on a Category 3 
basis. Commenters cited information that they say demonstrates that 
retaining the ESRD-specific telehealth flexibilities post-pandemic 
would be valuable to both patients and health care providers and would 
pose no material detriments to patient safety or quality of care. 
Commenters further offered that technology exists that would enable 
physicians and other practitioners to deliver effective ESRD care on a 
virtual basis beyond the PHE for COVID-19. Additionally, commenters 
noted that it may take time for medically complex and vulnerable 
patients to travel for in-person care, and that determining when a 
patient should return to a physician's office should be left to the 
patient and the physician.
    Response: We did not propose to add these services to the Medicare 
telehealth list on a Category 3 basis due to concerns regarding the 
patient receiving an adequate physical examination of the vascular 
access site and in-person evaluation of the patient's fluid status when 
a patient is only receiving 1 visit per month. We appreciate the 
additional information provided by commenters, particularly the 
information on how ESRD services are furnished using audio/video 
technology outside of the circumstances of the PHE for COVID-19. Based 
upon this information, we are finalizing the addition of the ESRD MCP 
services with a single face-to-face visit per month to the Medicare 
telehealth list on a Category 3 basis. We would note that, during the 
PHE for the COVID-19 pandemic, section 3705 of the CARES Act allowed 
for a waiver of the statutory provision in section 1881(b)(3)(B)(ii) of 
the Act, which requires that an individual determined to have ESRD 
receiving home dialysis must receive certain face-to-face clinical 
assessments without the use of telehealth. Therefore, outside of the 
PHE for COVID-19, for beneficiaries receiving home dialysis services, a 
face-to-face ESRD-related clinical assessment must be provided in 
person (without the use of telehealth) for the first 3 months of home 
dialysis, and once every 3 months thereafter.
    Comment: Some commenters requested that we add hospital observation 
and discharge day management services to the Medicare telehealth list 
on a Category 3 basis. Commenters cited information that they believe 
demonstrates that telehealth services in the emergency setting have 
proven to be successful and add clinical benefit to patients, and that 
they should be added on a Category 3 basis, if not permanently. 
Commenters stated that furnishing these services as telehealth services 
can be helpful or even essential to enable patients to receive high-
quality specialty care in isolated rural communities, communities 
affected by natural disasters, communities affected by local disease 
outbreaks, and similar situations. Commenters also requested that we 
add critical care services and established patient neonatal critical 
care services to the Medicare telehealth list on a Category 3 basis, 
stating that there are certain situations where it is appropriate to 
provide higher level and critical care to patients via telehealth. 
Commenters further offered that the clinical value of telehealth is 
particularly clear for patients being treated in rural EDs or at rural 
hospitals where effective telehealth collaboration for high-level cases 
could facilitate clinical collaboration and decrease unnecessary 
transfers. Commenters stated that there is a shortage of rural board-
certified emergency physicians, and that, if shortages of these 
physicians continue, more critical care services

[[Page 84527]]

may need to be delivered via telehealth over time to ensure that 
patients receive timely and necessary care. Finally, we received 
requests to add level four and five emergency department visits to the 
Medicare telehealth list on a Category 3 basis.
    All of these requests were accompanied by robust supporting 
evidence including information on teleICU and tele-stroke models of 
care. Commenters also submitted clinical studies pointing to the 
efficacy of telehealth in more acute care settings.
    Response: We are responding to the comments on these codes together 
because they are all E/M services that are furnished in a hospital or 
ED setting. We did not propose to add these services to the Medicare 
telehealth list on a Category 3 basis due to the presumption that in-
person assessment and care, particularly an in-person physical exam, 
was necessary for patients at this level of acuity. Based upon a review 
of the information provided by commenters, which included information 
on how distant site practitioners could collaborate with individuals at 
the originating site (which, outside of the circumstances of the PHE, 
must be a medical facility) to obtain an accurate and comprehensive 
evaluation of the patient, we agree that telehealth in the acute 
settings described by these codes could offer an excellent opportunity 
for care to patients if both the distant site and originating site 
facilities/teams have the appropriate infrastructure, technology, and 
training to effectively conduct such visits via telehealth. We continue 
to believe that in most instances, in order to fulfill the full scope 
of service elements described by codes for new patients, an in-person 
physical exam is necessary; however, we agree that, for services 
provided to established patients, such as established patient 
observation services and established patient neonatal critical care, 
and for emergency department visits and critical care services (the 
latter of which is being used extensively during the PHE to support 
surge capacity), more data are needed to understand how these E/M code 
families are being used in the field and whether their addition to the 
telehealth services list ultimately could be supported on a Category 2 
basis. Therefore, we are finalizing the addition of established patient 
observation services and established patient neonatal critical care 
services to the Medicare telehealth list on a Category 3 basis. We are 
also finalizing the addition of critical care services to the Medicare 
telehealth list on a Category 3 basis.
    Comment: Some commenters requested that we add electronic device 
management and treatment services to the Medicare telehealth list on a 
Category 3 basis, stating that safeguards are being developed to 
deliver safe and effective remote management of neuromodulation 
technologies during the PHE and beyond. The commenter suggested 
rationale for monitoring the provision of these services through use of 
these codes to ensure improved outcomes.
    Response: While we appreciate the additional information as to the 
safeguards being developed to ensure safe access to these services and 
the information on improved outcomes, it was not clear whether the 
capability for clinicians to remotely connect to a patient's hand-held 
device for the purposes of electronic assessment and analysis is widely 
available. It is also not within CMS's mandate under the PFS to ensure 
improved outcomes. Therefore, we remain unconvinced by the evidence 
provided by the commenter that these services can, in most instances, 
be conducted in full using two-way, audio/video communication 
technology. We were also uncertain as to which of these services 
involve a direct, clinical interaction between the patient and 
practitioner such that, if the service is furnished as a telehealth 
service, the interaction would be facilitated by audio/video 
technology; and those that do not involve such an interaction. To the 
extent these services do not involve a direct, clinical interaction 
between the patient and practitioner facilitated by audio/video 
technology, the services would not be subject to the statutory 
requirements for telehealth services under section 1834(m) of the Act, 
and there would be no need to consider adding them to the telehealth 
services list.
    Comment: Most commenters supported CMS not adding CPT code 77427 
(Radiation treatment management, 5 treatments) to the Medicare 
telehealth list on a Category 3 basis. These commenters stated that, 
given that most radiation oncology practices have been able to secure 
adequate PPE, it was no longer necessary for radiation treatment 
management to be available as a telehealth service. A few commenters 
disagreed, but did not provide supporting information.
    Response: We did not propose to add this service to the Medicare 
telehealth list on a Category 3 basis due to concerns over whether the 
full service elements described by CPT code 77427 could, in most cases, 
be furnished in full via two way, audio-video communication technology. 
We continue to believe this is the case and appreciate the additional 
information provided by commenters as to the necessity of adding this 
service to the Medicare telehealth list on a Category 3 basis.
    After considering the public comments, we are finalizing the 
addition of services to the Medicare telehealth list on a Category 3 
basis as explained above and detailed in Table 16.
2. Analysis and Response to the Comment Solicitation on Coding and 
Payment for Tele-ICU
    With regard to the critical care services listed in A-D 5 we have 
received a number of requests in prior years to add these services to 
the Medicare telehealth services list. In response to one such request, 
we finalized creation of two HCPCS G codes, G0508 (Telehealth 
consultation, critical care, initial, physicians typically spend 60 
minutes communicating with the patient and providers via telehealth) 
and G0509 (Telehealth consultation, critical care, subsequent, 
physicians typically spend 50 minutes communicating with the patient 
and providers via telehealth), to describe the work associated with 
furnishing consultation services via Medicare telehealth to critically 
ill patients in the CY 2017 PFS final rule (81 FR 80196 through 80197). 
We stated that CPT guidance makes clear that a variety of other 
services are bundled into the payment rates for critical care, 
including gastric intubations and vascular access procedures, among 
others. While we are adding critical care services to the Medicare 
telehealth list temporarily, on a Category 3 basis, we also solicited 
comment on whether current coding (either through the CPT codes 
describing in-person critical care or the HCPCS G codes describing 
critical care consults furnished via telehealth) does not reflect 
additional models of critical care delivery, specifically, models of 
care delivery that utilize a combination of remote monitoring and 
clinical staff at the location of the beneficiary to allow, when an 
onsite practitioner is not available, for a practitioner at a distant 
site to monitor vital signs and direct in-person care as needed.
    We sought comment on the definition, potential coding and valuation 
for this kind of remote service. Specifically, we sought comment on the 
following concerns:
     How to distinguish the technical component of the remote 
monitoring portion of the service from the

[[Page 84528]]

diagnosis-related group (DRG) payment already being provided to the 
hospital.
     How to provide payment only for monitoring and 
interventions furnished to Medicare beneficiaries when the remote 
intensivist is monitoring multiple patients, some of which may not be 
Medicare beneficiaries.
     How this service intersects with both the critical care 
consult G codes and the in-person critical care services.
    Comment: One commenter stated that, generally, there are two models 
of remote critical care services; the first of which is more of a 
telehealth consultant. Services performed under this scenario may be 
accurately reported via existing critical care consult G codes. The 
other model of care includes physicians providing tele-ICU services, 
which may be enhanced through the use of robotic technology or other 
methods to complete a remote clinical assessment of the critically ill 
patient. Commenters stated current critical care consult G-codes may be 
used for an episodic evaluation and recommendation to the bedside team 
or may be used for episodic telemedicine consults and do not reflect 
current models of care. One commenter noted the tele-ICU is involved 
both before and after the bedside intensivist or physician arrives and 
leaves the bedside. Several commenters also stated that current CPT and 
HCPCS coding does not adequately reflect the additional component of 
monitoring, surveillance, coaching of bedside nurses, physicians who 
are not intensivists, and active management in real-time and over 
extended timeframes by tele-ICU Intensivists. Many commenters 
encouraged CMS to adopt a coding proposal currently under consideration 
by the CPT editorial panel and the AMA RUC.
    Response: We appreciate the feedback regarding the different tele-
ICU models. As noted by commenters, the AMA is currently engaged in 
evaluating coding and valuation for services similar to those 
identified by commenters. We will keep these comments in mind and look 
forward to evaluating any new CPT coding and AMA RUC recommendations as 
part of our future annual rulemaking process.
    After considering the public comments, we will consider all of the 
feedback on the different tele-ICU models of care as well as potential 
gaps in coding for possible future rulemaking.

[[Page 84529]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.027

3. Technical Refinement to the Medicare Telehealth Services List To 
Reflect Current Coding
    For CY 2020, the CPT Editorial Panel deleted the six existing 
Health and Behavior Assessment and Intervention procedure CPT codes and 
replaced them with nine new CPT codes. The six deleted CPT codes 
include CPT code 96150 (Health and behavior assessment (e.g., health-
focused clinical interview, behavioral observations, 
psychophysiological monitoring, health oriented questionnaires), each 
15 minutes face-to-face with the patient;

[[Page 84530]]

initial assessment), CPT code 96151 (Health and behavior assessment 
(e.g., health-focused clinical interview, behavioral observations, 
psychophysiological monitoring, health oriented questionnaires), each 
15 minutes face-to-face with the patient; reassessment), CPT code 96152 
(Health and behavior intervention, each 15 minutes, face-to-face; 
individual), CPT code 96153 (Health and behavior intervention, each 15 
minutes, face-to-face; group (2 or more patients)), CPT code 96154 
(Health and behavior intervention, each 15 minutes, face-to-face; 
family (with the patient present)), and CPT code 96155 (Health and 
behavior intervention, each 15 minutes, face-to-face; family (without 
the patient present)). However, we inadvertently neglected to make the 
corresponding update to reflect these coding changes on the Medicare 
telehealth services list in CY 2020 PFS rulemaking. Therefore, we 
proposed to delete CPT codes 96150-96155 from the Medicare telehealth 
services list and replace them with the following successor codes: CPT 
code 96156 (Health behavior assessment, including reassessment (i.e., 
health-focused clinical interview, behavioral observations, clinical 
decision making)); CPT code 96158 (Health behavior intervention, 
individual, face-to-face; initial 30 minutes); CPT code 96159 (Health 
behavior intervention, individual, face-to-face; each additional 15 
minutes (list separately in addition to code for primary service)); CPT 
code 96164 (Health behavior intervention, group (2 or more patients), 
face-to-face; initial 30 minutes); CPT code 96165 (Health behavior 
intervention, group (2 or more patients), face-to-face; each additional 
15 minutes (list separately in addition to code for primary service)); 
CPT code 96167 (Health behavior intervention, family (with the patient 
present), face-to-face; initial 30 minutes); CPT code 96168 (Health 
behavior intervention, family (with the patient present), face-to-face 
each additional 15 minutes (list separately in addition to code for 
primary service)); CPT code 96170 (Health behavior intervention, family 
(without the patient present), face-to-face; initial 30 minutes); and 
CPT code 96171 (Health behavior intervention, family (without the 
patient present), face-to-face; each additional 15 minutes (list 
separately in addition to code for primary service)).
    We also proposed to amend our regulations to stipulate that when 
new codes are issued to replace codes that describe the same clinical 
services that are currently on the Medicare telehealth services list, 
we would consider those new codes to be successor codes to those that 
are on the Medicare telehealth services list, and would update the 
Medicare telehealth services list accordingly. At Sec.  410.78(f), we 
proposed to revise the final sentence of the paragraph to read: CMS 
maintains on the CMS website the Medicare telehealth services list 
under this section, including the current HCPCS codes that describe the 
services.
    We received public comments on the technical refinement to the 
Medicare telehealth services list to reflect current coding. The 
following is a summary of the comments we received and our responses.
    Comment: Commenters supported this proposal.
    Response: We are finalizing this technical refinement as proposed.
4. Furnishing Telehealth Visits in Inpatient and Nursing Facility 
Settings, and Critical Care Consultations
    The long term care facility regulations at Sec.  483.30(c) require 
that residents of SNFs receive an initial visit from a physician, and 
periodic personal visits subsequently by either a physician or other 
NPP. In the CY 2010 PFS final rule with comment period (74 FR 61762), 
we stated that these regulations ensure that at least a minimal degree 
of personal contact between a physician or a qualified NPP and a 
resident is maintained, both at the point of admission to the facility 
and periodically during the course of the resident's stay. In that rule 
we stated that we believe that these federally-mandated visits should 
be conducted in-person, and not as Medicare telehealth services. 
Therefore, we revised Sec.  410.78 to restrict physicians and 
practitioners from using telehealth to furnish the physician visits 
required under Sec.  483.30(c).
    During the PHE for COVID-19, we waived the requirement in 42 CFR 
483.30 for physicians and NPPs to perform in-person required visits for 
nursing home residents, and allowed visits to be conducted via 
telehealth (https://www.cms.gov/files/document/summary-covid-19-emergency-declaration-waivers.pdf).
    We solicited public comment on whether it would be appropriate to 
maintain this flexibility on a permanent basis outside of the PHE for 
COVID-19. We invited public comment on whether the in-person visit 
requirement is necessary, or whether two-way, audio/video 
telecommunications technology would be sufficient in instances when, 
due to continued exposure risk, workforce capacity, or other factors, 
the clinician determines an in-person visit is not necessary.
    We also received requests to revise our frequency limitations for 
telehealth subsequent inpatient and nursing facility visits. We limit 
the provision of subsequent inpatient visits via Medicare telehealth to 
once every 3 days and subsequent nursing facility visits to once every 
30 days. We received a request to remove the frequency limitation on 
the subsequent inpatient services and a separate request to revise the 
subsequent nursing facility visits to once every 3 days, rather than 30 
days.
    As we stated in the CY 2019 PFS final rule, we believed the 
potential acuity of illness of hospital inpatients is greater than that 
of patients who are likely to receive services that were on the 
Medicare telehealth services list at that time. We also stated that it 
would be appropriate to permit some subsequent hospital care services 
to be furnished through telehealth to ensure that hospitalized patients 
have sufficiently frequent encounters with their admitting 
practitioner. In addition, we expressed our belief that the majority of 
these visits should be furnished 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 illness of hospital 
inpatients, we finalized the addition of CPT codes 99231-99233 to the 
Medicare telehealth services list, but limited the provision of these 
subsequent hospital care services through telehealth to once every 3 
days. We noted that 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 with, and 
position on, the provision of subsequent hospital care services via 
telehealth have not changed (83 FR 59493). Therefore, we did not 
propose to modify the current policy.
    In the CY 2018 PFS final rule, we reiterated that we believed it 
would be appropriate to permit some subsequent nursing facility (NF) 
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 NF inpatients, we limited the provision of 
subsequent NF care services furnished through telehealth to once every 
30 days. We also stated that we continued to have concerns regarding 
more routine use of telehealth given the potential acuity and 
complexity of NF inpatients, and therefore, we were not proposing to

[[Page 84531]]

remove the frequency limitation for subsequent NF care services (83 FR 
59494). We received comments from stakeholders who stated that the once 
every 30-day frequency limitation for subsequent NF visits furnished 
via Medicare telehealth limits access to care for Medicare 
beneficiaries in the NF setting. Stakeholders stated that the use of 
Medicare telehealth is crucial to maintaining a continuum of care in 
this setting and that CMS should leave it up to clinicians to decide 
how frequently a visit may be furnished as a Medicare telehealth 
service rather than in person depending on the needs of specific 
patients. We noted that we were persuaded by the comments from these 
stakeholders, and therefore, we proposed to revise the frequency 
limitation from one visit every 30 days to one visit every 3 days. We 
noted that we believe this interval strikes the right balance between 
requiring in-person visits and allowing flexibility to furnish services 
via telehealth when clinically appropriate to do so. We solicited 
comment on whether frequency limitations broadly are burdensome and 
limit access to necessary care when services are available only through 
telehealth, and how best to ensure that patients are receiving 
necessary in-person care.
    We received public comments on furnishing telehealth visits in 
inpatient and nursing facility settings, and critical care 
consultations. The following is a summary of the comments we received 
and our responses.
    Comment: Many commenters requested that CMS revise the long term 
care facility regulations at Sec.  483.30(c), which require that 
residents of NFs receive an initial visit from a physician, and 
periodic personal visits subsequently by either a physician or other 
NPP, to allow the initial visit to be conducted via Medicare 
telehealth.
    Response: As we stated in the CY 2010 PFS final rule with comment 
period (74 FR 61762), we continue to believe that in-person contact 
between a physician or a qualified NPP and a resident is needed at the 
point of admission to the facility to ensure the appropriate level of 
care.
    Comment: Many commenters have stated their support for revising the 
frequency limitation for subsequent nursing facility visits furnished 
via telehealth from once every 30 days to once every 3 days, while 
other commenters encouraged CMS to remove frequency limitations 
entirely. A few commenters stated that CMS should maintain some 
frequency limitations so as to not to create a disincentive for in-
person care.
    Response: We thank all the commenters for their feedback. As 
discussed in the proposed rule, we have received requests to revise the 
frequency limitations on subsequent nursing facility visits from one 
every 30 days to one every 3 days to align with the frequency 
limitations in the inpatient setting; however, after additional 
consideration of the issue, we noted that patients in the nursing 
facility setting tend to have a longer lengths of stay compared to the 
patients in the inpatient setting. As such, we have further considered 
whether the frequency limitations for subsequent nursing facility 
visits furnished via telehealth should be the same as for the inpatient 
setting. Additionally, we acknowledge commenters' concerns about 
creating a disincentive for in-person care in the absence of any 
frequency limitations on services furnished through telehealth, and 
that a broader view of our frequency limitation policies across the 
different Part A and B care settings could potentially lead to 
inadequate in-person care in certain scenarios. While we appreciate 
that, in some cases, a subsequent nursing facility visit furnished via 
telehealth may allow flexibility for practitioners to appropriately 
treat patients, there are also situations where an in-person visit may 
be more appropriate. In seeking to find the right balance between 
providing greater access to care through more telehealth visits and 
ensuring adequate in-person care, especially given the longer length of 
stays for NF patients, we believe that one telehealth visit every 30 
days may be too infrequent and once every 3 days poses a risk of 
creating a disincentive for in-person care. Therefore, we believe it is 
appropriate to revise the frequency limitation for subsequent nursing 
facility visits to permit one Medicare telehealth visit every 14 days. 
This limitation provides an appropriate balance between increased 
access to care through telehealth and maintaining appropriate in-person 
care.
    After consideration of the public comments, we are finalizing a 
policy to allow subsequent nursing visits to be furnished via Medicare 
telehealth once every 14 days in the NF setting. We are not finalizing 
any revisions to the frequency limitations on inpatient visits or 
critical care consultations provided as telehealth services.
5. Proposed Technical Amendment To Remove References to Specific 
Technology
    The final sentence of our regulation at Sec.  410.78(a)(3) 
prohibits the use of telephones, facsimile machines, and electronic 
mail systems for purposes of furnishing Medicare telehealth services. 
In the March 31st COVID-19 IFC, we added a new Sec.  410.78(a)(3)(i) 
(and reserved Sec.  410.78(a)(3)(ii) for later use) to provide for an 
exception that removes application of that sentence during the PHE for 
COVID-19. We added the new section on an interim final basis because we 
believe that the first sentence of Sec.  410.78(a)(3) adequately 
describes the technology requirements for an interactive 
telecommunication system that may be used to furnish a Medicare 
telehealth service. That sentence defines interactive telecommunication 
system as ``multimedia communications equipment that includes, at a 
minimum, audio and video equipment permitting two-way, real-time 
interactive communication.'' We noted that we were also concerned that 
the reference to ``telephones'' in the second sentence of the 
regulation as impermissible technology could cause confusion in 
instances where otherwise eligible equipment, such as a smart phone, 
may also be used as a telephone Because these concerns are not 
situation- or time-limited to the PHE for COVID-19, we proposed to 
remove the second sentence of the regulation at Sec.  410.78(a)(3) that 
specified that telephones, facsimile machines, and electronic mail 
systems do not meet the definition of an interactive telecommunications 
system. As we proposed to adopt this change on a permanent basis, we 
also proposed to delete the paragraphs at Sec.  410.78(a)(3)(i) and 
(ii). We noted that we believe these amendments to our regulations 
would remove outdated references to specific types of technology and 
provide a clearer statement of our policy.
    We received public comments on proposed technical amendment to 
remove references to specific technology. The following is a summary of 
the comments we received and our responses.
    Comment: Commenters supported our proposal to amend the regulation. 
One commenter cited our statement in the March 31st COVID-19 IFC that 
mobile computing technology colloquially referred to as ``phones'' are 
now ubiquitous, and the wording of the regulatory text could be 
construed to prevent their use for purposes of conducting a telehealth 
service. According to another commenter, advances in digital 
communication technology should not be unnecessarily excluded as 
communication methods for patients and clinicians to utilize for 
telehealth services. Commenters agreed that the reference in the 
current regulation creates confusion about use

[[Page 84532]]

of equipment such as a smart phone or even an interactive telehealth 
platform operating within an electronic health information system. 
Commenters agreed that the reference to ``telephones'' in the 
regulation as an impermissible technology in the final sentence of 
regulation at Sec.  410.78(a)(3) has caused confusion in instances 
where equipment, such as smartphones, are also used as a telephone. 
They state that the references in these sections of the CFR are not 
situation- or time-limited to the PHE for COVID-19 and should be 
deleted.
    Response: We thank commenters for their support and agree with 
their stated points. .
    After consideration of the comments, we are finalizing this 
proposed technical amendment.
6. Communication Technology-Based Services (CTBS)
    In the CY 2019 PFS final rule, we finalized separate payment for a 
number of services that could be furnished via telecommunications 
technology, but that are not considered Medicare telehealth services. 
Specifically, we finalized HCPCS code G2010 (Remote evaluation of 
recorded video and/or images submitted by an established patient (e.g., 
store and forward), including interpretation with follow-up with the 
patient within 24 business hours, not originating from a related E/M 
service provided within the previous 7 days nor leading to an E/M 
service or procedure within the next 24 hours or soonest available 
appointment), and HCPCS code G2012 (Brief communication technology-
based service, e.g. virtual check-in, by a physician or other qualified 
health care professional who can report evaluation and management 
services, provided to an established patient, not originating from a 
related E/M service provided within the previous 7 days nor leading to 
an E/M service or procedure within the next 24 hours or soonest 
available appointment; 5-10 minutes of medical discussion). We 
finalized maintenance of these codes as part of the set of codes that 
is only reportable by those practitioners that can furnish E/M 
services. We stated that we believed this was appropriate since the 
service describes a check-in directly with the billing practitioner to 
assess whether an office visit is needed. However, we did note that 
similar check-ins provided by nurses and other clinical staff can be 
important aspects of coordinated patient care (83 FR 59486).
    In the CY 2020 PFS final rule, we finalized separate payment for 
HCPCS codes G2061 (Qualified nonphysician healthcare professional 
online assessment and management, for an established patient, for up to 
seven days, cumulative time during the 7 days; 5-10 minutes), G2062 
(Qualified nonphysician healthcare professional online assessment and 
management service, for an established patient, for up to seven days, 
cumulative time during the 7 days; 11-20 minutes), and G2063 (Qualified 
nonphysician qualified healthcare professional assessment and 
management service, for an established patient, for up to seven days, 
cumulative time during the 7 days; 21 or more minutes). In that rule, 
we stated that these codes may be billed by NPPs consistent with the 
definition of their respective benefit category, although we did not 
provide specific examples (84 FR 62796).
    We received a number of questions regarding which benefit 
categories HCPCS codes G2061 through G2063 fall under. In the March 
31st COVID-19 IFC (85 FR 19244-19245) we established on an interim 
basis for the duration of the PHE for COVID-19 that these services 
could be billed for example, by licensed clinical social workers and 
clinical psychologists, as well as PTs, OTs, and SLPs who bill Medicare 
directly for their services when the service furnished falls within the 
scope of these practitioner's benefit categories. In the CY 2021 PFS 
proposed rule (85 FR 50112 and 50113), we proposed to adopt that policy 
on a permanent basis. We noted that this is not an exhaustive list and 
we solicited comment on other benefit categories into which these 
services may fall.
    We also proposed to allow billing of other CTBS by certain NPPs, 
consistent with the scope of these practitioners' benefit categories, 
through the creation of two additional HCPCS G codes that can be billed 
by practitioners who cannot independently bill for E/M services:
     G2250 (Remote assessment of recorded video and/or images 
submitted by an established patient (e.g., store and forward), 
including interpretation with follow-up with the patient within 24 
business hours, not originating from a related service provided within 
the previous 7 days nor leading to a service or procedure within the 
next 24 hours or soonest available appointment.)
     G2251 (Brief communication technology-based service, e.g. 
virtual check-in, by a qualified health care professional who cannot 
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 a service or procedure within the next 
24 hours or soonest available appointment; 5-10 minutes of medical 
discussion).
    We proposed to value the services identically to HCPCS codes G2010 
and G2012, respectively. We acknowledged that it has been agency 
policy, in general, to differentially value similar services that are 
performed by practitioners who can and cannot, respectively, bill 
independently for E/M services, with higher values for the service 
performed by practitioners who can independently bill E/M services. 
However, given the relatively low values for HCPCS codes G2010 and 
G2012, we noted that we did not believe that there was a significant 
differential in resource costs to warrant different values, but 
solicited comment on whether we should value these services 
differentially, including potentially increasing the valuation of HCPCS 
codes G2010 and G2012.
    Further, to facilitate billing of the CTBS by rehabilitative 
therapists, we proposed to designate HCPCS codes G2250, G2251, G2061, 
G2062, and G2063 as ``sometimes therapy'' services. When billed by a 
private practice PT, OT, or SLP, the codes would need to include the 
corresponding GO, GP, or GN therapy modifier to signify that the CTB 
are furnished as therapy services furnished under an OT, PT, or SLP 
plan of care.
    We also noted that we proposed for CY 2021 to replace the eVisit G-
codes with corresponding CPT codes, and that this policy would also 
apply to those codes.
    For all of these CTBS, we also clarified that the consent from the 
patient to receive these services can be documented by auxiliary staff 
under general supervision, as well as by the billing practitioner. 
While we continue to believe that beneficiary consent is necessary so 
that the beneficiary is notified of cost sharing when receiving these 
services, we noted that we did not believe that the timing or manner in 
which beneficiary consent is acquired should interfere with the 
provision of one of these services. We retained the requirement that, 
in instances when the brief CTBS originates from a related E/M service 
(including one furnished as a telehealth service) provided within the 
previous 7 days by the same physician or other qualified health care 
professional, this service would be considered bundled into that 
previous E/M service and would not be separately billable.
    We received public comments on the CTBS proposals. The following is 
a summary of the comments we received and our responses.

[[Page 84533]]

    Comment: Several commenters supported our proposal to replace the 
eVisit G codes (G2061-G2063) with corresponding CPT codes 98970-98972 
for qualified nonphysician health care professional online digital E/M 
service.
    Response: We thank commenters for their feedback. After 
consideration of the comments received, we are finalizing our proposal 
to replace G2061-G2063 with CPT codes 98970-98972.
    Comment: Many commenters were supportive of the proposal to allow 
NPPs, such as licensed clinical social workers, clinical psychologists, 
PTs, OTs, and SLPs to bill HCPCS codes G2061 through G2063, consistent 
with the definition of their respective benefit category.
    Response: We thank the commenters for their support and feedback. 
After consideration of the comments received, we are finalizing our 
proposal to allow NPPs, such as licensed clinical social workers, 
clinical psychologists, PTs, OTs, and SLPs to bill HCPCS codes G2061 
through G2063, consistent with the definition of their respective 
benefit category.
    Comment: Commenters requested that CMS clarify that HCPCS codes 
G2061 through G2063 fell within the scope of the audiology diagnostic 
benefit category or the medical nutrition therapist benefit category.
    Response: We disagree with the commenter. HCPCS codes G2061-G2063 
describe online assessment and management while the audiology benefit 
is for diagnostic testing. Therefore, we believe these services fall 
outside the audiologists' benefit category. The benefit for medical 
nutrition therapists is limited by statute to a few specific services 
described by certain HCPCS codes, which do not include G2061-G2063.
    Comment: Many commenters were supportive of the proposal to allow 
billing of HCPCS codes G2250 and G2251 by certain NPPs, consistent with 
the scope of these practitioners' benefit categories.
    Response: We thank the commenters for their support and feedback. 
After consideration of the comments received, we are finalizing our 
proposal to allow billing of HCPCS codes G2250 and G2251 by certain 
NPPs, consistent with the scope of these practitioners' benefit 
categories.
    Comment: Many commenters supported the proposal to identically 
value HCPCS codes G2250 and G2251 to G2010 and G2012, respectively.
    Response: We thank commenters for their support and feedback.
    Comment: One commenter disagreed with the proposal to identically 
value HCPCS codes G2250 and G2251 to G2010 and G2012, respectively. The 
commenter stated that services furnished by NPPs should not be valued 
the same as those provided by physicians and encouraged CMS to increase 
the valuation of G2010 and G2012 while not offering recommended value 
for G2250 and G2251.
    Response: As we stated in the proposed rule, given the relatively 
low values for HCPCS codes G2010 and G2012, we do not believe that 
there is a significant differential in resource costs to warrant 
differential values for codes G2250 and G2251, and codes G2010 and 
G2012.
    After consideration of the comments, we are finalizing our proposal 
to identically value HCPCS codes G2250 and G2251 to G2010 and G2012, 
respectively.
    Comment: Several commenters urged CMS to consider increasing the 
value of G2010 and G2012.
    Response: We thank commenters for their feedback and will consider 
this matter and propose any potential changes through future 
rulemaking.
    Comment: Many commenters supported the proposal to designate HCPCS 
codes G2250, G2251, G2061, G2062, and G2063 as ``sometimes therapy'' 
services to facilitate billing of these CTBS by therapists. Including 
when billed by a private practice PT, OT, or SLP, the codes would need 
to include the corresponding GO, GP, or GN therapy modifier to signify 
that the CTB are furnished as therapy services furnished under an OT, 
PT, or SLP plan of care.
    Response: We thank the commenters for their support and feedback. 
After consideration of the comments received, we are finalizing our 
proposal to designate HCPCS codes G2250, G2251, G2061, G2062, and G2063 
as ``sometimes therapy'' services to facilitate billing of the CTBS by 
therapists. Additionally, we note that when billed by a private 
practice PT, OT, or SLP, the codes would need to include the 
corresponding GO, GP, or GN therapy modifier to signify that the CTB 
are furnished as therapy services furnished under an OT, PT, or SLP 
plan of care.
    Comment: Many commenters supported and thanked CMS for the 
clarification that consent from the patient to receive CTBS services 
can be documented by auxiliary staff under general supervision as well 
as by the billing practitioner.
    Response: We thank commenters for their feedback.
    Comment: Several commenters encouraged CMS to permanently allow the 
use of virtual check-ins and e-visits for new as well as established 
patients.
    Response: In the CY 2019 PFS proposed rule (83 FR 35724), we 
created HCPCS code G2012 and stated our expectation 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. 
Additionally, MedPAC noted particular concern regarding potential 
increases in volume that are not related to ongoing, informed patient 
care. CMS remains concerned about these issues outside of the PHE for 
COVID-19. As such, we did not propose, and do not anticipate proposing, 
to permanently allow billing for HCPCS codes G2020 and G2012 when 
furnished to new patients.
    Comment: One commenter suggested it may be helpful for CMS to 
provide data on specialty-specific uptake of CTBS and e-Visits, both 
before and after the PHE for COVID-19, in order to determine if there 
are access challenges in specific specialties.
    Response: We thank the commenter for their suggestion and will take 
this into future consideration after the PHE for COVID-19 ends.
7. Continuation of Payment for Audio-Only Visits
a. Background
    In the March 31st COVID-19 IFC, we established separate payment for 
audio-only telephone E/M services (85 FR 19264 through 19266). The 
telephone E/M services are CPT codes 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); 99442 
(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; 11-20 minutes of 
medical discussion); and 99443 (Telephone evaluation and management 
service by a physician or other qualified health

[[Page 84534]]

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; 21-30 minutes of medical discussion). We 
noted that, although these services were previously considered non-
covered under the PFS, in the context of the PHE for COVID-19 and with 
the goal of reducing exposure risks associated with COVID-19, 
especially in the case that two-way, audio and video technology is not 
available to furnish a Medicare telehealth service, we believed there 
are circumstances where prolonged, audio-only communication between the 
practitioner and the patient could be clinically appropriate, yet not 
fully replace a face-to-face visit. For example, an established patient 
who was experiencing an exacerbation of their condition could have a 
25-minute phone conversation with their physician during which the 
physician determines that an adjustment to the patient's medication 
would alleviate their symptoms. The use of CPT code 99443 in this 
situation prevents a similar in-person service as the evaluation of the 
patient's symptoms and determination to adjust medication could be 
conducted without patient and the practitioner being in the same 
location. We stated our belief that these telephone E/M codes, with 
their established description and valuation, were the best way to 
recognize the relative resource costs of these kinds of services and 
make payment for them under the PFS. For these codes, we initially 
finalized on an interim basis during the PHE for COVID-19, work RVUs as 
recommended by the American Medical Association (AMA) Relative Value 
Scale Update Committee (RUC), as discussed in the CY 2008 PFS final 
rule with comment period (72 FR 66371), of 0.25 for CPT code 99441, 
0.50 for CPT code 99442, and 0.75 for CPT code 99443. We also finalized 
the RUC-recommended direct PE inputs which consist of 3 minutes of 
post-service Registered Nurse/Licensed Practical Nurse/Medical 
Technical Assistant clinical labor time for each code.
    In the May 8th COVID-19 IFC, we noted that in the time since we 
established these payment amounts, stakeholders had informed us that 
use of audio-only services was more prevalent than we had previously 
considered, especially because many beneficiaries were not utilizing 
video-enabled communication technology from their homes. In other 
words, there were many cases where practitioners would under ordinary 
circumstances utilize telehealth or in-person visits to evaluate and 
manage patients' medical concerns, but were instead using audio-only 
interactions to manage more complex care (85 FR 27589 through 27590). 
While we had previously acknowledged the likelihood that, under the 
circumstances of the PHE for COVID-19, more time would be spent 
interacting with the patient via audio-only technology, we stated that 
the intensity of furnishing an audio-only visit to a beneficiary during 
the unique circumstances of the PHE for COVID-19 was not accurately 
captured by the valuation of these services we established in the March 
31st COVID-19 IFC. This would be particularly true to the extent that 
these audio-only services are actually serving as a substitute for 
office/outpatient Medicare telehealth visits for beneficiaries not 
using video-enabled telecommunications technology contrary to the 
situation we anticipated when establishing payment for them in the 
March 31st COVID-19 IFC. We stated that, given our understanding that 
these audio-only services were being furnished primarily as a 
replacement for care that would otherwise be reported as an in-person 
or telehealth visit using the O/O E/M codes, we established new RVUs 
for the telephone E/M services based on crosswalks to the most 
analogous O/O E/M codes, based on the time requirements for the 
telephone codes and the times assumed for valuation for purposes of the 
O/O E/M codes. Specifically, we crosswalked CPT codes 99212, 99213, and 
99214 to CPT codes 99441, 99442, and 99443, respectively. We therefore 
finalized, on an interim basis and for the duration of the PHE for 
COVID-19, the following work RVUs: 0.48 for CPT code 99441; 0.97 for 
CPT code 99442; and 1.50 for CPT code 99443. We also finalized the 
direct PE inputs associated with CPT code 99212 for CPT code 99441, the 
direct PE inputs associated with CPT code 99213 for CPT code 99442, and 
the direct PE inputs associated with CPT code 99214 for CPT code 99443. 
We did not finalize increased payment rates for CPT codes 98966-98968 
as these codes describe services furnished by practitioners who cannot 
independently bill for E/M services and so these telephone assessment 
and management services, by definition, are not being furnished in lieu 
of an O/O E/M service. We noted that to the extent that these extended 
phone services are taking place instead of O/O E/M visits (either in-
person or via telehealth), the direct crosswalk of RVUs also better 
maintains overall budget neutrality and relativity under the PFS. We 
stated that we believed that the resources required to furnish these 
services during the PHE for COVID-19 are better captured by the RVUs 
associated with the level 2-4 established patient O/O E/M visits. 
Additionally, we stated that, given our understanding that these audio-
only services were being furnished as substitutes for O/O E/M services, 
we recognized that they should be considered as telehealth services, 
and added them to the Medicare telehealth services list for the 
duration of the PHE for COVID-19. For these audio-only E/M services, we 
separately issued a waiver under section 1135(b)(8) of the Act, as 
amended by section 3703 of the CARES Act, of the requirements under 
section 1834(m) of the Act and our regulation at Sec.  410.78 that 
Medicare telehealth services must be furnished using video technology.
b. Summary of Comments Received in Response to Comment Solicitation on 
Continuation of Payment for Audio-Only Visits
    In the CY 2021 PFS proposed rule (85 FR 50113-50114), we did not 
propose to continue to recognize CPT codes 99441, 99442, and 99443 for 
payment under the PFS after conclusion of the PHE for COVID-19 because, 
outside of the circumstances of the PHE, we are not able to waive the 
requirement that telehealth services be furnished using an interactive 
telecommunications system that includes two-way, audio/video 
communication technology. However, we recognized that the need for 
audio-only interaction could remain as beneficiaries continue to try to 
avoid sources of potential infection, such as a doctor's office; and in 
that circumstance, a longer phone conversation may be needed to 
determine if an in-person visit is necessary rather than what is 
described by the virtual check-in. We solicited comment on whether CMS 
should develop coding and payment for a service similar to the virtual 
check-in but for a longer unit of time and with an accordingly higher 
value. We sought input from the public on the appropriate duration 
interval for such services and the resources in both work and PE that 
would be associated with furnishing them. We also solicited comment on 
whether separate payment for such telephone-only services should be a 
provisional policy to remain in effect until a year or some other 
period after the end of the PHE for COVID-19 or if

[[Page 84535]]

it should be PFS payment policy permanently.
    We received public comments on the comment solicitation on 
continuation of payment for audio-only visits. The following is a 
summary of the comments we received and our responses.
    Comment: Commenters broadly supported maintaining the availability 
of certain audio-only services after the duration of the PHE for COVID-
19. Commenters stated that many beneficiaries may not have access to or 
choose not to use two-way, audio/video communication technology, and 
therefore, maintaining some form of payment for audio-only services 
would be crucial for ensuring access to care for this vulnerable 
population. Some commenters urged CMS to continue payment for audio-
only evaluation or assessment and management services beyond the end of 
the PHE for COVID-19. Other commenters stated that allowing 
practitioners to furnish certain behavioral health and counseling 
services via audio-only communication technology has been crucial to 
ensuring access to these services and that CMS should continue payment 
for these audio-only services after the conclusion of the PHE for 
COVID-19. Commenters further suggested, in response to both this 
proposal and in the context of the proposed revision to the agency's 
regulation at Sec.  410.78(a)(3), that the statutory text laying out 
the telehealth services benefit uses the term ``telecommunications 
system'' but does not include an explicit definition of that term, 
except to say that in the case of federal telemedicine demonstrations 
in Alaska or Hawaii, the term ``includes store-and-forward technologies 
that provide for the asynchronous transmission of health care 
information in single or multimedia formats.'' Therefore, the statute 
leaves it up to the Department of Health and Human Services (HHS) to 
determine whether a telehealth telecommunications system must include 
both audio and video capabilities, and HHS is free to make the 
modification it proposes under this heading. Based on this assessment, 
commenters stated that CMS has the authority to redefine our 
longstanding regulatory interpretation of ``interactive 
telecommunications system'' at Sec.  410.78 to include audio-only 
services.
    While the majority of commenters stated that they preferred CMS 
continuing to recognize the audio evaluation/assessment and management 
services outside of the PHE for COVID-19, some commenters did state 
that, in the absence of continuing to recognize those codes, CMS should 
provide coding and payment for a longer virtual check-in. With regard 
to the valuation of a longer virtual check in, commenters provided a 
few recommendations. One commenter suggested that we value this service 
the same as 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; 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), other commenters suggested a range of times 
for a new virtual check in, such as 11-22 minutes or 15-20 minutes. 
Another commenter suggested that CMS could create more than one 
additional virtual check-in code.
    Response: We appreciate these comments. Section 1834(m)(2)(A) of 
the Act expressly provides payment to the distant site physician or 
practitioner of an amount equal to the amount that such physician or 
practitioner would have been paid under this title had such service 
been furnished without the use of a telecommunications system. This 
means that we pay an equal amount for a service furnished using a 
``telecommunications system'' as for a service furnished in person 
(without the use of a telecommunications system). Section 1834(m)(1) of 
the Act specifies that telehealth services must be furnished via a 
``telecommunications system,'' and it includes an exception to allow 
``store and forward'' technology to be considered a telecommunications 
system only for purposes of certain federal demonstrations. CMS has in 
place a longstanding interpretation of ``telecommunications system'' 
that includes only technology that enables a visit that is analogous to 
an in person visit--which aligns closely with our resource-based 
payment policy under the PFS, given that payment is made for a 
telehealth service at the same rate as an in-person visit. Our criteria 
for considering the addition of services to the telehealth services 
list also rely on an assessment of whether the service furnished via 
telehealth is analogous to one furnished in person. We continue to 
believe that our longstanding regulatory definition of 
``telecommunications system'' reflects the intent of statute.
    As the audio-only assessment and management or E/M visits are by 
definition replacements for in-person office visits, they would be 
subject to the statutory restrictions outlined in section 1834(m) of 
the Act. Outside of the circumstances of the PHE for COVID-19, we 
continue to believe that our longstanding regulatory interpretation of 
``telecommunications system'' precludes the use of audio-only 
technology for purposes of Medicare telehealth services.
    Comment: Some commenters stated that if CMS continues payment for 
the audio-only E/M visits, these should continue to be paid at rates 
commensurate to the level 2-4 established patient office visits, 
consistent with how these services have been paid during the PHE for 
COVID-19. Other commenters disagreed, stating that outside the 
circumstances of the PHE for COVID-19, these services should not have 
the same payment rate as in-person services.
    Response: After the end of the PHE, there will be no separate 
payment for the audio-only E/M visit codes. At the conclusion of the 
PHE, we will assign a status of ``bundled'' and post the RUC-
recommended RVUs for these codes in accordance with our usual practice.
    Comment: A few commenters requested that, if CMS continues to 
recognize the audio-only evaluation/assessment and management services 
or if CMS creates a longer virtual check-in service, the service should 
be available to both new and established patients. A few commenters, 
including MedPAC, suggested that if CMS creates a longer virtual check-
in, the policy should be provisional rather than permanent--for 
example, through the calendar year in which the PHE for COVID-19 ends.
    Response: We continue to believe that, outside of the circumstances 
of the PHE for COVID-19, CTBS services broadly should be billed only 
for established patients.
c. Interim Final Rule With Comment Period for Coding and Payment of 
Virtual Check-In Services (HCPCS Code GSADX1)
i. Background
    We note that we have historically established coding and payment on 
an interim final basis for truly new services when it is in the public 
interest to do so. Outside of the circumstances of the PHE for COVID-
19, Medicare does not provide separate payment for a service that would 
be a substitute for an in-person visit but is furnished using 
synchronous audio-only technology. However, we recognize that 
commenters were clear about the continuing need for coding and payment 
to reflect the

[[Page 84536]]

provision of lengthier audio-only services outside of the PHE for 
COVID-19, if not as substitutes for in-person services, then as a tool 
to determine whether an in-person visit is needed, particularly as 
beneficiaries may still be cautious about exposure risks associated 
with in-person services.
ii. Interim Final Policy
    Given the widespread concerns expressed by commenters about the 
continuing need for audio-only conversations with patients, we believe 
it would be expedient to establish additional coding and payment for an 
extended audio-only assessment service on an interim basis for CY 2021. 
We believe that establishing payment for this service on an interim 
basis will support access to care for beneficiaries who may be 
reluctant to return to in-person visits unless absolutely necessary, 
and allow us to consider whether this policy should be adopted on a 
permanent basis. Therefore, for CY 2021, on an interim basis, we are 
establishing HCPCS code G2252 (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; 11-20 minutes of medical discussion.). We are 
finalizing a direct crosswalk to CPT code 99442, the value of which we 
believe most accurately reflects the resources associated with a longer 
service delivered via synchronous communication technology, which can 
include audio-only communication. This is consistent with our approach 
to valuing the virtual check-in service (HCPCS code G2012), which used 
CPT code 99441 as the basis for valuation. In the case of HCPCS code 
G2252 and CPT code 99442, both codes describe 11-20 minutes of medical 
discussion when the practitioner may not necessarily be able to 
visualize the patient, and is used when the acuity of the patient's 
problem is not necessarily likely to warrant a visit, but when the 
needs of the particular patient require more assessment time from the 
practitioner. In the case of HCPCS code G2252, the additional time 
would be used to determine the necessity of an in person visit result 
in a work time/intensity that is similar to the crosswalk code. We are 
finalizing a work RVU of 0.50, direct PE inputs of 3 minutes of 
clinical labor code L037D, and 1 minute, 15 minutes, and 5 minutes of 
pre, intra and post service time, respectively. As this service is not 
a substitute for an in-person visit, but rather an assessment to 
determine the need for one, the restrictions in section 1834(m) of the 
Act do not apply and the only technological requirement is that the 
communication technology must be synchronous. If this service 
originates from a related E/M service provided within the previous 7 
days or leads to an E/M service or procedure within the next 24 hours 
or soonest available appointment it would be considered bundled into 
that in-person service. We would consider this service to be a CTBS and 
refer readers to the CY 2019 PFS final rule for additional discussion 
as to why these fall outside of the restrictions in 1834(m) of the Act 
(83 FR 59482 through 59491). We also note that HCPCS code GSADX1 is 
subject to the same billing requirements as HCPCS code G2012.
iii. Waiver of Proposed Rulemaking for Provisions
    Under the Administrative Procedure Act (APA), 5 U.S.C. 553(b), an 
agency is generally required to publish a notice and solicit comment on 
a proposed rule in the Federal Register before issuing a final rule. 
Similarly, section 1871(b)(1) of the Act requires the Secretary to 
provide for notice of a proposed rule in the Federal Register and 
provide a period of not less than 60 days for public comment. The APA 
provides for exceptions from the notice and comment requirements see 5 
U.S.C. 553(b)(B); in cases in which the APA exceptions apply, section 
1871(b)(2)(C) of the Act provides for exceptions from the notice and 
60-day comment period requirements of the Act as well. Section 
553(b)(B) of Title 5 and section 1871(b)(2)(C) of the Act authorize an 
agency to dispense with normal rulemaking requirements if the agency 
for good cause finds that the notice and comment process is 
impracticable, unnecessary, or contrary to the public interest.
    We find that there is good cause to waive the notice and comment 
requirements under sections 553(b)(B) of the APA and section 
1871(b)(2)(C) due to widespread concerns expressed by commenters about 
the continuing need for audio-only conversations with patients. We 
believe that establishing payment for this service on an interim basis 
will support access to care for beneficiaries who may be reluctant to 
return to in-person visits unless absolutely necessary, and allow us to 
consider whether this policy should be adopted on a permanent basis. We 
find that it would be impracticable and contrary to the public interest 
to undergo notice and comment procedures before finalizing these 
payment policies on an interim basis. We also find that delaying 
implementation of these policies is unnecessary because the impact on 
other PFS services for 2021 is negligible and the practical alternative 
for this treatment is no payment under Medicare Part B. In either case, 
payments for 2022 and beyond would be informed by public comments.
    Therefore, we find good cause to waive the notice of proposed 
rulemaking as provided under section 1871(b)(2)(C) of the Act and 
section 533(b)(B) of the APA and to issue this interim final rule with 
an opportunity for public comment. We are providing a 60-day public 
comment period as specified in the DATES section of this document.
8. Comment Solicitation on Coding and Payment for Virtual Services
    The health care community uses the term ``telehealth'' broadly to 
refer to medical services furnished via communications 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, we have also established several PFS policies to make 
separate payment for non-face-to-face services included as part of 
ongoing care management. Although all of the kinds of services stated 
above might be called ``telehealth'' by patients, payers of health care 
services, 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.
    In the CY 2021 PFS proposed rule, we noted that 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,

[[Page 84537]]

like professional consultations, office visits, and office psychiatry 
services. Generally, the services we have added to the Medicare 
telehealth services 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).
    In recent years, we have begun making separate payment for a number 
of services that use telecommunications technology but are not 
considered Medicare telehealth services. These CTB services include, 
for example, certain kinds of remote patient monitoring (either as 
separate services or as parts of bundled services), a virtual check-in, 
and a remote asynchronous service. These services are different than 
the kinds of services specified in section 1834(m) of the Act, in that 
they are not the kind of services that are ordinarily furnished in 
person but are routinely furnished using a telecommunications system.
    In the past, we have received requests to add certain services, 
such as chronic care management or remote physiologic monitoring to the 
Medicare telehealth services list. However, as these services fall 
outside the scope of services addressed, and the enumerated list of 
services included, in section 1834(m) of the Act, they are not 
considered telehealth services and, therefore, are not subject to the 
same restrictions. We solicited comment on whether there are additional 
services that fall outside the scope of telehealth services under 
section 1834(m) of the Act where it would be helpful for us to clarify 
that the services are inherently non-face-to-face, so do not need to be 
on the Medicare telehealth services list in order to be billed and paid 
when furnished using telecommunications technology rather than in 
person with the patient present. We also solicited comment on 
physicians' services that use evolving technologies to improve patient 
care that may not be fully recognized by current PFS coding and 
payment, including, for example, additional or more specific coding for 
care management services. Finally, we solicited comment on any 
impediments that contribute to healthcare provider burden and that may 
result in practitioners being reluctant to bill for CTBS. We noted that 
we appreciate the ongoing engagement and additional information from 
stakeholders as we work to improve coding and payment for these 
services that utilize telecommunications technology.
    We received public comments on the comment solicitation on coding 
and payment for virtual services. The following is a summary of the 
comments we received and our responses.
    Comment: Some commenters stated that CMS should provide utilization 
information for CTBS services before, during, and after the PHE. Others 
suggested that CMS establish separate coding and payment for additional 
consultations that may be furnished using communication technology. 
Other comments suggested that CMS issue clear and consistent guidance 
on how to code for and appropriately document both telehealth and CTBS. 
Commenters recommended that CMS collaborate with the AMA to accurately 
value services furnished using communication technology.
    Response: We thank commenters for their input and will consider 
them for potential future rulemaking or future subregulatory guidance, 
as appropriate.
9. Clarification of Current PFS Policies for Telehealth Services
    In response to the waiver of statutory requirements and the 
relaxation of regulatory requirements for telehealth during the PHE for 
COVID-19, we received a number of requests to clarify existing PFS 
policy for telehealth. For example, we received questions as to whether 
Medicare allows incident-to billing for telehealth services, 
particularly for practitioners such as counselors who are supervised by 
a physician in private practice. We noted that there are no Medicare 
regulations that explicitly prohibit eligible distant site 
practitioners from billing for telehealth services provided incident to 
their services. However, we also noted that our existing definition of 
direct supervision requires on-site presence of the billing clinician 
when the service is provided. That requirement could make it difficult 
for a billing clinician to provide the direct supervision of services 
provided via telehealth that is required for services furnished 
incident to their professional services by auxiliary personnel. Under 
the proposed revision to the definition of direct supervision to permit 
virtual presence (FR 85 50114 and 50115), we acknowledged that billing 
practitioners could more easily meet the direct supervision 
requirements for telehealth services provided incident to their 
services. Consequently, we noted that we believe services provided 
incident to the professional services of an eligible distant site 
physician or practitioner could be reported when they meet direct 
supervision requirements at both the originating and distant site 
through the virtual presence of the billing physician or practitioner. 
Therefore, we proposed to clarify that services that may be billed 
incident-to may be provided via telehealth incident to a physicians' 
(or authorized NPP's) service and under the direct supervision of the 
billing professional. This is consistent with a policy clarification 
that we made through the May 8th COVID-19 IFC (85 FR 27562).
    We also received questions as to whether services should be 
reported as telehealth services when the individual physician or 
practitioner furnishing the service is in the same location as the 
beneficiary; for example, if the physician or practitioner furnishing 
the service is in the same institutional setting but is utilizing 
telecommunications technology to furnish the service due to exposure 
risks. We also clarified, as we did in the May 8th COVID-19 IFC (85 FR 
27562), that if audio/video technology is used in furnishing a service 
when the beneficiary and the practitioner are in the same institutional 
or office setting, then the practitioner should bill for the service 
furnished as if it was furnished in person, and the service would not 
be subject to any of the telehealth requirements under section 1834(m) 
of the Act or Sec.  410.78 of our regulations.
    We received public comments on these proposed clarifications of 
current policies for telehealth services. The following is a summary of 
the comments we received and our responses.
    Comment: Several commenters supported our proposal to amend the 
definition of direct supervision to permit supervision through virtual 
presence because it would allow billing practitioners to more easily 
meet the direct supervision requirements for telehealth services 
provided ``incident to'' their services. Commenters stated that this 
policy would expand access to needed care in communities that may not 
have a supervising physician on site, and could make available services 
that another qualified healthcare professional could provide within 
their scope of practice if only they had the necessary direct 
supervision.
    Response: We appreciate commenters' support for this clarification. 
We are

[[Page 84538]]

finalizing our proposed clarification that telehealth services may be 
furnished and billed when provided incident to a distant site 
physicians' (or authorized NPP's) service under the direct supervision 
of the billing professional provided through virtual presence in 
accordance with our regulation at Sec.  410.26.
    Comment: One commenter requested that we specify in detail how time 
should be counted for services furnished and billed incident to the 
commenter's professional services when the required direct supervision 
is provided through virtual presence.
    Response: As we do not provide specific coding guidance, we suggest 
that this commenter refer to the AMA CPT guidelines for using time to 
bill for services furnished and also contact their Medicare 
Administrative Contractor for further assistance. We further note that 
time should be counted for telehealth services furnished by auxiliary 
personnel incident to a billing professional's services in the same way 
time is counted for other ``incident to'' services.
    Comment: Commenters supported our clarification that, if audio/
video technology is used while furnishing a service when the 
beneficiary and the practitioner are in the same institutional or 
office setting, then the practitioner should bill for the service 
furnished as if it was furnished in person. In addition, the service 
would not be subject to any of the telehealth requirements, such as 
geographic or site restrictions. Commenters state that this flexibility 
helps conserve personal protective equipment (PPE) and supports access 
to care.
    Response: We appreciate commenters' support for this clarification.
    Comment: One commenter recommended that CMS institute tracking 
methods to accurately attribute services to the professional who 
delivered the care when submitting services using Medicare's ``incident 
to'' billing provision. They reasoned that, when there is a lack of 
transparency regarding which clinicians are providing what services, it 
is difficult, if not impossible, to appropriately measure the type or 
volume of services or the quality of care delivered by each health 
professional.
    Response: We thank commenters for their feedback and suggestions. 
We note that CMS has very clear rules about when a physician or 
practitioner is permitted to bill for services furnished incident to 
their own. When practitioners bill for their services, they attest to 
the accuracy of the information they provide; and failure to provide 
accurate information can result in civil and criminal liability.
10. Direct Supervision by Interactive Telecommunications Technology
    Many services for which payment is made under the PFS can be 
furnished under a level of physician or NPP supervision rather than 
being performed directly by the billing practitioner. In many cases, 
the supervision requirements necessitate the presence of the physician 
or NPP in a particular location, usually in the same location as the 
beneficiary when the service is provided. For example, as described at 
Sec.  410.26, services furnished by auxiliary personnel incident to a 
physician's or NPP's professional service usually require the direct 
supervision of the physician or NPP. In addition to these ``incident 
to'' services, there are a number of diagnostic services under the PFS 
that also must be furnished under direct supervision. As currently 
defined in Sec. Sec.  410.26 and 410.32(b)(3)(ii), direct supervision 
means that the physician or NPP must be present in the office suite and 
immediately available to furnish assistance and direction throughout 
the performance of the procedure. Direct supervision does not require 
the physician or NPP to be present in the room when the service or 
procedure is performed.
    For the duration of the PHE for COVID-19, for purposes of limiting 
exposure to COVID-19, we adopted an interim final policy revising the 
definition of direct supervision to include virtual presence of the 
supervising physician or practitioner using interactive audio/video 
real-time communications technology (85 FR 19245). We recognized that 
in some cases, the physical proximity of the physician or practitioner 
might present additional infection exposure risk to the patient and/or 
practitioner. In the context of the PHE for COVID-19, given the risks 
of exposure, the immediate risk of foregone medical care, the increased 
demand for healthcare professionals, and the widespread use of 
telecommunications technology, we believed that individual 
practitioners were in the best position to make decisions about how to 
meet the requirement to provide appropriate direct supervision based on 
their clinical judgment in particular circumstances.
    We proposed to extend the policy until the later of the end of the 
calendar year in which the PHE for COVID-19 ends or December 31, 2021, 
to recognize the different and unique circumstances faced by individual 
communities that may continue after the PHE ends, and provide time to 
solicit public input on circumstances where the flexibility to use 
interactive audio/video real-time communications technology to provide 
virtual direct supervision could still be needed and appropriate. The 
extension of this flexibility would allow time for clinicians to make 
adjustments and for us to obtain public input on services and 
circumstances for which this policy might be appropriate on a permanent 
basis. We noted that if the proposal were finalized and the PHE for 
COVID-19 ended before the CY 2021 PFS final rule takes effect, the 
interim policy adopted during the PHE to allow direct supervision using 
real-time, interactive audio and video technology would no longer be in 
effect during the period between expiration of the PHE and the date the 
final policy takes effect.
    Given our continued interaction with practitioners during the PHE 
for COVID-19 and our growing understanding of how services may be 
furnished remotely and safely, we noted that we have a better 
understanding of how, in some cases, depending upon the unique 
circumstances of individual patients and billing practitioners or 
physicians, telecommunications technology could safely allow the 
practitioner or physician's immediate availability to furnish 
assistance and direction without necessarily requiring the supervising 
practitioner's or physician's physical presence in the location where 
the service is being furnished. In such cases, the use of real-time, 
audio and video telecommunications technology may allow the supervising 
practitioner or physician to observe the beneficiary and the auxiliary 
staff performing the service or be engaged (Direct supervision does not 
require the physician or NPP to be present in the room when the service 
or procedure is performed) to provide assistance and direction of the 
service through virtual means, and without the supervising practitioner 
or physician being physically present.
    Consequently, we proposed to revise Sec.  410.32(b)(3)(ii) to allow 
direct supervision to be provided using real-time, interactive audio 
and video technology through the later of the end of the calendar year 
in which the PHE for COVID-19 ends or December 31, 2021. Specifically, 
we proposed to continue our current rule that ``Direct supervision'' in 
the office setting would mean the physician (or other supervising 
practitioner) must be present in the office suite and immediately 
available to furnish assistance and direction throughout the 
performance of the procedure. It would not mean that the physician (or 
other

[[Page 84539]]

supervising practitioner) must be present in the room when the 
procedure is performed. We proposed to add that, until the later of the 
end of the calendar year in which the PHE for COVID-19 ends or December 
31, 2021, the presence of the physician (or other practitioner) may 
include virtual presence through audio/video real-time communications 
technology (excluding audio-only) subject to the clinical judgement of 
the supervising physician or (other supervising practitioner). In 
response to questions received since we issued the interim policy for 
the PHE for COVID-19, we clarified that, to the extent our policy 
allows direct supervision through virtual presence using audio/video 
real-time communications technology, the requirement could be met by 
the supervising physician (or other practitioner) being immediately 
available to engage via audio/video technology (excluding audio-only), 
and would not require real-time presence or observation of the service 
via interactive audio and video technology throughout the performance 
of the procedure.
    While flexibility to provide direct supervision through audio/video 
real-time communications technology was adopted to be responsive to 
critical needs during the PHE for COVID-19 to ensure beneficiary access 
to care, reduce exposure risk and to increase the capacity of 
practitioners and physicians to respond to COVID-19, we expressed 
concern that direct supervision through virtual presence may not be 
sufficient to support PFS payment on a permanent basis, beyond the PHE 
for COVID-19, due to issues of patient safety. For instance, in 
complex, high-risk, surgical, interventional, or endoscopic procedures, 
or anesthesia procedures, a patient's clinical status can quickly 
change, and we believe it is necessary for such services to be 
furnished or supervised in person to allow for rapid on-site decision-
making in the event of an adverse clinical situation. For example, 
there could be a case in which a practitioner or physician uses audio/
video interactive communications to virtually supervise a nurse 
performing a post-op evaluation following surgery for hip fracture, and 
the nurse might note that the patient is uncooperative. In this 
scenario, had a full exam been performed directly by the practitioner 
or physician, or under the in-person supervision of a practitioner or 
physician who was physically or immediately available in the clinic to 
provide the necessary direction, the physician or practitioner would 
have recognized that the patient exhibited signs of crystal-mediated 
acute arthritis, and that the patient's lack of cooperation was likely 
due to hypoactive delirium. Instead, the supervising practitioner or 
physician may not have been able to identify this clinical issue as a 
result of being available only via audio/video interactive 
communications technology. In this case, the presence of the 
supervising practitioner or physician through audio/video interactive 
communications technology would have been insufficient. There also may 
be certain patient populations that require greater clinical 
attentiveness and skill than the supervising practitioner or physician 
could provide via audio/video interactive communications technology. 
For example, patients with cognitive impairment or dementia, or 
patients with communication disabilities, may require the experience 
and skill of a physically present supervising practitioner or physician 
to recognize needs such as the need for specialized testing. It may not 
be possible for a supervising practitioner or physician to recognize or 
meet these clinical needs while being present for the service only 
through audio/video interactive communications technology. Moreover, 
the virtual connection between the individual performing the service 
and the supervising practitioner or physician could be disrupted, 
making it challenging for the supervising practitioner or physician to 
remain immediately available to provide assistance and direction to the 
physically present clinical staff or auxiliary personnel to furnish 
appropriate care to the patient.
    We solicited information from commenters as to whether there should 
be any additional ``guardrails'' or limitations to ensure patient 
safety/clinical appropriateness, beyond typical clinical standards, as 
well as restrictions to prevent fraud or inappropriate use if we were 
to finalize a policy to permit direct supervision through audio/video 
interactive communications technology, with consideration of relevant 
patient safety, clinical appropriateness criteria or other 
restrictions, on a temporary basis through the later of the end of the 
calendar year in which the PHE for COVID-19 ends or December 31, 2021, 
or consider it beyond the time specified. We solicited information on 
what risks this policy might introduce to beneficiaries as they receive 
care from practitioners that would supervise care virtually in this 
way. Further, we solicited comment on potential concerns around induced 
utilization and fraud, waste, and abuse and how those concerns might be 
addressed. We also invited commenters to provide data and information 
about their implementation experience with direct supervision using 
virtual presence during the PHE for COVID-19, and are interested in 
comments on the degree of aging and disability competency training that 
is required for effective use of audio/video real-time communications 
technology.
    We received public comments on the direct supervision by 
interactive telecommunications technology. The following is a summary 
of the comments we received and our responses.
    Comment: Commenters supported our proposal to revise the definition 
of direct supervision to allow virtual presence of the supervising 
physician or practitioner using real-time, interactive audio-video 
technology until the later of the end of the calendar year in which the 
PHE for COVID-19 ends or December 31, 2021, stating that this revision 
will greatly help reduce barriers to access, and that allowing 
physicians and auxiliary personnel to provide services from two 
separate locations will work to support the expansion of telehealth 
services and protects frontline workers by allowing appropriate social 
distancing.
    Response: We thank the commenters for their support and feedback.
    Comment: Many commenters requested that CMS make permanent the 
current temporary regulatory flexibility allowing physicians to provide 
direct supervision of clinical staff virtually, using real-time audio/
video technology. Others opposed the use of virtual direct supervision 
following the termination of the PHE due to issues of patient safety, 
stating it may not be possible for a supervising physician to recognize 
or meet urgent clinical needs while being present for the service, and 
potentially other services at the same time, only through audio/video 
interactive communications technology.
    We also received a variety of responses to our stated concerns that 
direct supervision through virtual presence may not be sufficient to 
support PFS payment on a permanent basis, beyond the PHE for COVID-19, 
due to issues of patient safety. Many commenters did not share these 
concerns, stating that there is no situation whereby clinical staff or 
auxiliary personnel would conduct complex, high-risk, surgical, 
interventional, or endoscopic procedures under any circumstance other 
than in-person. Many other commenters shared our patient-safety 
concerns, citing increased utilization and spending, and the potential 
for

[[Page 84540]]

fraud and abuse. Many stressed that virtual supervision can be done 
safely in certain scenarios, but it is not warranted in other 
scenarios. More specifically, some commenters said remote supervision 
would not be appropriate for in-person diagnostic or therapeutic 
procedures since the physician would not be physically available to 
help the individual being supervised if the need arises. Similarly, 
commenters suggested that it may not be appropriate when a remote 
physician is not on-site for an E/M service that requires finesse when 
performing the physical examination in person. According to some 
commenters, virtual direct supervision would not be appropriate for 
data interpretation, such as imaging studies or certain physiologic 
studies, where the patient is not physically present. A commenter 
agreed with the agency's assessment that anesthesia services must be 
furnished or supervised in person to allow for rapid, on-site decision-
making in the event of an adverse clinical situation. One commenter 
recommended that CMS provide clarifying language in the final rule to 
ensure that the supervising physician is in the United States when 
using audio-visual technology for purposes of direct supervision.
    Commenters offered a range of responses and suggestions in the 
interest of patient safety and program integrity in response to our 
request for information as to whether there should be any additional 
``guardrails'' or limitations to ensure patient safety/clinical 
appropriateness, beyond typical clinical standards, as well as 
restrictions to prevent fraud or inappropriate use, if we were to 
finalize a policy to permit direct supervision through audio/video 
interactive communications technology on a temporary basis. According 
to some commenters, we should defer entirely to physician judgment to 
determine clinical appropriateness. Others offered suggestions 
including that we should closely monitor the use of virtual direct 
supervision during the interim period to gain information on potential 
induced utilization or fraud, waste, and abuse concerns. Some 
commenters stated that virtual direct supervision should be robustly 
documented to ensure that patients are safely receiving clinically 
appropriate care from members of the care team. A commenter stated that 
program integrity concerns could be addressed through provider 
enrollment rather than through administrative barriers. Other 
suggestions included: That CMS develop a list of high risk procedures 
and complex patient populations for whom this policy may not be 
appropriate; that CMS limit the number of clinicians with whom a 
supervising physician may simultaneously engage, as well as the number 
of incident-to relationships in which a supervising physician may be 
involved at a given time, via audio/video technology; that testing 
sites that use interactive technologies rely on documentation and 
training; that we require that a caregiver be present physically with 
the patient when the services are furnished virtually; and that CMS 
identify conditions under which the extension of the virtual direct 
supervision policy may be revoked if evidence suggests such supervision 
is inadequate.
    Response: We appreciate the information and suggestions we received 
in response to this request for comment. This information will allow us 
to consider safety and program integrity issues in the context of 
virtual supervision, and to what degree and on what basis this 
flexibility could be continued following the PHE. We will consider this 
and other information as we determine future policy regarding use of 
communication technology to satisfy direct supervision requirements as 
well as the best approach for safeguarding patient safety while 
promoting use of technology to enhance access.
    After consideration of the comments, we are finalizing our proposal 
to allow direct supervision to be provided using real-time, interactive 
audio and video technology through the later of the end of the calendar 
year in which the PHE for COVID-19 ends or December 31, 2021.
11. Comment Solicitation on PFS Payment for Specimen Collection for 
COVID-19 Tests
    When physicians and other practitioners collect specimens for 
clinical diagnostic laboratory tests as part of their professional 
services, Medicare generally makes payment for the services under the 
PFS, though often that payment is bundled into the payment rate for 
other services, including office and outpatient visits. Typically, 
collection of a specimen via nasal swab or other method during the 
provision of a service might be reported as part of (bundled with) an 
O/O E/M visit (CPT codes 99201 through 99205, 99211 through 99215). In 
visits where a patient has a face-to-face interaction with a billing 
professional with whom they have an established relationship, these 
services are generally reported with a level 2 through a level 5 visit 
(CPT codes 99212 through 99215). In cases where the specimen is 
collected during a visit where the face-to-face interaction only 
involves clinical staff of the billing professional with whom the 
patient has an established relationship, these services are generally 
reported using CPT code 99211.
    In the May 8th COVID-19 IFC (85 FR 27604-27605), we finalized on an 
interim basis that physicians and NPPs may use CPT code 99211 to bill 
for services furnished incident to their professional services, for 
both new and established patients, when clinical staff assess symptoms 
and collect specimens for purposes of COVID-19 testing, if the billing 
practitioner does not also furnish a higher level E/M service to the 
patient on the same day. In the CY 2021 PFS proposed rule, we noted 
that we considered whether to extend or make permanent the policy to 
allow physicians and NPPs to use CPT code 99211 to bill for services 
furnished incident to their professional services, for both new and 
established patients, when clinical staff assess symptoms and collect 
specimens for purposes of COVID-19 testing, and solicited public 
comments on whether we should continue this policy for a period of 
time, or permanently, after the PHE for COVID-19 ends.
    We received public comments in response to our comment solicitation 
on PFS payment for specimen collection for COVID-19 tests. We 
appreciate the information and feedback provided. We will consider this 
information for potential future rulemaking.
12. Finalization of Interim Final Rule Provisions Related to 
Requirements of the Substance Use Disorder (SUD) Prevention That 
Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and 
Communities Act
a. Expanding Medicare Telehealth Services for the Treatment of Opioid 
Use Disorder and Other SUDs
    In the CY 2019 PFS interim final rule with comment period (83 FR 
59452, 59496, Nov. 23, 2018), we implemented on an interim final basis 
the amendments made by section 2001(a) of the SUPPORT for Patients and 
Communities Act (Pub. L. 115-271, October 24, 2018) (the SUPPORT Act) 
to section 1834(m) of the Act. First, section 2001(a) of the SUPPORT 
Act removed the originating site geographic requirements under section 
1834(m)(4)(C)(i) of the Act for telehealth services furnished on or 
after July 1, 2019 for the purpose of treating individuals diagnosed 
with a SUD or a co-occurring mental health disorder, as determined by 
the Secretary, at an originating site described in section

[[Page 84541]]

1834(m)(4)(C)(ii) of the Act, other than an originating site described 
in subclause (IX) of section 1834(m)(4)(C)(ii) of the Act. Subclause 
(IX) of section 1834(m)(4)(C)(ii) of the Act refers to a renal dialysis 
facility, which is only an allowable originating site for purposes of 
home dialysis monthly ESRD-related clinical assessments in section 
1881(b)(3)(B) of the Act. Section 2001(a) of the SUPPORT Act also added 
the home of an individual as a permissible originating site for 
telehealth services for the purpose of treating individuals diagnosed 
with a SUD or a co-occurring mental health disorder. Section 2001(a) of 
the SUPPORT Act also amended section 1834(m)(2)(B)(ii) of the Act to 
require that no originating site facility fee will be paid in instances 
when the individual's home is the originating site. Section 2001(b) of 
the SUPPORT Act granted the Secretary specific authority to implement 
the amendments made by section 2001(a) through an interim final rule, 
and under that authority, we issued such an interim final rule. In 
accordance with section 1834(m)(4)(C)(ii)(X) of the Act, as amended by 
section 2001(a) of the SUPPORT for Patients and Communities Act, we 
revised Sec.  410.78(b)(3) on an interim final basis, by adding Sec.  
410.78(b)(3)(xii), which adds the home of an individual as a 
permissible originating site for telehealth services furnished on or 
after July 1, 2019 to individuals with a SUD diagnosis for purposes of 
treatment of a SUD or a co-occurring mental health disorder. We amended 
Sec.  414.65(b)(3) on an interim final basis 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 individual's home. Additionally, we added Sec.  410.78(b)(4)(iv)(C) 
on an interim final basis to specify that the geographic requirements 
in section 1834(m)(4)(C)(i) of the Act do not apply for telehealth 
services furnished on or after July 1, 2019, to individuals with a SUD 
diagnosis for purposes of treatment of a SUD or a co-occurring mental 
health disorder at an originating site other than a renal dialysis 
facility. We noted that section 2001 of the SUPPORT Act 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. We also noted that 
practitioners would be responsible for assessing whether individuals 
have a SUD diagnosis and whether it would be clinically appropriate to 
furnish telehealth services for the treatment of the individual's SUD 
or a co-occurring mental health disorder. By billing codes on the 
Medicare telehealth list with the telehealth place of service code, 
practitioners would be indicating that the codes billed were used to 
furnish telehealth services to individuals with a SUD diagnosis for the 
purpose of treating the SUD or a co-occurring mental health disorder.
    Comment: Several commenters expressed support for the changes 
authorized by section 2001(a) of the SUPPORT Act, noting that these 
changes that will benefit beneficiaries and advance the use of 
telehealth as a critical tool to improving access to care. One 
commenter noted that the changes will mitigate barriers to treatment 
for this patient population, decreasing stigma associated with seeking 
mental health and SUD services caused by presenting at a qualified 
originating site, allow patients to receive services at home, and open 
access to telehealth services for patients living in urban areas.
    Response: We thank the commenters for their comments.
    Comment: A few commenters urged CMS to consider expanding this 
flexibility to beneficiaries without SUDs, particularly those with 
mental health disorders without a co-occurring SUD.
    Response: The interim final changes we adopted to our regulations 
under Sec.  410.78 described above were based on amendments to the 
statute made by section 2001(a) of the SUPPORT Act. These amendments 
were limited to telehealth services furnished to individuals diagnosed 
with a SUD for purposes of treatment of the SUD or a co-occurring 
mental health disorder. We do not have the statutory authority at this 
time to expand these changes to include treatment of mental health 
disorders that are not co-occurring with a SUD diagnosis.
    Comment: A few commenters urged CMS to ensure that the full scope 
of both SUD treatment services and applicable services for the 
treatment of co-occurring mental health disorders are included in the 
Medicare telehealth list in the future, citing examples such as 
screening, counseling, consultation, psychiatric services, care 
planning, initiation and continued management of Medication-Assisted 
Treatment (MAT), and others.
    Response: Thank you for your comment. We note that HCPCS codes 
G2086, G2087, and G2088 were added to the Medicare Telehealth list 
beginning in CY 2020 (84 FR 62628). These codes describe bundled 
payments for office-based treatment for opioid use disorder, including 
development of the treatment plan, care coordination, individual 
therapy, and group therapy and counseling. We note that for CY 2021, we 
are finalizing a revision to these code descriptions to include the 
treatment of any substance use disorder rather than just OUD. See 
discussion in this final rule describing expansion of these codes to be 
inclusive of all SUDs beginning in CY 2021. Also, as discussed earlier 
in this final rule, we are finalizing the addition of CPT codes 99347 
and 99348 (Home visit for the evaluation and management of an 
established patient) to the Medicare Telehealth list for CY 2021, which 
could be appropriately billed for treatment of an SUD or co-occurring 
mental health disorder, as well as CPT code 90853 (Group 
psychotherapy). We welcome recommendations of other codes for addition 
to the Medicare Telehealth list through our usual process by the 
February 10th deadline.
    Comment: One commenter encouraged CMS to amend section 
1834(m)(4)(f) of the Act to include MAT and remote opioid treatment as 
covered services on the Medicare telehealth list in order to provide 
the care needed to all patients with SUDs, including Opioid Use 
Disorder.
    Response: We do not have the authority to amend the statute; 
however, the services associated with the provision of MAT in the 
office setting, such as E/M visits and psychotherapy, are on the 
Medicare Telehealth List.
    Comment: One commenter cautioned against creating any 
administrative procedures that would complicate billing for these 
services when furnished via telehealth, which could create a barrier to 
implementation and stifle the ability of telehealth to be used 
effectively to facilitate SUD and co-occurring mental health services, 
while another commenter stated that CMS should publish clear sub-
regulatory guidance on how the current Medicare telehealth services can 
be billed when treating SUD.
    Response: As discussed in the CY 2019 PFS interim final rule with 
comment period (83 FR 59496), we noted that practitioners are 
responsible for assessing whether individuals have a SUD diagnosis and 
whether it would be clinically appropriate to furnish telehealth 
services for the treatment of the individual's SUD or a co-occurring 
mental health disorder. By billing codes on the Medicare telehealth 
list with the telehealth place of service code, practitioners would be 
indicating that the codes billed were used to furnish telehealth 
services to individuals with a SUD diagnosis for the purpose of

[[Page 84542]]

treating the SUD or a co-occurring mental health disorder.
    In summary, after consideration of the comments, we are finalizing 
the interim revisions to the regulation text at Sec. Sec.  410.78(b)(3) 
and 414.65(b)(3) described above.

E. Care Management Services and Remote Physiologic Monitoring Services

1. Background
    In recent years, we have updated PFS policies to improve payment 
for care management and coordination. Working with the CPT Editorial 
Panel and other clinicians, we have expanded the suite of codes 
describing these services. New CPT codes were created that describe 
services that involve direct patient contact (for some services, in-
person) or do not involve direct patient contact; represent a single 
encounter, monthly service, or both; are timed services; address 
specific conditions; and represent the work of the billing 
practitioner, auxiliary personnel (specifically, clinical staff), or 
both (see Table 17). In this final rule for CY 2021, we continue our 
work to improve payment for care management services through code 
refinements related to remote physiologic monitoring (RPM), 
transitional care management (TCM), and psychiatric collaborative care 
model (CoCM) services.
[GRAPHIC] [TIFF OMITTED] TR28DE20.028

2. Digitally Stored Data Services/Remote Physiologic Monitoring/
Treatment Management Services (RPM)
    RPM involves the collection and analysis of patient physiologic 
data that are used to develop and manage a treatment plan related to a 
chronic and/or acute health illness or condition. In recent years, we 
have finalized payment for seven CPT codes in the RPM code family. Five 
of the seven codes have been the focus of frequent questions from 
stakeholders.
    In response to proposals in the CY 2019 PFS proposed rule (83 FR 
35771) and the CY 2020 PFS proposed rule (84 FR 40555 through 40556), 
stakeholders requested that we clarify how we interpret aspects of the 
RPM code descriptors for CPT codes 99453, 99454, 99091, and 99457. 
Commenters asked us, for example, to identify who can furnish RPM 
services, what kinds of devices can be used to collect data, how data 
should be collected, and how ``interactive communication'' is defined. 
We stated in the CY 2020 PFS final rule (84 FR 62697) that we would 
provide guidance in the future about the codes. For CY 2021, we are 
clarifying how we

[[Page 84543]]

read CPT code descriptors and instructions associated with CPT codes 
99453, 99454, 99091, and 99457 (and the add-on code, CPT code 99458) 
and their use for remote monitoring of physiologic parameters of a 
patient's health.
    The RPM process begins with two PE only codes, CPT codes 99453 and 
99454, finalized in the CY 2019 PFS final rule (83 FR 59574 through 
59576). As PE only codes, they are valued to include clinical staff 
time, supplies, and equipment, including the medical device for the 
typical case of remote monitoring. CPT code 99453 (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) is valued to reflect clinical staff time that includes 
instructing a patient and/or caregiver about using one or more medical 
devices. CPT code 99454 (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) is valued to include the medical 
device or devices supplied to the patient and the programming of the 
medical device for repeated monitoring. We reviewed the PE inputs for 
CPT code 99454 in the proposed rule and clarified that the medical 
devices that are supplied to the patient and used to collect 
physiologic data are considered equipment and, as such, are direct PE 
inputs for the code.
    Review of CPT prefatory language (CPT[supreg] 2021 Professional 
Codebook (hereafter, CPT Codebook), pp. 52-53) provides additional 
information about the two PE-only codes. For example, the CPT prefatory 
language indicates that monitoring must occur over at least 16 days of 
a 30-day period in order for CPT codes 99453 and 99454 to be billed. 
Additionally, these two codes are not to be reported for a patient more 
than once during a 30-day period. This language suggests that even when 
multiple medical devices are provided to a patient, the services 
associated with all the medical devices can be billed only once per 
patient per 30-day period and only when at least 16 days of data have 
been collected. We also noted that CPT code 99453 can be billed only 
once per episode of care where an episode of care is defined as 
``beginning when the remote physiologic monitoring service is initiated 
and ends with attainment of targeted treatment goals'' (CPT Codebook, 
p. 52).
    Other stakeholder inquiries about CPT codes 99453 and 99454 focused 
upon the kinds of medical devices that can be used to collect a 
patient's physiologic data. Prefatory language in the CPT Codebook 
states that ``the device must be a medical device as defined by the 
FDA.'' CPT simply specifies that the device must meet the FDA's 
definition of a medical device as described in section 201(h) of the 
Federal, Food, Drug and Cosmetic Act (FFDCA). As discussed in the CY 
2021 PFS proposed rule (85 FR 50118), we found no language in the CPT 
Codebook indicating that a medical device must be FDA cleared as some 
stakeholders suggested, although such clearance may be appropriate. We 
also noted that we did not find information that suggested a medical 
device must be prescribed by a physician, although this could be 
possible depending upon the medical device. Beyond acknowledging the 
CPT specification that the medical device supplied for CPT code 99454 
must meet the FDA definition of a medical device, we clarified in the 
proposed rule that the medical device should digitally (that is, 
automatically) upload patient physiologic data (that is, data are not 
patient self-recorded and/or self-reported). We also noted that use of 
the medical device or devices that digitally collect and transmit a 
patient's physiologic data must, as usual for most Medicare covered 
services, be reasonable and necessary for the diagnosis or treatment of 
the patient's illness or injury or to improve the functioning of a 
malformed body member. Further, we noted that the device must be used 
to collect and transmit reliable and valid physiologic data that allow 
understanding of a patient's health status in order to develop and 
manage a plan of treatment.
    The CPT Codebook lists the RPM codes under the main heading 
Evaluation and Management (E/M). We clarified in the proposed rule that 
as E/M codes, CPT codes 99453, 99454, 99091, 99457, and 99458, can be 
ordered and billed only by physicians or NPPs who are eligible to bill 
Medicare for E/M services.
    Although we initially described RPM services in the CY 2019 PFS 
final rule (83 FR 59574) as services furnished to patients with chronic 
conditions, we clarified in the CY 2021 PFS proposed rule (85 FR 50118) 
that practitioners may furnish these services to remotely collect and 
analyze physiologic data from patients with acute conditions as well as 
from patients with chronic conditions.
    After the data collection period for CPT codes 99453 and 99454, the 
physiologic data that are collected and transmitted may be analyzed and 
interpreted as described by CPT code 99091, a code that includes only 
professional work (that is, there are no direct PE inputs). We 
finalized 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, each 30 days) in the CY 2018 PFS final 
rule (82 FR 53013 through 53014). The valuation for CPT code 99091 
includes a total time of 40 minutes of physician or NPP work, broken 
down as follows: 5 minutes of preservice work (for example, chart 
review); 30 minutes of intra-service work (for example, data analysis 
and interpretation, report based upon the physiologic data, as well as 
a possible phone call to the patient); and 5 minutes of post-service 
work (that is, chart documentation). We noted that stakeholders have 
expressed confusion about the specification in the code descriptor for 
CPT code 99091 that the service is furnished by a ``physician or other 
qualified health care professional, qualified by education, training, 
licensure/regulation.'' The phrase ``physician or other qualified 
health care professional'' is defined by CPT as ``an individual who is 
qualified by education, training, licensure/regulation (when 
applicable) and facility privileging (when applicable) who performs a 
professional service within his/her scope of practice and independently 
reports that professional service. These professionals are distinct 
from ``clinical staff . . . [which refers to] a person who works under 
the supervision of a physician or other qualified health care 
professional and who is allowed by law, regulation, and facility policy 
to perform or assist in the performance of a specified professional 
service but does not individually report that professional service.'' 
\3\ Accordingly, when referring to a particular service described by a 
CPT code for Medicare purposes, a physician or other qualified health 
care professional is an individual whose scope of practice and Medicare 
benefit category includes the service, and who is authorized to 
independently bill Medicare for the service. See our previous 
discussion of this in the CY 2016 PFS final rule at 80 FR 70957. 
Medicare also covers and makes payment for certain services performed 
by auxiliary personnel (which includes

[[Page 84544]]

clinical staff) ``incident to'' the professional services of the 
billing practitioner. Our regulation at Sec.  410.26(a) defines 
auxiliary personnel and delineates the conditions for payment for 
``incident to'' services.
---------------------------------------------------------------------------

    \3\ CPT Codebook, p. xiv.
---------------------------------------------------------------------------

    After analyzing and interpreting a patient's remotely collected 
physiologic data, we noted that the next step in the process of RPM is 
the development of a treatment plan that is informed by the analysis 
and interpretation of the patient's data. It is at this point that the 
physician or NPP develops a treatment plan with the patient and/or 
caregiver (that is, develops a patient-centered plan of care) and then 
manages the plan until the targeted goals of the treatment plan are 
attained, which signals the end of the episode of care. CPT code 99457 
(Remote physiologic monitoring treatment management services, clinical 
staff/physician/other qualified health care professional time in a 
calendar month requiring interactive communication with the patient/
caregiver during the month; first 20 minutes) and its add-on code, CPT 
code 99458 (Remote physiologic monitoring treatment management 
services, clinical staff/physician/other qualified health care 
professional time in a calendar month requiring interactive 
communication with the patient/caregiver during the month; each 
additional 20 minutes (list separately in addition to code for primary 
procedure)) describe the treatment and management services associated 
with RPM. Medicare stakeholders have requested that we clarify aspects 
of these two codes. The two most frequently asked questions include 
``Who can furnish the services described by CPT codes 99457 and 99458? 
'' and ``What does it mean to have an `interactive communication' with 
a patient? ''
    We addressed who can furnish CPT codes 99457 and 99458 in the CY 
2020 PFS final rule (84 FR 62697 through 62698) when we designated both 
codes as care management services. We explained that, like other care 
management services, services described by CPT codes 99457 and 99458 
can be furnished by clinical staff under the general supervision of the 
physician or NPP. We noted that RPM services are not considered to be 
diagnostic tests; that is, they cannot be furnished and billed by an 
Independent Diagnostic Testing Facility on the order of a physician or 
NPP.
    The services described by CPT codes 99457 and 99458 are services 
that are typically furnished remotely using communications technologies 
that allow ``interactive communication,'' which we read as real-time 
interaction, between a patient and the physician, NPP, or clinical 
staff who provide the services. Stakeholders have requested that we 
define ``interactive communication'' as used in the code descriptors 
for CPT codes 99457 and 99458. We explained in the proposed rule that 
we saw this remote, non-face-to-face exchange as being similar to the 
exchange that occurs in providing services described by HCPCS code 
G2012, Brief Communication Technology-Based Service, which we finalized 
in the CY 2019 PFS final rule (83 FR 59483 through 59486). We clarified 
that ``interactive communication'' for purposes of CPT codes 99457 and 
99458 involves, at a minimum, a real-time synchronous, two-way audio 
interaction that is capable of being enhanced with video or other kinds 
of data transmission. As indicated in the code descriptor for CPT code 
99457, we believed during the writing of the proposed rule that the 
interactive communication should total at least 20 minutes of time with 
the patient over the course of a calendar month for CPT code 99457 to 
be reported. Each additional 20 minutes of interactive communication 
between the patient and the physician/NPP/clinical staff would be 
reported using CPT code 99458. We developed our definition of time 
using the CPT Codebook. The CPT Codebook states that unless there are 
code- or code-range specific instructions, parenthetical instructions, 
or code descriptors to the contrary, time is considered to be ``face-
to-face'' time with the patient or patient's caregiver/medical 
decision-maker. See the CPT Codebook, page xvii for more information 
about measuring time. Although the services described by CPT codes 
99457 and 99458 are not typically in-person services, we interpreted 
time in the code descriptor to mean the time the practitioner spent in 
direct, real-time interactive communication with a patient.
    Lastly, we proposed to establish as permanent policy two of the 
changes we made on an interim basis to the requirements for furnishing 
RPM services in the March 31st and the May 8th COVID-19 IFCs. (See 85 
FR 19264 and 85 FR 27605 through 27606 for the interim modifications 
and clarifications to RPM services in response to the PHE for COVID-
19).
    Our goals during the PHE for COVID-19 have been to reduce exposure 
risks to the virus for practitioners and patients while also increasing 
access to health care services. We eliminated as many obstacles as 
possible to allow timely delivery of reasonable and necessary health 
care. We wanted patients to be able to access services quickly and 
without barriers. With the goals of reducing exposure and increasing 
access to services, we finalized that RPM services could be furnished 
to new patients, as well as established patients on an interim basis 
for the duration of the PHE for COVID-19. We also finalized several 
policies on an interim basis for the duration of the PHE for COVID-19. 
These include: (1) Allowing consent to be obtained at the time services 
are furnished; (2) allowing consent to be obtained by individuals 
providing RPM services under contract with the billing physician or 
practitioner; and (3) allowing RPM codes to be billed for a minimum of 
2 days of data collection over a 30-day period, rather than the 
required 16 days of data collection over a 30-day period as provided in 
the CPT code descriptors.
    For CY 2021, we proposed on a permanent basis to allow consent to 
be obtained at the time that RPM services are furnished. Because the 
CPT code descriptors do not specify that clinical staff must perform 
RPM services, we also proposed to allow auxiliary personnel (which 
includes other individuals who are not clinical staff but are employees 
or leased or contracted employees) to furnish services described by CPT 
codes 99453 and 99454 under the general supervision of the billing 
physician or practitioner.
    When the PHE for COVID-19 ends, we again will require that RPM 
services be furnished only to an established patient. We believe that a 
physician or practitioner who has an established relationship with a 
patient would likely have had an opportunity to provide a new patient 
E/M service. During the new patient E/M service, the physician or 
practitioner would have collected relevant patient history and 
conducted a physical exam, as appropriate. As a result, the physician 
or practitioner would possess information needed to understand the 
current medical status and needs of the patient prior to ordering RPM 
services to collect and analyze the patient's physiologic data and to 
develop a treatment plan. Additionally, and in keeping with the CPT 
prefatory language for CPT codes 99453 and 99454, when the PHE for 
COVID-19 ends, we will once again require that 16 days of data be 
collected within 30 days to meet the requirements to bill CPT codes 
99453 and 99454.
    In response to the May 19, 2020 E.O. 13924, ``Regulatory Relief To 
Support Economic Recovery,'' (85 FR 31353 through 31356), we solicited 
comment from the medical community and other members of the public on 
whether

[[Page 84545]]

current RPM coding accurately and adequately describes the full range 
of clinical scenarios where RPM services may be of benefit to patients. 
We requested information that would help us to understand whether it 
would be beneficial to consider establishing coding and payment rules 
that would allow practitioners to bill and be paid for RPM services 
with shorter monitoring periods. We expressed interest in understanding 
whether one or more codes that describe a shorter duration, for 
example, 8 or more days of remote monitoring within 30 days, might be 
useful. For example, CPT codes 99453 and 99454 currently require use of 
a medical device as defined by the FDA in section 201(h) of FFDCA that 
digitally collects and transmits 16 or more days of data every 30 days 
in order for the codes to be billed; however, some patients may not 
require remote monitoring for 16 or more days in a 30-day period. For 
some patients, continuous short-term monitoring might be more 
appropriate. For example, a post-surgical patient who is recovering at 
home might benefit from remote monitoring of his or her body 
temperature as a means of assessing infection and managing medications 
or dosage. In some clinical situations, monitoring several times 
throughout a day, over a period of 10 days, may be reasonable and 
necessary. Sixteen or more days might be unnecessary. We requested 
information that would help us to understand whether it would be 
beneficial to consider establishing coding and payment rules that would 
allow practitioners to bill and be paid for RPM services with shorter 
monitoring periods. Specifically, we were interested in understanding 
whether one or more codes that describe a shorter duration, for 
example, 8 or more days of remote monitoring within 30 days, might be 
useful. We welcomed comments including any additional information that 
the medical community and other members of the public believe might 
provide further clarification on how RPM services are used in clinical 
practice, and how they might be coded, billed, and valued under the 
Medicare PFS.
    We received public comments on our clarifications and proposals 
related to digitally stored data services/remote physiologic 
monitoring/treatment management services. The following is a summary of 
comments we received and our responses.
    Comment: Overall, commenters expressed appreciation and support for 
the clarifications proposed by CMS regarding RPM CPT codes 99453, 
99454, 99091, and 99457 (and the add-on code, CPT code 99458).
    Response: We thank commenters for their support, as well as for 
suggesting additional ways we might interpret the RPM codes. We hope to 
continue this dialogue as CPT creates more RPM codes.
    Comment: A group of commenters disagreed with our clarification 
that CPT codes 99453, 99454, 99091, 99457, and 99458 can be ordered and 
billed only by physicians and NPPs who are eligible to bill Medicare 
for E/M services. Some commenters suggested that we allow the CPT 
Editorial Panel and the RUC to establish appropriate coding for other 
practitioners.
    Response: We believe that as E/M codes, CPT codes 99453, 99454, 
99091, 99457, and 99458, can be ordered and billed only by physicians 
or NPPs who are eligible to bill Medicare for E/M services. We agree 
with commenters that additional coding would be necessary, specifically 
for practitioners who cannot order and bill E/M services.
    Comment: Commenters disagreed with our suggestion that CPT codes 
99091 and 99457 can be billed together. Commenters reported that these 
two codes are incompatible and cannot be reported in the same calendar 
month or in conjunction with one another.
    Response: We continue to believe that, if reasonable and necessary, 
CPT codes 99091 (Collection & interpretation physiologic data) and 
99457 (Remote physiologic monitoring treatment management), given their 
descriptions of services in the CPT Codebook, could be reported for the 
same patient. We believe the two codes, as currently described, provide 
different types of services. We agree with commenters that the CPT 
Codebook states on page 53, ``Do not report 99091 in conjunction with 
99457.'' However, the next section states, ``Do not report 99091 for 
time in a calendar month when used to meet the criteria for 99339, 
99340, 99374, 99375, 99377, 99378, 99379, 99380, 99457, and 99491.'' We 
note that these two statements suggest that there may be instances 
where both codes could be billed for the same patient in the same month 
as long as the same time was not used to meet the criteria for both CPT 
codes 99091 and 99457. We remind readers that the valuation for CPT 
code 99091 includes a total time of 40 minutes of physician or NPP work 
broken down as follows: 5 minutes of pre-service work (for example, 
chart review); 30 minutes of intra-service work (for example, data 
analysis and interpretation, report based upon the physiologic data, as 
well as a possible phone call to the patient); and 5 minutes of post-
service work (that is, chart documentation). We believe that in some 
instances when complex data are collected, more time devoted 
exclusively to data analysis and interpretation by a physician or NPP 
may be necessary such that the criteria could be met to bill for both 
CPT codes 99091 and 99457 within a 30-day period. The medically 
necessary services associated with all the medical devices for a single 
patient can be billed by only one practitioner, only once per patient 
per 30-day period, and only when at least 16 days of data have been 
collected.
    Comment: Commenters suggested that other devices that do not meet 
the FDA's definition of medical device, but collect physiologic data, 
should satisfy the requirements of RPM services.
    Response: We disagree with the commenters. The prefatory language 
and code descriptors developed by the CPT Editorial Panel indicate the 
device must meet the FDA definition of a medical device as found in 
section 201(h) of the FFDCA.
    Comment: One commenter stated that a coding gap exists between 
physiologic and non-physiologic remote monitoring and stated that 
additional coding is required for non-physiologic parameters.
    Response: We thank the commenter for this insight. We look forward 
to engaging with stakeholders on this topic to inform how we might 
consider a ``coding gap'' that exists for services related to remote 
monitoring for non-physiologic measures of health.
    Comment: Several commenters suggested that CMS should allow RPM 
services to be furnished to new patients, as well as to established 
patients. Other commenters supported our decision to require that 
patients be known to the practitioner (established patients) prior to 
the start of RPM services.
    Response: We continue to believe that a physician or NPP who has an 
established relationship with a patient would possess the information 
needed to understand the current medical status and needs of the 
patient prior to ordering RPM services to collect and analyze the 
patient's physiologic data and to develop a treatment plan. We note 
that during the PHE for COVID-19, RPM services may be furnished and 
billed for both new and established patients. We refer readers to the 
March 31st COVID-19 IFC (85 FR 19264) where we adopted the policy on an 
interim basis for the duration of the PHE for COVID-19 that RPM 
services could be furnished to new patients as well as established 
patients.

[[Page 84546]]

    After considering public comments, we are not extending this 
interim policy beyond the end of the PHE for COVID-19. At the 
conclusion of the PHE, there will need to be an established patient-
practitioner relationship in order to bill Medicare for CPT codes 
99453, 99454, 99457, and 99458.
    Comment: Some commenters suggested that we permit fewer than the 
required 16 days of monitoring per month that are required to bill CPT 
codes 99453 and 99454. One commenter indicated that patients and health 
care personnel are served best by a maximum data collection requirement 
of 6 days. Another commenter stated that the 8 days we suggested would 
be best. Another commenter suggested that at least 16 days of data 
should be required, and when 16 days of data are not collected within 
the 30-day period, that a modifier should be reported as a means of 
communicating that the service duration was reduced with an associated 
reduction in payment.
    Response: While we agree that a full 16 days of monitoring may not 
always be reasonable and necessary, we requested detailed information 
about meaningful, clinical situations that require fewer days or 
shorter durations of remote monitoring. We were interested in 
understanding under what clinical circumstances fewer days of 
monitoring would be medically reasonable and necessary and allow a 
practitioner to establish clinically meaningful care. Although we 
received general support for a reduction in the number of days of data 
collection required to bill for CPT codes 99453 and 99454, we did not 
receive specific clinical examples.
    After considering public comments, we are not extending the interim 
policy to permit billing for CPT codes 99453 and 99454 for fewer than 
16 days in a 30-day period beyond the end of the PHE for COVID-19. At 
the conclusion of the PHE for COVID-19, we will require, in accordance 
with the code descriptors for CPT codes 99453 and 99454, that 16 days 
of data each 30 days must be collected and transmitted to meet the 
requirements to bill CPT codes 99453 and 99454.
    Comment: A few commenters requested that Independent Diagnostic 
Testing Facilities (IDTFs) be allowed to bill for RPM services.
    Response: As we noted in the proposed rule, RPM services are not 
considered to be diagnostic tests; therefore, RPM services cannot be 
furnished and billed by an IDTF on the order of a physician or NPP.
    Comment: Commenters agreed with our clarification that 
practitioners should be allowed to furnish RPM services to patients 
with acute conditions, as well as patients with chronic conditions.
    Response: We thank commenters for their support of our 
clarification that practitioners may furnish RPM services to patients 
with acute conditions, as well as patients with chronic conditions.
    In the CY 2021 PFS proposed rule, we proposed to make permanent two 
policies that we adopted in the March 31st COVID-19 IFC (85 FR 19264). 
We received comments on our proposed policies. The following is a 
summary of the comments we received and our responses.
    Comment: Commenters wrote in favor of our proposal to allow consent 
to be obtained at the time the services of CPT codes 99453 and 99454 
are furnished.
    Response: We thank our stakeholders for their comments and support 
of this proposal.
    Comment: Commenters agreed with our proposal to allow auxiliary 
personnel to furnish the services of CPT codes 99453 and 99454 under 
the general supervision of the billing physician or practitioner.
    Response: We thank commenters for their support of this proposal.
    After considering comments related to these two proposals, we are 
finalizing both as proposed.
3. Transitional Care Management (TCM)
    Payment for TCM CPT codes 99495 (Transitional Care Management 
services with the following required elements: Communication (direct 
contact, telephone, electronic) with the patient and/or caregiver 
within two business days of discharge; medical decision-making of at 
least moderate complexity during the service period; face-to-face visit 
within 14 calendar days of discharge) and 99496 (Transitional Care 
Management services with the following required elements: Communication 
(direct contact, telephone, electronic) with the patient and/or 
caregiver within two business days of discharge; medical decision 
making of at least high complexity during the service period; face-to-
face visit within seven calendar days of discharge) was finalized in 
the CY 2013 PFS final rule (77 FR 68979 through 68993). At that time, 
we identified a list of 57 HCPCS codes (see 77 FR 68990 for the 
original guidance) that we stated could not be billed concurrently with 
TCM services because of potential duplication of services.
    For CY 2020, recognizing that use of TCM services was low when 
compared to the number of Medicare beneficiaries with eligible 
discharges and that increased utilization of medically necessary TCM 
services could improve patient outcomes, one of our proposals included 
modifying our prior rule that prohibited the billing of TCM services 
with many other services that we had viewed as duplicative (77 FR 
68990). In the CY 2020 PFS final rule (84 FR 62685 through 62687), we 
finalized a policy to allow concurrent billing of TCM services, when 
reasonable and necessary, with 16 actively priced (that is, not bundled 
or non-covered) codes during the 30-day period covered by TCM services. 
We stated at the time that we would continue to refine our billing 
policies for TCM through future notice and comment rulemaking.
    In the CY 2021 PFS proposed rule (85 FR 50120), we proposed to 
remove 14 additional actively priced (not bundled or non-covered) HCPCS 
codes from the list of remaining HCPCS codes that cannot be billed 
concurrently with TCM for CY 2021. We noted that we believe that no 
overlap exists that would warrant preventing concurrent reporting 
between TCM and the services of these 14 codes. We also proposed to 
allow the new Chronic Care Management code HCPCS code G2058 to be 
billed concurrently with TCM when reasonable and necessary. We stated 
that the minutes counted for TCM services cannot also be counted 
towards other services. Table 18 lists the 15 codes that we proposed 
could be billed concurrently with TCM services when reasonable and 
necessary. We welcomed comment on our proposal to allow these 
additional services to billed concurrently with the TCM service.
    We received public comments on the TCM proposals. The following is 
a summary of the comments we received and our responses.
    Comment: Commenters wrote in support of our proposal to allow HCPCS 
code G2058 to be billed concurrently with TCM when reasonable and 
necessary. Commenters agreed that time should not be double-counted, 
and that services should not overlap, but should be separately 
reportable.
    Response: We thank the commenters for their support of our proposal 
to allow HCPCS code G2058 to be billed concurrently with TCM when 
reasonable and necessary.
    Comment: Commenters stated that the services described by the 14 
ESRD codes proposed for separate payment do not overlap or duplicate 
TCM services and should be paid separately when reasonable and 
necessary.
    Response: We appreciate the support of commenters.
    Comment: A few commenters disagreed with our proposal to allow the

[[Page 84547]]

ESRD codes and the chronic care management code HCPCS code G2058 to be 
billed concurrently with TCM. These commenters instead urged CMS to 
allow the RUC process and recommendations determine how these codes 
should be valued/revalued and reported, rather than having CMS apply a 
different approach.
    Response: We recognize that some commenters would prefer that we 
follow the AMA RUC recommendations for code valuations and billing 
policies. We appreciate the work the AMA committees, and in particular 
the RUC, do to provide recommendations. We will continue to consider 
those recommendations along with other information when we develop 
values and payment policies under the PFS. We believe that allowing 
concurrent billing of TCM services with the proposed ESRD codes and 
HCPCS code G2058, when reasonable and necessary, can improve patient 
outcomes.
    After considering the public comments, we are finalizing our 
proposal to remove 14 additional actively priced (not bundled or non-
covered) HCPCS codes from the list of remaining HCPCS codes that cannot 
be billed concurrently with TCM for CY 2021. We also are finalizing our 
proposal to allow HCPCS code G2058 (which we are finalizing in this 
rule as new CPT code 99439, see the codes in section II.H. for further 
information) to be billed concurrently with TCM when reasonable and 
necessary.
[GRAPHIC] [TIFF OMITTED] TR28DE20.029

4. Psychiatric Collaborative Care Model (CoCM) Services (HCPCS Code 
G2214)
    In the CY 2017 PFS final rule (81 FR 80230), we established G-codes 
used to bill for monthly services furnished using the Psychiatric 
Collaborative Care Model (CoCM), an evidence-based approach to 
behavioral health integration that enhances ``usual'' primary care by 
adding care management support and regular psychiatric inter-specialty 
consultation. These G-codes were replaced by CPT codes 99492-99494, 
which we established for payment under the PFS in the CY 2018 PFS final 
rule (82 FR 53077).
    Stakeholders have requested additional coding to capture shorter 
increments of time spent, for example, when a patient is seen for 
services, but is then hospitalized or referred for specialized care, 
and the number of minutes required to bill for services using the 
current coding is not met. To accurately account for these resources 
costs, in the CY 2021 PFS proposed rule (85 FR 50121), we proposed to 
establish a G-code to describe 30 minutes of behavioral health care 
manager time. Since this code would describe one half of the time 
described by the existing code that describes subsequent months

[[Page 84548]]

of CoCM services, we proposed to price this code based on one half the 
work and direct PE inputs for CPT code 99493 (Subsequent psychiatric 
collaborative care management, first 60 minutes in a subsequent month 
of behavioral health care manager activities, in consultation with a 
psychiatric consultant, and directed by the treating physician or other 
qualified health care professional, with the following required 
elements):
     Tracking patient follow-up and progress using the 
registry, with appropriate documentation; participation in weekly 
caseload consultation with the psychiatric consultant;
     Ongoing collaboration with and coordination of the 
patient's mental health care with the treating physician or other 
qualified health care professional and any other treating mental health 
practitioners;
     Additional review of progress and recommendations for 
changes in treatment, as indicated, including medications, based on 
recommendations provided by the psychiatric consultant;
     Provision of brief interventions using evidence-based 
techniques such as behavioral activation, motivational interviewing, 
and other focused treatment strategies;
     Monitoring of patient outcomes using validated rating 
scales; and
     Relapse prevention planning with patients as they achieve 
remission of symptoms and/or other treatment goals and are prepared for 
discharge from active treatment.), which is assigned a work RVU of 
1.53.
    Therefore, as proposed, the work RVU for the new proposed code is 
0.77. We proposed that this code could be used for either the initial 
month or subsequent months. We noted that the existing CPT time rules 
for the CoCM services would apply. As proposed, the code would be:
     GCOL1: Initial or subsequent psychiatric collaborative 
care management, first 30 minutes in a month of behavioral health care 
manager activities, in consultation with a psychiatric consultant, and 
directed by the treating physician or other qualified health care 
professional.
    We proposed that the required elements listed for CPT code 99493 
would also be required elements for billing HCPCS cod GCOL1. 
Additionally, we proposed that CPT time rules would apply, consistent 
with the guidance in the CPT codebook for CPT codes 99492-99494.
    In the CY 2017 PFS final rule (81 FR 80235), we finalized that CCM 
and BHI services could be billed during the same month for the same 
beneficiary if all the requirements to bill each service are separately 
met. We also proposed that HCPCS code GCOL1 could be billed during the 
same month as CCM and TCM services, provided that all requirements to 
report each service are met and time and effort are not counted more 
than once. We noted that the patient consent requirement would apply to 
each service independently.
    In the CY 2017 PFS final rule (81 FR 80235), we finalized that the 
psychiatric CoCM services may be furnished under general supervision 
because we do not believe it is clinically necessary that the 
professionals on the team who provide services other than the treating 
practitioner (namely, the behavioral health care manager and the 
psychiatric consultant) must have the billing practitioner immediately 
available to them at all times, as would be required under a higher 
level of supervision. Therefore, consistent with the other codes in 
this code family (CPT codes 99492-99494), we proposed to add HCPCS code 
GCOL1 to the list of designated care management services for which we 
allow general supervision.
    We welcomed comments on the proposal to create this new code, as 
well as the proposed valuation.
    We received public comments on the CoCM services (HCPCS code GCOL1) 
proposal. The following is a summary of the comments we received and 
our responses.
    Comment: Several commenters supported the creation of a new code to 
describe a shorter duration of time than is captured by the existing 
codes describing the psychiatric collaborative care model, noting that 
this will provide greater flexibility, remove barriers, and encourage 
further adoption of this model of care. One commenter opposed 
implementing this code without obtaining further evidence that it is 
warranted, while another commenter encouraged CMS to work with the CPT 
Editorial Panel to create a CPT code that would be available for 
billing by all payers. One commenter urged CMS to eliminate the 
copayment and deductible for CoCM and other care management services.
    Response: We note that we do not have the statutory authority to 
remove application of the copayment or deductible for these services. 
After considering the public comments, we are finalizing the creation 
of HCPCS code GCOL1 as proposed. We note that HCPCS GCOL1 was a 
placeholder code identifier. The final code is HCPCS code G2214 
(Initial or subsequent psychiatric collaborative care management, first 
30 minutes in a month of behavioral health care manager activities, in 
consultation with a psychiatric consultant, and directed by the 
treating physician or other qualified health care professional). We 
welcome the opportunity to work with the CPT Editorial Panel in the 
event they are interested in adopting this code into the CPT code set.

F. Refinements to Values for Certain Services To Reflect Revisions to 
Payment for Office/Outpatient Evaluation and Management (E/M) Visits 
and Promote Payment Stability During the PHE for COVID-19

1. Background
a. Evaluation and Management (E/M) Visits Overview
    Physicians and other practitioners who are paid under the PFS bill 
for common office visits for E/M visits using a relatively generic set 
of CPT codes (Level I HCPCS codes) that distinguish visits based on the 
level of complexity, site of service, and whether the patient is new or 
established. These CPT codes are broadly referred to as E/M visit codes 
and historically have included three key components within their code 
descriptors: History of present illness (history), physical examination 
(exam), and medical decision-making (MDM).\4\
---------------------------------------------------------------------------

    \4\ 2019 CPT Codebook, Evaluation and Management, pages 6 
through 13.
---------------------------------------------------------------------------

    Currently, there are five levels of O/O E/M visits. There are five 
codes representing each level for new patients (CPT codes 99201 through 
99205), and five codes representing each level for established patients 
(CPT codes 99211 through 99215). CPT code 99211 (Level 1 established 
patient) is the only code in the O/O E/M visit code set that describes 
a visit that may be performed by the billing practitioner or by 
clinical staff under supervision, and that has no specified history, 
exam or MDM (see Table 19).
    In total, E/M visits billed using these CPT codes comprise 
approximately 40 percent of allowed charges for PFS services; and O/O 
E/M visits, in particular, comprise approximately 20 percent of allowed 
charges for PFS services. Within the E/M visits represented in these 
percentages, there is wide variation in the volume and level of E/M 
visits billed by different specialties. According to Medicare claims 
data, E/M visits are furnished by nearly all specialties, but represent 
a greater share of total allowed charges for physicians and other 
practitioners who do not routinely furnish procedural interventions or 
diagnostic tests.

[[Page 84549]]

Generally, these practitioners include primary care practitioners and 
certain other 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, tend to bill more E/M visits on the 
same day as they bill minor procedures.
b. Overview of Policies Finalized in CY 2020 for CY 2021
    In the CY 2020 PFS final rule (84 FR 62844 through 62860), for the 
O/O E/M visit code set (CPT codes 99201 through 99215), we finalized a 
policy to generally adopt the new coding, prefatory language, and 
interpretive guidance framework that has been issued by the AMA's CPT 
Editorial Panel (see https://www.ama-assn.org/practice-management/cpt/cpt-evaluation-and-management) and will be effective January 1, 2021. 
Under this new CPT coding framework, history and exam will no longer be 
used to select the level of code for O/O E/M visits. Instead, an O/O E/
M visit will include a medically appropriate history and exam, when 
performed. The clinically outdated system for number of body systems/
areas reviewed and examined under history and exam will no longer 
apply, and the history and exam components will only be performed when, 
and to the extent, reasonable and necessary, and clinically 
appropriate.
    The changes will include deletion of CPT code 99201 (Level 1 
office/outpatient visit, new patient), which the CPT Editorial Panel 
decided to eliminate because CPT codes 99201 and 99202 are both 
straightforward MDM and currently largely differentiated by history and 
exam elements. Table 19 provides an overview of how the level 1 and 
level 2 O/O E/M visits are currently structured, demonstrating this 
current overlap.
[GRAPHIC] [TIFF OMITTED] TR28DE20.030

    For levels 2 through 5 O/O E/M visits, selection of the code level 
to report will be based on either the level of MDM (as redefined in the 
new AMA/CPT guidance framework, also available on the AMA website at 
https://www.ama-assn.org/practice-management/cpt/cpt-evaluation-and-management) or the total time personally spent by the reporting 
practitioner on the day of the visit (including face-to-face and non-
face-to-face time). We continue to believe these policies will further 
our ongoing effort to reduce administrative burden, improve payment 
accuracy, and update the O/O E/M visit code set to better reflect the 
current practice of medicine.
    Regarding prolonged visits, we finalized separate payment for a new 
prolonged visit add-on CPT code (CPT code 99XXX), and discontinued the 
use of CPT codes 99358 and 99359 (prolonged E/M visit without direct 
patient contact) to report prolonged time associated with O/O E/M 
visits. We refer readers to the CY 2020 PFS final rule for a detailed 
discussion of this policy (84 FR 62849 through 62850). We are not 
opposed in concept to reporting prolonged office/outpatient visit time 
on a date other than the visit, but we believe there should be a single 
prolonged code specific to O/O E/M visits that encompasses all related 
time.
    Also, we finalized separate payment for HCPCS code GPC1X, to 
provide payment for visit complexity inherent to E/M associated with 
medical care services that serve as the continuing focal point for all 
needed health care services and/or with medical care services that are 
part of ongoing care related to a patient's single, serious condition, 
or a complex condition.
    The AMA RUC resurveyed and revalued the revised O/O E/M visit code 
set, concurrent with the CPT Editorial Panel redefining the services 
and associated interpretive guidance, and provided us with its 
recommendations. In the CY 2020 PFS final rule, we also addressed and 
responded to the AMA RUC recommendations. We finalized new values for 
CPT codes 99202 through 99215, and assigned RVUs to the new O/O E/M 
prolonged visit CPT code 99XXX, as well as the new HCPCS code GPC1X. 
These valuations were finalized with an effective date of January 1, 
2021. In Table 20, we provide a summary of the codes and work RVUs 
finalized in the CY 2020 PFS final rule for CY 2021.

[[Page 84550]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.031

c. Continuing Stakeholder Feedback
    Since issuing the CY 2020 PFS final rule, we have continued to 
engage with the stakeholder community on the issues addressed in this 
section of our CY 2021 PFS final rule. These include the time values 
for levels 2-5 O/O E/M visit codes, revaluation of services that are 
analogous to O/O E/M visits, the definition and utilization assumptions 
for the add-on code for office/outpatient visit complexity (GPC1X), and 
the required time to report prolonged O/O E/M visits. In the CY 2021 
PFS proposed rule (85 FR 50121 through 50139), we included proposals on 
these topics based on continued feedback from stakeholders in the form 
of public comments, written requests, meetings, and other formal and 
informal discussions. In this section of our final rule, we summarize 
and respond to the public comments we received in response to our CY 
2021 PFS proposals, and discuss our final polices.
2. Revisions for CY 2021
a. Time Values for Levels 2-5 Office/Outpatient E/M Visit Codes
    In the CY 2020 PFS proposed rule (84 FR 40675), we sought comment 
on the times associated with the O/O E/M visits as recommended by the 
AMA RUC. When surveying these services for purposes of valuation, the 
AMA RUC requested that survey respondents consider the total time spent 
on the day of the visit, as well as any pre- and post-service time 
occurring within a timeframe of 3 days prior to the visit and 7 days 
after, respectively. In developing its recommendations to us, the AMA 
RUC then separately averaged the survey results for pre-service, day of 
service, and post-service times, and the survey results for total time, 
with the result that, for some of the codes, the sum of the times 
associated with the three service periods does not match the RUC-
recommended total time. The approach used by the AMA RUC to develop 
recommendations sometimes resulted in two conflicting sets of times: 
The component times as surveyed and the total time as surveyed. In the 
CY 2020 PFS final rule, we finalized adoption of the RUC-recommended 
times as explained below, but stated that we would continue to consider 
whether this issue has implications for the PFS broadly. When we 
establish pre-, intra-, and post-service times for a service under the 
PFS, these times always sum to the total time. We believe it would be 
illogical for component times not to sum to the total, and this idea is 
reflected in our ratesetting system, which requires component times to 
sum to the total time. Commenters on the CY 2020 PFS proposed rule (84 
FR 62849) stated that we should adopt the times as recommended by the 
RUC, and did not provide any additional details on the times they 
believed we should use when the total time is not the sum of the 
component times. Table 21 illustrates the AMA RUC surveyed times for 
each service period and the surveyed total time. It also shows the 
actual total time calculated as the sum of the component times.

[[Page 84551]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.032

    Given the lack of clarity provided by commenters on the CY 2020 PFS 
proposed rule about why the sum of minutes in the components would 
differ from the total minutes, and our view and systems requirement 
that total time must equal the mathematical total of component times, 
we proposed beginning in CY 2021 to adopt the actual total times 
(defined as the sum of the component times) rather than the total times 
recommended by the RUC for CPT codes 99202 through 99215. The following 
is a summary of the comments we received and our responses.
    Comment: Some commenters did not support our proposal to adopt the 
actual total times (defined as the sum of the component times) rather 
than the total times recommended by the RUC for CPT codes 99202 through 
99215. These commenters further stated, if we were to use the sum of 
the component times instead of the RUC-recommended median total time, 
that we would not be appropriately capturing the physician time for the 
office visits, which were based on a robust survey, if we were to use 
the sum of the component times instead of the RUC recommended median 
total time.
    One commenter suggested that the median survey total time for the 
office visits should be utilized to retain relativity. The commenter 
explained that, while total time is usually a sum of the pre-, intra- 
and immediate post-service time, for purposes of the office visit 
survey, the pre-service time was described as 3 calendar days prior to 
the office visit, the intra-service time was described as the calendar 
day of the office visit and the post-service time was described as 
within 7 days following the office visit. The commenter stated that the 
median survey total time will not necessarily equal the sum of the 
median times for each of the 3 time periods because of different 
practitioner workflow patterns that result in different proportions of 
the practitioners' times being spent in different components of the 
service. However, the total times as recommended by the RUC accurately 
capture the time associated with furnishing the service, regardless of 
whether that work was performed on the date of encounter or other dates 
surrounding the office visit. The commenter also suggested that the 
median of the component times was mathematically more appropriate than 
the median of the total times, because the function of a median is to 
limit the influence of outlier values.
    Some commenters supported our proposal, stating that the RUC's 
survey methodology, which included collection of time before and after 
the day of the encounter, resulted in an overestimation of time and 
work, and that the total time in the CMS work time database should 
reflect the sum of the pre-, intra-, and post-times collected using the 
RUC survey. This methodology is consistent with the total times for all 
other codes in the fee schedule.
    Response: We continue to believe that it would be illogical for 
component times not to sum to the total, and we reiterate that our 
ratesetting programs are constructed in a manner that assumes this. 
While we recognize the value of robust survey data, for purposes of 
consistency and relativity, we believe we should use a consistent 
methodology across the fee schedule. Also it is not clear why the RUC 
surveyed time before and after the date of service since the new CPT 
coding guidance instructs practitioners to report this time using CPT 
codes 99358 and 99359 (although CMS will no longer recognize 99358-
99359 for this purpose, for reasons discussed elsewhere in this 
section). Having considered the public comments received, we are 
finalizing our proposal to adopt the actual total times (defined as the 
sum of the component times) rather than the total times recommended by 
the RUC for CPT codes 99202 through 99215.
b. Revaluing Services That Are Analogous to Office/Outpatient E/M 
Visits
    In our proposed rule, we recognized that there are services other 
than the global surgical codes for which the values are closely tied to 
the values of the O/O E/M visit codes. We proposed to increase the 
valuations for these services commensurate with the valuation increases 
we previously finalized for the O/O E/M visit codes for 2021. Our 
proposals took into account input from the public (especially our 2020 
comment solicitation on this topic) and our own internal review. We 
proposed to increase valuations for the following:
     End-Stage Renal Disease Monthly Capitation Payment (ESRD 
MCP) services.
     Transitional care management (TCM) services.
     Maternity services.
     Cognitive impairment assessment and care planning.
     Annual wellness visits (AWV) and initial preventive 
physical exam (IPPE).
     Emergency department (ED) visits.
     Therapy evaluations.
     Certain behavioral healthcare services.
    Many of these services were valued via a building block methodology 
and have O/O E/M visits explicitly built into their definition or 
valuation. We noted that, unlike the global surgical codes, some of 
these services always include an O/O E/M visit(s) furnished by the 
reporting practitioner as part of the service, and therefore, it may be 
appropriate to adjust their valuations commensurate with any changes 
made to the values for O/O E/M visits. Some of these services do not 
actually include an E/M visit, but we valued them using a direct 
crosswalk to the RVUs assigned to an O/O E/M visit(s), and for this

[[Page 84552]]

reason they are closely tied to values for O/O E/M visits. Overall, we 
believed that the magnitude of the changes to the values of the O/O E/M 
visit codes and the associated redefinitions of the codes themselves 
are significant enough to warrant an assessment of the accuracy of the 
values of services containing, or closely analogous to, O/O E/M visits.
    We received public comments in response to the CY 2020 PFS proposed 
rule in support of revaluing certain services commensurate with the new 
O/O E/M visit values. There was particular support from commenters for 
revaluing the ESRD (MCP) services, TCM services, cognitive impairment 
assessment and care planning services, and the (ED) visits. Based on 
input provided after publication of the CY 2020 PFS final rule by the 
American College of Obstetricians and Gynecologists (ACOG), we also 
proposed to revalue the maternity surgical packages, which, unlike 
other global surgery services, were valued using a methodology, 
described in more detail below, that allowed the valuation of the 
composite parts of the package to sum to the total value. Additionally, 
unlike the 10- and 90-day global surgical services codes (referred to 
in this section as 10- and 90-day globals), we had never expressed 
concerns as to the accuracy of the values of the maternity packages, 
and these services were not part of the policy we adopted to transition 
all 10- and 90- day globals to 0-day globals (79 FR 67591), though that 
policy was overridden by statutory amendments before it took effect. We 
also proposed to revalue certain physical therapy evaluations and 
behavioral healthcare services as closely analogous to the office/
outpatient E/M visits. We did not propose to revalue certain 
ophthalmology services that the public brought to our attention.
    In general, some commenters to the CY 2021 PFS proposed rule 
indicated that they believe CMS used inconsistent methodologies to 
revise the proposed RVUs to reflect the marginal increase in office/
outpatient E/M visits; that other code sets should go through the same 
consensus process whereby CMS, CPT and the AMA RUC all agree that the 
services need to be redefined to better describe existing practice and 
then be revalued; and that CMS should increase all of the global 
surgical codes if any single global code is increased to reflect 
changes to the office/outpatient E/M visits. Other commenters agreed 
with our proposals and methodologies, and a few suggested additional 
services that should be revalued as analogous to office/outpatient E/M 
visits. In the following section of our final rule, we discuss the 
public comments we received in greater detail, respond to the comments 
and discuss our final policies. By way of overview, we note that we did 
not rely on any single factor in deciding whether to consider a given 
code(s) as analogous to office/outpatient E/M visits. Different factors 
apply to different services, and we took into consideration all of the 
factors relevant for the code(s) in question, considered together.
(1) End-Stage Renal Disease Monthly Capitation Payment Services
    In the CY 2004 PFS final rule with comment period (68 FR 63216), we 
established new Level II HCPCS G codes for ESRD services and 
established MCP rates for them as specified under section 
1881(b)(3)(A)(ii) of the Act. For ESRD center-based patients, payment 
for the G codes varied based on the age of the beneficiary and the 
number of face-to-face visits furnished each month (for example, 1 
visit, 2-3 visits and 4 or more visits). We believed that many 
physicians would provide 4 or more visits to center-based ESRD 
patients, and a small proportion would provide 2 to 3 visits or only 
one visit per month. Under the MCP methodology, to receive the highest 
payment, a physician would have to furnish at least 4 ESRD-related 
visits per month. In contrast, payment for home dialysis MCP services 
only varied by the age of beneficiary. Although we did not initially 
specify a frequency of required visits for home dialysis MCP services, 
we stated that we expect physicians to provide clinically appropriate 
care to manage the home dialysis patient.
    The CPT Editorial Panel created new CPT codes to replace the G 
codes for monthly ESRD-related services, and we finalized the new codes 
for use under the PFS in CY 2009 (73 FR 69898). The codes created were 
CPT codes 90951 through 90962 for monthly ESRD-related services with a 
specified number of visits; CPT codes 90963 through 90966 for monthly 
ESRD-related services for home dialysis patients; and CPT codes 90967 
through 90970 for home dialysis patients with less than a full month of 
services. The latter set of codes is billed per encounter and valued to 
be 1/30 of the value of CPT codes 90965 and 90966.
    In response to our comment solicitation in the CY 2020 PFS final 
rule and interim final rule regarding whether to adjust the values of 
the ESRD MCP codes to reflect the increased values of the office/
outpatient E/M visit codes, we received a number of supportive 
comments. These commenters stated that the MCP bundled payments for all 
ESRD-related care for a month were constructed using a building block 
methodology and a number of office/outpatient E/M visits were component 
parts of those bundles; and that the specified number of visits in the 
code descriptor must be furnished in order to bill for the service. 
Commenters also noted that although the values of office/outpatient E/M 
visit codes have been increased once since the creation of the MCP G 
codes and once after adoption of the MCP CPT codes, the valuation of 
the ESRD MCP codes was never adjusted to account for increases to the 
office/outpatient E/M visit codes. In Table 22, we provide a summary of 
the visits included in the valuation of each ESRD MCP service.

[[Page 84553]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.033

    In the past, we have not updated the valuation of this code set to 
reflect updates to the valuation of the office/outpatient E/M visit 
code set, and we do not have information on the number and level of 
visits actually furnished in connection with these services. So over 
time, the values of the ESRD MCP codes may have become out of step with 
valuation of their constituent visits. We believe there is sufficient 
reason to revalue these services to take into account the changes in 
valuation for the office/outpatient E/M visits. These services were 
initially valued using a building block methodology that summed the 
value of the individual service from its components, and for some of 
the codes in this code set, a specified number of visits must be 
furnished in order to bill for the respective ESRD MCP code because 
they are included in the code descriptor.
    Therefore, we noted that we believe that the ESRD MCP codes should 
be updated to more accurately account for the associated office/
outpatient E/M visits. We proposed to increase the work, physician 
time, and PE inputs in the form of clinical staff time of the ESRD MCP 
codes based on the marginal difference between the 2020 and 2021 
office/outpatient E/M visit work, physician time, and PE inputs built 
into each code, as summarized in Tables 23 and 24. By improving payment 
accuracy for the ESRD MCP codes, we would also be supporting broader 
efforts at advancing kidney health.\5\ We noted that we believe the 
majority of the visits included in the ESRD MCP bundles are being 
furnished, but sought comment on whether there are instances where the 
number and/or level of visits being furnished are not consistent with 
the number and level of visits built into the valuation of the code. 
The following is a summary of the comments we received and our 
responses.
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    \5\ HHS Launches President Trump's `Advancing American Kidney 
Health' Initiative: https://www.hhs.gov/about/news/2019/07/10/hhs-launches-president-trump-advancing-american-kidney-health-initiative.html.
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    Comment: One commenter noted that CMS inadvertently indicated a 
proposed work RVU of 8.04 for CPT code 90966 in in Table 19 in the CY 
2021 PFS proposed rule (85 FR 50129). The commenter urged CMS to 
finalize a work RVU of 8.04 for this code to help eliminate structural 
barriers the commenter believes exist to home dialysis, and relieve the 
disparity in modality choice, as home dialysis receives a low RVU 
remuneration compared to in-center hemodialysis. Another commenter 
stated that the work RVU published in Addendum B of the proposed rule, 
5.52, is the more accurate value.
    Response: We regret the drafting error, and we reiterate that we 
did indeed propose a work RVU of 5.52 for CPT code 90966 as reflected 
in Addendum B. While we appreciate the concerns regarding access to 
care, we agree with comments stating that the proposed work RVU of 5.52 
is the more accurate value.
    Comment: Some commenters supported our proposal to increase the 
value of these services in light of previous changes to the E/M visit 
values. However, some commenters did not support increases to these 
code values absent a formal review, stating that it would be 
inconsistent to consider increasing values for some services and not 
others that are closely tied to the values of the office/outpatient E/M 
visit codes and/or codes that have E/M visits explicitly built into 
their definition or valuation, and that these codes should be subject 
to the same process for other potentially misvalued services. One

[[Page 84554]]

commenter disapproved of our proposed increasing the rates for these 
services, and stated that not all of the ESRD-related service CPT codes 
90951-90962 were valued with a building block methodology of discrete 
E/M services. These commenters stated that CPT code 90951 was valued 
using magnitude estimation with a crosswalk to CPT code 99295, while 
CPT code 90954 was valued with a crosswalk to CPT code 99293. The 
commenters noted that both CPT code 99293 and 99295 have since been 
deleted. The commenters further stated that for the rest of the ESRD 
codes, the numbers and levels of visits were not determined based on 
surveys that led to use of the building block methodology; rather, they 
were negotiated using magnitude estimation in comparison to the two 
codes, CPT codes 99295 and 99293.
    Response: Commenters are incorrect as to the methodology used to 
value CPT code 90951 in the proposed rule (as summarized in Table 22). 
We adopted the RUC recommended value for this service, which included 
the value of 13 instances of CPT code 99214 in the bundle. It was not 
valued using a crosswalk. However, we continue to believe it is 
accurate to consider these services as being among those for which 
values are closely tied to the values of the office/outpatient E/M 
visit codes. The ESRD MCP codes have numbers of visits explicitly built 
into their definitions, the majority of which we believe are taking 
place. Proportionate increases for these two codes will also maintain 
the relative relationships among the codes in this family.
    We agree with commenters that CPT code 90954, this code was 
initially valued based on a crosswalk to CPT code 99293. When CPT code 
99293 was deleted, it was replaced by CPT code 99471. By crosswalking 
CPT code 90954 to CPT code 99471, the relationship established between 
the two services is preserved. The public may nominate any code(s) as 
potentially misvalued through the usual misvalued code process or 
request resurvey or valuation through the AMA RUC.
    We did not receive responses to our request for comments on whether 
there are instances where the number and level of visits actually 
furnished by practitioners reporting the ESRD MCP services differs from 
the number and level assumed in the valuation.For example, as shown in 
Table 22, the valuations included specified numbers and levels of 
office/outpatient E/M visits, but because the descriptors do not 
require the same level and number of visits to be furnished in order to 
report the services, the office/outpatient E/M visit resources assumed 
to be included in the ESRD services might not actually be expended. CPT 
code 90957 (End-stage renal disease (ESRD) related services monthly, 
for patients 12-19 years of age to include monitoring for the adequacy 
of nutrition, assessment of growth and development, and counseling of 
parents; with 4 or more face-to-face visits by a physician or other 
qualified health care professional per month) was valued with 1x 99215, 
3x 99214, and 3x 99213. However, CPT code 90957 includes four or more 
visits of unspecified levels. Similar to the global surgical codes, 
this might suggest that we should not ``transfer'' the increase in 
valuation of the stand-alone office/outpatient E/M visits into these 
ESRD bundles. Unlike TCM, the number and level of visit included in the 
ESRD service valuations does not necessarily match the actual services 
furnished and billed. We continue to be concerned that the number and 
level of visits built into the valuation of these codes may not 
accurately reflect the number and level of visits actually being 
furnished, such that they may be misvalued. We may consider this issue 
through future rulemaking, as we have for the global surgical codes. 
However, we still believe the ESRD MCP codes are different from the 
global surgical codes in that they are valued using building block and 
involve largely medical care rather than procedural care. The ESRD 
monthly services include ongoing medical management of a chronic 
condition, which makes them more similar to the kind of work typically 
furnished and billed as office/outpatient E/M visits. Therefore, we 
continue to believe that the ESRD MCP services' valuation should be 
increased commensurate with the changes made to the values for office/
outpatient E/M visits at this time as was proposed, and we are 
finalizing as proposed.
2. TCM Services (CPT Codes 99495 and 99496)
    The goal of TCM services is to improve the health outcomes of 
patients recently discharged from inpatient and certain outpatient 
facility stays. We began making separate payment for TCM services in CY 
2013. At that time, CPT code 99495 (Transitional Care Management 
Services with the following required elements: Communication (direct 
contact, telephone, electronic) with the patient and/or caregiver with 
2 business days of discharge; medical decision making of at least 
moderate complexity during the service period; face-to-face visit 
within 14 calendar days of discharge) was valued to include one, level 
4 established patient office/outpatient visit, while CPT code 99496 
(Transitional Care Management Services with the following required 
elements: Communication (direct contact, telephone, electronic) with 
the patient and/or caregiver with 2 business days of discharge; medical 
decision making of high complexity during the service period; face-to-
face visit within 7 calendar days of discharge) was valued to include 
one, level 5 established patient office/outpatient visit (77 FR 68991). 
In the CY 2020 PFS final rule (84 FR 62687), we finalized the RUC-
recommended work and direct PE inputs for the TCM codes which resulted 
in small RVU increases for both codes.
    Because both TCM codes include a required face-to-face E/M visit 
(either a level 4 or 5 office/outpatient E/M visit), we proposed to 
increase the work RVUs associated with the TCM codes directly to the 
new valuations for the level 4 (CPT code 99214) and level 5 (CPT code 
99215) office/outpatient E/M visits for established patients. Please 
see Tables 23 and 24 for long descriptors, as well as current and final 
work RVUs, physician time, and clinical staff time, for the TCM codes.
    Comment: We received several comments specific to TCM, all in 
support of our proposal to revalue the TCM codes, although they did not 
provide specific rationale.
    Response: We continue to believe that the values for services that 
explicitly include a single E/M visit of a given setting and level, and 
that were valued using a direct crosswalk to that visit, should be 
increased to reflect the new values for the included E/M visit. At this 
time, we are finalizing our proposed revised values for the two TCM 
codes shown in Table 23.
3. Maternity Services
    In the CY 2002 PFS final rule with comment period (66 FR 55392-
55393), we finalized separate global payment for maternity care 
services. The maternity packages are unique within the PFS in that they 
are the only global codes that provide a single payment for almost 12 
months of services, including visits and other medical care, delivery 
services (that may include surgical services), and imaging; and were 
valued using a building-block methodology as opposed to the magnitude 
estimation method that is commonly used to value the 10- and 90-day 
global services. Seventeen CPT codes are used to bill for delivery, 
antepartum, and postpartum maternity care services, and these codes are 
all designated with a unique global period indicator ``MMM.''

[[Page 84555]]

    For CY 2021, the AMA RUC made a recommendation to revalue these 
services, along with their recommendations to revalue the 10- and 90- 
day global surgical packages, to account for increases in the values of 
office/outpatient E/M visits. In the CY 2020 PFS final rule, we decided 
not to make changes to the valuation of 10- and 90- day global surgical 
packages to reflect changes made to values for the office/outpatient E/
M visit codes while we continue to collect and analyze the data on the 
number and level of office/outpatient E/M visits that are actually 
being performed as part of these services.
    The 10- and 90-day global surgical packages are commonly valued 
using a methodology known as magnitude estimation. Magnitude estimation 
refers to a methodology for valuing work that identifies 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. Since its 
inception, the AMA RUC has worked under the prevailing assumption that 
magnitude estimation is the standard for valuation of all physicians' 
services, including those with global surgical packages. Consequently, 
the work values associated with expected typical E/M visits within a 
code's global period are not necessarily added to the physician work 
value for the code to determine the final work RVU. The postoperative 
visits in the 10- or 90-day global surgical code periods are often 
valued with reference to RVUs for separately-billed E/M visits, but the 
bundled post-operative visit RVUs do not directly contribute a certain 
number of RVUs to the valuation of the procedures.
    In contrast, the MMM codes are unique in both the length of the 
global period and the methodology under which they were valued. When 
CMS established values for the maternity packages, we based them on RUC 
recommendations developed by the relevant specialty societies using the 
building block methodology. When it is used for a CPT code representing 
a bundle of services, the building block methodology components are the 
CPT codes that are considered to make up the bundled code and the 
inputs associated with those codes. Therefore, when the maternity 
packages were valued, the work (and other inputs) associated with the 
office/outpatient E/M visits in each package were explicitly included 
(along with values associated with imaging and other services in the 
package).
    In addition, unlike the global surgical codes, we have reason to 
believe the visits included in the maternity codes are actually 
furnished given the evidence-based standards and professional 
guidelines for obstetrical care. For example, The Guidelines for 
Perinatal Care state that ``a woman with an uncomplicated first 
pregnancy is examined every 4 weeks for the first 28 weeks of 
gestation, every 2 weeks until 36 weeks of gestation, and weekly 
thereafter.''\6\ For this reason, we excluded the maternity codes from 
our recent global surgery data collection.
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    \6\ Kilpatrick SJ, Papile L, and Macones GA, eds. AAP Committee 
on Fetus and Newborn and ACOG Committee on Obstetric Practice. 
Guidelines for Perinatal Care. Eighth Edition. 2017. Page 150.
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    Given the valuation methodology and expectations for office/
outpatient E/M visits in the maternity package codes, and the 
revaluation recommendation developed by the AMA RUC, we believe that 
the maternity packages should be updated to more accurately reflect the 
values of the office/outpatient E/M visits included in the packages. We 
believe that, due to the use of the building block valuation 
methodology rather than magnitude estimation, and the likelihood that 
the bundled visits are actually being furnished, the valuations 
recommended to us by the AMA RUC more accurately reflect the resource 
costs associated with furnishing these services. In the past, the work, 
physician time, and PE for these services have not been revalued to 
reflect changes to the office/outpatient E/M visits that are included 
as part of the package and therefore, the valuation of the MMM surgical 
packages have become misaligned with the valuation of their constituent 
office visits.
    When revaluing the maternity packages, the AMA RUC used a 
methodology similar to what we used when revaluing the ESRD MCP codes 
and TCM by adding in the marginal differences in work, physician time, 
and PE in the form of clinical staff time between the current and 2021 
E/M values. We noted that we believe that this method accurately 
accounts for the increase in valuation relative to the office/
outpatient E/M visits. Therefore, we proposed to increase the work 
RVUs, physician time, and PE inputs in the form of clinical staff time 
associated with the maternity packages by accepting the revaluation 
recommendation from the AMA RUC as detailed in Tables 23 and 24.
    We also noted that, in addition to appropriately reflecting changes 
to values of the office and outpatient E/M visits, increases made to 
the valuation of the maternity package codes would be consistent with 
our broader focus on improving maternal health and birth outcomes. The 
proposed changes would account for additional resources involved with 
additional work that is needed on the part of practitioners to improve 
care for this patient population, such as risk identification and 
ensuring appropriate interventions and referrals.\7\
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    \7\ https://www.hhs.gov/blog/2020/01/29/achieving-better-health-mothers-and-babies.html; https://www.cms.gov/About-CMS/Agency-Information/OMH/equity-initiatives/rural-health/21-Maternal-Health-Forum-Improving-Maternal-Health-for-Our-Communities.pdf; https://innovation.cms.gov/innovation-models/maternal-opioid-misuse-model.
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    We received public comments on our proposal. The following is a 
summary of the comments we received and our responses.
    Comment: Some commenters supported our proposal regarding the 
global maternity codes. However, other commenters requested a fair and 
relative payment for maternity care codes and for all global codes, 
whether the value of the code is based on magnitude estimation, 
building block methodology, or a mix of both methodologies, not any 
subset of them using potentially disparate valuation methodologies. 
Some commenters stated that it is unfair to apply the RUC-recommended 
E/M value increases to stand-alone E/M visits, select global codes (for 
example, monthly end-stage renal disease (ESRD) and bundled maternity 
care), and select bundled services (for example, monthly psychiatric 
management), but not to the E/M visits that are included in the global 
surgical packages, and that this will disrupt the relativity of the 
MPFS.
    Response: We continue to believe that the maternity global surgical 
packages are distinct from the 10- and 90-day globals for the reasons 
articulated above. We note that commenters did not provide any 
information to suggest that the number and level of visits accounted 
for in the valuation of these codes are not being performed. In 
addition, unlike the global surgical packages, the maternity packages 
(and the ESRD monthly services discussed above) are focused on ongoing, 
comprehensive medical care. This kind of care is similar to the type of 
care typically furnished and billed as office/outpatient E/M visits 
and, as such, makes the services analogous. Having considered the 
public comments we received, we are finalizing our proposal to revalue 
the maternity bundles as recommended by the AMA RUC.

[[Page 84556]]

4. Assessment and Care Planning for Patients With Cognitive Impairment 
(CPT Code 99483)
    In CY 2017, we established payment for HCPCS code G0505 (Assessment 
and care planning for patients with cognitive impairment) to provide 
payment for cognitive assessment and care planning for patients with 
cognitive impairments, believing that the CPT Editorial Panel was 
developing new coding for that service. In response to the CY 2017 PFS 
proposed rule, the AMA RUC submitted recommended values for this code, 
which we adopted in the CY 2017 PFS final rule. In CY 2018, the CPT 
Editorial Panel created CPT code 99483 for reporting of this service 
and in CY 2018, CMS adopted CPT code 99483 (deleting HCPCS code G0505) 
without changing the service valuation. Based upon input from 
commenters and the AMA RUC, the valuation of this service reflected the 
complexity involved in assessment and care planning for patients with 
cognitive impairment by including resource costs that are greater than 
the highest valued office/outpatient E/M visit (CPT code 99205, new 
patient level 5 visit) (81 FR 80352). Specifically, the service 
includes an evaluation of a patient's cognitive functioning and 
requires collecting pertinent history and current cognitive status all 
of which require medical decision making of moderate or high 
complexity.
    With the forthcoming increased valuation for CPT code 99205 in CY 
2021, we noted that the current work RVU for CPT code 99483 would have 
a lower work RVU than a new patient level 5 office/outpatient E/M 
visit. Given the way CPT code 99483 was valued initially, we noted that 
this valuation would create a rank order anomaly between the two codes. 
Since CPT code 99483 was valued in relation to a level 5 office/
outpatient E/M new patient visit, we believed that an adjustment to the 
work, physician time, and PE for this service to reflect the marginal 
difference between the value of the level 5 new patient office/
outpatient E/M visit in CY 2020 and CY 2021 would be appropriate to 
maintain payment accuracy. Therefore, we proposed to adjust the work, 
time, and PE in the form of clinical staff time for CPT code 99483 as 
shown in Tables 23 and 24. We used the ratio between the CY 2020 and CY 
2021 values for the level 5 new patient office/outpatient visits and 
applied that ratio to increase the value of CPT code 99483 commensurate 
with the increase to CPT code 99205.
    We received public comments on the Assessment and Care Planning for 
Patients with Cognitive Impairment (CPT code 99483). The following is a 
summary of the comments we received and our responses.
    Comment: Commenters generally supported our proposal to increase 
the valuation of CPT code 99483 in order to maintain the relationship 
between CPT code 99483 and the level 5 new patient office/outpatient 
visit, which was an important part of the initial valuation. Commenters 
stated that accurate payment for this service is essential for 
maintaining access to care for beneficiaries with cognitive impairment.
    However, several commenters disagreed with our proposed revaluation 
of CPT code 99483. These commenters indicated that our proposed 
increase to CPT code 99483 would create a rank order anomaly between 
CPT codes 99205 and 99483. Commenters explained that the work RVU and 
time for code 99483 were based upon survey data and magnitude 
estimation. The RUC did not use any code as a crosswalk for valuation 
of CPT code 99483, and CPT code 99205 is not inherent to this service. 
Commenters suggested that in order to identify the relative valuation 
for the services of CPT code 99483, the code should be referred to the 
RUC for review.
    Response: While we appreciate the additional insight into the 
valuation of these codes, we continue to believe that maintaining the 
value of CPT code 99483 at its current rate would create a rank order 
anomaly. This service comprises a stand-alone E/M visit that is always 
furnished; has most of the same components as CPT code 99205, including 
identical interpretive guidance for level of medical decision making; 
and was (and continues to appropriately be) valued in direct relation 
to CPT code 99205. While the cognitive assessment and care planning 
code was valued using magnitude estimation, these other factors provide 
additional support for continuing to reflect its exact relationship 
with the level 5 new patient office/outpatient visit. Therefore, we 
believe these services are sufficiently analogous to warrant preserving 
the same relationship. Members of the public can request that the RUC 
review certain code sets at any time. After consideration of the public 
comments, we are finalizing this proposal to revalue CPT code 99483 as 
proposed.
5. Initial Preventive Physical Examination (IPPE) and Initial and 
Subsequent Annual Wellness Visits (AWV)
    In the CY 2011 PFS final rule with comment period, we finalized 
separate payment for HCPCS codes G0438 (Annual wellness visit; includes 
a personalized prevention plan of service (pps), initial visit) and 
G0439 (Annual wellness visit, includes a personalized prevention plan 
of service (pps), subsequent visit). These services were valued via a 
direct crosswalk to the work, time, and direct PE inputs associated 
with CPT codes 99204 and 99214, respectively. In that same rule, we 
stated that the HCPCS code G0402 (Initial preventive physical 
examination; face-to-face visit, services limited to new beneficiary 
during the first 12 months of Medicare enrollment) was also valued 
based on a direct crosswalk to the work, time, and direct PE inputs for 
CPT code 99204 (75 FR 73408 through 73411).
    Because these codes are valued using direct crosswalks to office/
outpatient E/M visits, we believed that to maintain payment accuracy 
for the IPPE and the AWV, their values should be adjusted to reflect 
the changes in value for CPT codes 99204 and 99214. Therefore, we 
proposed to revise the work, physician time, and direct PE inputs for 
these codes as shown in Tables 23 and 24. The following is a summary of 
the comments we received and our responses.
    Comment: Several commenters agreed with our proposal to revalue the 
IPPE and AWV HCPCS codes. These commenters agreed that because these 
services were valued using direct crosswalks to CPT codes 99204 and 
99214, their values should be updated to reflect the increases to those 
visits finalized for CY 2021.
    Response: We thank the commenters for their support.
    Comment: Several commenters disagreed with our proposal to revalue 
the IPPE and AWV HCPCS codes. A commenter indicated that because the 
AMA RUC has never reviewed these codes, it is unclear that the work 
associated with the services represents work described by a level 4 
office/outpatient E/M visit.
    Response: We continue to believe that because the IPPE and AWV were 
valued using direct crosswalks to CPT codes 99204 and 99214, 
respectively, changes to the work associated with CPT codes 99204 and 
99214 should be applied to the valuation of the IPPE and AWV codes. 
Regarding the point that these codes have not been reviewed by the RUC, 
we note that the IPPE and AWV are services that are unique to the 
Medicare program. These services are reported using Medicare-specific 
HCPCS G codes that are not applicable for other payers. As such, we do 
not see a need for these codes to be reviewed by

[[Page 84557]]

the RUC. If the RUC did review them, however, we would consider any RUC 
recommendations through our usual rulemaking process. As discussed 
above, our decision to consider a given code(s) as analogous to the 
office/outpatient E/M visits is not based on any single factor, but 
rather, takes into account various applicable factors. The public may 
nominate any code(s) as potentially misvalued through the usual 
misvalued code process, or request that codes reviewed by the AMA RUC.
    We received comments primarily in support of our proposal to 
revalue the IPPE and AWV codes. Our proposed revaluations reflect 
changes in value to the two office and outpatient E/M codes (that is, 
CPT codes 99204 and 99214) upon which the IPPE and AWV code values were 
originally crosswalked. We continue to believe that to maintain payment 
accuracy, the values for the IPPE and AWV codes should be adjusted 
accordingly. After considering the comments, we are finalizing as 
proposed.
BILLING CODE 4120-01-P

[[Page 84558]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.034


[[Page 84559]]


[GRAPHIC] [TIFF OMITTED] TR28DE20.035


[[Page 84560]]


[GRAPHIC] [TIFF OMITTED] TR28DE20.036


[[Page 84561]]


[GRAPHIC] [TIFF OMITTED] TR28DE20.037


[[Page 84562]]


[GRAPHIC] [TIFF OMITTED] TR28DE20.038

BILLING CODE 4120-01-C
6. Emergency Department Visits
    We have revalued the ED visit codes (CPT codes 99281-99285, see 
Table 25 for long descriptors) under the PFS three times: In 1997, 
2007, and most recently in 2020 as part of the misvalued code 
initiative. In the past, consistent with AMA RUC recommendations, we 
revalued these services such that the values of levels 1 through 3 of 
the ED visits were equal to levels 1 through 3 new patient office/
outpatient E/M visits, and the levels 4 and 5 ED visits were valued 
higher than the levels 4 and 5 new patient office/outpatient E/M visits 
to reflect higher typical intensity. Also in the CY 2018 PFS final 
rule, we finalized a proposal to nominate all five ED visit codes as 
potentially misvalued, based on information suggesting that the work 
RVUs for ED visits may not appropriately reflect the full resources 
involved in furnishing these services. Specifically, some stakeholders 
expressed concerns that the work RVUs for these services have been 
undervalued given the increased acuity of the patient population and 
the heterogeneity of the sites, such as freestanding and off-campus 
EDs, where ED visits are furnished (82 FR 53018). Accordingly, the AMA 
RUC resurveyed and reviewed these five codes for the April 2018 RUC 
meeting, and provided a recommendation to CMS for consideration in CY 
2020 rulemaking. In the CY 2020 PFS final rule (84 FR 62796), we 
finalized the RUC-recommended increases to the work RVUs of 0.48 for 
CPT code 99281, a work RVU of 0.93 for CPT code 99282, a work RVU of 
1.42 for 99283, a work RVU of 2.60 for 99284, and a work RVU of 3.80 
for CPT code 99285. The RUC did not recommend, and we did not finalize, 
any change in direct PE inputs for the codes in this family. We note 
that the AMA RUC submitted these recommended values to CMS prior to the 
submission of the RUC-recommended revaluation of the office/outpatient 
E/M visit code family.
    In response to our proposal to accept the RUC-recommended values 
for the ED visits, and to our comment solicitation in CY 2020 PFS 
proposed rule regarding whether we should revalue certain services 
commensurate with increases to the office/outpatient E/M visits (84 FR 
62859 through 62860), a commenter submitted a public comment stating 
that relativity between the ED visits and office/outpatient E/M visits 
should be maintained, and submitting a specific recommendation for CPT 
codes 99283-99285 that was higher than the RUC-recommended values. The 
commenter stated we should preserve the relationship between the ED and 
office/outpatient E/M visit code sets that was established in prior 
years and that they believe would have likely been maintained had the 
office/outpatient E/M visits been reviewed prior to the ED visits. In 
order to avoid the rank order anomaly whereby an ED visit would be 
valued lower than the analogous office/outpatient E/M visit in CY 2021, 
we proposed in this current rulemaking cycle to adopt the values 
recommended by this commenter, and as shown in Table 25. The following 
is a summary of the comments we received and our responses.
    Comment: One commenter supported our proposal. This commenter 
stated that levels 1-3 ED visits should remain the same as the levels 
1-3 new patient office visits, and that levels 4-5 ED visits should 
have a higher value than the corresponding office visits due to the 
complexity of the patients requiring that level of emergency care.
    Response: We are finalizing as proposed, as shown in Table 25, in 
order to avoid a rank order anomaly. We understand that the AMA 
workgroup on E/M services is continuing to consider further changes in 
coding and interpretive guidance for visit level selection for all of 
the E/M visit code sets other than the office/outpatient E/M visits, in 
light of the recent changes for office/outpatient visits. We will 
continue to stay abreast of this important work and continue 
considering the appropriate valuation of ED and other E/M visit code 
sets in light of any future changes in this arena by the CPT Editorial 
Panel and the AMA RUC.
    Comment: Several commenters requested that we consider the nursing 
facility visits (CPT codes 99304-99318), domiciliary visits (CPT codes 
99324-99337), and home visits (CPT codes 99341-99350) to be analogous 
to the office/outpatient E/M visits, noting that they are identical in 
every way except the setting of care and vulnerability of

[[Page 84563]]

the patient population. These commenters indicated that the CPT 
Editorial Panel and the AMA RUC will be reviewing these code sets in 
the near future, and their primary concern was to maintain access to 
care until this review is complete. Accordingly, these commenters 
recommended that we increase the work RVUs for these services to the 
extent necessary to maintain the payment rate for these codes at 2020 
levels. These commenters provided an estimate of the revised work RVUs 
necessary to achieve this as a temporary measure, stating that due to 
relatively low service volume, these changes would not negatively 
impact the conversion factor.
    Response: We did not propose to treat and revalue nursing facility 
visits, domiciliary visits and home visits as analogous to office/
outpatient E/M visits. We do not agree with the commenters' assertions 
that these visits are identical to the office/outpatient E/M visit 
codes. The setting of care means that these visits involve different 
resources. In particular, skilled nursing facility (SNF) visits are 
reported using the nursing facility visit codes, rendering them 
substantially different from office/outpatient visits. For these 
reasons, we do not believe the commenters' requested changes to values 
for nursing facility visits, domiciliary visits, and home visits would 
be appropriate at this time. Additionally, we understand that the AMA 
workgroup on E/M services is continuing to consider further changes in 
coding and interpretive guidance for visit level selection for all of 
the E/M visit code sets other than the office/outpatient E/M visits, in 
light of the forthcoming changes for office/outpatient visits. We will 
continue to stay abreast of this important work and consider the 
appropriate valuation of home, domiciliary, nursing facility and other 
E/M visit code sets in light of any future changes in this arena by the 
CPT Editorial Panel and the AMA RUC.
7. Therapy Evaluations
    There are a number of services paid under the PFS that are similar 
in many respects to the office/outpatient E/M visit code set, but do 
not specifically include, were not valued to include, and were not 
necessarily valued relative to, office/outpatient E/M visits. Some 
codes inherently include work associated with assessment and work 
associated with management, similar to the work included in the office/
outpatient E/M visits, which involve time spent face-to-face assessing 
and treating the patient. These services include therapy evaluation 
services and psychiatric diagnostic evaluation services. The 
practitioners who furnish these services are prohibited by CMS from 
billing E/M services due to the limitations of their Medicare benefit 
categories. As such, the CPT Editorial Panel has created specific 
coding to describe the services furnished by these practitioners. 
Although these services are billed using specific, distinct codes 
relating to therapy evaluations and psychiatric diagnostic evaluations, 
we believe that a significant portion of the overall work in the codes 
is for assessment and management of patients, as it is for the office/
outpatient E/M visit codes.
    Therefore, we proposed to adjust the work RVUs for these services 
based on a broad-based estimate of the overall change in the work 
associated with assessment and management to mirror the overall 
increase in the work of the office/outpatient E/M visits. We calculated 
this adjustment based on a volume-weighted average of the increases to 
the office/outpatient E/M visit work RVUs from CY 2020 to CY 2021. 
Details on this calculation are available as a public use file on the 
CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices. We proposed 
to apply that percentage increase, which we estimated to be 
approximately 28 percent, to the work RVUs for the therapy evaluation 
and psychiatric diagnostic evaluation services codes. We noted that we 
believe that it is important to the relativity of the PFS to revalue 
these services to reflect the overall increase in value associated with 
spending time assessing and managing patients, as reflected in the 
changes to work values for the office/outpatient E/M visits, 
particularly in recognition of the value of the clinicians' time which 
is spent treating a growing number of patients with greater needs and 
multiple medical conditions. We recognized that this is not the 
methodology typically used to value services under the PFS and 
solicited comment on potential alternative methodologies or specific 
values for these services, particularly about whether commenters 
believe it would be better to develop values using comparator codes 
from the office/outpatient E/M visit code set, and if so, why.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Some commenters supported our proposal to adjust the work 
RVUs for outpatient therapy evaluations and to consider alternative 
approaches submitted by stakeholders in future rulemaking that may 
better reflect the true values. Many commenters urged us to implement 
similar increases to the work RVUs of additional therapy services, 
including CPT codes 97140 (Manual therapy techniques (eg, mobilization/
manipulation, manual lymphatic drainage, manual traction), 1 or more 
regions, each 15 minutes), 97537 (Community/work reintegration training 
(eg, shopping, transportation, money management, avocational activities 
and/or work environment/modification analysis, work task analysis, use 
of assistive technology device/adaptive equipment), direct one-on-one 
contact, each 15 minutes), 97542 (Wheelchair management (eg, 
assessment, fitting, training), each 15 minutes), 97760 (Orthotic(s) 
management and training (including assessment and fitting when not 
otherwise reported), upper extremity(ies), lower extremity(ies) and/or 
trunk, initial orthotic(s) encounter, each 15 minutes), 97761 
(Prosthetic(s) training, upper and/or lower extremity(ies), initial 
prosthetic(s) encounter, each 15 minutes), 97763 (Orthotic(s)/
prosthetic(s) management and/or training, upper extremity(ies), lower 
extremity(ies), and/or trunk, subsequent orthotic(s)/prosthetic(s) 
encounter, each 15 minutes), 97597 (Debridement (eg, high pressure 
waterjet with/without suction, sharp selective debridement with 
scissors, scalpel and forceps), open wound, (eg, fibrin, devitalized 
epidermis and/or dermis, exudate, debris, biofilm), including topical 
application(s), wound assessment, use of a whirlpool, when performed 
and instruction(s) for ongoing care, per session, total wound(s) 
surface area; first 20 sq cm or less), 97598 (Debridement (eg, high 
pressure waterjet with/without suction, sharp selective debridement 
with scissors, scalpel and forceps), open wound, (eg, fibrin, 
devitalized epidermis and/or dermis, exudate, debris, biofilm), 
including topical application(s), wound assessment, use of a whirlpool, 
when performed and instruction(s) for ongoing care, per session, total 
wound(s) surface area; each additional 20 sq cm, or part thereof (List 
separately in addition to code for primary procedure)), 97750 (Physical 
performance test or measurement (eg, musculoskeletal, functional 
capacity), with written report, each 15 minutes), and 97755 (Assistive 
technology assessment (eg, to restore, augment or compensate for 
existing function, optimize functional tasks and/or maximize 
environmental accessibility),

[[Page 84564]]

direct one-on-one contact, with written report, each 15 minutes). These 
commenters stated that these services also involve assessment and 
management, and thus, are analogous to office/outpatient E/M visit 
codes.
    Response: In the proposed rule, we discussed that these evaluations 
contained types of work, specifically time spent assessing and managing 
patients, that is similar to the work described by the office/
outpatient E/M visit code set. We stated that the increase in value 
associated with the office/outpatient E/M visits reflected the changes 
to work values, particularly in recognition of the value of the 
clinicians' time spent treating a growing number of patients with 
greater needs and multiple medical conditions, that could also apply to 
physical therapy, occupational therapy, and speech language pathology 
evaluations. The CPT codes identified by commenters involve work that 
is not similar to that captured by the office/outpatient E/M codes, 
such as various types of therapeutic treatment. Therefore, we do not 
believe it would be appropriate to adjust the values of these codes to 
reflect the changes in valuation for the office/outpatient E/M codes.
    Comment: Some commenters did not support our proposal to implement 
the proposed increases to these therapy codes, stating that it will 
amplify a previous misvaluation by CMS for codes that do not 
specifically include, were not valued to include, and were not 
necessarily valued relative to, office/outpatient E/M visits. According 
to the commenters, these therapy codes were originally misvalued when 
CMS finalized a single RVU of 1.20 for all three codes rather than the 
RUC-recommended work RVUs, which created an overvaluation in aggregate 
for these services.
    Response: In the proposed rule, we discussed our rationale for 
proposing to increase the values of these services relative to the 
increased values for the office/outpatient E/M visit code set. If the 
commenters believe the therapy codes are not appropriately valued, we 
note the public may nominate any code(s) as potentially misvalued 
through the usual misvalued code process or request that it be surveyed 
or valued through the AMA RUC.
    After considering the public comments, we are finalizing the 
changes in values for the therapy codes as proposed.
8. Behavioral Healthcare Services
    The psychotherapy code set is divided into psychotherapy that can 
be furnished as a standalone service and psychotherapy furnished in 
conjunction with an office/outpatient E/M visit. The standalone 
psychotherapy services are CPT codes 90832, 90834, and 90837 (See Table 
25 for long descriptors). The CPT codes describing psychotherapy 
furnished in conjunction with an office/outpatient E/M visit are CPT 
codes 90833 (Psychotherapy, 30 minutes with patient when performed with 
an evaluation and management service (List separately in addition to 
the code for primary procedure)), 90836 (Psychotherapy, 45 minutes with 
patient when performed with an evaluation and management service (List 
separately in addition to the code for primary procedure)) and 90838 
(Psychotherapy, 60 minutes with patient when performed with an 
evaluation and management service (List separately in addition to the 
code for primary procedure)). As the values for the office/outpatient 
E/M visits are increasing, there will necessarily be an increase in the 
overall value for psychotherapy furnished in conjunction with office/
outpatient E/M visits. We believe that it is important, both in terms 
of supporting access to behavioral health services through appropriate 
payment and maintaining relativity within this code family, to increase 
the values for the standalone psychotherapy services to reflect changes 
to the value of the office/outpatient E/M visits which are most 
commonly furnished with the add-on psychotherapy services with 
equivalent times. For example, under the finalized revaluation of the 
office/outpatient E/M visits, the proportional work value of the 
standalone psychotherapy CPT code 90834 (Psytx w pt 45 minutes) would 
decrease relative to the combined work RVUs for CPT code 99214 (Level 4 
Office/outpatient visit est) when billed with CPT code 90836 (Psytx w 
pt w e/m 45 min). The current combined work RVU for CPT code 99214 when 
reported with CPT code 90836 is 3.40 (1.90 + 1.50) and the current work 
RVU for CPT code 90834 is 2.0. With the revaluation of the office/
outpatient E/M visits beginning for CY 2021, the combined work RVU for 
CPT codes 99214 and 90836 would be 3.82 (1.90 + 1.92), while the 
current work RVU for 90834 would remain at 2.0, resulting in a change 
to relativity between these services.
    To maintain the current relativity, which we believe to be 
appropriate based on the proportionate difference between these 
services, we are proposing to increase the work RVU for CPT code 90834 
from 2.00 to 2.25 based on the marginal increase in work value for CPT 
code 99214 from CY 2020 to CY 2021. Similarly, for CPT code 90832, 
which describes 30 minutes of psychotherapy, we proposed to increase 
its work RVU based on the increase to CPT code 99213, which is most 
commonly billed with the 30 minutes of psychotherapy add-on, CPT code 
90833. For CPT code 90837, which describes 60 minutes of psychotherapy, 
we propose to increase the work RVU based on the proportional increase 
to CPT codes 99214 and 90838, which is the office/outpatient E/M visit 
code most frequently billed with the 60 minutes of psychotherapy add-
on. Table 25 provides a summary of the current and final RVUs for these 
services.
BILLING CODE 4120-01-P

[[Page 84565]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.039


[[Page 84566]]


[GRAPHIC] [TIFF OMITTED] TR28DE20.040


[[Page 84567]]


[GRAPHIC] [TIFF OMITTED] TR28DE20.041

BILLING CODE 4120-01-C
    We received public comments on the Behavioral Healthcare services. 
The following is a summary of the comments we received and our 
responses.
    Comment: A few commenters did not support this proposal, stating it 
relies on a flawed methodology; specifically, the stand-alone codes, 
which were established for NPPs to report psychotherapy services, were 
not valued based on a comparison to the psychotherapy codes delivered 
in conjunction with an E/M (codes 90833, 90836 and 90838). These 
commenters noted that these are two distinct codes sets: one for NPPs 
and one for physicians/QHPs representing different levels of similar 
work. CMS should compare psychotherapy to psychotherapy, not 
psychotherapy to psychotherapy plus E/M. Accordingly, these commenters 
did not support CMS's proposal to increase the values of 90832, 90834, 
and 90837 to reflect changes to the value of the office/outpatient E/M 
visits which are most commonly furnished with the add-on psychotherapy 
services with equivalent times.
    Other commenters were concerned that the increases to some of the 
psychotherapy services will skew the relativity not only to the 
psychotherapy services provided along with an E/M service but to other 
services within the psychiatry section.
    Some commenters supported increases for these services, but stated 
that commensurate relativity adjustments are needed for all 
Psychotherapy, Psychological and Neuropsychological Testing, and HBAI 
codes. Specifically, these commenters recommended proportionate 
increases to CPT codes 90791 (Psychiatric diagnostic evaluation), 90839 
(Psychotherapy for crisis; first 60 minutes), 90845 (Psychoanalysis), 
90847 (Family psychotherapy (conjoint psychotherapy) (with patient 
present), 50 minutes), and 90853 (Group psychotherapy (other than of a 
multiple-family group)), as well as to the HBAI code set (CPT codes 
96156 (Health behavior assessment, or re-assessment (ie, health-focused 
clinical interview, behavioral observations, clinical decision 
making)), 96158 (Health behavior intervention, individual, face-to-
face; initial 30 minutes), 96159 (Health behavior intervention, 
individual, face-to-face; each additional 15 minutes (List separately 
in addition to code for primary service)), and 97170 (Athletic training 
evaluation, moderate complexity, requiring these components: A medical 
history and physical activity profile with 1-2 comorbidities that 
affect physical activity; An examination of affected body area and 
other symptomatic or related systems addressing a total of 3 or more 
elements from any of the following: body structures, physical activity, 
and/or participation deficiencies; and Clinical decision making of 
moderate complexity using standardized patient assessment instrument 
and/or measurable assessment of functional outcome. Typically, 30 
minutes are spent face-to-face with the patient and/or family.); and to 
the Psychological and Neuropsychological Testing code set (CPT codes 
96116 (Neurobehavioral status exam (clinical assessment of thinking, 
reasoning and judgment, [eg, 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), 96121 (Neurobehavioral status exam 
(clinical assessment of thinking, reasoning and judgment, [eg, 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 (List separately in addition to code for primary procedure)), 
96130 (Psychological 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), 96131 (Neuropsychological 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), 96132 
(Neuropsychological 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), 96133 (Neuropsychological 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 
(List separately in addition to code for

[[Page 84568]]

primary procedure)), 96136 (Psychological or neuropsychological test 
administration and scoring by physician or other qualified health care 
professional, two or more tests, any method; first 30 minutes), 96137 
(Psychological or neuropsychological test administration and scoring by 
physician or other qualified health care professional, two or more 
tests, any method; each additional 30 minutes (List separately in 
addition to code for primary procedure)), 96138 (Psychological or 
neuropsychological test administration and scoring by technician, two 
or more tests, any method; first 30 minutes), 96139 (Psychological or 
neuropsychological test administration and scoring by technician, two 
or more tests, any method; each additional 30 minutes (List separately 
in addition to code for primary procedure)), and 96146 (Psychological 
or neuropsychological test administration, with single automated, 
standardized instrument via electronic platform, with automated result 
only)), all of which were valued relative to the family of 
psychotherapy services through the AMA RUC process.
    Response: We identified standalone psychotherapy services for 
adjustment to preserve the relative value of these services to 
psychotherapy services performed in conjunction with an office/
outpatient E/M. We disagree with commenters who stated that, as the 
standalone psychotherapy codes were purposefully and appropriately 
valued without reference to the values of E/M services, we should not 
consider updating these values to retain relativity between standalone 
psychotherapy and psychotherapy billed in conjunction with an office/
outpatient E/M. With regard to requests from commenters to adjust 
values of additional services, we continue to believe that our 
rationale for proposing proportionate adjustments to the stand-alone 
psychotherapy services does not apply to the wider psychotherapy code 
set. We believe that the value of stand-alone psychotherapy is 
analogous to the values of the office/outpatient E/M visit codes due to 
the nature of the work performed. These services describe E/M-type 
services furnished in some circumstances by practitioners who would not 
bill E/M services. Health and Behavior Assessment and Intervention and 
Psychological and Neuropsychological Testing are fundamentally 
different in that they describe testing services.
    Having considered the public comments we received, we are 
finalizing our proposed increases to the values of CPT codes 90832, 
90834, and 90837.
9. Ophthalmological Services
    Prior to the CY 2021 PFS proposed rule, we had received a request 
to revalue the following ophthalmological services that we did not 
propose to revalue:
     CPT code 92002: Ophthalmological services: Medical 
examination and evaluation with initiation of diagnostic and treatment 
program; intermediate, new patient.
     CPT code 92004: Ophthalmological services: 
Medical examination and evaluation with initiation of diagnostic and 
treatment program; comprehensive, new patient, 1 or more visits.
     CPT code 92012: Ophthalmological services: 
Medical examination and evaluation, with initiation or continuation of 
diagnostic and treatment program; intermediate, established patient.
     CPT code 92014: Ophthalmological services: 
Medical examination and evaluation, with initiation or continuation of 
diagnostic and treatment program; comprehensive, established patient, 1 
or more visits.
    We did not propose to revalue these services because they are not 
sufficiently analogous to the office/outpatient E/M visit codes. While 
these ophthalmological services have historically been valued relative 
to office/outpatient E/M visits, the AMA RUC has not reviewed them 
since 2007. Two of these ophthalmological services can include more 
than one visit, and the number of visits included in the package is 
uncertain and therefore not so closely tied to office and outpatient E/
M services, which describe a single visit. In addition, starting in 
2021, the office/outpatient E/M visit codes will be substantially 
redefined to allow time or medical decision-making for code level 
selection--concepts that do not apply to the ophthalmological visits 
which rely on criteria specific to evaluation, examination, specified 
technical procedures, and treatment of ocular conditions for purposes 
of level selection.\8\ The number of levels is different within the two 
code sets, and the number of levels has changed for office/outpatient 
E/M visits. Given the revised code set and framework for level 
selection for office/outpatient E/M visits, the level of office/
outpatient E/M visits to which the ophthalmological visits might be 
analogous is unclear. We also noted that we are aware that 
ophthalmologists report office/outpatient E/M visits as well these 
ophthalmologic-specific evaluation codes. The relationship between the 
two separate code sets and the reason for maintaining and using both of 
them is unclear.
---------------------------------------------------------------------------

    \8\ CPT Codebook pp. 656-7.
---------------------------------------------------------------------------

    In the proposed rule, we also noted that the four ophthalmological 
evaluation codes are frequently reported with modifier -25 
(significant, separately identifiable E/M service by the same physician 
on the same day of the procedure or other service), as are ED visits. 
For the ophthalmological evaluations and ED visits, approximately one-
third of the time, the same-day E/M service is a zero-day global 
surgical code, whereas for the office/outpatient E/M visits, 
approximately one-fifth of the same-day claims are for zero-day global 
services. We noted that we believe that visit/evaluation codes 
furnished the same day as a minor procedure are not closely analogous 
to stand-alone office/outpatient E/M visits. As we discussed in prior 
rulemaking, we continue to believe that separately identifiable visits 
occurring on the same day as minor procedures (such as zero-day global 
procedures) have resources that are sufficiently distinct from the 
costs associated with furnishing office/outpatient E/M visits to 
warrant different payment (see, for example, the CY 2019 PFS final 
rule, 83 FR 59639). As we were still in process of analyzing these 
data, we solicited public comment on whether visits/evaluations that 
are furnished frequently with same-day procedures should be revalued 
commensurate with increases to the office/outpatient E/M visits, or 
whether they are substantially different enough to warrant independent 
valuation. We noted further that the stand-alone psychotherapy services 
would be revalued to maintain relativity with the psychotherapy 
services that can be performed in conjunction with an E/M visit. Stand-
alone psychotherapy services cannot be billed with office/outpatient E/
M visits while ophthalmological visits can, as well as with a separate 
procedure.
    We received public comments on our decision not to propose new 
valuations for these ophthalmological services. The following is a 
summary of the comments we received and our responses.
    Comment: One commenter stated that concurrent billing with same-
day, zero-day global procedures should not be factor in whether or not 
we increase the ophthalmology evaluation codes commensurate with 
office/outpatient E/M visits. The commenter stated that the 
intravitreal injection code accounting for much of the volume of these 
zero-day global procedures (CPT code 67028) does not include an office 
examination. The commenter also stated that resource

[[Page 84569]]

duplication between the same-day services is accounted for in the RUC 
valuation that reduces the pre- and post-times for the procedure if it 
is furnished more than 50 percent of the time with an E/M visit or eye 
evaluation. Another commenter noted that the AWV can be reported the 
same day as an office/outpatient E/M visit, and urged CMS not to treat 
primary care and surgical specialties differentially.
    Response: We continue to believe that separately identifiable 
visits occurring on the same day as minor procedures (such as zero-day 
global procedures) have resources that are sufficiently distinct from 
the costs associated with furnishing stand-alone office/outpatient E/M 
visits to warrant different payment. However, we understand that such a 
policy would apply to ophthalmology evaluations, ED visits and other 
services. We believe the better way to account for duplicative 
resources across the fee schedule would be a payment reduction along 
the lines of a multiple procedure payment reduction for services 
reported using modifier -25.We will continue to consider implementing a 
policy to address this issue. We note that the policy that we proposed 
and declined to finalize for CY 2019 would have applied a multiple 
``procedure'' payment adjustment to two visits reported the same day, 
as well as a visit with a minor procedure. We are also considering 
whether the office/outpatient visit complexity HCPCS add-on code GPC1X 
should be reported when the visit is reported with modifier -25 (see 
section II.F.2.c. of this final rule).
    Comment: One commenter stated that while the ophthalmological 
evaluations have not been recently revalued by the AMA RUC, the AWV has 
never been reviewed by the RUC.
    Response: We discuss above our rationale for considering the AWV as 
an analogous service to the office/outpatient E/M services. Regarding 
consideration of the AWV by the RUC, we note that the AWV is a service 
described by a code that is unique to Medicare and not applicable for 
other payers. As such, we do not see a need for the RUC to review this 
service, but if it did, we would consider its recommendations through 
our usual rulemaking process. As discussed above, our decision to 
consider a given code(s) as analogous to the office/outpatient E/M 
visits is not based on any single factor, but rather takes into account 
various applicable factors. The public may nominate any code(s) as 
potentially misvalued through the usual misvalued code process or 
request that it be surveyed or valued through the AMA RUC.
    Comment: The same commenter stated that all four of the 
ophthalmology codes are valued based on a single visit on the date of 
encounter, and the level of that visit is directly compared to levels 
of office E/M codes. The commenter also stated that while the 
ophthalmological codes do not rely on time to select visit level, both 
code sets will be able to use MDM to select visit level, and that MDM 
was a basis for prior comparison to office/outpatient E/M visit codes.
    Response: We continue to note that two of these ophthalmological 
services can include more than one visit, and therefore, the resource 
costs are not as closely tied to office and outpatient E/M visits (that 
describe a single visit) as the AWV/IPPE, TCM, cognitive impairment and 
other codes we are considering to be analogous to office/outpatient E/M 
visits. We disagree that reliance on time and differences in MDM 
interpretive guidance are not substantial differences between the 2021 
office/outpatient E/M visit codes and the ophthalmology evaluation 
codes. Also, we continue to believe that the corresponding visit levels 
for the two code sets are not clear, such that the level of office/
outpatient E/M visits to which the ophthalmological visits might be 
analogous is not apparent. We continue to note that ophthalmologists 
report office/outpatient E/M visits as well these ophthalmologic-
specific evaluation codes. The relationship between the two separate 
code sets and the reason for maintaining and using both of them remains 
unclear. Having considered the public comments we received, we are 
finalizing our decision not to revalue the ophthalmological evaluations 
commensurate with the changes to the office/outpatient EM visit 
valuations for 2021. Stakeholders may still request review of these 
services by the RUC or through our misvalued code initiative.
c. Comment Solicitation on the Definition of HCPCS Add-On Code G2211
    Although we believe that the RUC-recommended values for the revised 
office/outpatient E/M visit codes will more accurately reflect the 
resources involved in furnishing a typical office/outpatient E/M visit, 
we continue to believe that the typical visit described by the revised 
and revalued office/outpatient E/M visit code set still does not 
adequately describe or reflect the resources associated with primary 
care and certain types of specialty visits. Therefore, in the CY 2020 
PFS final rule (84 FR 62856), we finalized the HCPCS add-on code G2211 
(which replaces temporary HCPCS add-on code GPC1X) and which describes 
the ``visit complexity inherent to evaluation and management associated 
with medical care services that serve as the continuing focal point for 
all needed health care services and/or with medical care services that 
are part of ongoing care related to a patient's single, serious, or 
complex condition.'' We stated that we were not restricting billing 
based on specialty, but that we did assume that certain specialties 
furnished these types of visits more than others.
    Since the publication of the CY 2020 PFS final rule, some specialty 
societies have stated that our definition of this service, as 
articulated in the code descriptor and the associated preamble 
discussion, is unclear. For example, some stakeholders have suggested 
that HCPCS add-on code G2211, as currently described, could be 
applicable for every office/outpatient E/M visit. They have also 
expressed concerns regarding our utilization assumptions, since we 
assumed that specialties that predominantly furnish the kind of care 
described by the code would bill it with every visit. Therefore, we 
solicited public comments providing additional, more specific 
information regarding what aspects of the definition of HCPCS add-on 
code G2211 are unclear, how we might address those concerns, and how we 
might refine our utilization assumptions for the code.
    We continue to believe that the time, intensity, and PE involved in 
furnishing services to patients on an ongoing basis that result in a 
comprehensive, longitudinal, and continuous relationship with the 
patient and involves delivery of team-based care that is accessible, 
coordinated with other practitioners and providers, and integrated with 
the broader health care landscape, are not adequately described by the 
revised office/outpatient E/M visit code set. We believe the inclusion 
of HCPCS add-on code G2211 appropriately recognizes the resources 
involved when practitioners furnish services that are best-suited to 
patients' ongoing care needs and potentially evolving illness. We also 
believe the work reflected in HCPCS add-on code G2211 is inherently 
distinct from existing coding that describes preventive and care 
management services. For example, the AWV describes and pays for a 
static annual health assessment rather than the time, intensity, and PE 
involved in furnishing services to patients on an ongoing basis. 
Similarly, TCM service codes are focused on care management for 30 days

[[Page 84570]]

following a discharge rather than the time, intensity, and PE involved 
in furnishing services to patients on an ongoing basis. Chronic care 
management and principal care management service codes are limited to 
patients with chronic condition(s). Under chronic care management 
codes, patients have two or more chronic conditions that place the 
patient at significant risk of death, acute exacerbation/
decompensation, or functional decline, whereas principal care 
management services are for patients who have a single high-risk 
disease of sufficient severity to place the patient at risk of 
hospitalization or have been the cause of recent hospitalization. In 
contrast, we believe HCPCS add-on code G2211 reflects the time, 
intensity, and PE when practitioners furnish services that enable them 
to build longitudinal relationships with all patients (that is, not 
only those patients who have a chronic condition or single-high risk 
disease) and to address the majority of patients' health care needs 
with consistency and continuity over longer periods of time. For 
example, in the context of primary care, HCPCS add-on code G2211 could 
recognize the resources inherent in holistic, patient-centered care 
that integrates the treatment of illness or injury, management of acute 
and chronic health conditions, and coordination of specialty care in a 
collaborative relationship with the clinical care team. In the context 
of specialty care, HCPCS add-on code G2211 could recognize the 
resources inherent in engaging the patient in a continuous and active 
collaborative plan of care related to an identified health condition 
the management of which requires the direction of a clinician with 
specialized clinical knowledge, skill and experience. Such 
collaborative care includes patient education, expectations and 
responsibilities, shared decision-making around therapeutic goals, and 
shared commitments to achieve those goals. In both examples, HCPCS add-
on code G2211 reflects the time, intensity, and PE associated with 
providing services that result in care that is personalized to the 
patient. Finally, we believe that the HCPCS add-on code G2211 could 
bolster the efforts of practitioners in rural communities, including 
NPPs, to deliver the comprehensive and longitudinal care that HCPCS 
add-on code G2211 describes.
    We received public comments on our comment solicitation related to 
HCPCS add-on code G2211. The following is a summary of the comments we 
received and our responses.
    Comment: Many commenters who rely upon office/outpatient E/M visits 
to report the majority of their services continued to be supportive of 
HCPCS add-on code G2211. These commenters agreed with CMS that the 
revised office/outpatient E/M visit codes do not adequately describe or 
reflect the resources associated with primary care and certain types of 
specialty visits and agreed that the code descriptor fits its intended 
purpose, is well-defined, and did not allude to specific specialties. 
Other commenters disagreed, maintaining that the definition of HCPCS 
add-on code G2211 is unclear. Some commenters stated that it appeared 
that HCPCS add-on code G2211 could be reported with most office/
outpatient E/M visits and questioned whether widespread use accurately 
captured genuine longitudinal care relationships. These commenters 
requested that CMS provide clinical examples for appropriate reporting. 
Other commenters provided CMS with suggested clinical examples for when 
HCPCS add-on code G2211 could be reported. For example, some commenters 
stated that HCPCS add-on code G2211 would capture additional work by 
the reporting practitioner to treat patients with disease processes 
that require active monitoring outside of office/outpatient E/M visits 
and are not captured in current coding. This work could include 
oversight of medication refills; evaluating appropriateness of current 
and new medications, including those initially prescribed by other 
practitioners; and conducting medication-related monitoring and safety 
activities when these activities are not part of a visit. It could also 
include review of lab and imaging reports, including those requested by 
another practitioner, that fall outside the timeframe of an office/
outpatient E/M visit, and do not necessitate a new visit. Finally, some 
commenters suggested that CMS describe circumstances when HCPCS add-on 
code G2211 would not be reported with an office/outpatient E/M visit.
    Response: We appreciate all of the feedback from the commenters. We 
believe that HCPCS add-on code G2211 captures the work by the reporting 
practitioner for many office/outpatient E/M visits that is not 
accounted for in the valuation of the primary office/outpatient E/M 
visit code. In the context of primary care, a clinical example for the 
use of HCPCS add-on code G2211 could be: a 68 year-old woman with 
progressive congestive heart failure (CHF), diabetes, and gout, on 
multiple medications, who presents to her physician for an established 
patient visit. The clinician discusses the patient's current health 
issues, which includes confirmation that her CHF symptoms have remained 
stable over the past 3 months. She also denies symptoms to suggest 
hyper- or hypoglycemia, but does note ongoing pain in her right wrist 
and knee. The clinician adjusts the dosage of some of the patient's 
medications, instructs the patient to take acetaminophen for her joint 
pain, and orders laboratory tests to assess glycemic control, metabolic 
status, and kidney function. The practitioner also discusses age 
appropriate prevention with the patient and orders a pneumonia 
vaccination and screening colonoscopy. In this clinical example, the 
practitioner is serving as a focal point for the patient's care, 
addressing the broad scope of the patient's health care needs, by 
furnishing care for some or all of the patient's conditions across a 
spectrum of diagnoses and organ systems with consistency and continuity 
over time.
    Moreover, we believe that similar visits might be furnished by 
other specialists when management of a particular disease condition(s) 
is ongoing or serves as a focal point of care for a patient's overall 
health needs over a period of time. In other words, when care by 
specialists for a particular disease condition(s) is consistent and 
continuous over long periods of time, the work associated with those 
visits is similar to the kind of work described above.
    In contrast, there are many visits with new or established patients 
where HCPCS add-on code G2211 would not be appropriately reported, such 
as when the care furnished during the office/outpatient E/M visit is 
provided by a professional whose relationship with the patient is of a 
discrete, routine, or time-limited nature, such as a mole removal or 
referral to a physician for removal of a mole; for treatment of a 
simple virus; for counseling related to seasonal allergies, initial 
onset gastroesophageal reflux disease; treatment for a fracture; and 
where comorbidities are either not present or not addressed, and/or and 
when the billing practitioner has not taken responsibility for ongoing 
medical care for that particular patient with consistency and 
continuity over time, or does not plan to take responsibility for 
subsequent, ongoing medical care for that particular patient with 
consistency and continuity over time. Reporting the add-on code with 
these types of visits would be inconsistent with the code

[[Page 84571]]

descriptor, which describes care that is a continuing focal point and/
or part of ongoing care. We also would not expect that HCPCS add-on 
code G2211 would be reported when the office/outpatient E/M is reported 
with a payment modifier, such as the modifier -25 described in the 
ophthalmological services section above. It seems likely that visits 
reported with payment modifiers have resources that are sufficiently 
distinct from stand-alone office/outpatient E/M visits. We will be 
considering this issue to inform potential future rulemaking.
    Comment: Some commenters suggested that a lack of clarity in the 
definition of HCPCS add-on code G2211 poses program integrity 
challenges for CMS. They pointed out that CMS has offered no 
information about how appropriate use will be determined or what 
documentation will be expected. Some commenters requested guidance on 
what documentation would need to be included when HCPCS add-on code 
G2211 is reported.
    Response: We appreciate the concerns raised by the commenters. 
Since HCPCS add-on code G2211 is a new service paid under the PFS, we 
plan to monitor utilization for appropriate use of the add-on code, 
which could inform additional efforts to refine the code descriptor, or 
provide further guidance, as appropriate. With respect to 
documentation, we are considering an approach to minimize burden 
similar to what we finalized in the CY 2019 PFS final rule (83 FR 
59560) for HCPCS add-on codes GPC1X and GCG0X. In that rule, we 
discussed that we would expect that information included in the medical 
record or in the claims history for a patient/practitioner combination, 
such as diagnoses, the practitioner's assessment and plan for the 
visit, and/or other service codes billed could serve as supporting 
documentation. We believe Medicare claims data could be a useful gauge 
of appropriate use of the code. For example, when billing practitioners 
are separately reporting care management services for particular 
beneficiaries, the G2211 add-on service would be appropriately reported 
with their visits, as claims for these care management services could 
indicate an ongoing, continuous relationship with the patient. 
Likewise, patients returning to the same practitioner for routine 
preventive services would indicate that the practitioner has taken 
responsibility for ongoing medical needs for that patient with 
consistency and continuity over time. In contrast, an annual visit for 
ophthalmologic care, or a single episode of dermatologic care--even 
when several services are billed over a few months--would not suggest 
ongoing care provided with consistency and continuity over time and 
would suggest an inappropriate use of the code, were it to be billed 
with such visits. Additionally, to provide evidence of the ongoing 
relationship between the patient and practitioner, it is possible that 
use of patient relationship codes that were established under MACRA and 
finalized in the CY 2018 PFS (82 FR 53234) could be further example of 
evidence in the claims record to support the use of HCPCS add-on code 
G2211. These codes are Level II HCPCS modifiers that 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.
    Comment: Some commenters recommended that HCPCS add-on code G2211 
should be available for both new and established patients. A few other 
commenters noted that the code descriptor for HCPCS add-on code G2211 
had one version of the long descriptor in this section of the proposed 
rule and another version of the long descriptor in section II.D. 
Another commenter recommended an edit to the code descriptor to 
eliminate the comma between ``single'' and ``serious.''
    Response: We are confirming that HCPCS add-on code G2211 can be 
reported for both new and established patients. With respect to the 
version of the long descriptor, the version used in section II.D of the 
proposed rule was a drafting error. We regret the error and have 
corrected the description in section II.D of this final rule. While we 
appreciate the suggested edit to the code descriptor, we did not 
believe it offered additional clarification. To improve the clarity of 
the code descriptor, we are finalizing a refinement for the code 
description to clarify that the code applies to a single condition that 
is serious, rather than any single condition. We are inserting the word 
``condition'' after ``single, serious''. The revised descriptor reads 
as follows, ``Visit complexity inherent to evaluation and management 
associated with medical care services that serve as the continuing 
focal point for all needed health care services and/or with medical 
care services that are part of ongoing care related to a patient's 
single, serious condition or a complex condition. (Add-on code, list 
separately in addition to office/outpatient evaluation and management 
visit, new or established).''
    Comment: A few commenters recommended that CMS allow HCPCS add-on 
code G2211 to be reported with E/M services furnished in domiciliary 
care settings.
    Response: We reiterate that we are implementing HCPCS add-on code 
G2211 because we believe the that the typical visit described by the 
revised and revalued office/outpatient E/M visit code set still does 
not adequately describe or reflect the resources associated with 
primary care and certain types of specialty visits and as such, does 
not include other types of E/M visits. As the CPT Editorial Panel, the 
AMA RUC and CMS consider future changes to other E/M visit code sets, 
we will consider this issue in that context.
    Comment: Other commenters expressed continued concern regarding the 
necessity of HCPCS add-on code G2211 entirely and recommended that CMS 
withdraw the code. A few stated that HCPCS add-on code G2211 is not a 
separately identifiable service given the changes to the office/
outpatient E/M visit code set and that it may be duplicative to care 
management services, such as TCM or CCM.
    Response: As we stated in the proposed rule, we continue to believe 
that the time, intensity, and PE involved in furnishing services to 
patients on an ongoing basis that result in a comprehensive, 
longitudinal, and continuous relationship with the patient and involves 
delivery of team-based care that is accessible, coordinated with other 
practitioners and providers, and integrated with the broader health 
care landscape, are not adequately described by the revised office/
outpatient E/M visit code set. We also reiterate what we stated in the 
proposed rule that HCPCS add-on code G2211 is inherently distinct from 
coding that describes care management services. For example, TCM 
service codes are focused on care management for 30 days following a 
discharge rather than the time, intensity, and PE involved in 
furnishing services to patients on an ongoing basis. Chronic care 
management and principal care management service codes are limited to 
patients with chronic condition(s). Under chronic care management 
codes, patients have two or more chronic conditions that place the 
patient at significant risk of death, acute exacerbation/
decompensation, or functional decline, whereas principal care 
management services are for patients who have a single high-risk 
disease of sufficient severity to place the patient at risk of 
hospitalization or have been the cause of recent hospitalization. In 
contrast, we believe HCPCS add-on code G2211 reflects the time, 
intensity,

[[Page 84572]]

and PE when practitioners furnish services that enable them to build 
longitudinal relationships with all patients (that is, not only those 
patients who have a chronic condition or single-high risk disease) and 
to address the majority of patients' health care needs with consistency 
and continuity over longer periods of time.
    Comment: Many commenters expressed concerns about the utilization 
assumptions for HCPCS add-on code G2211. Commenters stated that, in the 
CY 2020 PFS rulemaking cycle, CMS appeared to assume that HCPCS add-on 
code G2211 would be reported with 50 percent of all office/outpatient 
E/M visits; and in the CY 2021 PFS proposed rule, CMS appeared to 
assume that HCPCS add-on code G2211 would be reported with 75 percent 
of all office/outpatient E/M visits. Commenters noted that this 
additional utilization further contributed to the redistributive effect 
of the budget neutrality adjustment related to revaluing the office/
outpatient visit codes. The AMA RUC requested that CMS publish the 
methodology used for the utilization assumptions in the CY 2021 PFS 
proposed rule prior to HCPCS add-on code G2211's implementation.
    Response: In the CY 2020 PFS rulemaking cycle, we proposed and 
finalized that HCPCS add-on code G2211 would be billed with every level 
of an office/outpatient E/M visit. We assumed that specialties that 
rely on office/outpatient E/M visit coding to report the majority of 
their services would be most likely to report HCPCS add-on code G2211 
with every office/outpatient E/M visit they reported and we did not 
restrict billing to any particular specialty or group of specialties. 
We published the utilization estimates for HCPCS add-on code G2211 in 
the CY 2020 PFS final rule in this public use file: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/CY2020-PFS-FR-EM-Add-on-Code.zip.
    In the CY 2021 PFS proposed rule, we continued to assume that the 
specialties listed in the aforementioned public use file would report 
HCPCS add-on code G2211 with all of their office/outpatient E/M visits. 
As part of updating our data sources from CY 2018 to CY 2019 claims 
data for setting rates for the CY 2021 PFS proposed rule, we included 
modifier -25 utilization, meaning that we assumed that HCPCS add-on 
code G2211 would also be reported with office/outpatient E/M visits 
that were reported with a modifier -25. While this additional 
utilization was included in the budget neutrality calculations, we note 
that other proposals for CY 2021 also factor into the budget neutrality 
adjustment.
    As we noted above, while we would not expect that HCPCS add-on code 
G2211 would be reported when the office/outpatient E/M visits is 
reported with a payment modifier, such as a modifier -25, we are not 
establishing any policies that prohibit reporting the add-on code under 
those circumstances. Thus, we will continue to include office/
outpatient visits reported with a modifier -25 in our utilization 
assumptions for HCPCS code G2211 as part of calculating the budget 
neutrality adjustment for the policies we are finalizing in this rule. 
As we noted above, we would not expect HCPCS add-on code G2211 to be 
reported when the visit is reported with a modifier 2-5, and will 
consider whether to establish an explicit prohibition in future 
rulemaking. We continue to believe that separately identifiable visits 
occurring on the same day as minor procedures (such as zero-day global 
procedures) have resources that are sufficiently distinct from the 
costs associated with furnishing stand-alone office/outpatient E/M 
visits to warrant different payment. We are also analyzing our data to 
determine if separately identifiable visits occurring on the same day 
as another visit have resources that are sufficiently distinct from the 
costs associated with furnishing stand-alone office/outpatient E/M 
visits to warrant different payment. We will consider these analyses to 
inform potential future rulemaking.
    Comment: Many commenters recommended that CMS reexamine and lower 
utilization assumptions for HCPCS add-on code G2211. These commenters 
stated that utilization tends to be lower than expected in the first 
year of implementation and cited the initial low utilization of the TCM 
and CCM codes These commenters also stated that they expected adoption 
to be slow given the necessity for medical societies to educate their 
members about appropriate use, ongoing implementation of the revisions 
to the office/outpatient E/M visit code set, electronic health records 
integration, and the persistence of the COVID-19 pandemic in many parts 
of the country. They recommended that utilization in the initial year 
could be as low as 10 percent of reported office/outpatient E/M visits 
and could range as high as 25 percent of reported office/outpatient E/M 
visits. Other commenters recommended that CMS delay the implementation 
of HCPCS add-on code G2211, citing the expected budget neutrality 
offset.
    Response: We acknowledge commenters' concerns that, given the 
necessity of medical societies to educate their members about 
appropriate use, ongoing implementation of the revisions to the office/
outpatient E/M visit code set, electronic health records integration, 
and the persistence of the COVID-19 pandemic, practitioners that rely 
on office/outpatient E/M visits to report the majority of their 
services are not likely to report HCPCS add-on code G2211 with every 
office visit. However, we disagree the utilization will be as low as 
the 10 percent to 25 percent range as recommended by these commenters. 
We have not implemented any additional policies that restrict the 
billing of this code, and so we are assuming that utilization will be 
90 percent of office/outpatient E/M visits instead of the 100 percent 
that we assumed in the proposed rule.
d. Prolonged Office/Outpatient E/M Visits (CPT Code 99417/HCPSC Code 
G2212)
    We reviewed our final policy for 2021 regarding the reporting of 
prolonged office/outpatient E/M visits finalized in the CY 2020 PFS 
final rule (84 FR 62848 through 62850). To report these visits 
beginning in 2021, we finalized CPT code 99417 (Prolonged office or 
other outpatient evaluation and management service(s) (beyond the total 
time of the primary procedure which has been selected using total 
time), requiring total time with or without direct patient contact 
beyond the usual service, on the date of the primary service; each 
additional 15 minutes (List separately in addition to CPT codes 99205, 
99215 for office or other outpatient evaluation and management 
services)), which was referred to in our previous rules as temporary 
CPT code 99XXX. Under CPT prefatory language, CPT code 99417 should 
only be reported when time is used to select the visit level, and only 
time of the physician or qualified healthcare professional is counted. 
In the CY 2020 PFS final rule, we stated that our interpretation of 
revised CPT prefatory language and reporting instructions would mean 
that CPT code 99417 could be reported when the physician's (or NPP's) 
time is used for code level selection and the time for a level 5 
office/outpatient E/M visit (the floor of the level 5 time range) is 
exceeded by 15 minutes or more on the date of service (84 FR 62848 
through 62849). The intent of the CPT Editorial Panel was unclear 
because of the use of the terms ``total time'' and ``usual service'' in 
the CPT code descriptor (``requiring total time with or without direct 
patient contact beyond the usual

[[Page 84573]]

service.'') The term ``total time'' is unclear because office/
outpatient E/M visits now represent a range of time, and ``total'' time 
could be interpreted as including prolonged time. Further, the term, 
``usual service'' is undefined. There is no longer a typical time in 
the code descriptor that could be used as point of reference for when 
the ``usual time'' is exceeded for all practitioners, and there would 
be variation (as well as potential double counting of time) if applied 
at the individual practitioner level.
    Having reviewed the policy we finalized last year, we believe that 
allowing reporting of CPT code 99417 after the minimum time for the 
level 5 visit is exceeded by at least 15 minutes would result in double 
counting time. As a specific example, the time range for CPT code 99215 
is 40-54 minutes. If the reporting practitioner spent 55 minutes of 
time, 14 of those minutes are included in the services described by CPT 
code 99215. Therefore, only 1 minute should be counted towards the 
additional 15 minutes needed to report CPT code 99417 and prolonged 
services should not be reportable as we finalized last year (see Table 
33 of the CY 2020 PFS final rule (84 FR 62849)). Therefore, we proposed 
that when the time of the reporting physician or NPP is used to select 
office/outpatient E/M visit level, CPT code 99417 could be reported 
when the maximum time for the level 5 office/outpatient E/M visit is 
exceeded by at least 15 minutes on the date of service. In Tables 26 
and 27, we provided examples.
[GRAPHIC] [TIFF OMITTED] TR28DE20.042

[GRAPHIC] [TIFF OMITTED] TR28DE20.043

    We received public comments on our proposal for use of CPT code 
99417. The following is a summary of the comments we received and our 
responses.
    Comment: Several commenters agreed with our concerns about the lack 
of clarity in the code descriptor and the potential for double-counting 
time. Several other commenters disagreed with our proposal and 
recommended that CMS adopt the CPT code descriptors. These commenters 
stated that a change in policy by CMS could be confusing to 
practitioners and disruptive to the ongoing work of medical societies 
to educate practitioners about the use of these codes. Some commenters 
also stated the CPT Editorial Panel intended to apply the general CPT 
rule where practitioners can report a timed code once the midpoint is 
reached.
    Response: In the CPT 2021 Professional Edition, CPT code 99417 is 
described as, ``Prolonged office or other outpatient evaluation and 
management service(s) beyond the minimum required time of the primary 
procedure which has been selected using total time, requiring total 
time with or without direct patient contact beyond the usual service, 
on the date of the primary service; each additional 15 minutes (List 
separately in addition to CPT codes 99205, 99215 for office or other 
outpatient evaluation and management services)).'' The terms ``total 
time'' and ``usual service'' continue to be unclear.
    While we prefer to align with CPT coding to reduce potential 
confusion to practitioners, we continue to believe that CPT code 99417 
as written is unclear and that allowing reporting of CPT code 99417 
when the minimum required time for the level 5 visit is exceeded by at 
least 15 minutes would result in double counting time. It has not been 
our understanding that CPT intended for the midpoint time to suffice 
for reporting this code, and regardless, we did not previously finalize 
or intend to apply such a policy.
    We continue to believe it is important for CMS and other 
stakeholders to know with certainty how much time practitioners spend 
furnishing office/outpatient E/M visits, in order to assess whether 
resources are accurately accounted for in their valuation. This is 
especially true once time can be used to select visit level, with new 
times established for this code set. To resolve the lack of clarity, we 
are finalizing our proposal regarding the time that may be counted for 
prolonged office/outpatient E/M visits; and to resolve the potential 
inconsistency of our policy with CPT code 99417, we are creating a new 
HCPCS code G2212 to be used when billing Medicare for this service 
instead of CPT code 99417, starting in 2021. HCPCS code G2212 is as 
follows,

[[Page 84574]]

``Prolonged office or other outpatient evaluation and management 
service(s) beyond the maximum required time of the primary procedure 
which has been selected using total time on the date of the primary 
service; each additional 15 minutes by the physician or qualified 
healthcare professional, with or without direct patient contact (List 
separately in addition to CPT codes 99205, 99215 for office or other 
outpatient evaluation and management services) ``(Do not report G2212 
on the same date of service as 99354, 99355, 99358, 99359, 99415, 
99416). (Do not report G2212 for any time unit less than 15 
minutes))''.''
    We believe the creation of HCPCS code G2212 will serve to resolve 
the potential differences between Medicare and other interpretations of 
CPT rules, and better address questions we frequently receive about the 
required times and what time may be counted toward the required time to 
report prolonged office/outpatient E/M visits. We also note that we are 
not opposed in concept to reporting prolonged office/outpatient visit 
time on a date other than the visit. However, we continue to believe 
there should be a single prolonged code specific to office/outpatient 
E/M visits that encompasses all related time (see the CY 2020 PFS final 
rule for a more detailed discussion of this issue, (84 FR 62849 through 
62850)). We will continue to stay abreast of any changes in CPT coding. 
The valuation for HCPCS code G2212 will be the same as for CPT code 
99417.

G. Scope of Practice and Related Issues

    We proposed several policies consistent with the President's E.O. 
13890 on ``Protecting and Improving Medicare for Our Nation's Seniors'' 
to modify supervision and other requirements of the Medicare program 
that limit healthcare professionals from practicing at the top of their 
license (84 FR 53573, October 8, 2019, E.O. 13890). In December 2019, 
we requested feedback in response to part of this E.O. seeking the 
public's help in identifying additional Medicare regulations which 
contain more restrictive supervision requirements than existing state 
scope of practice laws, or which limit health professionals from 
practicing at the top of their license (the request for feedback is 
available at https://www.cms.gov/files/document/request-information-reducing-scope-practice-burden.pdf). Through review of the feedback we 
received, we identified the proposed policies in section II.G. of the 
CY 2021 PFS proposed rule (85 FR 50139). We noted that we believe that 
physicians, NPPs, and other professionals should be able to furnish 
services to Medicare beneficiaries in accordance with their scope of 
practice and state licensure, including education and training, to the 
extent permitted under the Medicare statute, as long as it is not 
likely to result in fraud, waste or abuse or create potential risks to 
beneficiary safety. The proposed policies may also help ensure an 
adequate number of clinicians, in addition to physicians, are able to 
furnish critical services including primary care services in areas 
where there is a shortage of physicians.\9\ We noted that some of the 
proposals may also help alleviate the opioid crisis.
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    \9\ Zhang et al. Physician workforce in the United States of 
America: forecasting nationwide shortages. Human Resources for 
Health (2020); 18:8. Published online February 6, 2020 and available 
online at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7006215/.
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    We solicited information about the number and names of states that 
have licensure or scope of practice laws in place, as well as any 
facility-specific policies, that would impact the ability of clinicians 
to exercise the flexibilities we proposed, to help us assess the 
potential impact of, or challenges for, the proposed changes. We noted 
that information about specific services (service-level information) 
would be especially helpful. We solicited public comment on whether 
applicable state laws, scope of practice, and facility policies would 
permit practitioners to exercise the proposed flexibilities if we were 
to adopt the proposed policies, and to what extent practitioners would 
be permitted to exercise the proposed flexibilities, such as for all 
diagnostic tests or only a subset.
    We solicited information on these topics because the responses to 
our request for feedback issued in 2019 did not indicate the number of 
states that have more flexible scope of practice rules than our federal 
regulations, or whether facilities (such as hospitals or nursing 
facilities) have relevant policies that limit the ability of the 
impacted professionals to perform certain services. For example, if 
Medicare payment policy provided for payment of diagnostic tests 
supervised by NPPs, there may still be facility- or state-specific 
policies in place that limit NPPs' ability to supervise some or all 
diagnostic tests, and those limitations would inform the potential 
impact of changing our policy. While our proposed flexibility may 
increase the capacity and availability of practitioners who can 
supervise diagnostic tests, which would alleviate some of the demand on 
physicians as the only source to perform this particular function, we 
noted that we have not located information indicating the degree to 
which NPP scope of practice includes supervision of auxiliary staff, 
especially for the subset of services that are diagnostic tests. There 
is a wide range of diagnostic tests, from a simple strep throat swab to 
more sophisticated and/or invasive tests such as x-rays and cardiology 
procedures. We would need to understand the scope of practice for many 
types of auxiliary staff (some of whom are not licensed) who could 
potentially provide these tests under the supervision of an NPP, 
including RNs, LPNs, medical assistants, radiologic technicians, and 
many others. To the extent practice patterns change, there could be 
induced utilization that would increase costs, but this might be offset 
by reduced payment rates because direct payment to NPPs is at a lower 
rate than payment to physicians.
1. Teaching Physician and Resident Moonlighting Policies
a. Background
    In the March 31st COVID-19 IFC (85 FR 19258 through 19261) and the 
May 8th COVID-19 IFC (85 FR 27587 through 27589), we implemented 
several policies on an interim final basis related to PFS payment for 
the services of teaching physicians involving residents and resident 
moonlighting during the PHE for COVID-19. In the proposed rule, we 
noted that we planned to address comments received on the IFCs for 
those policies that we made proposals or solicited comment on in the 
proposed rule when we published the PFS final rule.
b. Finalization of Interim Final Rule With Comment Period Provisions 
Related to Application of Teaching Physician and Moonlighting 
Regulations During the PHE for the COVID-19 Pandemic
    We received public comments on the policies that we adopted on an 
interim basis in the Interim Final Rule with Comment Period provisions 
related to the Application of Teaching Physician and Moonlighting 
Regulations During the PHE for the COVID-19 Pandemic (85 FR 19258 
through 19261). The following is a summary of the comments we received 
and our responses.
i. Virtual Presence of a Teaching Physician Using Audio/Video Real-Time 
Communications Technology
    Comment: Commenters were generally supportive of the virtual 
presence policies in Sec. Sec.  415.172, 415.174, 415.180, and 415.184 
that we implemented on an interim basis during the PHE for COVID-19. 
Several commenters supported extending the flexibilities permanently, 
while several

[[Page 84575]]

other commenters recommended continuing the policy temporarily through 
the end of the PHE for COVID-19, or for a period of time following the 
end of the PHE for COVID-19.
    Response: We appreciate commenters' support for the virtual 
presence policies adopted on an interim basis during the PHE for COVID-
19. After considering the comments, we are finalizing these policies 
for the duration of the PHE for COVID-19.
    Comment: One commenter, in support of the virtual presence policies 
adopted on an interim basis during the PHE for COVID-19, recommended 
that CMS encourage residency programs, residency review committees, and 
ACGME to increase monitoring of clinical and educational work hour 
standards, acknowledge the impact of the changes to the teaching 
physician presence requirements on the residents and their optimal 
learning environment, and share additional information regarding how to 
best meet the need for reporting of information related to workload and 
growing service demands, patient safety, medical error, continuity of 
care, resident well-being and burnout, development of professionalism, 
resident learning outcomes, and preparation for independent practice as 
they relate to the use of teaching physician presence through real-time 
interactive audio and video technology.
    Response: We do not believe it is CMS' role to regulate or monitor 
training outcomes or advocate on behalf of the residents themselves. 
Organizations representing the interests of residents and overseeing 
the actual operation of residency programs are in a better position to 
establish rules regarding the impact of virtual presence and 
involvement of teaching physicians on residency training outcomes.
    Comment: One commenter noted that the GME community has learned 
many lessons during the pandemic, related to resident education and 
supervision. Consequently, the commenter believed that the GME 
community should be provided the flexibility to test new and better 
modalities of treatment and learning.
    Response: We appreciate the commenter's support of our policies. As 
described previously, we are finalizing these policies for the duration 
of the PHE for COVID-19.
    Comment: One commenter requested clarification of the definition of 
``telecommunications,'' and asked whether supervision, in the context 
of a teaching institution, can be performed by telephone as opposed to 
a tablet or smartphone.
    Response: The policy to allow a teaching physician to use audio/
video real-time communications technology for purposes of furnishing 
care with a resident, and in the case of the primary care exception, 
directing, managing, and reviewing the care furnished by the resident, 
generally requires real-time direct observation (not mere availability) 
by the teaching physician through interactive, real-time audio and 
video technology, and does not include audio-only technology (for 
example, telephone without video).
    Comment: Several commenters expressed support for the exclusion of 
surgical, high risk, interventional, endoscopic, or other complex 
procedures identified under Sec.  415.172(a)(1), and anesthesia 
services under Sec.  415.178 from the policy to allow the teaching 
physician to be present using audio/video real-time communications 
technology. One commenter recommended that the teaching physician 
virtual presence policy be permitted for CPT codes 31231 (Nasal 
endoscopy, diagnostic, unilateral or bilateral (separate procedure)), 
31575 (Laryngoscopy, flexible; diagnostic), and 31579 (Laryngoscopy, 
flexible or rigid telescopic, with stroboscopy) performed through an 
endoscope.
    Response: We continue to believe the requirement for the physical, 
in-person presence of the teaching physician during all key or critical 
portions of the procedure and immediately availability to furnish 
services during the entire service or procedure is necessary for 
patient safety given the risks associated with these services. In 
complex, high-risk procedures, including the endoscopic procedures 
associated with CPT codes 31231, 31575 and 31579, a patient's clinical 
status can quickly change. To permit payment under the PFS for such 
teaching physician services, we believe the services must be furnished 
with a certain level of personal oversight and involvement of the 
teaching physician who has the experience and judgment that is 
necessary for rapid on-site decision-making during these procedures. 
With respect to the procedures associated with CPT codes 31231, 31575 
and 31579, we do not believe that virtual presence by a teaching 
physician would provide sufficient personal involvement and control 
over the service to warrant billing of the services under the PFS or 
allow for the rapid on-site decision-making that could be necessary 
during the procedures, which could pose an increased risk to patients.
ii. Virtual Presence of a Teaching Physician During Medicare Telehealth 
Services
    Comment: Commenters were generally supportive of the policy adopted 
on an interim basis to allow payment under the PFS when residents 
furnish telehealth services to beneficiaries with the teaching 
physician present using audio/video real-time communications 
technology. In addition, several commenters supported extending the 
flexibility permanently.
    Response: We appreciate commenters' support for the policy, adopted 
on an interim basis during the PHE for COVID-19, to allow payment under 
the PFS when residents furnish telehealth services to beneficiaries 
with the teaching physician present using interactive, audio/video 
real-time communications technology (excluding audio-only). After 
considering the comments, we are finalizing this policy for the 
duration of the PHE for COVID-19.
iii. Resident Moonlighting in the Inpatient Setting
    Comment: Commenters were generally supportive of the policy under 
Sec.  415.208 that we adopted on an interim basis during the PHE for 
COVID-19 to allow PFS payment for services provided by fully licensed 
residents that are not related to their approved GME program in the 
inpatient setting of a hospital in which they are training, provided 
that the conditions specified in Sec.  415.208(b)(2)(i) through (iii) 
are met. Several commenters recommended that this policy be implemented 
permanently, and some other commenters recommended that the policy be 
implemented for the duration of the PHE only.
    Response: We appreciate commenters' support for the moonlighting 
policy we adopted on an interim basis during the PHE for COVID-19. 
After considering the comments, we are finalizing this policy for the 
duration of the PHE for COVID-19.
iv. Primary Care Exception Policies
    Comment: Commenters were generally supportive of the policy adopted 
on an interim basis under Sec.  415.174 to expand the primary care 
exception to include all levels of office and outpatient E/M codes. 
Some commenters recommended that this policy be implemented 
permanently, and some other commenters recommended that the policy be 
implemented for the duration of the PHE for COVID-19 only.

[[Page 84576]]

    Response: We appreciate commenters' support of the expansion of the 
primary care exception policy adopted on an interim basis during the 
PHE for COVID-19. After considering the comments, we are finalizing 
this policy for the duration of the PHE for COVID-19.
    Comment: One commenter interpreted the policy described in Sec.  
415.174 to mean that the ``immediately available supervision'' 
requirement described in this section could be met by the teaching 
physician being ``immediately available'' via real-time audio/video 
technology.
    Response: Subsequent to the publication of the March 31st COVID-19 
IFC, the May 8th COVID-19 IFC amended Sec.  415.174 to add a new 
paragraph (c) to allow that, on an interim basis for the duration of 
the PHE for COVID-19, the teaching physician may not only direct the 
care furnished by residents, but also review the services provided with 
the resident, during or immediately after the visit, remotely through 
virtual means via interactive, audio/video real-time communications 
technology (excluding audio-only).
v. Payment Under the PFS for Teaching Physician Services When Resident 
Under Quarantine
    Comment: A commenter supported the interim policy for the duration 
of the PHE for COVID-19 to permit PFS payment for teaching physician 
services that do not require face-to-face patient care when the 
resident is furnishing such services while in quarantine when the 
teaching physician is present through audio/video real-time 
communications technology.
    Response: We thank the commenter for their support. After 
considering the comments, we are finalizing this policy for the 
duration of the PHE for COVID-19.
c. Finalization of Interim Final Rule Provisions Related to Additional 
Flexibility Under the Teaching Physician Regulations
    We received public comments on the policies that we adopted on an 
interim basis in the Interim Final Rule provisions related to 
Additional Flexibility Under the Teaching Physician Regulations (85 FR 
27587 through 27589). The following is a summary of the comments we 
received and our responses.
i. Primary Care Exception Policies
    Comment: Several commenters supported the policy adopted on an 
interim basis to allow, under the primary care exception described in 
Sec.  415.174(c), the teaching physician to direct the care furnished 
by the resident, and to review the services furnished by the resident 
during or immediately after the visit, remotely using audio/video real-
time communications technology. Several commenters supported a 
temporary extension of the policy through the end of the PHE for COVID-
19 or through 2021, while other commenters suggested a permanent 
extension of this flexibility.
    Response: We appreciate the commenters' support of this policy 
during the PHE for COVID-19. After considering the comments and for the 
reasons discussed above, we are finalizing this policy for the duration 
of the PHE for COVID-19.
    Comment: Some commenters requested clarification of the phrase 
``interactive audio/visual real-time communication technology'' because 
CMS has used various terms when expressing technology requirements for 
remote supervision and in the context of teaching physician services, 
and because the presence of the slash mark in the phrase makes it 
unclear whether both audio and visual communication must be utilized to 
meet the requirement, or if one or the other is sufficient. One 
commenter also recommended that the phrase be revised to explicitly 
state that a real-time audio-only communication is sufficient in order 
to meet the regulations set forth in Sec.  415.174(a)(3) for use of the 
primary care exception.
    Response: While we believe our statements have been clear on this 
point, we clarify here that this virtual presence policy requires real-
time observation (not mere availability) by the teaching physician 
through a contemporaneous, interactive combination of both audio and 
video communications technology, and does not include audio-only 
technology (for example, telephone without video). We note that we have 
used the ``audio/video'' formulation in our regulations, and that the 
``slash'' should be read consistently to mean a synchronous, 
interactive, real-time combination of both audio and video technology, 
which would not include audio-only communications for any portion of 
the time of the furnished service.
    Comment: Commenters were generally supportive of the policy adopted 
on an interim basis to allow Medicare to make payment to the teaching 
physician for additional services under the primary care exception, 
including all levels of office and outpatient E/M codes, audio-only 
telephone E/M services, transitional care management, and communication 
technology-based services. Several commenters supported a temporary 
extension of the policy through the end of the PHE for COVID-19 or 
through 2021, while other commenters suggested a permanent expansion of 
the services that residents could furnish under the primary care 
exception.
    Response: We appreciate commenters' support of this policy during 
the PHE for COVID-19. After considering the comments, we are finalizing 
the policy for the duration of the PHE for COVID-19.
    Comment: Several commenters thanked CMS for the clarification that 
Medicare may make payment under the PFS for teaching physician services 
when a resident furnishes services permitted under the primary care 
exception, including via telehealth, and the teaching physician can 
provide the necessary direction, management and review of the 
resident's services using interactive audio/video real-time 
communications technology.
    Response: We appreciate the commenters' support for this policy 
during the PHE.
    Comment: Several commenters supported the interim policy during the 
PHE for COVID-19 that the office/outpatient E/M level selection for 
services under the primary care exception when furnished via telehealth 
can be based on medical decision-making or time.
    Response: We thank the commenters for their support of this policy 
during the PHE. This policy is similar to the policy that will apply to 
all office/outpatient E/M services beginning in 2021 under policies 
finalized in the CY 2020 PFS final rule and thus, we are not finalizing 
it.
d. Summary of Proposed Rule Provisions and Public Comments
i. Background
    In the proposed rule, we considered whether the policies 
implemented on an interim basis in the March 31st COVID-19 IFC or the 
May 8th COVID-19 IFC should be extended on a temporary basis (that is, 
if the PHE for COVID-19 ends in 2021, these policies could be extended 
to December 31, 2021, to allow for a transition period before reverting 
to status quo policy) or be made permanent, and solicited public 
comment. We noted that the public comments would assist us in 
identifying appropriate policies that we would consider in drafting the 
CY 2021 PFS final rule.
    For teaching physicians, section 1842(b)(7)(A)(i)(I) of the Act 
specifies

[[Page 84577]]

that in the case of physicians' services furnished to a patient in a 
hospital with a teaching program, the Secretary shall not provide 
payment for such services unless the physician renders sufficient 
personal and identifiable physicians' services to the patient to 
exercise full, personal control over the management of the portion of 
the case for which payment is sought.
    Regulations regarding PFS payment for teaching physician services 
and services of moonlighting residents are codified in 42 CFR part 415. 
In general, under Sec.  415.170, payment is made under the PFS for 
services furnished in a teaching hospital setting if the services are 
personally furnished by a physician who is not a resident, or the 
services are furnished by a resident in the presence of a teaching 
physician, with exceptions as specified in subsequent regulatory 
provisions in part 415. Under Sec.  415.172, if a resident participates 
in a service furnished in a teaching setting, PFS payment is made only 
if the teaching physician is present during the key portion of any 
service or procedure for which payment is sought. The regulation at 
Sec.  415.180 states that, for the interpretation of diagnostic 
radiology and other diagnostic tests, PFS payment is made if the 
interpretation is performed or reviewed by a physician other than a 
resident. Under Sec.  415.184, PFS payment is made for psychiatric 
services furnished under an approved graduate medical education (GME) 
program if the requirements of Sec. Sec.  415.170 and 415.172 are met, 
except that the requirement for the presence of the teaching physician 
during psychiatric services in which a resident is involved may be met 
by observation of the service by use of a one-way mirror, video 
equipment, or similar device.
ii. Supervision of Residents in Teaching Settings Through Audio/Video 
Real-Time Communications Technology
    In both the March 31st COVID-19 IFC (85 FR 19258 through 19261) and 
the May 8th COVID-19 IFC (85 FR 27587 through 27589), we adopted a 
policy on an interim basis during the PHE for COVID-19 that, under 
Sec.  415.172, the requirement for the presence of a teaching physician 
during the key portion of the service furnished with the involvement of 
a resident can be met using audio/video real-time communications 
technology. In other words, the teaching physician must be present, 
either in person or virtually through audio/video real-time 
communications technology, during the key portion of the service. This 
policy generally requires real-time observation (not mere availability) 
by the teaching physician through audio and video technology, and does 
not include audio-only technology (for example, telephone without 
video). For the primary care exception under Sec.  415.174(c), we 
adopted a policy on an interim final basis for the duration of the PHE 
for COVID-19 to allow the teaching physician to direct the care 
furnished by the resident, and to review the services furnished by the 
resident during or immediately after the visit, remotely using audio/
video real-time communications technology.
    Under Sec.  415.180, we adopted a policy on an interim basis for 
the duration of the PHE for COVID-19 to allow PFS payment for the 
interpretation of diagnostic radiology and other diagnostic tests if 
the interpretation is performed by a resident when the teaching 
physician is present through audio/video real-time communications 
technology. A physician other than the resident must still review the 
resident's interpretation. Under Sec.  415.184, we adopted a policy on 
an interim basis during the PHE for COVID-19 that the requirement for 
the presence of the teaching physician during the psychiatric service 
in which a resident is involved may be met by the teaching physician's 
direct supervision using audio/video real-time communications 
technology. We considered whether the flexibilities described above 
that we implemented on an interim basis during the PHE for COVID-19 
under Sec. Sec.  415.172, 415.174, 415.180, and 415.184 should be 
extended on a temporary basis (that is, if the PHE ends in 2021, these 
policies could be extended to December 31, 2021, to allow for a 
transition period before reverting to status quo policy) or be made 
permanent, and solicited public comments on whether these policies 
should continue once the PHE for COVID-19 ends. We noted that the 
public comments would assist us in identifying appropriate policy 
continuation decisions that we would consider finalizing in the CY 2021 
PFS final rule. In addition, we proposed to make a technical edit to 
the regulation text at Sec.  415.184 to eliminate the term ``direct 
supervision'' to conform with the language in sections Sec. Sec.  
415.172, 415.174, and 415.180 regarding the presence of the teaching 
physician via audio/video real-time communications technology.
    While we believe it was appropriate to permit teaching physicians 
to be involved in services furnished with residents through audio/video 
real-time communications technology to respond to critical needs during 
the PHE to reduce exposure risk and to increase the capacity of 
teaching settings to respond to COVID-19, we expressed concern that 
continuing to permit teaching physicians to be involved through their 
virtual presence may not be sufficient to warrant PFS payment to the 
teaching physician on a temporary or permanent basis. Absent the 
circumstances of the PHE for COVID-19, the physical, in-person presence 
of the teaching physician may be necessary to provide oversight to 
ensure that care furnished to Medicare beneficiaries is medically 
reasonable and necessary, and to ensure that the teaching physician 
renders sufficient personal services to exercise full, personal control 
of the key portion of the case.
    We also noted concerns about patient safety when the teaching 
physician is only virtually present. For example, in the March 31st 
COVID-19 IFC, we excluded the surgical, high risk, interventional, 
endoscopic, or other complex procedures identified under Sec.  
415.172(a)(1), and anesthesia services under Sec.  415.178 from the 
policy to allow the teaching physician to be present using audio-video 
real-time communications technology because we believed the requirement 
for the physical, in-person presence of the teaching physician for 
either the entire procedure or the key portion of the service with 
immediate availability throughout the procedure, as applicable, is 
necessary for patient safety given the risks associated with these 
services. In complex, high-risk, surgical, interventional, or 
endoscopic procedures, or anesthesia procedures, a patient's clinical 
status can quickly change. To permit payment under the PFS for these 
teaching physician services, we believed the services must be furnished 
with a certain level of personal oversight and involvement of the 
teaching physician who has the experience and judgment that is 
necessary for rapid on-site decision-making during these procedures.
    We also noted that there may be circumstances in which virtual 
presence of the teaching physician, considered in light of the 
potential risks to patient safety and absent exposure risk concerns due 
to COVID-19, does not demonstrate sufficient personal involvement in 
the service to the patient to warrant payment to the teaching physician 
under the PFS. For example, a resident could evaluate a patient for 
change in mental status following surgery for hip fracture, perform a 
physical exam and report it as unrevealing, and note that the patient 
is uncooperative with a full exam. If a full exam had been performed by 
the

[[Page 84578]]

teaching physician or with the physical presence of the teaching 
physician (or with the teaching physician immediately available in the 
clinic to provide the necessary direction, under the primary care 
exception) to render personal and identifiable physicians' services to 
the patient, the exam would likely have revealed crystal-mediated acute 
arthritis, and that the patient's lack of cooperation was due to 
hypoactive delirium. However, the teaching physician may not have been 
able to identify this concern through the use of audio/video 
interactive communications technology. In this case, the presence of 
the teaching physician through audio/video interactive communications 
technology might have been insufficient to allow the teaching physician 
to render personal and identifiable physicians' services to exercise 
full, personal control over the key portion of the encounter.
    We stated that there also may be certain patient populations that 
require greater clinical attentiveness and skill than the teaching 
physician could provide via audio/video interactive communications 
technology. For example, patients with cognitive impairment or dementia 
may require the experience and skill to recognize a need for 
specialized testing, and patients with communication disabilities may 
require more experience and skill to recognize specialized needs. It 
may not be possible for the teaching physician to meet these clinical 
needs and exercise full, personal control while being present for the 
key portion of the service through audio/video interactive 
communications technology. Moreover, the virtual connection between the 
teaching physician and the resident who is with the patient could be 
disrupted (as with any virtual supervision scenario), rendering it 
impossible for the teaching physician to provide necessary direction 
for the resident to furnish appropriate care to the patient, thus 
foreclosing the ability of the teaching physician to exercise full, 
personal control over the key portion of the services, and potentially 
putting the patient's safety at risk.
    While we expressed significant concerns about extending our interim 
policy to permit virtual presence of the teaching physician, whether on 
a temporary or permanent basis, we noted that we believe public 
comments would be helpful as we further consider the status of this 
policy. For example, because COVID-19 may continue to persist in some 
communities after the expiration of the PHE for COVID-19, we considered 
extending our policy to permit the teaching physician to be present 
through audio/video interactive communications technology on a 
temporary basis until the end of the calendar year in which the PHE for 
COVID-19 ends. The presence of COVID-19 may result in a need for some 
teaching settings to continue to limit exposure risks, especially for 
high risk patients isolated for their own protection or in cases where 
the teaching physician has been exposed to the virus and must be under 
quarantine. If the teaching physician is under quarantine, termination 
of the policy to permit virtual presence of the teaching physician 
could unintentionally limit the number of licensed practitioners 
available to furnish services to Medicare patients in some communities, 
and could have the unintended consequence of limiting access to 
services for Medicare patients. Some communities may experience a 
resurgence of COVID-19, and extending our policy until the end of the 
calendar year in which the PHE for COVID-19 ends to permit PFS payment 
when the teaching physician is present through audio/video real-time 
communications technology could temporarily help teaching settings 
remain prepared with surge capacity.
    Based on the clinical experience gained during the PHE for COVID-
19, we noted that we might identify circumstances or procedures for 
which the teaching physician can routinely render sufficient personal 
and identifiable services to the patient to exercise full, personal 
control over the management of the key portion of the case when the 
services are furnished by a resident with the teaching physician 
present through audio/video real-time communications technology. For 
example, under ordinary circumstances for the primary care exception at 
Sec.  415.174, we permit PFS payment to the teaching physician when a 
resident furnishes office/outpatient evaluation and management (E/M) 
visit codes of lower and mid-level complexity and annual wellness 
visits without the presence of a teaching physician (these codes are 
discussed in section II.F. of this final rule (85 FR XXXXX)). 
Additionally, the teaching physician may be able to provide sufficient 
involvement for simple procedures such as CPT code 36410 (Venipuncture, 
age 3 years or older, necessitating the skill of a physician or other 
qualified health care professional (separate procedure), for diagnostic 
or therapeutic purposes (not to be used for routine venipuncture) or 
CPT code 51701 (Insertion of non-indwelling bladder catheter (e.g., 
straight catheterization for residual urine)). For such circumstances 
and procedures, we stated that it may be appropriate to continue the 
virtual presence policy on a temporary or permanent basis.
    We noted that having the virtual presence policy in place 
temporarily or permanently would not preclude teaching physicians from 
providing a greater degree of involvement in services furnished with 
residents, and teaching physicians would still have discretion to 
determine whether, and if so, when it is appropriate to be present 
virtually rather than in person depending on the services being 
furnished and the experience of the particular residents involved. We 
solicited comments to help us understand how the option to provide for 
teaching physician presence using audio/video real-time communications 
technology would support patient safety for all patients and 
particularly for at-risk patients (for example, patients who are aged 
and/or who have a disability); ensure burden reduction without creating 
risks to patient care or increasing fraud; avoid duplicative payment 
between the PFS and the IPPS for GME programs; and support emergency 
preparedness. We also solicited comments to provide data and other 
information on experiences implementing this policy during the PHE for 
COVID-19.
    We received public comments on our proposal to make a technical 
edit to the regulation text at Sec.  415.184 to eliminate the term 
``direct supervision'' to conform with the language in sections 
Sec. Sec.  415.172, 415.174, and 415.180 regarding the presence of the 
teaching physician via audio/video real-time communications technology. 
The following is a summary of the comments we received and our 
responses.
    Comment: Multiple commenters supported striking the term ``direct 
supervision'' from Sec.  415.184 to conform to related sections 
describing the requirements for supervision of residents in teaching 
settings.
    Response: We appreciate the commenters' support and are finalizing 
the technical edit to the regulation text at Sec.  415.184 as proposed.
    We also received public comments in response to the CY 2021 PFS 
proposed rule on whether the policies we adopted on an interim basis 
during the PHE for COVID-19 under Sec. Sec.  415.172, 415.174, 415.180, 
and 415.184 should continue once the PHE ends. The following is a 
summary of the comments we received and our responses.
    Comment: Commenters were generally supportive of the virtual 
presence policies in Sec. Sec.  415.172,

[[Page 84579]]

415.174, 415.180, and 415.184 that we implemented on an interim basis 
during the PHE for COVID-19. Several commenters supported extending the 
flexibilities permanently and asserted that a permanent expansion would 
promote patient access to physicians' services, particularly in rural 
areas, as well as continuity, convenience, flexibility, choice, and a 
decrease in the spread of COVID-19. Another commenter stated that in 
rural settings, it was not always possible for the teaching physician 
to accompany a resident while also being present with other residents. 
This commenter stated that the ability for the resident to be 
physically with a patient while the teaching physician is virtually 
present has increased patient access to physicians' services in rural 
areas. Similarly, other commenters stated that the permanent ability 
for teaching physicians to be virtually present when not physically 
present could open up additional training opportunities to care for 
underserved populations or increase specialty training opportunities 
for rural training programs.
    Commenters broadly supported the exclusion of surgical, high risk, 
interventional, endoscopic, or other complex procedures, including 
anesthesia, from the virtual presence policy. While supportive of the 
flexibilities that we implemented on an interim basis, some commenters 
recommended temporarily extending the policies through the end of the 
PHE for COVID-19 to provide flexibility for communities that may 
experience resurgences in COVID-19 infections. These commenters cited a 
need to gather data regarding patient safety and potential impacts on 
resident training outside the context of the PHE before considering 
permanent implementation of the policies. For example, one commenter 
noted that CMS could use data from procedures furnished by residents 
during the PHE under virtual presence of the teaching physician to 
determine which procedures may be appropriate for virtual supervision 
on an ongoing basis.
    Response: We appreciate commenters' support of the virtual presence 
policies that we implemented on an interim basis during the PHE for 
COVID-19. We remain concerned that, absent the circumstances of the 
PHE, virtual presence may not allow the teaching physician to render 
sufficient personal and identifiable physicians' services to the 
patient to exercise full, personal control over the management of the 
portion of the case for which the payment is sought, in accordance with 
section 1842(b)(7)(A)(i)(I) of the Act in most settings. For rural 
areas, however, we found compelling the commenters' statements that our 
virtual presence policy has increased access to Medicare-covered 
services. Accordingly, we believe that permitting the teaching 
physician to meet the requirements to bill under the PFS for their 
services through virtual presence when furnishing services involving 
residents in rural training settings could increase access to Medicare-
covered services by preventing the beneficiary from potentially having 
to travel long distances to obtain care, particularly as rural areas 
have stretched and diminishing clinical workforces.\10\
---------------------------------------------------------------------------

    \10\ Supply and Distribution of the Primary Care Workforce in 
Rural America: 2019: https://depts.washington.edu/fammed/rhrc/wp-content/uploads/sites/4/2020/06/RHRC_PB167_Larson.pdf. https://www.hrsa.gov/sites/default/files/hrsa/ruralhealth/reports/HRSA-Rural-Collaboration-Guide.pdf.
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    Increasing beneficiary access to care in rural areas is also 
consistent with our longstanding interest in increasing beneficiary 
access to Medicare-covered services in rural areas.\11\ Further, 
permitting the virtual presence of the teaching physician could 
facilitate expanded training opportunities for residents in rural 
settings, which have historically been in limited supply.\12\ As such, 
the need to improve rural access to care for patients and training for 
residents overshadows our concerns about the ability for the teaching 
physician to render sufficient personal and identifiable physicians' 
services through virtual presence. Accordingly, we believe it would be 
appropriate to continue our policy to permit teaching physicians to 
meet the requirements to bill under the PFS for their services through 
virtual presence when furnishing services involving residents in rural 
settings after the conclusion of the PHE for COVID-19. This policy not 
only furthers our goals to increase beneficiary access to Medicare-
covered services, it also facilitates needed training opportunities in 
a similar way to the longstanding primary care exception under Sec.  
415.174. The primary care exception permits the teaching physician to 
bill for certain types of physicians' services furnished by residents 
in certain settings even when the teaching physician is not present 
with the resident. Like the policy we are finalizing in this rule, the 
primary care exception facilitates access to Medicare-covered services 
and expanded residency training opportunities in primary care settings.
---------------------------------------------------------------------------

    \11\ CMS Rural Health Strategy: https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Rural-Strategy-2018.pdf.
    \12\ HHS awards $20 million to 27 organizations to increase the 
rural workforce through the creation of new rural residency 
programs: https://www.hhs.gov/about/news/2019/07/18/hhs-awards-20-million-to-27-organizations-to-increase-rural-workforce.html.
---------------------------------------------------------------------------

    Therefore, we are finalizing a permanent policy to permit teaching 
physicians to meet the requirements to bill for their services 
involving residents through virtual presence, but only for services 
furnished in residency training sites that are located outside of an 
OMB-defined metropolitan statistical area (MSA).\13\ In order to ensure 
that the teaching physician renders sufficient personal and 
identifiable physicians' services to the patient to exercise full, 
personal control over the management of the portion of the case for 
which the payment is sought in accordance with section 
1842(b)(7)(A)(i)(I) of the Act, we are clarifying our existing 
documentation requirements to specify that, when a teaching physician, 
through virtual presence, furnishes services involving residents in a 
residency training site located outside of a MSA, the patient's medical 
record must clearly reflect how and when the teaching physician was 
present for the service in accordance with our regulations. For 
example, in the medical record, the teaching physician could document 
their physical or virtual presence at the training site during the key 
portion of a service, along with a notation describing the specific 
portion(s) of the service for which the teaching physician was 
virtually present, and/or that the teaching physician reviewed the 
service with the resident during or immediately after the service in 
accordance with the primary care exception under Sec.  415.174. We also 
expect that, if the teaching physician is virtually present and bills 
for services during which there is a disruption to the virtual 
connection between the teaching physician and the resident who is with 
the patient, the encounter would be paused until the connection 
resumes, or the appointment would be rescheduled.
---------------------------------------------------------------------------

    \13\ Revised Delineations of Metropolitan Statistical Areas, 
Micropolitan Statistical Areas, and Combined Statistical Areas, and 
Guidance on Uses of the Delineations of These Areas: https://www.whitehouse.gov/wp-content/uploads/2020/03/Bulletin-20-01.pdf.
---------------------------------------------------------------------------

    For all other settings, we are not permanently finalizing our 
teaching physician virtual presence policies; however, they will remain 
in place for the duration of the PHE to provide flexibility for 
communities that may experience resurgences in COVID-19 infections. 
While we do not anticipate any program integrity concerns to arise from 
this expanded flexibility in rural areas, we agree with commenters that 
it is necessary for use to consider

[[Page 84580]]

additional data prior to proposing additional policies in this area, 
which could range from expanding this flexibility to include non-rural 
settings to terminating this flexibility in all settings. Specifically, 
we anticipate considering to what degree the permanent establishment of 
the policy to permit teaching physician virtual presence in residency 
training sites that are located outside of a MSA increased patient 
access to Medicare-covered services and provided additional training 
opportunities for residents while enabling the teaching physician to 
render sufficient personal and identifiable physicians' services. We 
may use such information, obtained through, for example, a commissioned 
study, analysis of Medicare claims data or another assessment 
mechanism, to further study the impacts of this limited permanent 
expansion of the virtual presence policy to inform potential future 
rulemaking, and in an effort to prevent possible fraud, waste and 
abuse.
    We are amending our regulations to reflect this final policy. In 
Sec.  415.172(a), to conform with the regulation text we are finalizing 
to describe direct supervision in Sec.  410.32(b)(3)(ii), we are adding 
language to state that, as a general rule, the required presence of a 
teaching physician in order to bill under the PFS for their services at 
a residency training site that is located outside of a MSA can be met 
through interactive, audio/video real-time communications technology, 
which, as noted above, means synchronous, interactive, audio and video 
communications technology, and does not include audio-only 
communications. We are also adding language to provide that, for the 
duration of the PHE for COVID-19, in all teaching settings, the 
required presence of a teaching physician can be met through 
interactive, audio/video real-time communications technology (excluding 
audio-only).
    In Sec.  415.172(a)(2), we are adding language to note the 
exceptions under which virtual presence is permitted in the case of E/M 
services.
    In Sec.  415.172(b), which discusses existing documentation 
requirements, we are adding language to clarify that, for residency 
training sites that are located outside of a MSA, the medical record 
must clearly reflect whether the teaching physician was physically or 
virtually present at the training site during the key portion of the 
service. We are also adding language to clarify that, for all teaching 
settings and for the duration of the PHE for COVID-19, the patient's 
medical record must clearly reflect whether the teaching physician was 
physically or virtually present during the key portion of the service. 
Finally, we are adding language to clarify that the medical records 
must contain a notation describing the specific portion(s) of the 
service for which the teaching physician was present through 
interactive, audio/video real-time communications technology (excluding 
audio-only).
    In Sec.  415.174(c), we are adding language to state that, for all 
teaching settings and for the duration of the PHE for COVID-19, the 
teaching physician may not only direct the care furnished by residents, 
but also review the services provided with the resident, during or 
immediately after the visit, remotely through interactive, audio/video 
real-time communications technology (excluding audio-only).
    In Sec.  415.174(d), we are adding language to state that, for 
residency training sites that are located outside of a MSA, the 
teaching physician may not only direct the care furnished by residents, 
but also review the services provided with the resident, during or 
immediately after the visit, remotely through interactive, audio/video 
real-time communications technology (excluding audio-only).
    In Sec.  415.180(a), we are adding language to state that, for 
residency training sites that are located outside of an MSA, PFS 
payment may be made for the interpretation of diagnostic radiology and 
other diagnostic tests when the interpretation is performed by a 
resident and when the teaching physician is present through 
interactive, audio/video real-time communications technology (excluding 
audio-only). We are also adding language to state that, for all 
teaching settings and for the duration of the PHE for COVID-19, PFS 
payment may be made for the interpretation of diagnostic radiology and 
other diagnostic tests when the interpretation is performed by a 
resident and when the teaching physician is present through 
interactive, audio/video real-time communications technology (excluding 
audio-only). Finally, we are adding language to clarify that the 
medical records must document the extent of the teaching physician's 
participation in the interpretation or review of the diagnostic 
radiology or diagnostic test.
    In Sec.  415.184, we are adding language to state that, for 
residency training sites that are located outside of a MSA, the 
requirement for the presence of the teaching physician during the 
psychiatric service in which a resident is involved may be met using 
interactive, audio/video real-time communications technology (excluding 
audio-only). We are also adding language to state that, for all 
teaching settings and for the duration of the PHE for COVID-19, the 
requirement for the presence of the teaching physician during the 
psychiatric service in which a resident is involved may be met using 
interactive, audio/video real-time communications technology (excluding 
audio-only). Finally, we are adding language to clarify that the 
medical records must document the extent of the teaching physician's 
participation in the service.
    While difficult to quantify, we believe that permanently extending 
the policy to permit virtual presence of teaching physicians in 
residency training sites that are located outside of an MSA will 
improve patient access to Medicare-covered physicians' services in 
rural areas. In addition, the ability of a teaching physician to meet 
the requirements to bill for services furnished involving residents 
through their virtual presence in these settings will improve teaching 
capabilities and potentially allow for additional resident education 
opportunities in rural areas. Settings that have traditionally been 
inaccessible as training sites for residents due to the limited ability 
of teaching physicians to be physically present will be more readily 
available, thereby affording increased access to physicians' services 
to patients in these areas. However, in order to ensure that this 
limited extension of the virtual presence policy is also consistent 
with section 1842(b)(7)(A)(i)(I) of the Act, we are clarifying our 
existing documentation requirements to specify that the medical record 
must clearly reflect how and when the teaching physician was present 
for the service. We believe this documentation clarification will 
ensure that the teaching physician renders sufficient personal and 
identifiable physicians' services to the patient to exercise full, 
personal control over the management of the portion of the case for 
which the payment is sought. Further, in order to minimize potential 
risks to patients, we remind physicians and other practitioners that 
the adoption of these virtual presence policies in residency training 
sites that are located outside a MSA does not preclude teaching 
physicians from being physically present when providing services 
furnished with residents. We therefore urge teaching physicians to 
continue to use their professional judgment to determine the 
circumstances under which it is appropriate to be present virtually 
rather than in person depending on the services being furnished and the 
experience of the

[[Page 84581]]

particular resident(s) and/or teaching physician involved.
    Comment: In response to our comment solicitation for information 
regarding how the virtual presence of a teaching physician would 
support patient safety, several commenters stated that guardrails exist 
through the Accreditation Council for Graduate Medical Education 
(ACGME) and other accrediting organizations that have standards and 
systems to ensure patient safety and oversight of residents when 
virtual supervision of residents occurs.
    Response: We appreciate commenters' suggestions that the policies 
of the ACGME and other accrediting organizations could serve as 
guardrails in the context of virtual supervision; however, the 
commenters provided no specific description of any such policies or any 
other evidence to further identify those guardrails. Without further 
information, CMS cannot opine on the sufficiency of ACGME or other 
accrediting organization policies. Therefore, we continue to rely on 
the clinical judgment of teaching physicians and the residents they 
involve in their care to ensure appropriate patient safety.
iii. Virtual Teaching Physician Presence During Medicare Telehealth 
Services
    In the March 31st COVID-19 IFC (85 FR 19230), we adopted a policy 
on an interim basis to allow Medicare to make payment under the PFS for 
teaching physician services when a resident furnishes Medicare 
telehealth services to beneficiaries while a teaching physician is 
present using audio/video real-time communications technology. We also 
noted that we were considering whether this policy should be extended 
on a temporary basis (that is, if the PHE for COVID-19 ends in 2021, 
this policy could be extended to December 31, 2021, to allow for a 
transition period before reverting to status quo policy) or be made 
permanent, and solicited public comments on whether this policy should 
continue once the PHE for COVID-19 ends. We noted that the public 
comments would assist us in identifying appropriate policy continuation 
decisions that we would consider finalizing in the CY 2021 PFS final 
rule. Outside the circumstances of the PHE for COVID-19, under the 
requirements at section 1834(m) of the Act that discuss payment for 
telehealth services, the patient would be located at a telehealth 
originating site, and the teaching physician would be furnishing the 
service as the distant site practitioner with the involvement of the 
resident.
    While teaching physician presence through audio/video real-time 
communications technology when a resident furnishes Medicare telehealth 
services was responsive to critical needs during the PHE for COVID-19 
to reduce exposure risk and to increase the capacity of teaching 
settings to respond to COVID-19, we expressed concern that the policy 
to permit virtual presence of the teaching physician may not allow for 
sufficient personal and identifiable physicians' services to exercise 
full, personal control over the services such that PFS payment to the 
teaching physician would be appropriate outside the circumstances of 
the PHE for COVID-19 on a temporary or permanent basis. We also noted 
concern that if the resident was furnishing the service at the distant 
site and the teaching physician was at a third site and present with 
the resident through audio/video real-time communications technology, 
the teaching physician may not be able to render sufficient personal 
and identifiable physicians' services to the patient to exercise full, 
personal control over the service to warrant separate payment on the 
PFS.
    Absent the need to reduce exposure risk to COVID-19 during the PHE, 
we also expressed some concerns about patient safety when the teaching 
physician is present only virtually during a telehealth service 
furnished by a resident. For example, the virtual connection between 
the teaching physician and the resident who is with the patient could 
be disrupted (as with any virtual supervision scenario), rendering it 
impossible for the teaching physician to provide necessary direction 
for the resident to furnish appropriate care to the patient, thus 
foreclosing the ability of the teaching physician to exercise full, 
personal control over the key portion of the service, and potentially 
putting the patient's safety at risk.
    However, because COVID-19 may continue to persist in some 
communities and some communities may experience a resurgence of COVID-
19 after the expiration of the PHE for COVID-19, we solicited comments 
about whether it would be appropriate to extend this policy on a 
temporary basis until the end of the calendar year in which the PHE for 
COVID-19 ends. The presence of COVID-19 may result in a need to 
continue to limit exposure risks. In cases where the teaching physician 
has been exposed to the virus and is under quarantine, termination of 
the policy to permit virtual presence of the teaching physician could 
unintentionally limit the number of licensed practitioners available to 
furnish services to Medicare patients in some communities, and could 
have the unintended consequence of limiting access for Medicare 
patients. Finally, based on experience gained during the PHE for COVID-
19, we noted that we might identify circumstances for which the 
teaching physician can routinely render sufficient personal and 
identifiable services to the patient to exercise full, personal control 
over the management of the key portion of the case while providing 
virtual presence during Medicare telehealth services furnished by a 
resident on a permanent basis. For example, under ordinary 
circumstances for the primary care exception at Sec.  415.174, we 
permit PFS payment to the teaching physician when a resident furnishes 
office/outpatient E/M visit codes of lower and mid-level complexity and 
annual wellness visits without the presence of a teaching physician 
(these codes were discussed in section II.F. of the proposed rule (85 
FR 50121)). For such services, we noted that it may be appropriate to 
continue the virtual presence policy on a temporary or permanent basis. 
We solicited comments to help us understand how the option to allow 
teaching physician presence using audio/video real-time communications 
technology could support patient safety for all patients and 
particularly for at-risk patients (for example, patients who are aged 
and/or who have a disability), ensure burden reduction without creating 
risks to patient care or increasing fraud, avoid duplicative payment 
between the PFS and the IPPS for GME programs, and support emergency 
preparedness. We also solicited comments to provide data and other 
information on experiences implementing this policy during the PHE for 
COVID-19.
    We received public comments on whether the policy we adopted on an 
interim final basis during the PHE for COVID-19 to allow Medicare to 
make payment under the PFS to the teaching physician when a resident 
furnishes Medicare telehealth services to beneficiaries while a 
teaching physician is present using audio/video real-time 
communications technology should continue once the PHE for COVID-19 
ends. The following is a summary of the comments we received and our 
responses.
    Comment: Commenters were generally supportive of our interim policy 
to allow Medicare to make payment under the PFS to the teaching 
physician when a resident furnishes Medicare telehealth services to 
beneficiaries while a teaching physician

[[Page 84582]]

is present using audio/video real-time communications technology. 
Several commenters supported extending the flexibility permanently, 
while others recommended temporarily extending the policy through the 
end of the PHE for COVID-19, and cited a need to gather data regarding 
patient safety and potential impacts on resident training outside the 
context of the PHE for COVID-19. One commenter stated that in rural 
settings, it was not always possible for the teaching physician to 
accompany a resident while also being present to other residents. This 
commenter stated that the ability for the teaching physician is 
virtually present has increased patient access to physicians' services 
in rural areas. Similarly, other commenters stated that the permanent 
ability for teaching physicians to be virtually present when not 
physically present could increase training opportunities for rural 
training programs, and better prepare residents for the nuances and 
differences of providing care over video instead of in person.
    Response: We appreciate commenters' support of our interim policy 
to allow Medicare to make payment under the PFS for teaching physician 
services when a resident furnishes Medicare telehealth services to 
beneficiaries while a teaching physician is present using interactive, 
audio/video real-time communications technology (excluding audio-only). 
We remain concerned that, absent the circumstances of the PHE, a 
teaching physician's presence via interactive, audio/video real-time 
communications technology (excluding audio-only) when a resident is 
furnishing Medicare telehealth services may not allow the teaching 
physician to render sufficient personal and identifiable physicians' 
services to the patient to exercise full, personal control over the 
management of the portion of the case for which payment is sought, in 
accordance with section 1842(b)(7)(A)(i)(I) of the Act, in most 
settings. For rural areas, however, we found compelling the commenters' 
statements that our virtual presence policy has increased access to 
Medicare-covered services. Accordingly, we believe that a policy to 
permit Medicare to make PFS payment for teaching physician services 
when a resident located within a rural training setting furnishes 
Medicare telehealth services to beneficiaries while a teaching 
physician is present through interactive, audio/video real-time 
communications technology (excluding audio-only) could increase access 
to Medicare-covered services in rural areas by preventing the 
beneficiary from potentially having to travel long distances to obtain 
care, particularly as rural areas have stretched and diminishing 
clinical workforces.\14\ Increasing beneficiary access to care in rural 
areas is also consistent with our longstanding interest in increasing 
beneficiary access to Medicare-covered services in rural areas; 
therefore, in order to allow for more widespread access to care for 
beneficiaries in rural areas, we believe it would be appropriate for a 
resident located within a rural training setting to furnish telehealth 
services to a beneficiary who is in a separate location within the same 
rural area as the resident or within a different rural area, while a 
teaching physician is present, through interactive, audio/video real-
time communications technology (excluding audio-only), in a third 
location, either within the same rural training setting as the resident 
or outside of that rural training setting.\15\ Further, allowing 
Medicare to make PFS payment for teaching services when a resident 
furnishes Medicare telehealth services to a beneficiary while a 
teaching physician is present through interactive, audio/video real-
time communications technology (excluding audio-only) could facilitate 
additional training opportunities for residents in rural settings, 
which have historically been in limited supply.\16\ As such, the need 
to improve rural access to care for patients and training for residents 
overshadows our concerns about the ability for the teaching physician 
to render sufficient personal and identifiable physicians' services to 
the patient to exercise full, personal control over the management of 
the portion of the case for which payment is sought. Accordingly, in 
rural areas, we believe it would be appropriate to continue our policy 
to permit teaching physicians to meet the requirements to bill under 
the PFS for their services when a resident furnishes Medicare 
telehealth services to beneficiaries while a teaching physician is 
present through interactive, audio/video real-time communications 
technology (excluding audio-only) after the conclusion of the PHE for 
COVID-19. This policy not only furthers our goals to increase 
beneficiary access to Medicare-covered services, it also facilitates 
needed training opportunities in a similar way to the longstanding 
primary care exception under Sec.  415.174. The primary care exception 
permits the teaching physician to bill for certain types of physicians' 
services furnished by residents in certain settings even when the 
teaching physician is not present with the resident. Like the policy we 
are finalizing in this rule, the primary care exception facilitates 
access to Medicare-covered services and expanded residency training 
opportunities in primary care settings. Therefore, we are permanently 
finalizing our policy that Medicare may make payment under the PFS for 
teaching physician services when a resident furnishes Medicare 
telehealth services in a residency training site located outside of a 
MSA to a beneficiary who is in a separate location outside the same MSA 
(that is, in the same rural area) as the residency training site or is 
within a rural area outside of a different MSA, while a teaching 
physician is present, through interactive, audio/video real-time 
communications technology (excluding audio-only), in a third location, 
either within the same rural training site as the resident or outside 
of that rural training site. In order to ensure that the teaching 
physician renders sufficient personal and identifiable physicians' 
services to the patient to exercise full, personal control over the 
management of the portion of the case for which the payment is sought, 
in accordance with section 1842(b)(7)(A)(i)(I) of the Act, we are 
clarifying our existing documentation requirements to specify that, 
when a resident furnishes Medicare telehealth services in a residency 
training site located outside of a MSA and the teaching physician is 
present using interactive, audio/video real-time communications 
technology (excluding audio-only), the patient's medical record must 
clearly reflect how and when the teaching physician was present during 
the key portion of the service, in accordance with our regulations. For 
example, in the medical record, the teaching physician could document 
their physical or virtual presence at the training site during the key 
portion of the service, along with a notation describing the specific 
portion(s) of the service for which the teaching physician was 
virtually present, and/or that the teaching physician reviewed the 
service with the resident during or immediately after the service in 
accordance with the primary

[[Page 84583]]

care exception under Sec.  415.174. We also expect that, if the 
teaching physician is virtually present and bills for services during 
which there is a disruption to the virtual connection between the 
teaching physician and the resident who is with the patient, the 
encounter would be paused until the connection resumes, or the 
appointment would be rescheduled.
---------------------------------------------------------------------------

    \14\ A Guide for Rural Health Care Collaboration and 
Coordination: https://www.hrsa.gov/sites/default/files/hrsa/ruralhealth/reports/HRSA-Rural-Collaboration-Guide.pdf.
    \15\ CMS Rural Health Strategy: https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Rural-Strategy-2018.pdf.
    \16\ HHS awards $20 million to 27 organizations to increase the 
rural workforce through the creation of new rural residency 
programs: https://www.hhs.gov/about/news/2019/07/18/hhs-awards-20-million-to-27-organizations-to-increase-rural-workforce.html.
---------------------------------------------------------------------------

    For all other settings, we are not permanently finalizing this 
policy; however, the policy will remain in place for the duration of 
the PHE for COVID-19 to provide flexibility for communities that may 
experience resurgences in COVID-19 infections. While we do not 
anticipate any program integrity concerns from this expanded 
flexibility, we agree with commenters that it is necessary for us to 
consider additional data prior to proposing additional policies in this 
area, which could range from expanding this flexibility to include non-
rural settings to terminating this flexibility in all settings. 
Specifically, we anticipate considering to what degree the permanent 
implementation of the policy to allow PFS payment for teaching services 
when a teaching physician is virtually present while a resident 
furnishes Medicare telehealth services in a residency training site 
located outside of an MSA increased patient access to Medicare-covered 
services and provided more training opportunities for residents while 
enabling the teaching physician to render sufficient personal and 
identifiable physicians' services. We may use such information, 
obtained through, for example, a commissioned study, analysis of 
Medicare claims data or another assessment mechanism, to further study 
the impacts of this limited permanent expansion of the policy to allow 
PFS payment for teaching services when a teaching physician is 
virtually present while a resident furnishes Medicare telehealth 
services to inform potential future rulemaking, and in an effort to 
prevent possible fraud, waste and abuse.
    We are amending our regulations to reflect this final policy. In 
Sec.  415.172(a), we are adding language to state that, in a residency 
training site located outside of an MSA, a teaching physician may bill 
under the PFS for services furnished when they are present with the 
resident during the key portion of the service through interactive, 
audio/video real-time communications technology (excluding audio-only), 
including when the resident provides Medicare telehealth services. We 
are also adding language to state that, for all teaching settings and 
for the duration of the PHE for COVID-19, payment under the PFS is 
permitted if a teaching physician is present during the key portion of 
the service, including Medicare telehealth services, through 
interactive, audio/video real-time communications technology (excluding 
audio-only). In Sec.  415.172(b), which discusses existing 
documentation requirements, we are adding language to clarify that, for 
residency training sites that are located outside of a MSA, the 
patient's medical record must clearly reflect whether the teaching 
physician was physically or virtually present at the training site 
during the key portion of the service, including for Medicare 
telehealth services. We are also adding language to clarify that, for 
all teaching settings and for the duration of the PHE for COVID-19, the 
patient's medical record must clearly reflect whether the teaching 
physician was physically or virtually present during the key portion of 
the service, including for Medicare telehealth services. Finally, we 
are adding language to clarify that the medical records must contain a 
notation describing the specific portion(s) of the service, including 
Medicare telehealth services, for which the teaching physician was 
present through interactive, audio/video real-time communications 
technology (excluding audio-only).
    While difficult to quantify, we believe that permanently extending 
our policy to allow payment under the PFS for teaching physician 
services when a resident furnishes Medicare telehealth services in a 
residency training site located outside of an MSA and the teaching 
physician is present through interactive audio/video real-time 
communications technology (excluding audio-only) will promote enhanced 
patient access to Medicare-covered physicians' services in rural areas. 
In addition, allowing PFS payment for teaching physician services when 
a resident furnishes Medicare telehealth services in a residency 
training site located outside of an MSA and the teaching physician is 
present through interactive audio/video real-time communications 
technology (excluding audio-only) will improve teaching capabilities 
and potentially allow for additional resident education opportunities 
in rural areas. Settings that have traditionally been inaccessible as 
training sites for residents due to the limited ability of teaching 
physicians to be physically present will be more readily available, 
thereby affording increased access to physicians' services to patients 
in these areas. However, in order to ensure that the limited extension 
of this policy is also consistent with section 1842(b)(7)(A)(i)(I) of 
the Act, we are clarifying the existint documentation requirements to 
specify that the medical record must clearly reflect how and when the 
teaching physician was present for the Medicare telehealth service. We 
believe this documentation clarification will ensure that the teaching 
physician renders sufficient personal and identifiable physicians' 
services to the patient to exercise full, personal control over the 
management of the portion of the case for which payment is sought. 
Further, in order to minimize potential risks to patients, we remind 
physicians and other practitioners that the adoption of this policy in 
residency training sites that are located outside of an MSA does not 
preclude teaching physicians from being physically present when a 
resident is furnishing Medicare telehealth services. We therefore urge 
teaching physicians to continue to use their professional judgment to 
determine the circumstances under which it is appropriate to be present 
virtually rather than in person, depending on the Medicare telehealth 
services being furnished and the experience of the particular residents 
involved.
    Comment: One commenter, who favored a permanent policy to allow PFS 
payment for teaching physician services when a resident furnishes 
Medicare telehealth services in a residency training site located 
outside of a MSA and the teaching physician is present using 
interactive audio/video real-time communications technology, advocated 
for the permanent extension of the policy by noting that ACGME 
recognizes and endorses an expansion of telemedicine as well as the use 
of audio/visual communications devices by residents and their teaching 
physicians. Further, the commenter stated that, as long as the virtual 
presence of teaching physicians during Medicare telehealth services 
continues to adhere to ACGME standards, an optimal learning 
environment, with appropriate education and supervision, would be 
maintained.
    Response: We appreciate the commenter's feedback regarding ACGME 
standards in the context of the expansion of telemedicine and the use 
of audio/visual communication devices by residents and teaching 
physicians; however, the commenter provided no specific description of 
ACGME's standards or any evidence to support a permanent implementation 
of the policy to allow PFS payment for teaching services when a 
resident furnishes Medicare telehealth services in all settings when a 
teaching physician is present through interactive, audio/video

[[Page 84584]]

real-time communications technology (excluding audio-only). Without 
further information, CMS cannot opine on whether or not ACGME's 
standards would support a wider permanent implementation of this 
policy. Therefore, we continue to rely on the clinical judgment of 
teaching physicians and the residents they involve in their care to 
ensure appropriate patient safety.
iv. Resident Moonlighting in the Inpatient Setting
    Under certain conditions, the services of a licensed resident 
physician who is ``moonlighting'' are considered to be furnished by the 
individual in their capacity as a physician, rather than as a resident 
in an approved GME program. As specified in the regulation at Sec.  
415.208, except during the PHE for COVID-19, as defined in the 
regulation at Sec.  400.200, the services of residents to inpatients of 
hospitals in which the residents have their approved GME program are 
not considered separately billable as physicians' services and instead 
are payable under Sec. Sec.  413.75 through 413.83 regarding direct GME 
payments, whether or not the services are related to the approved GME 
training program. When a resident furnishes services that are not 
related to their approved GME programs in an outpatient department or 
emergency department of a hospital in which they have their training 
program, those services can be billed separately as physicians' 
services and payable under the PFS if they meet the criteria described 
in our regulation at Sec.  415.208(b)(2)(i) through (iii). In addition, 
under Sec.  415.208(c), services of a licensed resident furnished 
outside the scope of an approved GME program when moonlighting in a 
hospital or other setting that does not participate in the approved GME 
program are payable under the PFS when the resident is fully licensed 
to practice in the state where the services are furnished, and the 
resident's time spent in patient care activities in that setting is not 
counted for the purpose of Medicare direct GME payments.
    In the March 31st COVID-19 IFC, we amended our regulation at Sec.  
415.208 to state that, during the PHE for COVID-19, the services of 
residents that are not related to their approved GME programs and are 
furnished to inpatients of a hospital in which they have their training 
program are separately billable physicians' services for which payment 
can be made under the PFS provided that the services are identifiable 
physicians' services and meet the conditions for payment of physicians' 
services to beneficiaries by providers in Sec.  415.102(a), the 
resident is fully licensed to practice medicine, osteopathy, dentistry, 
or podiatry by the state in which the services are performed, and the 
services can be separately identified from those services that are 
required as part of the approved GME program. We considered whether 
this flexibility that we implemented on an interim basis should be 
extended on a temporary basis (that is, if the PHE for COVID-19 ends in 
2021, these policies could be extended to December 31, 2021, to allow 
for a transition period before reverting to status quo policy) or be 
made permanent, and solicited public comments on whether this policy 
should continue once the PHE ends. We expressed concerns that there may 
be risks to program integrity in allowing residents to furnish 
separately billable physicians' services to inpatients in the teaching 
hospitals where they are training when the services are outside the 
scope of their approved GME program. For example, there could be a risk 
of duplicate Medicare payment for the resident's services under the 
IPPS for GME and the PFS if the physicians' services furnished by 
residents were not adequately separately identified from those services 
that are required as part of the GME program. However, because COVID-19 
may continue to persist in some communities or some communities may 
experience a resurgence of COVID-19 after the expiration of the PHE, we 
noted that it may be appropriate for us to extend this policy on a 
temporary basis to meet the needs of teaching hospitals to ensure that 
there are as many qualified practitioners available as possible. We 
noted that the public comments would assist us in identifying 
appropriate policy continuation decisions that we would consider 
finalizing in this CY 2021 PFS final rule. We also solicited comments 
to provide data and other information on experiences implementing this 
policy during the PHE for COVID-19.
    We received public comments from our comment solicitation in the 
proposed rule regarding whether our resident moonlighting policy under 
Sec.  415.208 that we implemented on an interim basis for the PHE for 
COVID-19 should continue once the PHE ends. The following is a summary 
of the comments we received and our responses.
    Comment: Commenters were generally supportive of the policy under 
Sec.  415.208 that we adopted on an interim basis during the PHE for 
COVID-19. Several commenters supported extending the flexibility 
permanently, while others recommended temporarily extending the policy 
through the end of the PHE for COVID-19, and cited a need to maintain 
surge capacity and to allow more data to be gathered regarding patient 
safety and potential impacts on resident training outside the context 
of the PHE. A few commenters suggested that to prevent duplicate 
billing, CMS should educate practitioners about the need for sufficient 
documentation to demonstrate that services furnished while residents 
are moonlighting are separate from those services that are required as 
part of approved GME programs.
    Response: We appreciate commenters' support for our interim policy. 
After considering the comments, we are finalizing our interim policy 
for the services of moonlighting residents on a permanent basis. 
Consequently, we are amending our regulation at Sec.  415.208(b)(2) to 
state that the services of residents that are not related to their 
approved GME programs and are performed in the outpatient department, 
emergency department, or inpatient setting of a hospital in which they 
have their training program are separately billable physicians' 
services for which payment can be made under the PFS provided that the 
services are identifiable physicians' services and meet the conditions 
of payment for physicians' services to beneficiaries in providers in 
Sec.  415.102(a), the resident is fully licensed to practice medicine, 
osteopathy, dentistry, or podiatry by the State in which the services 
are performed, and the services are not performed as part of the 
approved GME program.
    We agree with commenters about the need for sufficient 
documentation to allay concerns about potential duplication of payment 
with the IPPS for GME. Thus, we are also amending Sec.  415.208(b)(2) 
to clarify that, regardless of whether the resident's services are 
performed in the outpatient department, emergency department or 
inpatient setting of a hospital in which they have their training 
program, the patient's medical record must clearly reflect that the 
resident furnished identifiable physician services that meet the 
conditions of payment of physician services to beneficiaries in 
providers in Sec.  415.102(a), that the resident is fully licensed to 
practice medicine, osteopathy, dentistry, or podiatry by the State in 
which the services are performed, and that the services are not 
performed as part of the approved GME program. For example, in the 
medical record, the resident could state that they are licensed to 
practice medicine, osteopathy, dentistry or podiatry by the

[[Page 84585]]

state in which the service was performed, document that the service was 
performed outside of their approved GME program, and include a notation 
describing the specific physician service that was furnished,
v. Primary Care Exception Policies
    The regulation at Sec.  415.174 sets forth an exception to the 
conditions for PFS payment for services furnished in teaching settings 
in the case of certain E/M services furnished in certain centers. Under 
the so-called ``primary care exception,'' Medicare makes PFS payment in 
certain teaching hospital primary care centers for certain services of 
lower and mid-level complexity furnished by a resident without the 
physical presence of a teaching physician. Section 415.174(a)(3) 
requires that the teaching physician must not direct the care of more 
than four residents at a time, and must direct the care from such 
proximity as to constitute immediate availability (that is, provide 
direct supervision) and must review with each resident during or 
immediately after each visit, the beneficiary's medical history, 
physical examination, diagnosis, and record of tests and therapies. 
Section 415.174(a)(3) also requires that the teaching physician must 
have no other responsibilities at the time, assume management 
responsibility for the beneficiaries seen by the residents, and ensure 
that the services furnished are appropriate.
    As provided in the regulation at Sec.  415.174(a), the codes of 
lower and mid-level complexity that can be furnished under the primary 
care exception are specified in section 100 of chapter 12 of the 
Medicare Claims Processing Manual (https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf). They are the 
following:
     CPT code 99201 (Office or other 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);
     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; 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);
     CPT code 99203 (Office or other 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);
     CPT code 99211 (Office or other 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);
     CPT code 99212 (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 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);
     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; 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);
     HCPCS code G0402 (Initial preventive physical examination; 
face-to-face visit, services limited to new beneficiary during the 
first 12 months of Medicare enrollment);
     HCPCS code G0438 (Annual wellness visit; includes a 
personalized prevention plan of service (PPS), initial visit); and
     HCPCS code G0439 (Annual wellness visit, includes a 
personalized prevention plan of service (PPS), subsequent visit).
    In the March 31st COVID-19 IFC, we amended Sec.  415.174 of our 
regulations to allow, during the PHE for COVID-19, all levels of 
office/outpatient E/M visits to be furnished by the resident and billed 
by the teaching physician under the primary care exception. In the May 
8th COVID-19 IFC), we further expanded the list of services included in 
the primary care exception during the PHE for COVID-19. We also allowed 
PFS payment to the teaching physician for services furnished by 
residents via telehealth under the primary care exception if the 
services were also on the list of Medicare telehealth services.
    We noted that we were considering whether these policies should be 
extended on a temporary basis (that is, if the PHE for COVID-19 ends in 
2021, these policies could be extended to December 31, 2021, to allow 
for a transition period before reverting to status quo policy) or be 
made permanent, and solicited public comments on whether these policies 
should continue once the PHE for COVID-19 ends. We also noted that the 
public comments would assist us in identifying appropriate policy 
continuation decisions that we would consider finalizing in the CY 2021 
PFS final rule. We also considered whether specific services added 
under the primary care exception should be extended temporarily or made 
permanent and solicited public comments on whether these services 
should continue as part of the primary care exception once the PHE for 
COVID-19 ends. These services are the following:
     CPT code 99204 (Office or other 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

[[Page 84586]]

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);
     CPT code 99205 (Office or other 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);
     CPT code 99214 (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 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);
     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; 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);
     CPT code 99495 (Transitional Care Management services with 
the following required elements: Communication (direct contact, 
telephone, electronic) with the patient and/or caregiver within two 
business days of discharge; medical decision making of at least 
moderate complexity during the service period; face-to-face visit 
within 14 calendar days of discharge);
     CPT code 99496 (Transitional Care Management services with 
the following required elements: Communication (direct contact, 
telephone, electronic) with the patient and/or caregiver within two 
business days of discharge; medical decision making of at least high 
complexity during the service period; face-to-face visit within 7 
calendar days of discharge);
     CPT code 99421 (Online digital evaluation and management 
service, for an established patient, for up to 7 days, cumulative time 
during the 7 days; 5-10 minutes);
     CPT code 99422 (Online digital evaluation and management 
service, for an established patient, for up to 7 days, cumulative time 
during the 7 days; 11-20 minutes);
     CPT code 99423 (Online digital evaluation and management 
service, for an established patient, for up to 7 days, cumulative time 
during the 7 days; 21 or more minutes);
     CPT code 99452 (Interprofessional telephone/internet/
electronic health record referral service(s) provided by a treating/
requesting physician or qualified health care professional, 30 
minutes);
     HCPCS code G2012 (Brief communication technology-based 
service, e.g. virtual check-in, by a physician or other qualified 
health care professional who can report evaluation and management 
services, provided to an established patient, not originating from a 
related E/M service provided within the previous 7 days nor leading to 
an E/M service or procedure within the next 24 hours or soonest 
available appointment; 5-10 minutes of medical discussion); and
     HCPCS code G2010 (Remote evaluation of recorded video and/
or images submitted by an established patient (e.g., store and 
forward), including interpretation with follow-up with the patient 
within 24 business hours, not originating from a related E/M service 
provided within the previous 7 days nor leading to an E/M service or 
procedure within the next 24 hours or soonest available appointment).
    We noted that expanding the array of services for which Medicare 
may make PFS payment to the teaching physician when furnished by a 
resident under the primary care exception was responsive to critical 
needs during the PHE for COVID-19 for patients who may be quarantined 
at home or who may need to be isolated for purposes of minimizing 
exposure risk based on presumed or confirmed COVID-19 infection. 
Because COVID-19 may continue to persist in some communities or some 
communities may experience a resurgence of COVID-19 after the 
expiration of the PHE for COVID-19, we also noted that it may be 
appropriate for us to extend all of these services on a temporary basis 
(that is, until the end of the calendar year in which the PHE for 
COVID-19 ends).
    However, we expressed concern that it may be inappropriate to 
extend all of these services on a temporary basis or add them to the 
primary care exception permanently. The intent of the primary care 
exception as described in Sec.  415.174 is that E/M visits of lower and 
mid-level complexity furnished by residents are simple enough to permit 
a teaching physician to be able to direct and manage the care of up to 
four residents at any given time and direct the care from such 
proximity as to constitute immediate availability. While CPT code 99421 
and HCPCS code G2012 may be simple services, others such as levels 4 
and 5 office/outpatient E/M visits (CPT codes 99204 through 99205 and 
CPT codes 99214 through 99215) and transitional care management codes 
(CPT codes 99495 through 99496) require medical decision-making that is 
of at least moderate complexity. We also noted concern that the 
teaching physician may not be able to maintain sufficient personal 
involvement in all of the care to warrant PFS payment for the services 
being furnished by up to four residents when some or all of the 
residents might be furnishing services that are more than lower and 
mid-level complexity. We noted that when the teaching physician is 
directing the care of a patient that requires moderate or higher 
medical decision-making, the ability to be immediately available to 
other residents could be compromised, potentially putting patients at 
risk. Thus, we considered whether, upon expiration of the PHE for 
COVID-19, we should extend on a temporary basis some or all of the 
services we added to the primary care exception list during the PHE and 
solicited public comments on whether these services should continue as 
part of the primary care exception after the PHE ends. We also 
solicited comments to provide data and other information on experiences 
implementing this policy during the PHE for COVID-19.
    We also considered whether our interim policy that PFS payment 
could be made to the teaching physician when residents furnish 
telehealth services under the primary care exception should be extended 
on a temporary basis or be made permanent, and solicited public 
comments on whether this policy should continue once the

[[Page 84587]]

PHE for COVID-19 ends. In these cases, outside the circumstances of the 
PHE for COVID-19, the patient would be at the originating site and the 
resident furnishing the care, along with the teaching physician billing 
for it, would be located at the primary care center as the distant site 
practitioner. If we were to temporarily extend or add permanently to 
the primary care exception services such as e-visits or communication 
technology-based services, we noted that it may also make sense to 
permit PFS payment to the teaching physician when the resident 
furnishes an office/outpatient E/M visit via telehealth, on the basis 
that the patient is not physically in the clinic and that these 
services all involve the use of virtual technology (for example, 
patient portals for e-visits, telecommunications technology for the 
office/outpatient E/M visit) to facilitate care delivery. Further, we 
noted that, if we were to remove the services that we added to the 
primary care exception on an interim basis, we could separately 
consider continuing to permit PFS payment to the teaching physician 
when the resident furnishes an office/outpatient E/M visit via 
telehealth because the teaching physician would be immediately 
available in the distant site clinic with the resident to direct and 
manage the care.
    We received public comments on the primary care exception policies. 
The following is a summary of the comments we received and our 
responses.
    Comment: Commenters were generally supportive of the policy adopted 
on an interim basis under Sec.  415.174 to allow Medicare to make 
payment to the teaching physician for additional services under the 
primary care exception, including all levels of office and outpatient 
E/M, audio-only telephone E/M services, transitional care management, 
and communication technology-based services. Commenters were also 
generally supportive of our interim policy to allow Medicare to make 
payment under the PFS to the teaching physician for services furnished 
by residents via telehealth under the primary care exception if the 
services are on the list of Medicare telehealth services. These 
commenters stated that in general, the expansion of the primary care 
exception increases beneficiary access to Medicare-covered services and 
provides additional training opportunities for residents, particularly 
in rural areas.
    Several commenters supported making permanent all the services that 
we implemented on an interim basis during the PHE for COVID-19. Several 
other commenters supported making certain services permanent, stating 
that services such as communication technology-based services (for 
example, CPT codes 99421-99423 and HCPCS codes G2010 and G2012) were 
simple, require low to moderate complexity medical decision-making, and 
do not involve a diagnostic complexity that is beyond a resident's 
skill. In addition, some commenters supported the permanent inclusion 
of CPT code 99452 and stated that in some models of care, these inter-
professional consults are typically initiated by a primary care 
practitioner to a specialist for a low acuity, condition-specific 
question that can be answered without an in-person visit.
    Some commenters supported the permanent inclusion of CPT codes 
99204 and 99214, while other commenters did not. Commenters in support 
of including these codes stated that office/outpatient level 4 visits 
are typical visit for the Medicare population and that these visits do 
not involve a level of diagnostic complexity that is beyond a 
resident's skill. Other commenters stated that office/outpatient level 
4 visits should be furnished with the teaching physician present, 
either physically or through interactive audio/video real-time 
communications technology. These commenters were concerned that 
allowing office/outpatient level 4 visits to be furnished without the 
presence of the teaching physician could pose risks to patient safety 
and potential for abuse.
    Some commenters did not support the permanent inclusion of high-
complexity services, including office/outpatient level 5 visits (CPT 
codes 99205 and 99215) and transitional care management (CPT code 
99496), due to the high level of medical complexity, patient safety 
concerns, and potential for abuse.
    Several commenters recommended temporarily extending the primary 
care exception policies through the end of the PHE for COVID-19 and 
cited a need to gather data regarding patient safety and potential 
impacts on resident training outside the context of the PHE. Other 
commenters stated that the expansion of the primary care exception has 
allowed residents to be trained based on ``real life,'' which will 
leave them better prepared to furnish additional services upon 
completion of their residency programs.
    Response: We appreciate commenters' support of our interim policy 
to allow Medicare to make payment to the teaching physician when the 
resident furnishes an expanded array of services under the primary care 
exception. We remain concerned that permanently adding all of the 
proposed services to the primary care exception may be inappropriate 
because some of the services require at least a moderate level of 
medical decision-making, whereas the intent of the primary care 
exception as described in Sec.  415.174 is that E/M visits of lower and 
mid-level complexity furnished by residents are simple enough for a 
teaching physician to be able to direct and manage the care of up to 
four residents at any given time and direct the care from such 
proximity as to constitute immediate availability. We also remain 
concerned that the teaching physician may not be able to maintain 
sufficient personal involvement in all of the care to warrant PFS 
payment for the services being furnished by up to four residents when 
some or all of the residents might be furnishing services that are more 
than lower and mid-level complexity. However, we found the comments 
regarding the advantages of an expansion of services under the primary 
care exception in rural areas particularly compelling. Specifically, 
allowing PFS payment for additional primary care services furnished by 
residents without the physical presence of a teaching physician in 
rural areas could increase the availability of Medicare-covered 
services, which is consistent with our longstanding interest in 
increasing beneficiary access to Medicare-covered services in rural 
areas\17\. For example, permitting PFS payment to the teaching 
physician when the resident furnishes communication-technology based 
services, an inter-professional consultation, or an office/outpatient 
visit via telehealth without a teaching physician present could prevent 
the beneficiary from potentially having to travel long distances to 
obtain care. Accordingly, we believe that permitting Medicare to make 
PFS payment to the teaching physician when the resident furnishes an 
expanded array of services under the primary care exception in rural 
settings could increase access to Medicare-covered services. Further, 
this policy could also provide the benefit of additional training 
opportunities for residents in rural settings, which have historically 
been in limited supply. As such, the need to improve rural access to 
care for patients and training for resident overshadows our concerns 
that the teaching physician may not be able to maintain sufficient 
personal involvement in all of the care to warrant PFS payment for the 
services being furnished by up to four residents when

[[Page 84588]]

some or all of the residents might be furnishing services that are more 
than lower and mid-level complexity. Accordingly, we are finalizing, 
for residency training sites that are located outside of a MSA, a 
policy to allow Medicare to make payment to the teaching physician when 
the resident furnishes an expanded array of services under the primary 
care exception. However, in accordance with the original intent of the 
primary care exception to limit the scope of services to those of lower 
and mid-level complexity, we are limiting the permanent expanded array 
of services under the primary care exception to include communication-
technology based services and inter-professional consults. These 
services are described by CPT codes 99421-99423, and 99452, and HCPCS 
codes G2010 and G2012. We are also adding to the primary care 
exception, for residency training sites that are located outside of an 
MSA, Medicare telehealth services that furnished by residents. Based on 
the descriptors, these codes all represent E/M services of a low-to-
mid-level complexity, which is consistent with our regulations in Sec.  
415.174.
---------------------------------------------------------------------------

    \17\ CMS Rural Health Strategy: https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Rural-Strategy-2018.pdf.
---------------------------------------------------------------------------

    As noted above, some commenters supported adding office/outpatient 
E/M level 4 visits (CPT codes 99204 and 99214) to the primary care 
exception. While we included these services in the exception during the 
PHE to meet the needs of all teaching settings to ensure that there are 
as many qualified practitioners available as possible, we agree with 
the commenters who stated that it is inappropriate to allow these 
services to be billed by the teaching physician when furnished by 
residents without the presence of a teaching physician on a permanent 
basis because these services involve medical decision-making of at 
least a moderate level of complexity, so the ability for the teaching 
physician to be immediately available to other residents could be 
compromised. Thus, we agree with the commenters who stated that adding 
office/outpatient E/M level 4 visits to the primary care exception 
could pose risks to patient safety. We also believe that, because the 
transitional care management codes require medical decision-making of 
at least moderate complexity, the ability for the teaching physician to 
be immediately available to other residents could be compromised.
    This policy to limit the expanded array of services permitted to be 
furnished under the primary exception only to those services furnished 
in residency training sites that are located outside of a MSA is 
consistent with other teaching physician payment policies regarding 
virtual presence and telehealth that we are finalizing as described 
earlier in this final rule, and which were also similarly limited to 
residency training sites that are located outside of a MSA. However, 
practitioners are reminded that the permanent extension of the expanded 
primary care exception in residency training sites that are located 
outside of a MSA does not preclude teaching physicians from being 
physically present when a resident is furnishing these primary care 
services. We therefore urge teaching physicians to continue to use 
their professional judgment to determine the circumstances under which 
it is appropriate for residents to perform these services without the 
presence of the teaching physician, depending on the Medicare service 
being furnished and the experience of the particular resident involved.
    For all other settings, we are not finalizing a policy to allow 
Medicare to make payment to the teaching physician when the resident 
furnishes an expanded array of services under the primary care 
exception, including when those services are furnished under Medicare 
telehealth; however, the interim policy to include an expanded set of 
services under the primary care exception will remain in place for the 
duration of the PHE for COVID-19 to provide flexibility for communities 
that may experience resurgences in COVID-19 infections. Accordingly, at 
the end of the PHE, we will be terminating the inclusion of CPT codes 
99204, 99214, 99205, 99215, 99495 and 99496 from the primary care 
exception for all settings.
    While we do not anticipate any program integrity concerns to arise 
from the final policy to expand the services that may be furnished 
under the primary care exception in rural settings, we also agree with 
commenters that it is necessary for us to consider additional data 
prior to proposing additional policies in this area, which could range 
from expanding this flexibility to include non-rural settings to 
terminating this flexibility in all settings. Specifically, anticipate 
considering to what degree the permanent establishment of the policy to 
allow PFS payment to teaching physicians when the resident furnishes an 
expanded array of services under the primary care exception in 
residency training sites that are located outside of an MSA increased 
patient access to care and provided more training opportunities for 
residents while enabling the teaching physician to remain immediately 
available. We may use such information, obtained through, for example, 
a commissioned study, analysis of Medicare claims data or another 
assessment mechanism, to further study the impacts of this limited 
permanent expansion of the policy to allow PFS payment to teaching 
physicians when the resident furnishes an expanded array of services 
under the primary care exception in residency training sites of a 
teaching setting that are outside of an MSA to inform potential future 
rulemaking, and in an effort to prevent possible fraud, waste and 
abuse.
    Comment: One commenter requested clarification that when teaching 
physicians meet all of the requirements of the primary care exception, 
they are also able to provide direction and immediate availability thru 
virtual presence for moderate to high complexity encounters, such CPT 
codes 99204, 99205, 99214, and 99215.
    Response: Through the end of the PHE for COVID-19, a teaching 
physician that meets the requirements of the primary care exception 
described in Sec.  415.174(c) to direct the care and then to review the 
services furnished by each resident during or immediately after each 
visit may be met through interactive, audio/video real-time 
communications technology (excluding audio-only). This policy applies 
for moderate to high complexity encounters, including all levels of 
office/outpatient services. Once the PHE for COVID-19 ends, in 
accordance with the final policy to allow PFS payment to teaching 
physicians when the resident furnishes an expanded array of services 
under the primary care exception in residency training sites that are 
located outside of an MSA, a teaching physician may meet the 
requirements of the primary care exception described in Sec.  415.174 
to direct the care and then to review the services furnished by each 
resident during or immediately after each visit through interactive, 
audio/video real-time communications technology (excluding audio-only) 
when residents furnish services that we are including under the primary 
care exception, as described above. We believe that establishing this 
policy for residency training sites that are located outside of an MSA 
is consistent with the expansion of services that are permitted under 
the primary care exception in residency training sites that are located 
outside of an MSA, and that similarly, this policy will also increase 
beneficiary access to Medicare-covered primary care services and 
provide additional training opportunities for residents in settings to 
which there has previously been limited access. However, as noted 
above, the

[[Page 84589]]

services we are permanently including under the primary care exception 
in residency training sites that are located outside of an MSA do not 
include codes 99204, 99214, 99205, 99215, 99495 and 99496 because these 
services are of moderate to high complexity, and we believe it is 
inappropriate to allow these services to be furnished by residents 
without the presence of a teaching physician.
    We are amending our regulations to reflect this final policy. In 
Sec.  415.174, we are adding a new paragraph (d) to state that, in 
residency training sites that are located outside of an MSA, a teaching 
physician that meets the requirements of the primary care exception 
described in Sec.  415.174 may meet the requirement to direct the care 
and then to review the services furnished by each resident during or 
immediately after each visit through interactive, audio/video real-time 
communications technology (excluding audio-only) when residents furnish 
services that are included under the primary care exception associated 
with these sites.
    Comment: One commenter requested clarification that office/
outpatient E/M services furnished by residents under the primary care 
exception described in Sec.  415.174 may be billed on the basis of 
time, and also requested confirmation that, under the primary care 
exception, the teaching physician need not be present with the resident 
for the period of time billed.
    Response: In the May 8th COVID-19 IFC, we stated that, consistent 
with policy that we established in the March 31st COVID-19 IFC for 
selecting the level of office/outpatient E/M visits when furnished as 
Medicare telehealth services, (85 FR 19268 through 19269), the office/
outpatient E/M level selection for services under the primary care 
exception when furnished via telehealth can be based on medical 
decision-making or time, with time defined as all of the time 
associated with the E/M on the day of the encounter; and the 
requirements regarding documentation of history and/or physical exam in 
the medical record do not apply. As described in section II.Z. of the 
May 8th COVID-19 IFC, the typical times for purposes of level selection 
for an office/outpatient E/M are the times listed in the CPT code 
descriptor.
vi. Conclusion
    In summary, we reminded stakeholders that during the PHE for COVID-
19 we implemented these policies on an interim basis to support our 
goals of ensuring beneficiary access to necessary services and 
maintenance of sufficient workforce capacity by offering flexibility to 
practitioners. While we anticipated reverting to our previous teaching 
physician policy that was in place prior to the PHE for COVID-19 for 
the reasons discussed above, we considered whether the teaching 
physician and resident moonlighting policies that we implemented on an 
interim basis during the PHE for COVID-19 should be extended on a 
temporary basis (that is, if the PHE ends in 2021, these policies could 
be extended to December 31, 2021, to allow for a transition period 
before reverting to status quo policy) or be made permanent policy for 
CY 2021. As discussed above, we noted concern that the teaching 
physician may not be able to maintain sufficient personal involvement 
in all of the care to warrant PFS payment for the services being 
furnished by up to four residents when some or all of the residents 
might be furnishing services that are more than lower or mid-level 
complexity. We also noted concern that when the teaching physician is 
directing the care of a patient that requires moderate or higher 
medical decision-making, their ability to be immediately available to 
other residents could be compromised, which can potentially put 
patients at risk. We noted that we would consider under which scenarios 
our policies for moonlighting or virtual presence as discussed above, 
should apply, if any. As discussed for our moonlighting policy, we 
expressed concern that there may be risks to program integrity in 
allowing residents to furnish separately billable physicians' services 
to inpatients in the teaching hospitals where they are training when 
the services are outside the scope of their approved GME program. For 
example, there could be a risk of duplicate Medicare payment for the 
resident's services under the IPPS for GME and the PFS if the 
physicians' services furnished by residents were not adequately 
separately identified from those services that are required as part of 
the GME program. Under our discussion of virtual presence, we 
highlighted concerns about how continuing to permit teaching physicians 
to be involved through their virtual presence may not be sufficient to 
warrant PFS payment to the teaching physician on a temporary or 
permanent basis. Absent the circumstances of the PHE for COVID-19, the 
physical, in-person presence of the teaching physician may be necessary 
to provide oversight to ensure that care furnished to Medicare 
beneficiaries is medically reasonable and necessary, and to ensure that 
the teaching physician renders sufficient personal services to exercise 
full, personal control of the key portion of the case. We also 
discussed concerns about patient safety when the teaching physician is 
only virtually present.
    We noted that public comments, especially those that focused on the 
variables we identified regarding the specific services included on the 
primary care exception list, and clinical scenarios under which 
residents could moonlight or furnish certain types of services under 
the supervision of a teaching physician via virtual presence, would 
assist us in identifying the appropriate policy continuation decisions 
after the end of the PHE for COVID-19, which we would consider while 
drafting this CY 2021 PFS final rule. As part of our review of public 
comments, we would weigh and make decisions based on the potential 
benefits and risks associated with the potential temporary or permanent 
continuation, in whole or in part, of these policies. We noted that the 
benefits of continuation may include limiting COVID-19 exposure risk 
for practitioners and patients, increasing workforce capacity of 
teaching settings to respond to continuing effects following the PHE 
for COVID-19 as practitioners may be asked to assist with the response, 
and increasing access so that we do not unintentionally limit the 
number of licensed practitioners available to furnish services to 
Medicare beneficiaries. We noted that the risks may include the 
potential for duplicative payment with Medicare Part A reimbursement 
for GME training programs, the potential for increases to cost-sharing 
for Medicare beneficiaries that could result from additional Part B 
claims for services furnished by the teaching physician with the 
involvement of residents, and potential threats to patient safety.
    Comment: Commenters were generally supportive of the teaching 
physician and resident moonlighting policies that we implemented on an 
interim basis during the PHE for COVID-19. Several commenters 
recommended that we finalize our policies and asserted that making 
these policies permanent would promote patient access to physicians' 
services, particularly in rural and underserved areas and could provide 
additional training opportunities for rural training programs. Other 
commenters recommended that we extend the policies on a temporary 
basis, to provide flexibility for communities that may experience 
resurgences in COVID-19 infections. In addition, these commenters cited 
a need to gather data regarding patient safety and potential

[[Page 84590]]

impacts on resident training outside the context of the PHE before 
considering permanent implementation of the polices.
    Response: We appreciate commenters' support of the teaching 
physician and resident moonlighting policies that we implemented on an 
interim basis during the PHE for COVID-19. As we reviewed these 
comments, we considered the benefits and risks of finalizing the 
proposals. After considering the comments, we are finalizing our 
virtual presence and primary care exception policies for residency 
training sites that are located outside of an MSA. We are finalizing 
our resident moonlighting policies for all inpatient teaching settings.
    We found compelling the comments regarding the benefits of the 
virtual presence and primary care exception policies in rural settings. 
Accordingly, we believe that permitting the teaching physician to meet 
the requirements to bill under the PFS for their services through 
virtual presence when furnishing services involving residents in rural 
training settings, and allowing PFS payment for additional primary care 
services furnished by residents without the physical presence of a 
teaching physician in rural areas could increase access to Medicare-
covered services by preventing the beneficiary from potentially having 
to travel long distances to obtain care, particularly as rural areas 
have stretched and diminishing clinical workforces.\18\ Increasing 
beneficiary access to care in rural areas is also consistent with our 
longstanding interest in increasing beneficiary access to Medicare-
covered services in rural areas.\19\ Further, these policies could 
provide the benefit of additional training opportunities for residents 
in rural settings, which have historically been in limited supply.\20\ 
As such, the need to improve rural access to care for patients and 
training for residents overshadows our aforementioned concerns about 
the teaching physician's ability to render sufficient personal and 
identifiable physicians' services through virtual presence, or to 
maintain sufficient personal involvement in all of the care to warrant 
PFS payment for the services being furnished by up to four residents 
when some or all of the residents might be furnishing services that are 
more than lower and mid-level complexity. Accordingly, we believe it 
would be appropriate to continue these policies in rural settings after 
the conclusion of the PHE for COVID-19. These policies not only further 
our goal to increase beneficiary access to Medicare-covered services, 
they also facilitate needed training opportunities is similar to the 
rationale for the existing primary care exception under Sec.  415.174. 
The primary care exception permits the teaching physician to bill for 
certain types of physicians' services furnished by residents in certain 
settings even when the teaching physician is not present with the 
resident. Like the policies we are finalizing in this rule, the primary 
care exception facilitates access to Medicare-covered services and 
expanded residency training opportunities in primary care settings. 
Therefore, we are finalizing our virtual presence and primary care 
exception policies for residency training sites that are located 
outside of an OMB-defined MSA. In addition, in order to ensure that the 
teaching physician renders sufficient personal and identifiable 
physicians' services to the patient to exercise full, personal control 
over the management of the portion of the case for which the payment is 
sought in accordance with section 1842(b)(7)(A)(i)(I) of the Act, we 
are clarifying existing documentation requirements to specify that the 
patient's medical record must clearly reflect how and when the teaching 
physician was present during the key portion of the service, in 
accordance with our regulations.
---------------------------------------------------------------------------

    \18\ A Guide for Rural Health Care Collaboration and 
Coordination: https://www.hrsa.gov/sites/default/files/hrsa/ruralhealth/reports/HRSA-Rural-Collaboration-Guide.pdf.
    \19\ CMS Rural Health Strategy. https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Rural-Strategy-2018.pdf.
    \20\ HHS awards $20 million to 27 organizations to increase the 
rural workforce through the creation of new rural residency 
programs: https://www.hhs.gov/about/news/2019/07/18/hhs-awards-20-million-to-27-organizations-to-increase-rural-workforce.html.
---------------------------------------------------------------------------

    For our resident moonlighting policies, we believe that complete 
documentation in the medical record would guard against the risk of 
potential duplicative payment with the IPPS. Consequently, we are 
clarifying that, regardless of whether the resident's services are 
performed in the outpatient department, emergency department or 
inpatient setting of a hospital in which they have their training 
program, the patient's medical record must clearly reflect that the 
resident furnished identifiable physician services that meet the 
conditions of payment of physician services to beneficiaries in 
providers in Sec.  415.102(a), that the resident is fully licensed to 
practice medicine, osteopathy, dentistry, or podiatry by the State in 
which the services are performed, and that the services are not 
performed as part of the approved GME program.
    For the virtual presence, primary care exception and resident 
moonlighting policies, while we do not anticipate any program integrity 
concerns, we agree with commenters that it is necessary for us to 
consider additional data prior to proposing additional policies in this 
area, which could range from expanding these flexibilities to include 
non-rural settings to terminating these flexibilities in all settings. 
Specifically, we anticipate considering to what degree the permanent 
establishment of these policies increased patient access to Medicare-
covered services and provided additional training opportunities for 
residents while enabling the teaching physician to render sufficient 
personal and identifiable physicians' services. We may use such 
information, obtained through, for example, a commissioned study, 
analysis of Medicare claims data, or another assessment mechanism, to 
further study the impacts of these policies to inform potential future 
rulemaking, and in an effort to prevent possible fraud, waste and 
abuse.
2. Supervision of Diagnostic Tests by Certain NPPs
    In response to E.O. 13890 discussed above, we sought assistance 
from stakeholders in identifying Medicare regulations that contain more 
restrictive supervision requirements than existing state scope of 
practice laws, or that limit health professionals from practicing at 
the top of their license. In response to our request for feedback 
discussed above, physician assistants (PAs) and nurse practitioners 
(NPs) recommended regulatory changes that would allow them to supervise 
the performance of diagnostic tests because they are currently 
authorized to do so under their state scope of practice rules in many 
states. In the May 8th COVID-19 IFC (85 FR 27550 through 27629), we 
established on an interim basis during the PHE for COVID-19, a policy 
to permit these and certain other NPPs to supervise diagnostic tests. 
In the CY 2021 PFS proposed rule, we proposed to make those changes 
permanent by making modifications to the regulations at Sec.  410.32. 
We noted that we planned to address comments we received on the 
proposals from the CY 2021 PFS proposed rule and comments received on 
the May 8th COVID-19 IFC (85 FR 27550 through 27629) simultaneously in 
this final rule.
    Prior to the PHE for COVID-19, under Sec.  410.32(a)(2), 
physicians, NPs, CNSs, PAs, certified nurse-midwives (CNMs), clinical 
psychologists (CPs), and clinical social workers (CSWs) who are 
treating

[[Page 84591]]

a beneficiary for a specific medical problem may order diagnostic tests 
when they use the results of the tests in the management of the 
beneficiary's specific medical problem. However, generally only 
physicians were permitted to supervise diagnostic tests. The regulation 
at Sec.  410.32(b)(1) provided as a basic general rule that all 
diagnostic tests paid under the PFS must be furnished under an 
appropriate level of supervision by a physician as defined in section 
1861(r) of the Act. Section 410.32(b)(2) then provided for certain 
exceptions to which this basic rule did not apply. For instance, under 
Sec.  410.32(b)(2)(v), the requirement that diagnostic tests must be 
furnished under the appropriate level of supervision by a physician did 
not apply for tests performed by an NP or CNS authorized under 
applicable state law to furnish the test. (We noted that, as for all 
services furnished by a NP or CNS, they would have to be furnished 
working in collaboration with a physician as provided in regulations at 
Sec. Sec.  410.75 and 410.76, respectively). Similarly, under the 
regulation at Sec.  410.32(b)(2)(vii), the requirement that diagnostic 
tests must be furnished under the appropriate level of supervision by a 
physician did not apply for tests performed by a CNM authorized under 
applicable state law to furnish the test. This exception is in place 
because the Medicare statute does not include any physician supervision 
requirement for CNM services. Thus, while NPs, CNSs, PAs, and CNMs were 
permitted to furnish diagnostic tests to the extent they were 
authorized under state law and their scope of practice to do so, the 
regulations at Sec.  410.32 did not address whether these practitioners 
could supervise others who furnished diagnostic tests.
    In light of stakeholder feedback to CMS on identifying additional 
Medicare regulations that contain more restrictive supervision 
requirements than existing state scope of practice laws, or that limit 
health professionals from practicing at the top of their license, 
effective January 1, 2021, we proposed to amend the basic rule under 
the regulation at Sec.  410.32(b)(1) to allow NPs, CNSs, PAs or CNMs to 
supervise diagnostic tests on a permanent basis as allowed by state law 
and scope of practice. These NPPs have separately enumerated benefit 
categories under Medicare law that permit them to furnish services that 
would be physician's services if furnished by a physician, and are 
authorized to receive payment under Medicare Part B for the 
professional services they furnish either directly or ``incident to'' 
their own professional services, to the extent authorized under state 
law and scope of practice.
    We proposed to amend the regulation at Sec.  410.32(b)(2)(iii)(B) 
on a permanent basis to specify that supervision of diagnostic 
psychological and neuropsychological testing services can be done by 
NPs, CNS's, PAs or CNMs to the extent that they are authorized to 
perform the tests under applicable State law and scope of practice, in 
addition to physicians and CPs who are currently authorized to 
supervise these tests. We also proposed to amend on a permanent basis, 
the regulation at Sec.  410.32 to add paragraph (b)(2)(ix) to specify 
that diagnostic tests performed by a PA in accordance with their scope 
of practice and State law do not require the specified level of 
supervision assigned to individual tests, because the relationship of 
PAs with physicians as defined under Sec.  410.74 would continue to 
apply. We also proposed to make permanent the removal of the 
parenthetical, previously made as part of the May 8th COVID-19 IFC (85 
FR 27550 through 27629), at Sec.  410.32(b)(3) that required a general 
level of physician supervision for diagnostic tests performed by a PA.
    We received public comments on whether the policies we adopted on 
an interim basis during the PHE for COVID-19 under Sec.  410.32 should 
continue once the PHE ends. The following is a summary of the comments 
we received and our responses.
    Comment: We received many comments expressing appreciation for the 
flexibilities that we put in place for purposes of the PHE for COVID-
19, allowing NPPs to supervise the performance of diagnostic tests and 
treat patients at the top of their scope of practice. Additionally, 
they encouraged CMS to make this flexibility permanent, beyond the 
COVID-19 pandemic.
    Response: We appreciate the feedback from these commenters and plan 
to finalize these provisions as proposed, with modifications described 
below.
    Comment: We received a comment that certified registered nurse 
anesthetists (CRNAs) should be listed among the delineated NPPs, 
explaining the value of their services within the health care system. 
The commenter noted that in the CY 2013 PFS final rule (77 FR 69006), 
CMS indicated Medicare coverage of CRNA services within their state 
scope of practice. The commenter stated that CRNAs have continuously 
practiced autonomously, and provide every aspect of anesthesia delivery 
as well as acute and chronic pain management services.
    Response: We appreciate the information provided and are adding 
CRNAs to the previously enumerated list of NPPs.
    Comment: Some commenters opposed our proposed change to allow NPPs 
to supervise the performance of psychological and neuropsychological 
tests. These commenters provided information indicating that these 
tests are not within the scope of practice of the proposed NPPs, and 
require special training only available to psychologists and 
physicians.
    Response: We appreciate the information provided by these 
commenters stating that the specified NPPs are not qualified or 
authorized by their scope of practice and State law to supervise the 
performance of this specific category of diagnostic tests. As directed 
under the E.O. to allow NPPs to practice at the top of their license, 
our intent regarding this supervision flexibility is to allow NPPs with 
separate benefit categories under Medicare law to supervise the 
performance of diagnostic tests, regardless of the specific category of 
diagnostic tests, only to the extent their scope of practice and State 
laws authorize them to do so. Accordingly, we believe that the scope of 
practice and State laws for the State in which the specified NPPs 
furnish diagnostic psychological and neuropsychological tests will 
determine whether these NPPs are qualified to supervise the performance 
of diagnostic psychological and neuropsychological tests in addition to 
physicians and clinical psychologists who are already authorized to 
supervise such tests.
    Comment: Some commenters expressed concern about the ability of 
NPPs to supervise diagnostic tests beyond the PHE for COVID-19. They 
opined that such supervision should not extend beyond the PHE for 
COVID-19. These commenters expressed that while NPPs are critical team 
members, it is vital to maintain physician-led teams for quality and 
cost of care. They cited information indicating that NPPs order more 
tests and prescribe opioids more than physicians, that patients prefer 
physicians, and that increasing the supply of NPPs does not increase 
access to care.
    Response: We appreciate the commenters' feedback; however, we did 
not find sufficient evidence to support altering our proposal. 
Accordingly, we are finalizing our policy as proposed on a permanent 
basis and amending regulations text at Sec.  410.32(b) to include CRNAs 
in the group of specified NPPs with a separately enumerated Medicare 
benefit category to who are allowed to supervise the performance of 
diagnostic tests, as permitted within their scope of

[[Page 84592]]

practice and State law for the State in which the test is furnished.
3. Pharmacists Providing Services Incident to Physicians' Services
    Stakeholders have asked us to clarify that pharmacists can provide 
services incident to the professional services of a physician or other 
NPP just as other clinical staff may do. These stakeholders have asked 
us, in particular, about pharmacists who provide medication management 
services. Medication management is covered under both Medicare Part B 
and Part D. We are reiterating the clarification we provided in the May 
8th COVID-19 IFC (85 FR 27550 through 27629), that pharmacists fall 
within the regulatory definition of auxiliary personnel under our 
regulations at Sec.  410.26. As such, pharmacists may provide services 
incident to the services, and under the appropriate level of 
supervision, of the billing physician or NPP, if payment for the 
services is not made under the Medicare Part D benefit. This includes 
providing the services incident to the services of the billing 
physician or NPP and in accordance with the pharmacist's state scope of 
practice and applicable state law.
    We noted that when a pharmacist provides services that are paid 
under the Part D benefit, the services are not also reportable or paid 
for under Part B. In addition to circumstances where medication 
management is offered as part of the Part D benefit, Part B payment is 
also not available for services included in the Medicare Part D 
dispensing fees, such as a pharmacist's time in checking the computer 
for information about an individual's coverage, measurement or mixing 
of the covered Part D drug, filling the container, physically providing 
or delivering the completed prescription to the Part D enrollee. 
Similarly, performing required quality assurance activities consistent 
with Sec.  423.153(c)(2), such as screening for potential drug therapy 
problems due to therapeutic duplication, age/gender-related 
contraindications, potential over-utilization and under-utilization, 
drug-drug interactions, incorrect drug dosage or duration of drug 
therapy, drug-allergy contraindications, and clinical abuse/misuse are 
considered part of dispensing fees under Part D and are not separately 
reportable services under Part B. Additionally, services and supplies 
paid under the incident to benefit must be an integral, though 
incidental, part of the service of a physician (or other practitioner) 
in the course of diagnosis or treatment of an injury or illness (Sec.  
410.26). We also noted that our manual provisions specify that 
``incident to'' services must be of a type that are medically 
appropriate to provide in the office setting; and that where a 
physician supervises auxiliary personnel to assist him or her in 
rendering services to patients and includes the charges for their 
services in his or her own bills, the services of such personnel are 
considered incident to the physicians' service if there is a 
physicians' service rendered to which the services of such personnel 
are an incidental part and there is direct supervision by the physician 
(section 60.1 of chapter 15 of the Medicare Benefit Policy Manual (Pub. 
100-02) available on the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf).
    Although it is fully consistent with current CMS policy for 
pharmacists to provide services incident to the services of the billing 
physician or NPP, we believe this clarification may encourage 
pharmacists to work with physicians and NPPs in new ways where 
pharmacists are working at the top of their training, licensure and 
scope of practice. It may free up the time of physicians and NPPs for 
other work and increase access to medication management services, for 
individuals with chronic conditions and other conditions. As an 
example, we found that this clarification was helpful in recently 
addressing in the May 8th COVID-19 IFC (85 FR 27550 through 27629), the 
ability of pharmacies to enroll as laboratories and work with 
physicians in the assessment of clinical information, specimen 
collection and reporting results of COVID-19 clinical diagnostic 
laboratory tests.
    We received a few public comments on this clarification made in our 
IFC and proposed rule. The following is a summary of the comments we 
received and our responses.
    Comment: We received several comments asking us to allow 
pharmacists to directly bill office/outpatient E/M visit codes (CPT 
codes 99202-99215), or if this is not possible, allow physicians to 
bill these codes for time spent by pharmacists providing services 
incident to a physician's service. One commenter questioned why we 
referred to pharmacists as auxiliary staff or auxiliary personnel, and 
whether the AMA CPT Editorial Panel would agree with this 
classification.
    Response: As mentioned above, the Medicare Part B benefit category 
of services furnished ``incident to'' the professional services of a 
physician, describe services furnished by the staff (or contracted 
staff) of a physician under his or her supervision. Specifically, 
section 1861(s)(2)(A) of the Act describes, services and supplies 
(including drugs and biologicals which are not usually self-
administered by the patient) furnished as an incident to a physician's 
professional service, of kinds which are commonly furnished in 
physicians' offices and are commonly either rendered without charge or 
included in the physicians' bills.'' Our regulation that implements 
section 1861(s)(2)(A) of the Act similarly describes these services in 
Sec.  410.26(b) where we specify, among other things, that ``incident 
to'' services and supplies must be an integral, though incidental, part 
of the service of a physician (or other practitioner) in the course of 
diagnosis or treatment of an injury or illness. In the regulation at 
Sec.  410.26(a), we have long used the term ``auxiliary personnel'' to 
describe the individuals who may provide services incident to the 
professional services of a physician or practitioner who is authorized 
by law to bill Medicare for their services. The regulation defines the 
term as any individual who is acting under the supervision of a 
physician (or other practitioner), regardless of whether the individual 
is an employee, leased employee, or independent contractor of the 
physician (or other practitioner) or of the same entity that employs or 
contracts with the physician (or other practitioner) and meets other 
stated rules, including licensure rules imposed by the State in which 
the services are being furnished. This Medicare Part B framework 
applies to any individual working with the billing physician or other 
practitioner to provide services on an ``incident to'' basis, for 
example, a physician assistant, medical assistant, nurse, pharmacist, 
administrative assistant or others, whether they have a clinical role 
or not. The Medicare term ``auxiliary personnel'' could include staff 
that have clinical roles and staff that do not.
    The CPT codebook that delineates a common system of codes for use 
by all payers, describes individuals who perform or report a given 
service using different terms, ``physician or qualified health care 
professional'' (QHP) and ``clinical staff.'' The CPT codebook defines 
these terms as follows, ``A `physician or other qualified health care 
professional' as an individual who is qualified by education, training, 
licensure/regulation (when applicable), and facility privileging (when 
applicable) who performs a professional service within his or her scope 
of practice and independently reports that

[[Page 84593]]

professional service. These professionals are distinct from `clinical 
staff.' A clinical staff member is a person who works under the 
supervision of physician or other qualified healthcare professional, 
and who is allowed by law, regulation, and facility policy to perform 
or assist in the performance of a professional service, but does not 
individually report that professional service. Other policies may also 
affect who may report specific services.'' \21\ Under the PFS, we 
sometimes use the term ``clinical staff'' to describe specially 
qualified auxiliary personnel who perform services specifically 
comprised of ``clinical staff'' time (such as chronic care management 
services by clinical staff), even though our regulations refers to them 
as ``auxiliary personnel.'' Under the PFS, ``clinical staff'' is a 
subset of ``auxiliary personnel.''
---------------------------------------------------------------------------

    \21\ CPT 2021 Professional Edition, p. xiv.
---------------------------------------------------------------------------

    As commenters noted, pharmacists could be considered QHPs by some 
other payers who provide for their direct payment. We do not consider 
them such because there is no Medicare statutory benefit allowing them 
to enroll, bill and receive direct payment for PFS services. As such, 
pharmacists are not among the physicians and QHPs that can furnish and 
bill for the 2021 office/outpatient E/M visit codes, because levels two 
through five are by definition only performed and directly reported by 
physicians or QHPs.\22\ For example, when time is used to select visit 
level, only the time of the physician or QHP is counted. By definition, 
these codes cannot be furnished and billed as ``incident to'' services; 
therefore, they cannot be used to report services consisting of time 
spent solely by a pharmacist working ``incident to'' the services of a 
billing physician. We also note that services furnished directly by 
pharmacists are listed in a separate section of the CPT Codebook that 
includes codes describing Medication Therapy Management Services.\23\
---------------------------------------------------------------------------

    \22\ CPT 2021 Professional Edition, pp.14-17.
    \23\ CPT 2021 Professional Edition, p.818.
---------------------------------------------------------------------------

    In summary, we agree with certain stakeholders that under the 
general CPT framework, pharmacists could be considered QHPs or clinical 
staff, depending on their role in a given service. However, under the 
current Medicare law which includes the PFS, we do not have ability to 
pay (or even price) services that are furnished and billed directly by 
pharmacists. Regarding office/outpatient E/M visit levels 2 through 5 
in particular, because CPT does not define these codes as clinical 
staff codes and instead designed them to be directly furnished and 
reported by physicians and other QHPs, they cannot be used to bill the 
PFS for services performed by a pharmacist on an ``incident to'' basis. 
We understand and appreciate the expanding, beneficial roles certain 
pharmacists play, particularly by specially trained pharmacists with 
broadened scopes of practice in certain states, commonly referred to as 
collaborative practice agreements. We note that new coding might be 
useful to specifically identify these particular models of care.
4. Provision of Maintenance Therapy by Therapy Assistants
a. Finalization of the Interim Final Rule Related to Provision of 
Maintenance Therapy by Therapy Assistants During the PHE for COVID-19
    As a means of increasing the availability of needed health care 
services during the PHE for COVID-19, we amended our therapy policy on 
an interim basis in the May 8th COVID-19 IFC (85 FR 27550 through 
27629) to allow physical therapists (PT) and occupational therapists 
(OT) that have established a therapy maintenance program for a patient 
to assign a PTA or OTA to furnish the maintenance therapy services when 
clinically appropriate. We indicated as part of the CY 2021 PFS 
proposed rule that we would respond to comments we received in response 
to our amended policy for the provision of maintenance therapy 
services.
    Comment: We received several comments, all of which expressed 
support for allowing therapy assistants to furnish maintenance therapy 
when delegated by a therapist, including one commenter that requested 
the CMS make the change permanent.
    Response: We appreciate the commenters' support for our adopted 
interim policy to allow therapy assistants to furnish maintenance 
therapy services.
    After considering comments, we are finalizing our interim policy 
from the May 8th COVID-19 IFC to allow physical and occupational 
therapists to delegate maintenance therapy services to therapy 
assistants as clinically appropriate through the end of the PHE for 
COVID-19.
b. Summary of Proposals and Public Comments Related to Provision of 
Maintenance Therapy by Therapy Assistants
    In response to our request for feedback on scope of practice (noted 
above), consistent with E.O. 13890 (84 FR 53573 through 53576), 
respondents requested that we allow physical therapy assistants (PTAs) 
and occupational therapy assistants (OTAs) to furnish maintenance 
therapy services associated with a maintenance therapy program. 
Respondents commented that our Part B therapy policy was not consistent 
with policies for these services when provided to patients in skilled 
nursing facilities (SNF) and home health (HH) settings paid under Part 
A. Respondents also wrote that because a therapist is responsible for a 
patient's care over an episode, that this should allow the therapist to 
assign responsibility for maintenance therapy to an assistant when it 
is clinically appropriate. Some respondents stated that permitting PTAs 
and OTAs to furnish maintenance therapy services would give Medicare 
patients greater access to care and give therapists more flexibility in 
allocating therapy resources.
    After considering respondents' concerns about the incongruity 
between our Part B and Part A maintenance therapy policies and as a 
means of increasing availability of needed health care services during 
the PHE for COVID-19, we amended our policy on an interim final basis 
in the May 8th COVID-19 IFC (85 FR 27550 through 27629) to allow the 
physical therapist (PT) or occupational therapist (OT) who establishes 
a maintenance program to assign a PTA or OTA to furnish maintenance 
therapy services when clinically appropriate.
    We explained that making this change could free-up the PT or OT to 
furnish other services, particularly services related to the PHE for 
COVID-19 that require a therapist's assessment and intervention skills. 
We stated explicitly that the maintenance therapy services furnished by 
therapist-supervised OTAs and PTAs will be paid in the same manner as 
those we already pay for as rehabilitative therapy services. We 
referred readers to regulatory payment conditions for Part B outpatient 
occupational and physical therapy services (Sec. Sec.  410.59 and 
410.60, respectively) that require, as a basic rule, that the services 
be provided by an individual meeting qualifications in 42 CFR part 484 
for an OT or PT, or an appropriately supervised OTA or PTA.
    In the CY 2021 PFS proposed rule, we proposed to make permanent our 
Part B policy for maintenance therapy services effective January 1, 
2021 in order to create greater conformity in payment policy for 
maintenance therapy services that are furnished and paid under Part B 
with those in SNF and HH settings under Part A. We noted that if 
finalized, our policy would dovetail with our

[[Page 84594]]

amended policy set forth in the May 8th COVID-19 IFC (85 FR 27550 
through 27629) that grants PTs and OTs the discretion to delegate 
maintenance therapy services to the PTAs and OTAs, as clinically 
appropriate, for the duration of the PHE for COVID-19. If the PHE for 
COVID-19 were to end prior to January 1, 2021, the therapist would need 
to personally furnish the maintenance therapy services until the 
finalized policy change took effect. We also noted that we planned to 
address comments from the May 8th COVID-19 IFC in conjunction with the 
comments from the CY 2021 PFS proposed rule in the CY 2021 PFS final 
rule.
    Our policy for maintenance therapy services is explained in section 
220.2 of chapter 15 of the Medicare Benefit Policy Manual (see https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf). Maintenance programs that can be carried out by a 
patient alone or with the assistance of caregivers are not covered. 
Also, sections 230.1 and 230.2 of chapter 15 of the Medicare Benefit 
Policy Manual specify that a PTA or OTA may not provide skilled 
maintenance program services.
    In considering this proposal, we reviewed regulatory requirements 
for conditions of payment for outpatient occupational therapy, physical 
therapy, and speech-language pathology services at Sec. Sec.  410.59, 
410.60, and 410.62; the regulation for therapy treatment plans at Sec.  
410.61; and the regulations specifying treatment plan certification and 
recertification requirements at Sec.  424.24 for Part B occupational 
therapy, physical therapy, and speech-language pathology services along 
with the above mentioned manual provisions.
    Given that we already make payment for rehabilitative services 
requiring improvement in the patient's functional status when they are 
furnished by PTAs and OTAs at the discretion of the supervising 
therapist treating the patient in accordance with the therapist-
established plan of care, we noted that it would be appropriate for the 
therapist to use that same judgment to decide whether to delegate 
maintenance therapy services under the associated plan of care to a PTA 
or OTA. We stated that there is little difference between the 
rehabilitative therapy services furnished to improve a patient's 
functional status and those for maintenance therapy services other than 
the goals set by the therapist in the therapy plan. We do not believe 
that the therapist-only maintenance therapy requirement is needed in 
the case of outpatient physical or occupational therapy services. 
Instead, we believe that it would be appropriate for an OT or PT to use 
their professional judgment to assign the performance of maintenance 
therapy services to an OTA or PTA when it is clinically appropriate to 
do so.
    As such, we proposed to allow, on a permanent basis, therapists to 
delegate performance of maintenance therapy services to an OTA or PTA 
for outpatient occupational and physical therapy services in Part B 
settings beginning January 1, 2021. This proposal would better align 
our Part B policy with that in SNFs and HH paid under Part A where 
maintenance therapy services may be performed by a therapist or a 
therapy assistant. Since our regulations at Sec. Sec.  410.59, 410.60, 
410.61, 410.62, and 424.24, do not distinguish between rehabilitative 
and maintenance therapy services, we did not propose to amend them. 
Instead, we proposed to revise sections 220.2, 230.1 and 230.2 of 
chapter 15 of the Medicare Benefit Policy Manual to clarify that PTs 
and OTs no longer need to personally perform maintenance therapy 
services and to specifically remove the prohibitions on PTAs and OTAs 
from furnishing such services. We noted that we believe the proposal to 
allow PTs and OTs to delegate maintenance therapy services to their 
supervised assistants is in keeping with E.O. 13890 and appeals by 
respondents to our request for feedback on scope of practice that 
followed, rather than the alternative option of maintaining the pre-
COVID-19 policy of requiring PTs and OTs to personally furnish them, 
after the PHE for COVID-19 has ended.
    We noted also that therapists and therapy providers should consult 
the CQ and CO modifier policies to consider whether these modifiers 
should be applied to claims for services furnished in whole or in part 
by PTAs and OTAs which will, beginning January 1, 2022, be paid at 85 
percent of the amount that would otherwise apply for the service, as 
required by section 1834(v) of the Act, which was added to section 
53107 of the Bipartisan Budget Act of 2018. See the CY 2020 PFS 
rulemaking for policies related to the application of CQ and CO 
modifiers and the associated regulatory requirements (84 FR 40558 
through 40564 (proposed rule) and 84 FR 62702 through 60708 (final 
rule)).
    We received public comments on the provision of maintenance therapy 
to be furnished by therapy assistants. The following is a summary of 
the comments we received and our responses.
    Comment: Commenters expressed uniform support for our proposal to 
allow therapy assistants to furnish maintenance therapy services. 
Commenters indicated that having Part B policy align with current Part 
A policy for Home Health and SNF settings will promote consistency as 
well as continuity of care across Medicare programs.
    Response: We appreciate the commenters' support for our proposal to 
allow therapy assistants to furnish maintenance therapy services. After 
considering comments, we are finalizing our proposal to allow physical 
and occupational therapists to delegate maintenance therapy services to 
therapy assistants on a permanent basis as clinically appropriate.
5. Medical Record Documentation
a. Finalization of Interim Final Rule With Comment Period Provisions 
Related to Therapy Student Documentation During the PHE for the COVID-
19 Pandemic
    In the May 8th COVID-19 IFC (85 FR 27556 through 27557), to 
increase the availability of clinicians who may furnish healthcare 
services during the PHE, we announced a general policy that there is 
broad flexibility for all members of the medical team to add 
documentation in the medical record which is then reviewed and verified 
(signed) by the appropriate clinician. Specifically, we stated on an 
interim basis during the PHE for COVID-19, any individual who has a 
separately enumerated benefit under Medicare law that authorizes them 
to furnish and bill for their professional services, whether or not 
they are acting in a teaching role, may review and verify (sign and 
date), rather than re-document, notes in the medical record made by 
physicians, residents, nurses, and students (including students in 
therapy or other clinical disciplines), or other members of the medical 
team. We noted that although there are currently no statutory or 
regulatory documentation requirements that would impact payment for 
therapists when documentation is added to the medical record by persons 
other than the therapist, we discussed this issue in response to 
stakeholder concerns about burden and in consideration of the current 
PHE for COVID-19. Specifically, this policy will ensure that 
therapists, as members of the clinical workforce, are able to spend 
more time furnishing therapy services, including pain management 
therapies to patients that may minimize the use of opioids and other 
medications, rather than spending time documenting in the medical 
record. We emphasized that our established principle is focused on the

[[Page 84595]]

clinician, as described above who furnishes and bills for their 
professional services rather than the individuals who may enter 
information into the medical record. We emphasized that information 
entered into the medical record should document that the furnished 
services are reasonable and necessary.
    We received public comments on Therapy Student Documentation. The 
following is a summary of the comments we received and our responses.
    Comment: One commenter recommended that CMS make the therapy 
student documentation waiver under the PHE for COVID-19 permanent so 
that it aligns with the flexibility extended to physicians and several 
NPPs as promulgated in the CY 2020 PFS final rule.
    Response: We appreciate the commenter's support of this provision 
for student documentation and making permanent the broad flexibility 
for all members of the medical team to add documentation in the medical 
record which is then reviewed and verified (signed) by the appropriate 
clinician.
    Comment: One commenter supported these changes which will give more 
flexibility to practitioners and other providing clinically appropriate 
therapy services but asked that CMS clarify who would be considered 
other members of the ``treatment team'' in addition to those enumerated 
(that is, physicians, residents, nurses, and students)--in particular, 
whether this would encompass non-licensed member.
    Response: We appreciate the commenters request for clarification. 
Any individual who is authorized under Medicare law to furnish and bill 
for their professional services, whether or not they are acting in a 
teaching role, may review and verify (sign and date) the medical record 
for the services they bill, rather than re-document, notes in the 
medical record made by physicians, residents, nurses, and students 
(including students in therapy or other clinical disciplines), or other 
members of the medical team), or other members of the medical team.
    Comment: One commenter agreed with CMS that these measures should 
be temporary, and should not persist once the PHE for COVID-19 has 
ended. The commenter stated that training-appropriate scope of practice 
standards are important to ensuring quality of care for our members.
    Response: We appreciate the commenter's feedback. We are discussing 
this issue in response to stakeholder concerns about burden and in 
consideration of the current PHE for COVID-19. Specifically, this 
policy will ensure that therapists, as members of the clinical 
workforce, are able to spend more time furnishing therapy services, 
including pain management therapies to patients that may minimize the 
use of opioids and other medications, rather than spending time 
documenting in the medical record. The provision related to therapy 
student documentation was to increase the availability of clinicians 
who may furnish healthcare services during the PHE for COVID-19 and on 
an interim basis during the PHE for COVID-19.
    In summary, we reiterate that our clarification about this policy 
as discussed in the May 8th COVID-19 IFC (85 FR 27556 through 27557) 
notes that any individual who has a separately enumerated benefit under 
Medicare law that authorizes them to furnish and bill for their 
professional services, whether or not they are acting in a teaching 
role, may review and verify (sign and date), rather than re-document, 
notes in the medical record made by physicians, residents, nurses, and 
students (including students in therapy or other clinical disciplines), 
or other members of the medical team. We emphasized that our 
established principle is focused on the clinician, as described above 
who furnishes and bills for their professional services rather than the 
individuals who may enter information into the medical record. We 
emphasized that information entered into the medical record should 
document that the furnished services are reasonable and necessary.
b. Medical Record Documentation Clarification
    As we established in the CY 2020 PFS final rule (84 FR 62681 
through 62684), and similarly expressed in the May 8th COVID-19 IFC (85 
FR 27556 through 27557), any individual who is authorized under 
Medicare law to furnish and bill for their professional services, 
whether or not they are acting in a teaching role, may review and 
verify (sign and date) the medical record for the services they bill, 
rather than re-document, notes in the medical record made by 
physicians, residents, nurses, and students (including students in 
therapy or other clinical disciplines), or other members of the medical 
team. We noted that although there are currently no documentation 
requirements that would impact payment for PTs, OTs, or SLPs when 
documentation is added to the medical record by persons other than the 
therapist, we are responding in this proposed rule to stakeholder 
requests for clarification. Specifically, we clarified that the broad 
policy principle that allows billing clinicians to review and verify 
documentation added to the medical record for their services by other 
members of the medical team also applies to therapists. We noted that 
this would help ensure that therapists are able to spend more time 
furnishing therapy services, including pain management therapies to 
patients that may minimize the use of opioids and other medications, 
rather than spending time documenting in the medical record. We 
emphasized that, while any member of the medical team may enter 
information into the medical record, only the reporting clinician may 
review and verify notes made in the record by others for the services 
the reporting clinician furnishes and bills. We also emphasized that 
information entered into the medical record should document that the 
furnished services are reasonable and necessary.
    We received public comments on the medical record documentation 
clarification. The following is a summary of the comments we received 
and our responses.
    Comment: Many commenters were in support of and commended CMS for 
including therapists in the list of practitioners who may review and 
verify documentation instead of having to re-document notes made by 
students for Medicare Part B patients and stated that this is a 
significant burden reduction that will allow for better use of 
therapists' time.
    Two commenters appreciated this medical record documentation 
flexibility so long as the provision falls within existing scope of 
practice laws and only reduces the burden of re-documenting. The 
commenter noted that administrative burden is a major reason for 
physician burnout and by alleviating this burden and allowing others to 
share in the administrative process, physicians will spend less time 
documenting and perhaps have a decrease in burnout. Another commenter 
noted in rural areas, there are shortages of therapy and mental health 
professionals and that documentation and paperwork take time away from 
patients who need help.
    A few commenters noted that this flexibility would better prepare 
clinicians to enter practice by increasing safety and education on how 
to document effectively and appropriately the skilled services they 
provide. One commenter questioned how this flexibility may impact 
documentation requirements pertaining to completion of the progress 
report and Medicare's billing rules in relation to therapy students. 
Another commenter requested licensed audiologists be added to the group 
that can review and verify (sign and date) the documentation entered 
into the medical record by members of

[[Page 84596]]

their medical team for their own, appropriately supervised services 
that are paid under the PFS.
    One commenter requested that CMS issue guidance to clarify that it 
is possible that no additional documentation is required if the 
entirety of the documentation could be included from members of the 
medical team, thus allowing the billing practitioner to ``sign and 
verify'' the entire note.
    Response: We appreciate commenters' support of this clarification 
to allow therapists to review and verify student documentation instead 
of therapists having to re-document notes made by students. We 
appreciate the insight provided by commenters about how the broad 
flexibility would aide in burden reduction and allow for better use of 
time by therapists.
    This clarification similarly aligns with what was finalized in the 
CY 2020 PFS final rule which provided broad flexibility to the 
physicians, PAs and APRNs (regardless of whether they are acting in a 
teaching capacity) who document and who are paid under the PFS for 
their professional services. We explained that this principle would 
apply across the spectrum of all Medicare-covered services paid under 
the PFS. We emphasize that, while any member of the medical team may 
enter information into the medical record, only the billing clinician 
may review and verify notes made in the record by others for the 
services the reporting clinician furnishes and bills. As we emphasized 
in our proposal, information entered into the medical record should 
document that the services furnished are reasonable and necessary if 
the billing practitioner has signed and verified complete medical 
record documentation by other members of the medical team.
    Comment: One commenter supported the CMS policy to provide added 
flexibility for NPPs authorized to deliver part B services including 
nurse practitioners, CNSs and PAs to document teaching physician 
involvement and another commenter noted they believe that the 
additional flexibility will significantly reduce burden for teaching 
physicians.
    Response: We appreciate the support of this flexibility for NPPs to 
document teaching physician involvement. We would like to reiterate 
that this flexibility does not negate the teaching physician rules, or 
the need to document personal services or split share rules, or other 
aspects of the service provided.
    Comment: One commenter urged CMS not to expand payment for 
independent NPPs and pressure inappropriate scope-of-practice expansion 
through these proposed rules. The commenter encouraged all advanced 
nurse practitioners and physician assistants to work within their 
respective licensed scope of practice in a team approach to expand 
access and ensure quality of care. Another commenter expressed concern 
that based on the language proposed by CMS, this policy might allow 
therapists to change or modify a physician's documentation, including 
their diagnostic evaluation and treatment plan.
    Response: We appreciate the commenters concerns and want to 
emphasize that this medical record documentation clarification only 
applies to the clinician who is billing for their professional service. 
The intent of this clarification is to reduce burden and allow the 
billing practitioner to review and verify the documentation in the 
medical record instead of re-documenting information entered by 
students and other members of the medical team. The billing 
practitioner needs to ensure, as we reiterated in our clarification, 
that, while any member of the medical team may enter information into 
the medical record, they review and verify that the information in the 
medical record is accurate and complete for the services the reporting 
clinician furnishes and bills.
    After considering the comments received, we note that we are 
reiterating what we finalized in the CY 2020 PFS final rule, that any 
individual who is authorized under Medicare law to furnish and bill for 
their professional services, whether or not they are acting in a 
teaching role, may review and verify (sign and date) the medical record 
for the services they bill, rather than re-document, notes in the 
medical record made by physicians, residents, nurses, and students 
(including students in therapy or other clinical disciplines), or other 
members of the medical team. We emphasize that, while any member of the 
medical team may enter information into the medical record, only the 
reporting clinician may review and verify notes made in the record by 
others for the services the reporting clinician furnishes and bills. We 
want to emphasize that information entered into the medical record must 
document that the furnished services are reasonable and necessary.

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.C. of this proposed rule, Potentially Misvalued Services under the 
PFS. 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 (79 FR 67547), 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 (81 FR 46162), 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

[[Page 84597]]

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 
(81 FR 80170), we reviewed the comments received during the 60-day 
public comment period following release of the CY 2016 PFS final rule 
with comment period (80 FR 70886), 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.
    As part of our obligation to establish RVUs for the PFS, we 
thoroughly review and consider available information including 
recommendations and supporting information 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. 
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 proposed 
those values as recommended. Additionally, we continually 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 conduct a review that 
includes 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 include, but have 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 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. 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 use in the building block approach may include 
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 use 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 utilize 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 refine 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 a service is typically furnished to a beneficiary on the same day 
as an 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 believe that the RUC has not 
adequately accounted for the overlapping activities in the recommended 
work RVU and/or times, we adjust 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 remove 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 remove a work RVU of 
0.09 (4 minutes x 0.0224 IWPUT) if we do 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

[[Page 84598]]

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 use 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 believe that such changes in time are 
already accounted for in the RUC's recommendation, then we do not make 
such adjustments. Likewise, we do not arbitrarily apply time ratios to 
current work RVUs to calculate proposed work RVUs. We use the ratios to 
identify potential work RVUs and consider 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 believe 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 
(81 FR 46162), 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 are 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 received several comments regarding our methodologies for work 
valuation in response to the CY 2021 PFS proposed rule and those 
comments are summarized below.
    Comment: Several commenters disagreed with our reference to older 
work time sources, and stated that their use led to the proposal of 
work RVUs based on flawed assumptions. Commenters stated that codes 
with ``CMS/Other'' or ``Harvard'' work time sources, used in the 
original valuation of certain older services, were not surveyed, and 
therefore, were not resource-based. Commenters also stated that it was 
invalid to draw comparisons between the current work times and work 
RVUs of these services to the newly surveyed work time and work RVUs as 
recommended by the RUC.
    Response: We agree that it is important to use the recent data 
available regarding work times, and we note that when many years have 
passed between when time is measured, significant discrepancies can 
occur. However, we also believe that our operating assumption regarding 
the validity of the existing values as a point of comparison is 
critical to the integrity of the relative value system as currently 
constructed. The work times currently associated with codes play a very 
important role in PFS ratesetting, both as points of comparison in 
establishing work RVUs and in the allocation of indirect PE RVUs by 
specialty. If we were to operate under the assumption that previously 
recommended work times had routinely been overestimated, this would 
undermine the relativity of the work RVUs on the PFS in general, given 
the process under which codes are often valued by comparisons to codes 
with similar times. It also would undermine the validity of the 
allocation of indirect PE RVUs to physician specialties across the PFS.
    Instead, we believe that it is crucial that the code valuation 
process take place with the understanding that the existing work times 
used in the PFS ratesetting processes are accurate. We recognize that 
adjusting work RVUs for changes in time is not always a straightforward 
process and that the intensity associated with changes in time is not 
necessarily always linear, which is why we apply various methodologies 
to identify several potential work values for individual codes. 
However, we reiterate that we believe it would be irresponsible to 
ignore changes in time based on the best data available, and that we 
are statutorily obligated to consider both time and intensity in 
establishing work RVUs for PFS services. For additional

[[Page 84599]]

information regarding the use of old work time values that were 
established many years ago and have not since been reviewed in our 
methodology, we refer readers to our discussion of the subject in the 
CY 2017 PFS final rule (81 FR 80273 through 80274).
    Comment: Several commenters disagreed with the use of time ratio 
methodologies for work valuation. Commenters stated that this use of 
time ratios is not a valid methodology for valuation of physician 
services. Commenters stated that treating all components of physician 
time (preservice, intraservice, postservice and post-operative visits) 
as having identical intensity is incorrect, and inconsistently applying 
it to only certain services under review creates inherent payment 
disparities in a payment system, which is based on relative valuation. 
Commenters stated that in many scenarios, CMS selects an arbitrary 
combination of inputs to apply rather than seeking a valid clinically 
relevant relationship that would preserve relativity. Commenters 
suggested that CMS determine the work valuation for each code based not 
only on surveyed work times, but also the intensity and complexity of 
the service and relativity to other similar services, rather than 
basing the work value entirely on time.
    Response: We disagree and continue to believe that the use of time 
ratios is one of several appropriate methods for identifying potential 
work RVUs for particular PFS services, particularly when the 
alternative values recommended by the RUC and other commenters do not 
account for information provided by surveys that suggests the amount of 
time involved in furnishing the service has changed significantly. We 
reiterate that, consistent with the statute, we are required to value 
the work RVU based on the relative resources involved in furnishing the 
service, which include time and intensity. When our review of 
recommended values reveals that changes in time have been unaccounted 
for in a recommended RVU, then we believe we have the obligation to 
account for that change in establishing work RVUs since the statute 
explicitly identifies time as one of the two elements of the work RVUs.
    We recognize that it would not be appropriate to develop work RVUs 
solely based on time given that intensity is also an element of work, 
but in applying the time ratios, we are using derived intensity 
measures based on current work RVUs for individual procedures. We 
clarify again that we do not treat all components of physician time as 
having identical intensity. If we were to disregard intensity 
altogether, the work RVUs for all services would be developed based 
solely on time values and that is definitively not the case, as 
indicated by the many services that share the same time values but have 
different work RVUs. For example, among the codes reviewed in this 
current CY 2021 PFS final rule, CPT codes 10006 (Fine needle aspiration 
biopsy, including ultrasound guidance; each additional lesion) and 
57465 (Computer-aided mapping of cervix uteri during colposcopy, 
including optical dynamic spectral imaging and algorithmic 
quantification of the acetowhitening effect), 76513 (Ophthalmic 
ultrasound, diagnostic; anterior segment ultrasound, immersion (water 
bath) B-scan or high resolution biomicroscopy, unilateral or 
bilateral), 93224 (External electrocardiographic recording up to 48 
hours by continuous rhythm recording and storage; includes recording, 
scanning analysis with report, review and interpretation by a physician 
or other qualified health care professional) and 99439 (Prolonged 
office or other outpatient evaluation and management service(s) (beyond 
the total time of the primary procedure which has been selected using 
total time), requiring total time with or without direct patient 
contact beyond the usual service, on the date of the primary service; 
each 15 minutes) share the identical total work time of 15 minutes. 
However, these codes have very different proposed work RVUs of 1.00 and 
0.81 and 0.53 and 0.39 and 0.61 respectively. In addition, CPT codes 
10010 (Fine needle aspiration biopsy, including CT guidance; each 
additional lesion) and 93662 (Intracardiac echocardiography during 
therapeutic/diagnostic intervention, including imaging supervision and 
interpretation) both share the same intraservice and total work time of 
25 minutes but each code has a different work RVU. These examples 
demonstrate that we do not value services purely based on work time; 
instead, we incorporate time as one of multiple different factors 
employed in our review process. Furthermore, we reiterate that we use 
time ratios to identify potentially appropriate work RVUs, and then use 
other methods (including estimates of work from CMS medical personnel 
and crosswalks to key reference or similar codes) to validate these 
RVUs. For more details on our methodology for developing work RVUs, we 
direct readers to the discussion CY 2017 PFS final rule (81 FR 80272 
through 80277).
    We also want to clarify for the commenters that our review process 
is not arbitrary in nature. Our reviews of recommended work RVUs and 
time inputs generally include, but have 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 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. 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). With regard to the 
invocation of clinically relevant relationships by the commenters, we 
emphasize that we continue to believe that the nature of the PFS 
relative value system is such that all services are appropriately 
subject to comparisons to one another. Although codes that describe 
clinically similar services are sometimes stronger comparator codes, we 
do not agree that codes must share the same site of service, patient 
population, or utilization level to serve as an appropriate crosswalk.
    Comment: Several commenters discouraged the use of valuation based 
on work RVU increments. Commenters stated that this methodology 
inaccurately treats all components of the physician time as having 
identical intensity and would lead to incorrect work valuations. 
Commenters stated that CMS should carefully consider the clinical 
information justifying the changes in physician work intensity provided 
by the RUC and other stakeholders.
    Response: We believe the use of an incremental difference between 
codes is a valid methodology for setting values, especially in valuing 
services within a family of revised codes where it is important to 
maintain appropriate intra-family relativity. Historically, we have 
frequently utilized an incremental methodology in which we value a code 
based upon its incremental difference between another code or another 
family of codes. We note that the RUC has also

[[Page 84600]]

used the same incremental methodology on occasion when it was unable to 
produce valid survey data for a service. We have no evidence to suggest 
that the use of an incremental difference between codes conflicts with 
the statute's definition of the work component as the resources in time 
and intensity required in furnishing the service. We do consider 
clinical information associated with physician work intensity provided 
by the RUC and other stakeholders as part of our review process, 
although we remind readers again that we do not agree that codes must 
share the same site of service, patient population, or utilization 
level to serve as an appropriate crosswalk.
    Comment: Several commenters stated that they were concerned about 
CMS' lack of consideration for compelling evidence that services have 
changed. Commenters stated that CMS appeared to dismiss the fact that 
services may change due to technological advances, changes in the 
patient population, shifts in the specialty of physicians providing 
services or changes in the physician work or intensity required to 
perform services. Commenters requested that CMS address the compelling 
evidence that was submitted with the RUC recommendations when the 
agency does not accept the RUC recommendation.
    Response: The concept of compelling evidence was developed by the 
RUC as part of its review process for individual codes to justify an 
increase in valuation. The RUC's compelling evidence criteria include 
documented changes in physician work, an anomalous relationship between 
the code and multiple key reference services, evidence that technology 
has changed physician work, analysis of other data on time and effort 
measures, and evidence that incorrect assumptions were made in the 
previous valuation of the service. While we appreciate the submission 
of this additional information for review, we emphasize that compelling 
evidence is a concept developed by the RUC for its own review process. 
Compelling evidence is not part of our statutory framework which 
requires that the valuation of codes should be based on time and 
intensity. We do consider changes in technology, patient population, 
etc. insofar as they affect the time and intensity of the service under 
review. However, we do not specifically address the RUC's compelling 
evidence criteria in our rulemaking since it is outside the purview of 
the code valuation process stipulated by statute.
    In response to comments, in the CY 2019 PFS final rule (83 FR 
59515), we clarified that terms ``reference services'', ``key reference 
services'', and ``crosswalks'' as described by the commenters are part 
of the RUC's process for code valuation. These are not terms that we 
created, and we do not agree that we necessarily must employ them in 
the identical fashion for the purposes of discussing our valuation of 
individual services that come up for review. However, in the interest 
of minimizing confusion and providing clear language to facilitate 
stakeholder feedback, we will seek to limit the use of the term, 
``crosswalk,'' to those cases where we are making a comparison to a CPT 
code with the identical work RVU. We also occasionally make use of a 
``bracket'' for code valuation. A ``bracket'' refers to when a work RVU 
falls between the values of two CPT codes, one at a higher work RVU and 
one at a lower work RVU.
    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 the detailed discussion in this section of the valuation 
considered for specific codes. Table 28 contains a list of codes and 
descriptors for which we proposed work RVUs; this included all codes 
for which we received RUC recommendations by February 10, 2020. As 
noted in the CY 2021 PFS proposed rule, the proposed work RVUs, work 
time and other payment information for all CY 2021 payable codes are 
available on the CMS website under downloads for the CY 2021 PFS final 
rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
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 the RUC-recommended direct PE inputs 
includes many refinements that are common across codes, as well as 
refinements that are specific to particular services. Table 29 details 
our refinements of the RUC's direct PE recommendations at the code-
specific level. In section II.B. of the proposed rule (85 FR 50077), 
Determination of Practice Expense Relative Value Units (PE RVUs), we 
addressed certain refinements that would be common across codes. 
Refinements to particular codes are addressed in the portions of that 
section that are dedicated to particular codes. We noted that for each 
refinement, we indicated the impact on direct costs for that service. 
We noted that, on average, in any case where the impact on the direct 
cost for a particular refinement is $0.35 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 noted that approximately 
half of the refinements listed in Table 29 result in changes under the 
$0.35 threshold and are unlikely to result in a change to the RVUs.
    We also noted that the direct PE inputs for CY 2021 are displayed 
in the CY 2021 direct PE input files, available on the CMS website 
under the downloads for the CY 2021 PFS final rule at http://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 CY 2021 PE RVUs as 
displayed in Addendum B.

[[Page 84601]]

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 noted 
that 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 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 the proposed rule (85 FR 
50077), Determination of Practice Expense Relative Value Units (PE 
RVUs), 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. However, some recommendations 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 2021 we received invoices for several new supply and 
equipment items. Tables 31 and 32 detail the invoices received for new 
and existing items in the direct PE database. As discussed in section 
II.B. of the proposed rule (85 FR 50077), Determination of Practice 
Expense Relative Value Units, we encouraged 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 encouraged stakeholders to submit invoices or other 
information to improve the accuracy of pricing for these items in the 
direct PE database by February 10th of the following year for 
consideration in future rulemaking, similar to our 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 31 and 32 also included 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 did not use the price listed on the invoice that

[[Page 84602]]

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 
final 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 direct PE 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 addressed 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 noted that the public use files for the PFS proposed and final 
rules for each year display the services subject to the MPPR for 
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 
2021 are available on the CMS website under downloads for the CY 2021 
PFS final rule at http://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 through 
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 through 69662).
4. Proposed Valuation of Specific Codes for CY 2021
(1) Fine Needle Aspiration (CPT Codes 10021, 10004, 10005, 10006, 
10007, 10008, 10009, 10010, 10011, and 10012)
    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. In the CY 2019 PFS final rule, we finalized the RUC-
recommended work RVU for seven of the ten codes in the family, while 
finalizing a lower work RVU for CPT codes 10005 (Fine needle aspiration 
biopsy, including ultrasound guidance; first lesion), 10009 (Fine 
needle aspiration biopsy, including CT guidance; first lesion), and 
10021 (Fine needle aspiration biopsy, without imaging guidance; first 
lesion). For a full discussion of this review, we refer readers to the 
CY 2019 PFS final rule (83 FR 59517 through 59521).
    Following the publication of the CY 2019 PFS final rule, RUC staff 
stated that CMS erroneously double-counted the utilization for new 
codes that had image guidance bundled. We disagreed that this 
constituted a technical error and communicated to the RUC in 
conversations following the publication of the rule that the surveying 
specialties could instead nominate the affected codes from these 
families as being potentially misvalued. At the January 2020 RUC 
meeting, the RUC reaffirmed its CY 2019 recommendations for physician 
work and direct PE for the ten codes in the Fine Needle Aspiration code 
family.
    In discussing this group of codes, we would like to clarify again 
that we disagree with the RUC and do not believe that utilization was 
erroneously double-counted for this code family. We publish our 
proposed utilization crosswalk each year as a public use file available 
on the CMS website; the current such file is available under downloads 
for the CY 2021 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. During the CY 2019 rule cycle, we proposed the 
utilization crosswalk for the Fine Needle Aspiration family as it was 
recommended to CMS by the RUC, and we did not receive any comments on 
this subject until after the valuation of these codes had been 
finalized. We proposed and finalized the utilization crosswalk for this 
code family as recommended by the RUC without receiving any comments 
from the RUC or other stakeholders. If the RUC or other stakeholders 
believed that what CMS had proposed was incorrect or misunderstood what 
the RUC had recommended, there was an opportunity to comment during the 
60 days following the publication of the proposed rule. We disagreed 
that the utilization crosswalk was erroneous, and we did not make a 
technical correction following the publication of the CY 2019 PFS final 
rule for this reason.
    We also disagreed with the RUC that the utilization crosswalk was 
``the principle reason CMS rejected the RUC recommendations'' for the 
codes in the Fine Needle Aspiration family, as stated in the RUC's CY 
2021 recommendations for this code family. As we stated in the CY 2019 
PFS proposed rule and restated in the CY 2019 PFS final rule, our 
refinements to the work RVUs of CPT codes 10021, 10005, and 10009 were 
primarily based on changes in surveyed work time and the relationship 
between the codes in the family. For example, this was our rationale 
for refining the work RVU of CPT code 10021 from the RUC-recommended 
value of 1.20 to the finalized value of 1.03: 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. In the case of CPT code 10021, we believed that it was 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 (83 FR 
59518). We noted that this primary rationale for refining the work RVU 
did not mention the utilization crosswalk at all.
    When we communicated to the RUC following the publication of the CY 
2019 PFS final rule that the codes in the Fine Needle Aspiration family 
could be nominated as potentially misvalued, we indicated that we were 
open to receiving new information about the valuation of these codes. 
In reaffirming its recommendations from CY 2019, however, the RUC has 
not provided any

[[Page 84603]]

new information that was not already presented for the previous CMS 
review of these codes. Therefore, we did not propose any changes to the 
codes in the Fine Needle Aspiration family, as the reaffirmed CY 2021 
RUC recommendations are identical to the CY 2019 RUC recommendations 
that already went through notice and comment rulemaking. We welcomed 
the submission of new information regarding these services that was not 
part of the previous CY 2019 review of the code family.
    We received public comments on the Fine Needle Aspiration code 
family. The following is a summary of the comments we received and our 
responses.
    Comment: Several commenters maintained that CMS inadvertently 
double counted each bundled image guidance code during their RUC 
recommendation evaluation in CY 2019 due to a misinterpretation of the 
RUC's utilization crosswalk recommendations. Commenters stated that 
after correcting for double counting the utilization for the newly 
created bundled codes, the work pool based on the RUC-recommended 
values would have instead resulted in a decrease by 15 percent using 
the CMS utilizations from the CY 2019 PFS proposed rule. Commenters 
stated that based on the CMS proposed reductions, the work pool for the 
family would decrease by 23 percent based on the utilization data 
available during the CY 2019 rulemaking.
    Response: As we stated in the CY 2021 PFS proposed rule (85 FR 
50152), we continue to disagree with the RUC and do not believe that 
utilization was erroneously double-counted for this code family. We 
proposed and finalized the utilization crosswalk for this code family 
as recommended by the RUC without receiving any comments from the RUC 
or other stakeholders and we did not make a technical correction 
following the publication of the CY 2019 PFS final rule for this 
reason.
    Comment: Several commenters stated that they had new information to 
provide based on reviewing actual claim data from CY 2019 to assess the 
accuracy of the RVU pool estimates during the CY 2019 rulemaking 
process. Commenters stated that CMS' projected RVU pool for CY 2019 for 
the updated Fine Needle Aspiration code family was over twice as high 
as what actually occurred in 2019 even though the utilization for the 
newly created codes is largely identical to the source utilization from 
CPT codes 10021 and 10022. Commenters recommended CMS to finalize the 
RUC-recommended work RVUs for CPT codes 10005, 10009, and 10021.
    Response: We appreciate the additional information provided by the 
commenters in their review of the claims data from CY 2019. However, we 
note that it is not typically part of our methodology to review the 
accuracy of the RUC-recommended utilization crosswalk against the 
claims data when it becomes available 2 years later. Historically, 
there have been many times when the projected crosswalk overestimated 
utilization for a new service. Also, there have been many times when 
the projected crosswalk underestimated utilization. In the absence of a 
systematic process to investigate the accuracy of these projected 
utilization crosswalks across a broad range of services, we do not 
believe that it would serve the interests of relativity to single out 
individual code families and compare them against their projected 
crosswalks. It would distort relativity to conduct this analysis in 
situations where it might be advantageous for valuation while failing 
to conduct the same analysis in situations where it might be 
disadvantageous.
    More importantly, we continue to disagree with the RUC that the 
utilization crosswalk was ``the principle reason CMS rejected the RUC 
recommendations'' for the codes in the Fine Needle Aspiration family, 
as stated in the RUC's CY 2021 recommendations for this code family. As 
we stated in the CY 2019 PFS proposed rule, restated in the CY 2019 PFS 
final rule, and again restated in the CY 2021 PFS proposed rule, our 
refinements to the work RVUs of CPT codes 10021, 10005, and 10009 were 
primarily based on changes in surveyed work time and the relationship 
between the codes in the family. We noted that this primary rationale 
for refining the work RVU did not mention the utilization crosswalk at 
all. We continue to believe that the changes in surveyed work time and 
the relationship between the codes in the family support the work 
valuations finalized in CY 2019 rulemaking.
    Comment: Several commenters disagreed with the rationale provided 
by CMS when the work RVUs for these codes were finalized in CY 2019 
rulemaking. Commenters stated that CMS continued to use intraservice 
time ratios to revalue codes and then applied inappropriate crosswalks 
to justify their logic. Commenters stated that the CMS crosswalk codes, 
such as CPT code 36440 (Push transfusion, blood, 2 years or younger), 
are not clinically similar to the reviewed codes including the 
associated risks and required decision-making. Commenters stated that 
the work RVU for CPT code 10005 could be more appropriately crosswalked 
to CPT code 76978 (Ultrasound, targeted dynamic microbubble sonographic 
contrast characterization (non-cardiac); initial lesion) based on the 
identical intraservice work time, intensity, complexity similarities, 
and ultrasound service similarities. Commenters similarly stated that 
the work RVU of CPT code 10021 could be more accurately crosswalked to 
CPT code 95866 (Needle electromyography; hemidiaphragm). Commenters 
again suggested CMS to finalize the RUC's reaffirmed work RVUs for 
these services.
    Response: We disagree with these valuation suggestions presented by 
the commenters as they reiterate the same arguments that we considered 
and ultimately did not finalize when the codes in the Fine Needle 
Aspiration were previously reviewed. For a full discussion of this 
subject, we direct readers to the CY 2019 PFS final rule (83 FR 59517-
59521). We continue to believe that the changes in surveyed work time 
and the relationship between the codes in the family support the work 
valuations finalized in CY 2019 rulemaking.
    Comment: Several commenters stated that for several equipment 
items, including the mayo stand (EF015), the exam table (EF023), and 
the portable ultrasound unit (EQ250), it appeared that there was a 
calculation error in CMS' direct PE refinement table. Commenters 
provided a spreadsheet which clarified the RUC's comments on individual 
refinements of direct PE inputs with suggested equipment times for 
these items.
    Response: We disagree with the commenters and we continue to 
believe that the equipment times finalized in CY 2019 rulemaking are 
correct. The finalized equipment times for these three equipment items 
conform to the standard established policies for non-highly technical 
equipment. The equipment times recommended by the commenters do not 
conform to these standard equipment time formulas, instead adding 
additional time for the ``Complete post-procedure diagnostic forms, lab 
and x-ray requisitions'' (CA027) and ``Review home care instructions, 
coordinate visits/prescriptions'' (CA035) clinical labor activities. In 
particular, we note that the CA035 clinical labor activity is not part 
of the standard established policies for non-highly technical equipment 
formula; the RUC has mistakenly labeled it as such on some of their 
recommended PE spreadsheets. Since

[[Page 84604]]

these clinical labor activities are not part of the standard equipment 
time formula, and we have no reason to believe that they would be 
typical for the services in question; we continue to believe that the 
equipment times finalized in CY 2019 rulemaking are correct.
    We did not propose any changes to the codes in the Fine Needle 
Aspiration family and although we appreciate the information supplied 
by the commenters, we are not finalizing any changes to these services. 
In the event that there is a new review of these services, as opposed 
to a reaffirmation of the previous review, we would look forward to 
receiving any additional information or new data.
(2) Tissue Expander Other Than Breast (CPT Code 11960)
    This service was included in a larger group of similarly related 
codes that were recommended for review for the October 2019 RUC 
meeting. The RUC recommended re-reviewing this code at a more granular 
level for the January 2020 RUC meeting.
    We disagreed with the RUC-recommended work RVU of 12.40 for CPT 
code 11960 (tissue expander other than breast). We proposed to maintain 
the current work RVU of 11.49 supported by a reference code, CPT code 
45560 (repair of rectocele (separate procedure)), which has a work RVU 
of 11.50. CPT code 45560 shares the same intraservice time of 90 
minutes with CPT code 11960 and has a slightly higher total time of 367 
minutes. The recommended total time for CPT code 11960 decreased from 
444 minutes to 357 minutes, with a slight increase in intraservice time 
of 78 minutes to 90 minutes. We noted that we believe the similar work 
RVU of the reference CPT code 45560, as well as the reduction in total 
time, supports maintaining the current work RVU of 11.49 for CPT code 
11960. We proposed the RUC-recommended direct PE inputs for CPT code 
11960 without refinements.
    We received public comments on the Tissue Expander Other Than 
Breast.
    The following is a summary of the comments we received and our 
responses.
    Comment: Several commenters disagreed with the proposal to maintain 
the current work RVU of 11.49 for CPT code 11960 (Tissue expander other 
than breast) and stated that CMS should finalize the RUC-recommended 
work RVU of 12.40. In particular, commenters stated they believe that 
there is an anomalous relationship between current work RVU and current 
physician time reflected in an inappropriate intensity. The commenters 
also believe that we have not appropriately accounted for the RUC-
recommended increase in intraservice time.
    Response: We acknowledge that the RUC recommended an increase in 
intraservice time. However, we believe that when our review of 
recommended values reveals changes in time that have been unaccounted 
for in a recommended RVU, such as in the decrease of total time 
unaccounted for with CPT code 11960, we believe it is appropriate to 
account for that change in establishing work RVUs since the statute 
explicitly identifies time as one of the two elements of the work RVUs. 
To validate further our valuations for work RVUs, we incorporate 
multiple methodologies, which also consider intensity of the service. 
For additional information regarding our use of methodologies for code 
valuation, we refer readers to our discussion of the subject in the 
Methodology for Establishing Work RVUs section of this rule (section 
II.H.2. of this final rule).
    Comment: Commenters stated that they disagree with our use of the 
chosen reference code, CPT code 45560 (Repair of rectocele (separate 
procedure)). Commenters stated that they believe the chosen reference 
code does not accurately support the proposed work times for this code 
because it is ``low volume'' and it has been too long since the last 
survey to be an accurate comparison for determining an appropriate 
valuation. The commenters also stated that there is no evidence to 
support a clinical comparison between CPT code 11960 and the chosen 
reference code.
    Response: We consider reference codes as supportive of a code 
valuation rather than as a direct ``cross-walk.'' CPT code 45560 has a 
work RVU of 11.50. It shares the same intraservice time of 90 minutes 
with CPT code 11960 and has a slightly higher total time of 367 
minutes. We do not agree that codes must share the same patient 
population or utilization level to serve as an appropriate reference 
code. We also recognize that it is important to use recent data 
available regarding work times. However, we believe that while some 
reference codes may not have been recently surveyed, they still provide 
support for revision of work RVUs when survey times show a marked 
decrease in time.
    After consideration of these public comments, we are finalizing the 
work RVU and direct PE inputs for CPT code 11960 as proposed.
(3) Breast Implant-Expander Placement (CPT Codes 11970, 19325, 19340, 
19342, and 19357)
    These services were included in a larger group of 22 breast 
reconstruction and similarly related codes that were recommended for 
survey for the October 2019 RUC meeting. At the October 2019 RUC 
meeting, these codes were recommended for a more granular review for 
the January 2020 RUC meeting.
    We disagreed with the RUC-recommended work RVU of 8.01 for CPT code 
11970 (replacement of tissue expander with permanent implant). We 
proposed a work RVU of 7.49 supported by a reference code CPT code 
35701 (exploration not followed by surgical repair, artery; neck (e.g., 
carotid, subclavian)), which has a work RVU of 7.50. CPT code 35701 
shares the same intraservice time of 60 minutes with CPT code 11970 and 
has a slightly higher total time of 229 minutes as compared to 216 
minutes. In addition, during our review of CPT code 11970, we noted 
that the recommended intraservice time is decreasing from 78 minutes to 
60 minutes and the recommended total time of 231 minutes is decreasing 
to 216 minutes. We also noted that the proposed work RVU of 7.49 for 
CPT code 11970 is equal to the total time ratio amount, which is the 
current total time compared to the RUC-recommended total time. We 
proposed the RUC-recommended direct PE inputs for CPT code 11970.
    We disagreed with the RUC-recommended work RVU of 8.64 for CPT code 
19325 (breast augmentation with implant). Although we disagreed with 
the RUC-recommended work RVU, we concurred that the relative difference 
in work between CPT codes 11970 and 19325 is equivalent to the RUC-
recommended interval of 0.63 RVUs. Therefore, we proposed a work RVU of 
8.12 for CPT code 19325, based on the RUC-recommended interval of 0.63 
additional RVUs above our proposed work RVU of 7.49 for CPT code 11970. 
We noted that we believe the use of an incremental difference between 
these CPT codes is a valid methodology for setting values, especially 
in valuing services within a family of revised codes where it is 
important to maintain appropriate intra-family relativity. We also 
supported the proposed work RVU of 8.12 based on a reference code, CPT 
code 25652 (open treatment of ulnar styloid fracture). CPT code 25652 
shares the same intraservice time of 60 minutes and the same total time 
of 225 minutes with a lower work RVU of 8.06. In addition, during our 
review of CPT code

[[Page 84605]]

19325, we noted that the total time has decreased from 244 minutes to 
225 minutes and the intraservice time has decreased from 90 minutes to 
60 minutes. We proposed the RUC-recommended direct PE inputs for CPT 
code 19325.
    We disagreed with the RUC-recommended work RVU of 11.00 for CPT 
code 19340 (insertion of breast implant on same day of mastectomy (i.e. 
immediate)). Although we disagreed with the RUC-recommended work RVU, 
we concurred that the relative difference in work between CPT codes 
19325 and 19340 is equivalent to the RUC-recommended interval of 2.36 
RVUs. Therefore, we proposed a work RVU of 10.48 for CPT code 19340, 
based on the recommended interval of 2.36 additional RVUs above our 
proposed work RVU of 8.12 for CPT code 19325. We also supported our 
proposed work RVU of 10.48 based on a reference code, CPT code 47562 
(laparoscopy, surgical; cholecystectomy). CPT code 47562 shares the 
same intraservice time of 80 minutes and only a slightly lower total 
time of 251 minutes with a similar work RVU of 10.47. In addition, 
during our review of CPT code 19340, we noted that the total time has 
decreased from 366 minutes to 261 minutes and the intraservice time has 
decreased from 120 minutes to 80 minutes. We proposed the RUC-
recommended direct PE inputs for CPT code 19340.
    We disagreed with the RUC-recommended work RVU of 11.00 for CPT 
code 19342 (insertion or replacement of breast implant on different day 
from mastectomy). Although we disagreed with the RUC-recommended work 
RVU, we concurred that the relative difference in work between CPT 
codes 19325 and 19342 is equivalent to the RUC-recommended interval of 
2.36 RVUs. Therefore, we proposed a work RVU of 10.48 for CPT code 
19342, based on the recommended interval of 2.36 additional RVUs above 
our proposed work RVU of 8.12 for CPT code 19325. We also noted that 
the RUC-recommended work RVU of 11.00 is equal to the RUC-recommended 
work RVU for CPT code 19340 because they have stated that both services 
involve an identical amount of physician work and similar times. We 
also supported our proposed work RVU of 10.48 based on a reference 
code, CPT code 47562 (laparoscopy, surgical; cholecystectomy). CPT code 
47562 shares the same intraservice time of 80 minutes and only a 
slightly lower total time of 251 minutes with a similar work RVU of 
10.47. The total time for CPT code 19342 has decreased from 320 minutes 
to 252 minutes and the intraservice time has decreased from 115 minutes 
to 80 minutes. We proposed the RUC-recommended direct PE inputs for CPT 
code 19342.
    We disagreed with the RUC-recommended work RVU of 15.36 for CPT 
code 19357 (tissue expander placement in breast reconstruction, 
including subsequent expansion). Although we disagreed with the RUC-
recommended work RVU, we concurred that the relative difference in work 
between CPT codes 11970 and 19357 is equivalent to the RUC-recommended 
interval of 7.35 RVUs. Therefore, we proposed a work RVU of 14.84 for 
CPT code 19357, based on the recommended interval of 7.35 additional 
RVUs above our proposed work RVU of 7.49 for CPT code 11970. We also 
supported our proposed work RVU of 14.84 based on a reference code, CPT 
code 37605 (ligation; internal or common carotid artery). CPT code 
37605 shares the same intraservice time of 90 minutes and only a 
slightly lower total time of 342 minutes with a lower work RVU of 
14.28. In addition, during our review of CPT code 19357, we noted that 
the total time has decreased from 468 minutes to 344 minutes and the 
intraservice time has decreased from 110 minutes to 90 minutes. We 
proposed the RUC-recommended direct PE inputs for CPT code 19357.
    We received public comments on the Breast Implant-Expander 
Placement code family. The following is a summary of the comments we 
received and our responses.
    Comment: Commenters disagreed with the proposed work RVU of 7.49 
for CPT code 11970 and stated that CMS should finalize the RUC-
recommended work RVU of 8.01. Commenters stated that they disagree with 
the use of the total time ratio methodology for the valuation of this 
code. The commenters stated that they believe the total time ratio is 
invalid because it uses 30-year-old total time from the Harvard Study. 
Additionally, commenters stated that they believe CMS did not consider 
intensity of the service while using this methodology, which they 
believe is actually much higher than what CMS has accounted for. 
Commenters stated that they believe CMS substituted an arbitrary 
determination of work values derived from time and a subjective 
estimate of intensity based on an unknown and clinically uniformed 
opinion.
    Response: We disagree and continue to believe that the use of time 
ratios is an appropriate method for identifying potential work RVUs for 
particular PFS services. In regard to the age of the data from the 
Harvard study, if we were to operate under the assumption that 
previously recommended work times are now arbitrarily invalid, this 
would undermine the relativity of the work RVUs on the PFS in general, 
given that codes are, and have been over many years, often valued by 
comparisons to codes with similar times. For CPT code 11970, survey 
times showed a total time and intraservice time decrease. Therefore, we 
believe the total time ratio, as a comparison of the current work time 
versus the RUC-recommended work times, is an appropriate methodology to 
value the work for this CPT code. For additional information regarding 
our use of time ratios for code valuation, we refer readers to our 
discussion of the subject in the Methodology for Establishing Work RVUs 
section of this rule (section II.H.2. of this final rule).
    Comment: Commenters disagreed with the proposed work RVU of 8.12 
for CPT code 19325 and stated that CMS should finalize the RUC-
recommended work RVU of 8.64. Commenters also disagreed with the 
proposed work RVU of 10.48 for CPT code 19340 and CPT code 19342 and 
stated that we should finalize the RUC-recommended work RVU of 11.00 
for both CPT codes. Commenters also stated that they disagreed with the 
proposed work RVU of 14.84 for CPT code 19357 and stated that instead 
we should finalize the RUC-recommended work RVU of 15.36. Commenters 
stated that they do not support the use of an incremental methodology 
as an appropriate method for identifying work RVUs for these PFS 
services. In particular, commenters noted that they believe this 
methodology adds fragility to the relative value system, as an error in 
the foundation code could affect the entire code family.
    Response: We believe the use of an incremental difference between 
codes is a valid methodology for setting values, especially in valuing 
services within a family of revised codes where it is important to 
maintain appropriate intra-family relativity. We have no evidence to 
suggest that the use of an incremental difference between codes 
conflicts with the statute's definition of the work component as the 
resources in time and intensity required in furnishing the service. We 
do consider clinical information associated with physician work 
intensity provided by the RUC and other stakeholders as part of our 
review process, although we remind readers again that we do not agree 
that codes must share the same site of service, patient population, or 
utilization level to serve as an appropriate crosswalk. For additional 
information regarding

[[Page 84606]]

our use of an incremental difference for code valuation, we refer 
readers to our discussion of the subject in the Methodology for 
Establishing Work RVUs section of this rule (section II.H.2. of this 
final rule).
    Comment: Commenters disagreed with our use of the chosen supporting 
reference codes throughout the code family. For CPT code 11970, CPT 
code 19325, and CPT code19357, commenters stated that they believe the 
chosen reference codes are too ``low-volume'' to accurately support the 
proposed work times for these codes. Additionally, commenters stated 
that for CPT code 19325, CPT code 19340, CPT code 19342, and CPT code 
19357, that the work values for the reference codes chosen by CMS are 
too old to be accurate comparisons for determining appropriate 
valuations. The commenters also stated that several of the reference 
codes are not relevant for purposes of valuation because there is no 
evidence to support clinical comparison.
    Response: We are statutorily obligated to consider both time and 
intensity in establishing work RVUs for PFS services. Additionally, we 
use other methods to validate work RVUs, such as reference codes. When 
using reference codes to support a proposed work RVU, we do not 
consider them as a direct ``cross-walk'' between the CPT code that is 
being revalued and the chosen reference code. Instead, a reference code 
used as a supportive check in validating work times. We continue to 
believe that the relative value system of the PFS is such that all 
services are appropriately subject to comparisons to one another. We do 
not agree that codes must share the same patient population or 
utilization level to serve as an appropriate reference code. We also 
recognize that it is important to use the most recent data available 
regarding work times. However, we believe that while some reference 
code values may be considered older, they still provide support for 
revision of work RVUs when survey times show a marked increase or 
decrease in total and intraservice time, such as was the case for this 
code family.
    Comment: Commenters stated that CMS must ensure that any RVU 
reduction of more than 19 percent is phased in over 2 years, under 
1848(c)(7) of the Act. The commenter stated that the magnitude of the 
proposed RVU reductions for CPT codes 19340 and 19357 would trigger the 
phase-in requirements since they would be decreasing by more than 19 
percent.
    Response: Section 1848(c)(7) of the Act, as added by section 220(e) 
of the PAMA, 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. We proposed to exempt 
all of the CPT codes in the Breast Implant-Expander Placement family 
from the phase-in of significant RVU reductions required by section 
1848(c)(7) of the Act due to the fact that they were designated as 
``revised'' codes by CPT as a result of significant revisions to their 
code descriptors. Since all of the codes in the family fall under the 
revised designation, the phase-in requirement does not apply to them.
    Comment: Commenters stated that they are concerned that reducing 
reimbursement for the services in this code family could limit access 
to breast reconstruction following mastectomy. The commenters cited a 
study done by Kamali P et al., titled: Immediate Breast Reconstruction 
among Patients with Medicare and Private Insurance: A Matched Cohort 
Analysis. Commenters also stated that they wanted to bring to our 
attention the Women's Health and Cancer Rights Act of 1998 (WHCRA). The 
commenters stated that this act provides coverage protection for 
patients who choose to have breast reconstruction following a 
mastectomy.
    Response: We remain committed to supporting the health of all 
Medicare beneficiaries, as well as remaining vigilant in support of all 
services related to minority and women's health. While the WHCRA (Pub. 
L. 105-277, Title IX, Oct. 21, 1998) is an important federal law that 
furthers protections for women's healthcare rights and access to 
services, we note that Medicare does provide coverage for these 
important services.
    After consideration of these public comments, we are finalizing the 
work RVU and direct PE inputs for the Breast Implant-Expander
(4) Breast Implant-Expander Removal (CPT Codes 11971, 19328, and 19330)
    These services were included in a group of codes that were 
recommended for survey for the October 2019 RUC meeting as part of a 
large group of 22 breast reconstruction and similarly related services. 
At its October 2019 meeting, the RUC agreed that a 22-code family was 
too expansive. They recommended these codes be re-reviewed as part of a 
smaller and more granular code family for the January 2020 RUC meeting.
    We disagreed with the RUC-recommended work RVU of 7.02 for CPT code 
11971 (removal of tissue expander w/out insertion of implant). Although 
we disagreed with the RUC-recommended work RVU, we concurred that the 
relative difference in work between CPT codes 11970 and 11971 is 
equivalent to the RUC recommended interval of 0.99 RVUs. Therefore, we 
proposed a work RVU of 6.50 for CPT code 11971, based on the 
recommended interval of 0.99 RVUs below our proposed work RVU of 7.49 
for CPT code 11970. We noted that as stated previously, we believed the 
use of an incremental difference between these CPT codes is a valid 
methodology for setting values, especially in valuing services within 
families of similarly revised codes. We also supported our proposed 
work RVU of 6.50 based on a reference code, CPT code 25671 
(percutaneous skeletal fixation of distal radioulnar dislocation). CPT 
code 25671 shares the same intraservice time of 45 minutes and a 
slightly less total time of 210 minutes with a very similar work RVU of 
6.46. In addition, during our review of CPT code 11971, we noted that 
the total time has decreased from 303 minutes to 215 minutes and the 
intraservice time has decreased from 90 to 45 minutes. We proposed the 
RUC-recommended direct PE inputs for CPT code 11971.
    We disagreed with the RUC-recommended work RVU of 7.44 for CPT code 
19328 (removal of intact breast implant). Although we disagreed with 
the RUC-recommended work RVU, we proposed increasing the current work 
RVU from 6.48 to 6.92 to account for the increases in total and 
intraservice time. We also concurred that the relative difference in 
work between CPT codes 11971 and 19328 is equivalent to the RUC-
recommended interval of 0.42 RVUs. Therefore, we proposed a work RVU of 
6.92 for CPT code 19328, based on the recommended interval of 0.42 
additional RVUs above our proposed work RVU of 6.50 for CPT code 11970. 
We also supported our proposed work RVU of 6.92 based on a reference 
code, CPT code 28289 (Hallux rigidus correction with cheilectomy, 
debridement and capsular release of the first metatarsophalangeal 
joint; without implant). CPT code 28289 shares the same intraservice 
time of 45 minutes and a slightly higher total time of 210 minutes with 
a very similar work RVU of 6.90. The total time for CPT code 19328 has 
increased from 173 minutes to 199 minutes and the intraservice time has 
increased from 38 to 45 minutes. We proposed the RUC-recommended direct 
PE inputs for CPT code 19328.
    We proposed the RUC-recommended work RVU of 9.00 for CPT code 19330

[[Page 84607]]

(removal of ruptured breast implant, including implant contents). The 
survey total time for CPT code 19330 has increased from 218 minutes to 
229 minutes and the intraservice time has increased from 62 minutes to 
75 minutes. We also proposed the RUC-recommended direct PE inputs for 
this code without refinements.
    We received public comments on the Breast Implant-Expander Removal 
code family. The following is a summary of the comments we received and 
our responses.
    Comment: Commenters disagreed with the proposed work RVU of 6.50 
for CPT code 11971 and stated that CMS should finalize the RUC-
recommended work RVU of 7.02. Commenters also disagreed with the 
proposed work RVU of 6.92 for CPT code 19328 and stated that CMS should 
finalize the RUC-recommended work RVU of 7.44. Commenters stated that 
they do not support the proposed work RVU because they do not support 
the use of an incremental methodology as an appropriate tool for 
valuing services in this code family. In particular, commenters noted 
that they believe this methodology is further inappropriate because it 
uses a foundation code that is not within the same code family, which 
adds further fragility to the use of the incremental methodology for 
valuation of this code family.
    Response: We believe the use of an incremental difference between 
codes is a valid methodology for setting values, especially in valuing 
services within a family of revised codes where it is important to 
maintain appropriate intra-family relativity.
    Comment: Commenters disagreed with our use of the chosen supporting 
reference codes for CPT code 11971 and CPT code 19328. The commenters 
stated that they believe there is not adequate clinical comparison for 
the work portion of the service. Commenters also stated that they 
believe the reference code values are too old because they are from 
outdated survey results and do not have adequately comparable 
intensities.
    Response: When using referencing codes to support a proposed work 
RVU, we do not consider them as a direct ``cross-walk'' between the CPT 
code that is being revalued and the chosen reference code. Instead, 
reference codes are used as a supportive check in validating work 
times. We continue to believe that the relative value system of the PFS 
is such that all services are appropriately subject to comparisons to 
one another.
    After consideration of these public comments, we find the arguments 
for maintaining consistency in methodology and reducing the risk of 
anomalies within the valuation of this code family to be compelling. We 
are finalizing the RUC-recommended work RVU of 7.02 for CPT code 11971 
and the RUC-recommended work RVU of 7.44 for CPT code 19328. We are 
also finalizing the direct PE inputs as proposed.
(5) Modified Radical Mastectomy (CPT Code 19307)
    The RUC recommended that CPT code 19307 (Mastectomy, modified 
radical, including axillary lymph nodes, with or without pectoralis 
minor muscle, but excluding pectoralis major muscle) be surveyed for 
the January 2020 RUC meeting for site of service anomaly. The 
Relativity Assessment Workgroup identified services performed less than 
50 percent of the time in the inpatient setting yet included inpatient 
hospital E/M services within the global period and with 2018 Medicare 
utilization over 5,000. The RUC recommended lowering the work RVU to 
17.99 which is the survey's 25th percentile.
    We proposed the RUC-recommended work RVUs of 17.99 for CPT code 
19307. We also proposed the RUC-recommended direct PE inputs for this 
code.
    We received public comments on Modified Radical Mastectomy (CPT 
code 19307). The following is a summary of the comments we received and 
our responses.
    Comment: Commenters were overall in support of CMS proposing the 
RUC recommendations for this code. One commenter noted strong support 
for the process and of the RUC. Additionally, the commenters suggested 
CMS to accept the RUC recommendations to extend the office and 
outpatient E/M work RVU increases to the office and outpatient visits 
included in 10- and 90-day globals.
    Response: We appreciate the commenters' support for CMS proposing 
the RUC recommendation for Modified Radical Mastectomy (CPT code 19307) 
and note the commenters concern with regard to office and outpatient E/
M work RVU increases to the office and outpatient visits included in 
10- and 90-day global.
    After consideration of these public comments, we are finalizing as 
proposed the RUC-recommended work RVU of 17.99 for CPT code 19307. We 
are also finalizing as proposed the RUC-recommended direct PE inputs 
for this code.
(6) Breast Lift-Reduction (CPT Codes 19316 and 19318)
    These services were included in a larger code group of similarly 
related services that were recommended for review for the October 2019 
RUC meeting. CPT code 19316 (mastopexy) and CPT code 19318 (Breast 
reduction) were then recommended for a more granular review for the 
January 2020 RUC meeting.
    We proposed the RUC-recommended work RVU of 11.09 for CPT code 
19316 (mastopexy) and 16.03 for CPT code 19318 (Breast reduction). We 
proposed the RUC-recommended direct PE inputs for this code family 
without refinements.
    We did not receive public comments on this code family, and are 
finalizing as proposed.
(7) Secondary Breast Mound Procedure (CPT Codes 19370, 19371, and 
19380)
    These services were included in a large group of breast 
reconstruction codes that were recommended to be surveyed for the 
October 2019 RUC meeting. At the October 2019 RUC meeting, the RUC 
concurred with the more granular code families but recommended these 
codes be re-surveyed for the January 2020 RUC meeting.
    We disagreed with the RUC-recommended work RVU of 10.0 for CPT code 
19370 (Revision of peri-implant capsule, breast, including 
capsulorrhaphy, and/or partial capsulectomy). We proposed to maintain 
the current work RVU of 9.17 based on a supporting reference code, CPT 
code 28299 (Correction, hallux valgus (bunionectomy), with 
sesamoidectomy, when performed; with double osteotomy, any method), 
which has a work RVU of 9.29. CPT code 28299 shares a similar 
intraservice time of 75 minutes with CPT code 19370 and has a slightly 
higher total time of 256 minutes. In addition, we noted during our 
review of CPT code 19370 that the recommended total time has increased 
minimally from 253 minutes to 255 minutes, with a slight decrease in 
intraservice time of 82 minutes to 78 minutes. We noted that we believe 
the similar work RVU of the supporting CPT code 28299, as well as the 
minimal changes in physician work time for CPT code 19370, supports 
maintaining the current work RVU of 9.17. We proposed the RUC-
recommended direct PE inputs for CPT code 19370 without refinements.
    We disagreed with the RUC-recommended work RVU of 10.81 for CPT 
code 19371 (Peri-implant

[[Page 84608]]

capsulectomy, breast, complete, including removal of all intra-capsular 
contents). Although we disagreed with the RUC-recommended work RVU, we 
concur that the relative difference in work between CPT codes 19370 and 
19371 is equivalent to the RUC-recommended interval of 0.81 RVUs. 
Therefore, we proposed a work RVU of 9.98 for CPT code 19371, based on 
the recommended interval of 0.81 additional RVUs above our proposed 
work RVU of 9.17 for CPT code 19370. We noted that as stated 
previously, we believe the use of an incremental difference between 
these CPT codes is a valid methodology for setting values, especially 
in valuing services within a family of revised codes where it is 
important to maintain appropriate intra-family relativity. We also 
supported our proposed work RVU of 9.98 based on a reference code, CPT 
code 25628 (Open treatment of carpal scaphoid (navicular) fracture, 
includes internal fixation, when performed). CPT code 25628 shares the 
same intraservice time of 90 minutes and a slightly higher total time 
of 277 minutes with a work RVU of 9.67. In addition, during our review 
of CPT code 19371, we noted that the total time for CPT code 19371 has 
decreased from 306 minutes to 261 minutes and the intraservice time has 
decreased from 117 to 90 minutes. We proposed the RUC-recommended 
direct PE inputs for CPT code 19371.
    We disagreed with the RUC-recommended work RVU of 12.00 for CPT 
code 19380 (Revision of reconstructed breast (e.g., significant removal 
of tissue, re-advancement and/or re-inset of flaps in autologous 
reconstruction or significant capsular revision combined with soft 
tissue excision in implant-based reconstruction)). Although we 
disagreed with the RUC-recommended work RVU, we concurred that the 
relative difference in work between CPT codes 19371 and 19380 is 
equivalent to the RUC recommended interval of 1.19 RVUs. Therefore, we 
proposed a work RVU of 11.17 for CPT code 19380, based on the 
recommended interval of 1.19 additional RVUs above our proposed work 
RVU of 9.98 for CPT code 19371. We also supported our proposed work RVU 
of 11.17 based on a reference code, CPT code 64569 (Revision or 
replacement of cranial nerve (e.g., vagus nerve) neurostimulator 
electrode array, including connection to existing pulse generato). CPT 
code 64569 shares the same intraservice time of 120 minutes and only a 
slightly higher total time of 312 minutes with a work RVU of 11.0. The 
total time increased from 277 minutes to 307 minutes and the 
intraservice time has increased from 89 minutes to 120 minutes. We 
proposed the RUC-recommended direct PE inputs for CPT code 19380.
    We received public comments on the Secondary Breast Mound Procedure 
(CPT codes 19370, 19371, and 19380). The following is a summary of the 
comments we received and our responses.
    Comment: Several commenters disagreed with the proposal to maintain 
the current work RVU of 9.17 for CPT code 19370 (Revision of peri-
implant capsule, breast, including capsulorrhaphy, and/or partial 
capsulectomy) and stated that CMS should finalize the RUC- recommended 
work RVU of 10.00. Some of the commenters disagreed with comparing the 
current intraservice time and total time from the Harvard study to the 
RUC-recommended physician time. The commenters also believed that we 
have not appropriately accounted for the CPT Editorial Panel's revised 
additional physician work that is now inclusive in the code descriptor 
and increased intensity.
    Response: We disagree with the commenter. For CPT code 19370, 
survey times showed only a slight increase in total time and slight 
decrease in intraservice time. Therefore, we continue to believe that 
the survey time does not support increasing the work RVU; in 
particular, there was no significant change in total time.
    Comment: Commenters disagreed with the proposed work RVU of 9.98 
for CPT code 19371 (Peri-implant capsulectomy, breast, complete, 
including removal of all intra-capsular contents) and stated that CMS 
should finalize the RUC-recommended work RVU of 10.81. Commenters also 
disagreed with the proposed work RVU of 11.17 for CPT code 1980 
(Revision of reconstructed breast (e.g., significant removal of tissue, 
re-advancement and/or re-inset of flaps in autologous reconstruction or 
significant capsular revision combined with soft tissue excision in 
implant-based reconstruction)) and stated that we should finalize the 
RUC-recommended work RVU of 12.00. Commenters stated that they do not 
support the use of an incremental methodology as an appropriate method 
for identifying work RVUs for these PFS services. In particular, 
commenters noted that they believe this methodology adds fragility to 
the relative value system, as an error in the foundation code could 
affect the entire code family.
    Response: We believe the use of an incremental difference between 
codes is a valid methodology for setting values, especially in valuing 
services within a family of revised codes where it is important to 
maintain appropriate intra-family relativity. We have no evidence to 
suggest that the use of an incremental difference between codes 
conflicts with the statute's definition of the work component as the 
resources in time and intensity required in furnishing the service. We 
do consider clinical information associated with physician work 
intensity provided by the RUC and other stakeholders as part of our 
review process, although we remind readers again that we do not agree 
that codes must share the same site of service, patient population, or 
utilization level to serve as an appropriate crosswalk. For additional 
information regarding our use of an incremental difference for code 
valuation, we refer readers to our discussion of the subject in the 
Methodology for Establishing Work RVUs section of this rule (section 
II.H.2. of this final rule).
    Comment: For CPT codes 19370, CPT code 19371, and CPT code 19380, 
commenters disagreed with our use of the chosen supporting reference 
codes throughout the code family stating they were not strong reference 
codes, and not relevant for purposes of valuation because there is no 
evidence of clinical comparison. A commenter also stated that the 
reference code used for CPT code 19380 had very low volume.
    Response: We are statutorily obligated to consider both time and 
intensity in establishing work RVUs for PFS services. Additionally, we 
use other methods to validate work RVUs, such as reference codes. When 
using referencing codes to support a proposed work RVU, we do not 
consider there to be a direct ``cross-walk'' between the CPT code that 
is being revalued and the chosen reference code. Instead, it is meant 
to be supportive in validating work times. We continue to believe that 
the relative value system of the PFS is such that all services are 
appropriately subject to comparisons to one another. We do not agree 
that codes must share the same patient population or utilization level 
to serve as an appropriate reference code. We also recognize that it is 
important to use recent available data regarding work times. However, 
we believe that while some reference code values may be considered 
older, they still provide support for revision of work RVUs when survey 
times show a marked increase or decrease in total and intraservice 
time, such as was the case for this code family.
    After consideration of public comments, we are finalizing the work 
RVU and direct PE inputs for the

[[Page 84609]]

Secondary Breast Mound Procedure code family as proposed.
(8) Hip-Knee Arthroplasty (CPT Codes 27130 and 27447)
    CPT codes 27130 (Arthroplasty, acetabular and proximal femoral 
prosthetic replacement (total hip arthroplasty), with or without 
autograft or allograft) and 27447 (Arthroplasty, knee, condyle and 
plateau; medial AND lateral compartments with or without patella 
resurfacing (total knee arthroplasty)) were identified as potentially 
misvalued codes under the CMS high expenditure procedural code screen 
in the CY 2014 PFS final rule with comment period (78 FR 74334). These 
codes were reviewed by the AMA RUC who provided recommendations for 
work RVUs and physician time for these services for CY 2014. We agreed 
with the RUC recommendation to value CPT code 27130 and CPT code 27447 
equally and thus established the same CY 2014 interim final work RVUs 
for these two procedures (78 FR 74334). This change resulted in a 1.12 
work RVU increase for the visits in the global period. We added the 
additional work to the AMA RUC-recommended work RVU of 19.60 for CPT 
codes 27130 and 27447, resulting in an interim final work RVU of 20.72 
for both services.
    In the CY 2015 PFS final rule with comment period (79 FR 67632), we 
discussed how in the CY 2014 PFS final rule with comment period, we 
sought public comment regarding the appropriate work RVUs for these 
services and the most appropriate reconciliation for the conflicting 
information regarding time values for these services as presented to us 
by the physician community. We did not find the rationales provided for 
modifying the interim final work values established in CY 2014 
compelling, and thus we finalized the CY 2014 interim final values for 
these procedures based upon the best data we had available and to 
preserve appropriate relativity with other codes.
    In the CY 2019 PFS final rule (83 FR 59500 through 595303), CPT 
code 27130 and CPT code 27447 were added to the list of potentially 
misvalued codes. A stakeholder submitted information requesting that 
CMS nominate these codes as potentially misvalued. The stakeholder 
stated that there were substantial overestimates in pre-service and 
post-service time including follow-up inpatient and outpatient visits 
that do not take place included in the valuation of the service. As a 
result, the codes were resurveyed for the October 2019 RUC meeting.
    We proposed the RUC-recommended work RVU of 19.60 for CPT code 
27130 and the RUC-recommended work RVU of 19.60 for CPT code 27447. We 
also proposed the RUC-recommended direct PE inputs for both codes. 
Additionally, we solicited comment from the medical community on how to 
consider and/or include pre-optimization time (pre-service work and/or 
activities to improve surgical outcomes) going forward. We also noted 
that we were interested in stakeholders' thoughts on what codes could 
be used to capture these pre-optimization activities that could be 
billed in conjunction with the services discussed previously. Overall, 
we noted interest in continuing our ongoing dialog with stakeholders 
about how CMS might pay more accurately for improved clinical outcomes 
that may result from increased efficiency in furnishing care through 
activities, such as pre-optimization and are appreciative of 
information provided by the medical community. We invited the medical 
community to continue to engage with CMS on this and other topics.
    We received public comments on Hip-Knee Arthroplasty (CPT codes 
27130 and 27447). The following is a summary of the comments we 
received and our responses.
    Comment: Many commenters were overall opposed to the proposal to 
reduce the work RVUs associated with CPT codes 27447 and 27130. 
Commenters noted that pre-optimization time is not captured in the 
current RUC survey. Commenters requested that CMS forgo any changes or 
delay adoption of the reduced work RVU for these procedures until an 
accurate assessment of this time can be determined. The commenters 
noted that delaying the adoption of these RVUs would provide time for 
CMS to work with stakeholders to better capture pre-optimization work 
performed by physicians to improve surgical outcomes. One commenter 
recommended the creation of a G code to account for arthroplasty pre-
optimization work.
    Two commenters appreciated CMS' interest in capturing these pre-
optimization activities and seeking comment from the medical community 
on how to consider and/or include pre-optimization time going forward. 
Some stakeholders articulated that CMS may not have fully accounted for 
the preoperative work required to make value-based care cost-effective 
and high-quality. Commenters note, in light of the pandemic, that any 
cuts in payment to health care providers or medically necessary 
services would be harmful, and a reduction in work RVU is not justified 
by a reduction in time spent on patients, but will undercut the 
transition to bundled models.
    One commenter was in support of CMS accepting the RUC 
recommendation for hip and knee arthroplasty and believes accepting the 
RUC recommendation will address the reimbursement imbalance, increase 
the primary care workforce, and improve the finances in primary care. 
Another commenter opposed the reduction because, if both the CF and RVU 
changes take effect, it would be a 15 percent reduction for physician 
payment. The commenter noted the RUC methodology does not capture the 
patient pre-optimization work related to the APM incentive that 
improves patient outcomes and lowers costs.
    One commenter noted that patients with a higher BMI are more 
complex and the RVU should go up or a separate category be made for 
complicated joint replacement for those with a Body Mass Index (BMI) 
over 40. Additionally, the commenter noted that implants (for these 
procedures) should be reimbursed to facilities at cost or cost plus 10 
percent, which would save millions of dollars per calendar year; and 
the commenter also believed lowering the RVUs may cause physicians to 
stop taking Medicare and reduce access to care.
    One commenter noted overwhelming evidence that physicians and/or 
QHPs are spending more time with the typical patient in pre-service 
optimization work and stated that they believe CMS has broad authority 
to remedy the issues presented by the RUC recommendations for 
preservice time. Another commenter stated that there was logical 
outgrowth to add preservice time to the existing code.
    One commenter noted that there are issues with the existing CPT 
codes in capturing arthroplasty pre-optimization activities or changes 
in practice patterns, and that creation of a new G code would account 
for arthroplasty pre-optimization work. For these procedures, this time 
includes patient screening and education, as well as coordinating with 
other health care providers to help manage the entire episode of care.
    Response: We appreciate the commenters' feedback about maintaining 
the work RVU and potential resource costs that are not reflected in the 
RUC recommendation. We are also appreciative of the dialog we have had 
with stakeholders. We continue to assess the accuracy of service 
valuations, including global services paid under the PFS, and believe 
it would be prudent before considering

[[Page 84610]]

further changes to better understand how existing codes that could be 
billed prior to these procedures do not reflect the pre-optimization 
activities as described by stakeholders.
    After considering the comments received, we are finalizing the RUC-
recommended work RVU of 19.60 for CPT code 27130 and the RUC-
recommended work RVU of 19.60 for CPT code 27447. We are also 
finalizing the RUC-recommended direct PE inputs for both codes. As we 
continue to consider this issue and how to best reflect pre-
optimization in the valuation for the services, we welcome information 
from stakeholders as to which services may be included or which coding 
selections would be appropriate for various services that are or would 
be provided outside of the global period. We continue to be interested 
in stakeholders' thoughts and would like to discuss and consider the 
potential for more accurate coding, and what kind of coding framework, 
if there is currently none, could be used to capture these pre-
optimization activities.
(9) Toe Amputation (CPT Codes 28820 and 28825)
    These services were identified by the RUC Relativity Assessment 
Workgroup through a site of service anomaly screen based on the review 
of 3 years of data (2015, 2016 and 2017) for services with utilization 
over 10,000 in which a service is typically performed in the inpatient 
hospital setting, yet only a half discharge day management identified 
by CPT code 99238 is included. Prior to conducting the RUC survey, the 
specialty societies recommended that it would be appropriate for these 
services to have their global period changed from 090-day to 000-day so 
the site of service is less of a contributing factor to the codes' 
valuation. These codes were surveyed as a 000-day global service, and 
we proposed them as 000-day global services.
    We disagreed with the RUC-recommended work RVU of 4.10 for CPT code 
28820 (Amputation, toe; metatarsophalangeal joint). We noted that we 
believe that it would be more accurate to propose a work RVU of 3.51, 
and we are supporting this value with a crosswalk to CPT code 33958 
(Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support 
(ECLS) provided by physician; reposition peripheral (arterial and/or 
venous) cannula(e), percutaneous, 6 years and older (includes 
fluoroscopic guidance, when performed)), which has a work RVU of 3.51, 
to account for the decrease in the surveyed work time. We do not 
believe the RUC-recommended reduction in work RVU from the current 
value of 5.82 is commensurate with the RUC-recommended 102-minute 
reduction in total time. We believe that a further reduction in work 
RVUs is warranted given the significant reduction in RUC-recommended 
physician time.
    We disagreed with the RUC-recommended work RVU of 4.00 for CPT code 
28825 (Amputation, toe; interphalangeal joint). We proposed a work RVU 
of 3.41 based on the RUC-recommended increment relationship between 
this code and CPT code 28820 (a difference of -0.10), which we apply to 
our proposed value for the latter code. We noted that we do not believe 
the RUC-recommended reduction in work RVU from the current value of 
5.37 is commensurate with the RUC-recommended 97-minute reduction in 
total time. We also noted that we believe that a further reduction in 
work RVUs is warranted given the significance of RUC-recommended 
reduction in physician time.
    For the direct PE inputs, we proposed to refine the pre-service 
clinical labor times to conform to the 000-day global period standards 
for both codes in the family for CPT codes 28820 and 28825. We also 
proposed to refine the clinical labor times for the ``Provide 
education/obtain consent'' (CA011) and the ``Prepare room, equipment 
and supplies'' (CA013) activities to conform to our established 
standard time of 2 minutes each in the non-facility setting for CPT 
codes 28820 and 28825. We proposed to refine the equipment time to 
conform to these changes in the clinical labor time for both codes.
    We received public comments on the Toe Amputation (CPT codes 28820 
and 28825).The following is a summary of the comments we received and 
our responses.
    Comment: Commenters stated that CMS made this proposal without 
demonstrating that the agency also considered the disparity between the 
physician work intensity of the post-operative services that were 
previously bundled in 28820 and the physician work intensity of the 
skin-to-skin time of the service.
    Response: We disagree with the commenter that we did not consider 
the disparity in intensity between the post-operative services that 
were previously bundled in CPT code 28820 and the skin-to-skin time of 
the service. Consistent with the statute, we are required to value the 
work RVU based on the relative resources involved in furnishing the 
service, which include time and intensity. When our review of 
recommended values reveals that changes in time have been unaccounted 
for in a recommended RVU, then we believe it is appropriate to account 
for that change in establishing work RVUs since the statute explicitly 
identifies time as one of the two elements of the work RVUs. This 
includes changes in the resource of time associated with the post-
operative services that were previously bundled in CPT code 28820. We 
clarify again that we do not treat all components of physician time as 
having identical intensity. If we were to disregard intensity 
altogether, the work RVUs for all services would be developed based 
solely on time values and that is definitively not the case, as 
indicated by the many services that share the same time values but have 
different work RVUs. In the case of CPT codes 28220 and 28222, we 
believe that in many cases the work time was reduced substantially but 
the work RVU only minimally, which resulted in an implied increase in 
the intensity of work that does not appear to be valid, and ultimately 
creates work intensity anomalies.
    Comment: Commenters stated that the crosswalk code that CMS used to 
support its proposal to reject the RUC recommendation, CPT code 33958, 
is not an appropriate reference code to use for making valuation 
decisions. The commenter stated that CPT code 33958 is an atypical 000-
day global code that includes a bundled inpatient hospital visit making 
it inappropriate to use as a direct work value crosswalk for a service 
that does not include bundled visits and it is a low volume service.
    Response: We continue to believe that the nature of the PFS 
relative value system is such that all services are appropriately 
subject to comparisons to one another. Although codes that describe 
clinically similar services are sometimes stronger comparator codes, we 
do not agree that codes must share the same site of service, patient 
population, or utilization level to serve as an appropriate crosswalk.
    Comment: One commenter stated that they would also like to remind 
CMS of both the Agency's and the RUC's longstanding position that 
treating all components of physician time (pre-service, intra-service, 
post-service and post-operative visits) as having identical intensity 
is incorrect and that inconsistently applying it to only certain 
services under review creates inherent payment disparities in a payment 
system which is based on relative valuation.
    Response: We reiterate our previous clarification that we do not 
treat all components of physician time as having

[[Page 84611]]

identical intensity. As we have consistently stated, when our review of 
recommended values reveals that changes in time have been unaccounted 
for in a recommended RVU, then we believe it is appropriate to account 
for that change in establishing work RVUs since the statute explicitly 
identifies time as one of the two elements of the work RVUs.
    Comment: Commenters stated that it does not appear that CMS 
considered the change in the global surgical period from a 90-day 
global to a 000-day global when referencing the decrease in total time 
for the procedure, which would make sense for a change in the global 
period and the associated intensity for the procedure. The intra-
service time for the procedure did not change.
    Response: We noted that in reviewing the recommended values for CPT 
codes 28820 and 28825, the change in global periods was taken into 
consideration. However, consistent with the statute, we are required to 
value the work RVU based on the relative resources involved in 
furnishing the service, which include time and intensity. When our 
review of recommended values reveals that changes in time have been 
unaccounted for in a recommended RVU, then we believe it is appropriate 
to account for that change in establishing work RVUs since the statute 
explicitly identifies time as one of the two elements of the work RVUs. 
This includes changes in the resource of time associated with the post-
operative services that were previously bundled in CPT code 28820.
    Comment: Several commenters stated that CMS should not impose the 
standard 000-day clinical labor times for CA011 and CA013 with respect 
to CPT codes 28820 and 28825 without regard to the clinically 
significant information that these are major procedures that are 
typically performed in a facility setting.
    Response: We have reviewed all the information provided by 
commenters and we believe it would be appropriate to maintain 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 provides greater 
consistency among codes that share the same clinical labor tasks and 
could improve relativity of values among codes. Therefore, we maintain 
that these refinements are consistent with the clinical labor times of 
a 000-day global service.
    After consideration of the comments, we are finalizing the work 
RVUs and direct PE inputs for the Toe Amputation codes as proposed.
(10) Shoulder Debridement (CPT Codes 29822 and 29823)
    In September 2019, the CPT Editorial Panel approved revision of CPT 
code 29822 (Arthroscopy, shoulder, surgical; debridement, limited, 1 or 
2 discrete structures (e.g., humeral bone, humeral articular cartilage, 
glenoid bone, glenoid articular cartilage, biceps tendon, biceps anchor 
complex, labrum, articular capsule, articular side of the rotator cuff, 
bursal side of the rotator cuff, subacromial bursa, foreign body[ies])) 
and CPT code 29823 (Arthroscopy, shoulder, surgical; debridement, 
extensive, 3 or more discrete structures (e.g., humeral bone, humeral 
articular cartilage, glenoid bone, glenoid articular cartilage, biceps 
tendon, biceps anchor complex, labrum, articular capsule, articular 
side of the rotator cuff, bursal side of the rotator cuff, subacromial 
bursa, foreign body[ies])) to clarify limited and extensive debridement 
by specifying the number of discrete structures debrided and providing 
examples of the structures.
    We proposed the RUC-recommended work RVU of 7.03 for CPT code 29822 
and 7.98 for CPT code 29823 without refinement.
    For the direct PE inputs, we proposed the RUC recommendations CPT 
codes 29822 and 29823 without refinement.
    We did not receive public comments on this code family, and are 
finalizing as proposed.
(11) Absorbable Nasal Implant Repair (CPT Codes 30468)
    In September 2019, the CPT Editorial Panel approved the addition of 
CPT code 30468 (Repair of nasal valve collapse with subcutaneous/
submucosal lateral wall implant(s)) to report repair of nasal valve 
collapse with subcutaneous/submucosal lateral wall implant(s)).
    We proposed the RUC-recommended value of 2.80 work RVUs without 
refinement for CPT code 30468.
    For the direct PE inputs, we also proposed the RUC-recommended 
values without refinement.
    We received public comments on the Absorbable Nasal Implant Repair 
family (CPT code 30468). The following is a summary of the comments we 
received and our responses.
    Comment: Several commenters stated their support for our proposal 
to adopt the RUC-recommended values without refinement.
    Response: We thank commenters for their feedback and support.
    After consideration of the comments, we are finalizing the work RVU 
and direct PE inputs for CPT code 30468 as proposed.
(12) Lung Biopsy-CT Guidance Bundle (CPT Code 32408)
    CPT codes 32405 (Biopsy, lung or mediastinum, percutaneous needle) 
and 77012 (Computed tomography guidance for needle placement (e.g., 
biopsy, aspiration, injection, localization device), radiological 
supervision and interpretation) were identified by the AMA through a 
screen of code pairs that are reported on the same day, same patient 
and same NPI number at or more than 75 percent of the time. The CPT 
Editorial Panel deleted CPT code 32405 and replaced it with 32408 (Core 
needle biopsy, lung or mediastinum, percutaneous, including imaging 
guidance, when performed).
    We did not propose the RUC-recommended work RVU of 4.00, which is 
the survey median, because we believe this value somewhat overstates 
the increase in intensity. Although we do not imply that the decrease 
in time, when considering the aggregate time values for CPT codes 32405 
and 77012, 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 the work RVU. 
Intraservice and total time ratios using the aggregate time values of 
current CPT codes 32405 and 77012 suggest a significantly lower work 
RVU; however, we did not believe a decrease from the current aggregate 
value of 32405 and 77012 was warranted. We noted that we believe there 
is some overlap in physician work and time for the two current 
services, and that the recommended increase to 4.00 does not 
appropriately recognize this overlap. Therefore, we proposed a work RVU 
of 3.18, which is the sum of the work RVUs of the two base codes.
    We proposed the RUC-recommended direct PE inputs without 
refinement.
    We received public comments on Lung Biopsy-CT Guidance Bundle (CPT 
code 32408). The following is a summary of the comments we received and 
our responses.
    Comment: A commenter disagreed with our valuation methodology, 
stating that it inappropriately relies on time-based ratios. The 
commenter stated this methodology is flawed and inaccurately treats all 
components of the physician time as having identical intensity and is 
incorrect. In addition, the commenter suggested it lacks the rigor of 
the survey

[[Page 84612]]

process and RUC panel evaluation. The commenter stated that CMS does 
not provide any supporting rationale or clinical information for the 
proposed work RVU of 3.18 other than debating survey times, primarily 
the intraservice time and total time ratios for this service, then 
justifying the proposed work RVU with the work RVU sum of deleted code 
32405 and imaging code 77012.
    The commenter also states that CMS overlooked the compelling 
evidence rationale for why this service is presently misvalued, and 
that cancer treatment protocols have evolved significantly to require 
more definitive tissue diagnosis including biomolecular marker 
profiles. The new code 32408 has increased the total time and the 
intensity/complexity, warranting the RUC-recommended work RVU of 4.00
    Response: We disagree and continue to believe that the use of time 
ratios is one of several appropriate methods for identifying potential 
work RVUs for particular PFS services, particularly when the 
alternative values recommended by the RUC and other commenters do not 
account for information provided by surveys that suggests the amount of 
time involved in furnishing the service has changed significantly. We 
reiterate that, consistent with the statute, we are required to value 
the work RVU based on the relative resources involved in furnishing the 
service, which include time and intensity. When our review of 
recommended values reveals that changes in time have been unaccounted 
for in a recommended RVU, then we believe it is appropriate to account 
for that change in establishing work RVUs since the statute explicitly 
identifies time as one of the two elements of the work RVUs. Please see 
above for our discussion of compelling evidence rationale. We do 
consider changes in technology, patient population, etc., insofar as 
they affect the time and intensity of the service under review. 
However, we do not specifically address the RUC's compelling evidence 
criteria in our rulemaking since it is outside the purview of the code 
valuation framework stipulated by statute. In addition, we reiterate 
that our proposal for this code was based on our analysis which 
indicated that there is some overlap in the work described in the two 
base services CPT codes 32405 and 77012. We continue to believe that a 
work RVU that is in excess of the aggregate work RVU of these two codes 
would result in an overestimation of intensity.
    After consideration of the comments, we are finalizing the work RVU 
and direct PE inputs for CPT code 32408 as proposed.
(13) Atrial Septostomy (CPT Codes 33741, 33745, 33746)
    Septostomy procedures are performed on extremely small newborns and 
neonates with severe forms of congenital heart disease and are 
lifesaving/temporizing procedures that do not provide definitive 
therapy to these critically ill patients. These procedures are not 
typical of the Medicare population and are of low volume. CPT code 
92992 (Atrial septectomy or septostomy; transvenous method, balloon 
(e.g., Rashkind type) (includes cardiac catheterization)) and CPT code 
92993 (Atrial septectomy or septostomy; blade method (Park septostomy) 
(includes cardiac catheterization)), are carrier-priced codes. These 
services were not formally designated as potentially misvalued in the 
CY 2019 PFS final rule (83 FR 59500), but we did make mention that the 
RUC had signaled its intention to review these two codes. Both services 
were referred to the CPT Editorial Panel by the specialty societies who 
indicated that CPT code 92992 may not have included related imaging 
guidance, and also commented that CPT code 92993 was antiquated and 
rarely performed. The CPT Editorial Panel deleted both CPT codes and 
proposed to replace them with the following new CPT codes.
    CPT code 33741 (Transcatheter atrial septostomy (TAS) for 
congenital cardiac anomalies to create effective atrial flow, including 
all imaging guidance by the proceduralist, when performed, any method 
(e.g., Rashkind, Sang-Park, balloon, cutting balloon, blade)), is one 
of three codes intended to replace the two deleted Septostomy codes. 
For CPT code 33741, the RUC recommended an RVU only crosswalk to CPT 
code 33340 (Percutaneous transcatheter closure of the left atrial 
appendage with endocardial implant, including fluoroscopy, transseptal 
puncture, catheter placement(s), left atrial angiography, left atrial 
appendage angiography, when performed, and radiological supervision and 
interpretation), which has a work RVU of 14.00. The RUC recommended 20 
minutes of preservice evaluation time, 15 minutes of preservice 
positioning time, 15 minutes preservice scrub/dress/wait time, 55 
minutes intraservice time and 45 minutes immediate postservice time, 
for 150 minutes total time. We proposed the RUC-recommended work RVU of 
14.00 and physician times without refinement.
    CPT code 33745 (Transcatheter intracardiac shunt (TIS) creation by 
stent placement for congenital cardiac anomalies to establish effective 
intracardiac flow, all imaging guidance by the proceduralist when 
performed, left and right heart diagnostic cardiac catherization for 
congenital cardiac anomalies, and target zone angioplasty, when 
performed (e.g., atrial septum, Fontan fenestration, right ventricular 
outflow tract, Mustard/Senning/Warden baffles); initial intracardiac 
shunt) is another new procedure code proposed by the CPT Editorial 
Panel. The service is currently performed on neonate infants to 
children with severe forms of congenital heart disease, by having a 
stent implanted inside of an infant's beating heart (and not within a 
blood vessel). This stent replaces the methods described in the deleted 
atrial septostomy codes utilizing the balloon and blade method. The RUC 
recommended 25 minutes preservice evaluation time, 15 minutes 
preservice positioning time, 15 minutes preservice scrub/dress/wait 
time, 92 minutes intraservice time and 60 minutes immediate postservice 
time, for 207 minutes total time. The RUC recommended 20.00 work RVUs 
for CPT code 33745. We proposed to adopt the RUC-recommended work RVUs 
and physician times.
    CPT code 33746, (Transcatheter intracardiac shunt (TIS) creation by 
stent placement for congenital cardiac anomalies to establish effective 
intracardiac flow, all imaging guidance by the proceduralist when 
performed, left and right heart diagnostic cardiac catherization for 
congenital cardiac anomalies, and target zone angioplasty, when 
performed (e.g., atrial septum, Fontan fenestration, right ventricular 
outflow tract, Mustard/Senning/Warden baffles); each additional 
intracardiac shunt location (List separately in addition to code for 
primary procedure)), is the add-on code to the proposed new procedure 
CPT code 33745, for 60 minutes of physician intraservice time. The RUC 
recommended a work RVU of 10.50 for CPT code 33746. This value for the 
add-on code, in comparison to the recommended work value of 20.00 RVUs 
with 92 minutes/intraservice time and 207 minutes of total time for CPT 
code 33745, appears to be unsupportable given the 60 minutes of 
additional physician intraservice time. We proposed a work RVU of 8.00 
for add-on CPT code 33746, which is the 25th percentile 
value from the survey and of similar valuation from reference CPT code 
93592 (Percutaneous

[[Page 84613]]

transcatheter closure of paravalvular leak; each additional occlusion 
device (List separately in addition to code for primary procedure)).
    This family of CPT codes are facility-only services and have no 
direct PE inputs.
    We received public comments on the proposed values for the Atrial 
Septostomy CPT codes 33741, 33745, 33746. The following is a summary of 
the comments we received and our responses.
    Comment: Commenters were supportive of CMS proposing the work RVUs 
as recommended by the AMA RUC for CPT code 33741, at 14.00, and for CPT 
code 33745, at 20.00. Commenters disagreed with CMS proposing 8.00 work 
RVUs for CPT code 33746, that differs from the AMA RUC recommended 
value of 10.50. Commenters did not believe that the work RVU of 8.00 
from CPT reference code 93592 (also an add-on code with the same amount 
of physician time), and from the survey's 25th-percentile 
work RVU value adequately reflected the resources involved in 
furnishing the service and suggested instead the survey's 
50th-percentile median value of 10.50 RVUs due to the 
intensity of the work in CPT code 33746, which involves the typical 
patient who is a small child or infant. The commenters stated that add-
on code 33746 is not intended as an extension of an initial stent 
procedure described by CPT code 33745 and that CPT code 33746 is the 
placement of a second stent where the work is more intense than the 
primary procedure, CPT code 33745.
    Response: For the new proposed CPT codes 33741 and 33745, the AMA 
RUC-recommended work RVUs values are considered higher in relationship 
to the physician times to perform the procedures and they note that 
this higher relationship is due to these procedures' higher than 
typical work intensity. The surveyed work RVU for CPT code 33741 at the 
25th-percentile was 10.99 but the AMA RUC-recommended value 
was 14.00, which was lower than the 50th-percentile median 
value of 17.00 RVUs and about midpoint between these upper and low 
quartiles. The surveyed work RVU at the 25th-percentile for 
CPT code 33745 was 20.00 which the AMA RUC recommended.
    The surveyed work RVU for add-on code CPT code 33746 at the 25th-
percentile was 8.00 but the AMA RUC recommended the work RVU of 10.50 
from the 50th-percentile median value, based on rationale 
similar to the rationale discussed above. For CPT code 33746, on the 
measure of physician time alone for 60 minutes we see comparable add-on 
codes with the identical amounts of physician time, valued at much less 
than their recommended 10.50 work RVUs, and much less than the CMS' 
referenced CPT code 93592's 8.00 work RVUs. Seeing that AMA RUC 
surveyed work RVU at the 25th percentile yielded a value of 
8.00 and that our comparator CPT code 93592 is also valued at 8.00 for 
60 minutes of physician time, we continue to believe that 8.00 work 
RVUs is the correct value for CPT code 33746.
    After consideration of the comments, we are finalizing the work RVU 
for CPT code 33741, CPT code 33745, and CPT code 33746, as proposed.
(14) Percutaneous Ventricular Assist Device Insertion (CPT Codes 33995, 
33990, 33991, 33992, 33997, and 33993)
    In May 2019, the CPT Editorial Panel approved the revision of four 
codes to clarify the insertion and removal of right and left heart 
percutaneous ventricular assist devices (PVAD), and the addition of two 
codes to report insertion of PVAD venous access and removal of right 
heart PVAD. These codes were surveyed with 000-day global periods and 
reviewed at the October 2019 RUC meeting.
    We proposed the RUC-recommended work RVUs for all six codes in the 
family. We proposed a work RVU of 6.75 for CPT code 33990 (Insertion of 
ventricular assist device, percutaneous, including radiological 
supervision and interpretation; left heart, arterial access only), a 
work RVU of 6.75 for CPT code 33995 (Insertion of ventricular assist 
device, percutaneous, including radiological supervision and 
interpretation; right heart, venous access only), a work RVU of 8.84 
for CPT code 33991 (Insertion of ventricular assist device, 
percutaneous, including radiological supervision and interpretation; 
left heart, both arterial and venous access, with transseptal 
puncture), a work RVU of 3.55 for CPT code 33992 (Removal of 
percutaneous left heart ventricular assist device, arterial or arterial 
and venous cannula(s), separate and distinct session from insertion), a 
work RVU of 3.00 for CPT code 33997 (Removal of percutaneous right 
heart ventricular assist device, venous cannula, separate and distinct 
session from insertion), and a work RVU of 3.10 for CPT code 33993 
(Repositioning of percutaneous right or left heart ventricular assist 
device, with imaging guidance, at separate and distinct session from 
insertion).
    Stakeholders contacted CMS regarding the valuation of the codes in 
this family following the arrival of the RUC recommendations. They 
stated that the RUC recommendations did not accurately reflect the work 
time of these procedures, which they stated to be increasing due to the 
adoption of new technology. The stakeholders requested that CMS propose 
to maintain the current work RVUs for the codes in this family and to 
crosswalk the work RVU of the new codes to existing codes.
    We disagreed with the stakeholders and proposed the RUC-recommended 
work RVUs for each code in this family as noted previously. We noted 
that in this case where the surveyed work times for the existing codes 
are decreasing and the utilization of CPT code 33990 is increasing 
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 support for proposing the RUC's recommended work RVUs. 
Although the incorporation of new technology can sometimes make 
services more complex and difficult to perform, it can also have the 
opposite effect by making services less reliant on manual skill and 
technique. We disagreed with the stakeholders that the incorporation of 
this new technology would necessarily be grounds for maintaining the 
current work RVU, as improvements in technology are commonplace across 
many different services and are not specific to this procedure. As 
detailed earlier, we also have reason to believe that the improved 
technology has led to greater efficiencies in the procedure which, 
under the resource-based nature of the RVU system, lends further 
support for proposing a lower work RVU for the existing CPT codes.
    The RUC did not recommend and we did not propose any direct PE 
inputs for this facility only code family. We proposed a 000-day global 
period for all six codes as surveyed by the RUC.
    We received public comments on the codes in the Percutaneous 
Ventricular Assist Device Insertion family. The following is a summary 
of the comments we received and our responses.
    Comment: Several commenters supported the CMS decision to propose 
the RUC-recommended work RVUs for each code in the family and 
recommended that CMS finalize the proposal.
    Response: We appreciate the commenters' support for our proposals.
    Comment: A commenter stated that the RUC recommendations included 
in the PFS proposed rule did not accurately reflect the full work 
associated with percutaneous ventricular assist device (PVAD) 
procedures. The commenter stated that

[[Page 84614]]

the RUC recommendations do not reflect increases in intra-procedure 
time resulting from the increased usage of SmartAssist technology and 
that if work value reductions continue over multiple years, it will 
impede physician adoption of these new technologies, resulting in a 
negative impact on patient access.
    Response: We appreciate the information provided by the commenter 
and we share in their concerns regarding the need to maintain patient 
access to these services. However, as we stated in the proposed rule, 
we have reason to believe that practitioners are becoming more 
efficient at performing the procedures, which, under the resource-based 
nature of the RVU system, gives support for proposing the RUC's 
recommended work RVUs. We disagree with the commenter that the 
incorporation of this new technology would necessarily be grounds for 
maintaining the current work RVU, as improvements in technology are 
commonplace across many different services and are not specific to this 
procedure. We continue to believe that the RUC-recommended work RVUs 
are the most accurate valuations for the codes in this family.
    After consideration of the public comments, we are finalizing our 
proposed work RVUs for the codes in the Percutaneous Ventricular Assist 
Device Insertion family. We did not propose and we are not finalizing 
any direct PE inputs for this facility only code family.
(15) Esophagogastroduodenoscopy (EGD) With Biopsy (CPT Code 43239)
    In the CY 2019 PFS final rule (83 FR 59500), CPT code 43239 
(Esophagogastroduodenoscopy, flexible, transoral; with biopsy, single 
or multiple) was publicly nominated for review under the potentially 
misvalued code initiative. As requested, the specialty societies 
conducted a survey for the April 2019 RUC meeting. The RUC survey 
results showed that the current work RVU of 2.39, which is below the 
survey 25th percentile work RVU of 2.50, accurately reflects 
the physician work for CPT code 43239.
    We proposed to maintain the current work RVU of 2.39 as recommended 
by the RUC. We proposed the RUC-recommended direct PE inputs for CPT 
code 43239 without refinement.
    We received public comments on Esophagogastroduodenoscopy (EGD) 
with Biopsy (CPT code 43239). The following is a summary of the 
comments we received and our responses.
    Comment: The commenters all agreed with the CMS proposal to 
maintain the current work RVU of 2.39 as recommended by the RUC. The 
commenters also all agreed with the CMS proposal of the RUC-recommended 
direct PE inputs with without refinement.
    Response: We appreciate the commenters' support for CMS proposing 
the RUC recommendation for CPT code 43239.
    After consideration of the public comments, we are finalizing the 
RUC-recommended work RVU of 2.39 for CPT code 43239. We are also 
finalizing the RUC-recommended direct PE inputs for CPT code 43239 
without refinement.
(16) Colonoscopy (CPT Code 45385)
    In the CY 2019 PFS final rule (83 FR 59500), CPT code 45385 
(Colonoscopy, flexible; with removal of tumor(s), polyp(s), or other 
lesion(s) by snare technique) was publicly nominated for review under 
the potentially misvalued code initiative. As requested, the specialty 
societies conducted a survey for the April 2019 RUC meeting. The RUC 
survey results showed that the current work RVU of 4.57, which is 
slightly above the survey 25th percentile work RVU of 4.50, 
accurately reflects the physician work for CPT code 45385.
    We proposed to maintain the current work RVU of 4.57 as recommended 
by the RUC. We proposed the RUC-recommended direct PE inputs for CPT 
code 45385 without refinement.
    We received public comments on Colonoscopy (CPT code 45385). The 
following is a summary of the comments we received and our responses.
    Comment: The commenters all agreed with the CMS proposal to 
maintain the current work RVU of 4.57 as recommended by the RUC. The 
commenters also all agreed with the CMS proposal of the RUC-recommended 
direct PE inputs with without refinement.
    Response: We appreciate the commenters' support for our proposal to 
adopt the RUC recommendation for CPT code 45385.
    After consideration of the public comments, we are finalizing the 
RUC-recommended work RVU of 4.57 for CPT code 45385. We are also 
finalizing the RUC-recommended direct PE inputs for CPT code 45385 
without refinement.
(17) Transrectal High Intensity Focused US Prostate Ablation (CPT Codes 
55880)
    In May 2019, the CPT Editorial Panel established a new code to 
report ablation of malignant prostate tissue with high intensity 
focused ultrasound (HIFU), including ultrasound guidance. For CPT code 
55880, we did not propose the RUC recommendation to use the survey 
median work RVU of 20.00 to value this service because we believe total 
time ratios to the two key reference codes, CPT codes 55840 
(Prostatectomy, retropubic radical, with or without nerve sparing) and 
55873 (Cryosurgical ablation of the prostate (includes ultrasonic 
guidance and monitoring)) indicate that this value is somewhat 
overstated and does not accurately reflect the physician time, and 
because an analysis of all 090-global period codes with similar time 
values indicates that this service is overvalued.
    We proposed a work RVU of 17.73 based on a crosswalk to CPT code 
69930 (Cochlear device implantation, with or without mastoidectomy) 
which has similar total time and identical intraservice time values and 
is more consistent with other codes of similar time. We proposed the 
RUC-recommended PE inputs without refinement.
    We received public comments on Transrectal High Intensity Focused 
US Prostate Ablation (CPT code 55880). The following is a summary of 
the comments we received and our responses.
    Comment: Commenters noted that, for CPT code 55880, the RUC 
recommended the survey 25th percentile work RVU of 20.00, not the 
survey median work RVU, as it is misstated in the proposed rule.
    Response: We regret the error, and we note that the RUC indeed 
recommended the survey 25th percentile work RVU.
    Comment: In response to this section, the RUC commented that they 
are increasingly concerned that CMS is eschewing the bedrock principles 
of valuation within the RBRVS (namely, magnitude estimation, survey 
data and clinical expertise) in favor of arbitrary mathematical 
formulas and, in their opinion, making distinctions in the different 
types of physician time, which are ``CMS/Other'' time source, 
``Harvard'' time source, and ``RUC'' time source (from physician 
surveys). The RUC suggested CMS use valid survey data and review the 
actual relativity for all elements (physician work, time, intensity and 
complexity) when developing work values for services and not foster 
flawed methodologies.
    Response: As we have discussed in previous rules, we agree that it 
is important to use the most recent data available regarding time, and 
we note that when many years have passed between when physician times 
are measured, significant discrepancies can occur. However, we also 
continue to believe that our operating assumption regarding the 
validity of the existing time values as a point of comparison is 
critical to the integrity of the current relative value system. The 
physician times and intensities currently

[[Page 84615]]

associated with codes play important roles in PFS ratesetting in their 
comparativeness to each other, in establishing work RVUs. The PFS is 
grounded in and reliant on the original relativity of the RBRVS, and 
then as services, codes and values evolve over the years, the PFS 
statute contemplates maintaining and building on that base-level of 
relativity. If we were to question the assumption that previously 
recommended work times had routinely been over- or underestimated, this 
would undermine the basis for relativity of the work RVUs on the PFS. 
Given that the process under which codes are often valued by comparison 
to codes with similar times, we acknowledge the distinction between 
``CMS/Other'' times, ``Harvard'' times, and ``RUC'' physician surveyed 
times, but we do not believe we can apply different validation weights 
to any of these sources of time values while remaining consistent with 
our obligation to consider time and intensity as these are currently 
reflected in the fee schedule. They are all physician time data 
collected over many years. We understand that some time values may not 
have been reviewed or re-surveyed in a number of years, but that alone 
is not an indicator of the current relative accuracy of a time value.
    We believe that, over the years as more codes are being reviewed 
and examined, the entire collective fee schedule of procedure codes 
should align in a very reliable and accurate relative value system 
reflecting each code's relativity with respect to other codes (in their 
work RVUs, in their procedure times, and in their work intensities). We 
recognize that adjusting work RVUs for changes in physician times is 
not always a straightforward process and that the intensity associated 
with changes in time is not necessarily always linear, which is why we 
always try to apply various methodologies to identify several potential 
work values for individual codes before deciding on the one we find 
most appropriate. Our review of code values under the PFS not only 
examines the relationships between work, time, and intensity, but we 
also look at magnitude and rank order anomalies, particularly in 
families or groups of codes that are closely related but may differ 
slightly in degrees found in their clinical descriptions and possibly 
in the typical beneficiary populations that each code might serve. 
Among these codes, we try to maintain the accurate relative 
relationships in terms of time, work, and intensity measurements. In 
some cases, where there are marked improvements in medical techniques 
and technologies, we may find efficiencies in physician's work for 
certain services that warrant decreases in physician's times, but we 
also recognize that some improvements may introduce greater complexity 
and either an increase in intensity and/or in physician times. We 
reiterate that we believe it would be irresponsible to ignore or 
discount ``CMS/Other'' times or ``Harvard'' times in our data system, 
and that we need to consider all times and all intensities and all 
clinically relevant relatedness (or non-relatedness) of procedure codes 
to each other in establishing more refined work RVUs for PFS services. 
Also note that physician times considered to be ``RUC'' physician times 
as they are listed in the RUC database are not always necessarily AMA 
RUC surveyed times. We may have adjusted AMA RUC surveyed times in our 
annual review of all HCPCS codes; and the same can be said of times 
that the AMA labels as ``Harvard'' or ``CMS/Other'' physician times.
    Comment: Many commenters stated that the proposed work RVU was too 
low to adequately reflect the work, skill and complexity required for 
this procedure. Commenters were concerned about patient access, stating 
that a significant number of Medicare beneficiaries with prostate 
cancer will not have access to this procedure. Commenters encouraged 
CMS to finalize the RUC-recommended work RVU of 20.00. Commenters 
stated that CMS did not provide any supporting rationale or clinical 
information for the proposed work RVU of 17.73 other than debating 
survey times, primarily the total time ratios between a service that is 
not currently covered to the two key reference codes, then justifying 
our proposed work RVU with a crosswalk to CPT code 69930. Commenters 
stated that this crosswalk is flawed in that it was surveyed 12 years 
ago, and it is clinically a very different procedure. A commenter 
suggested CPT code 42420 (Excision of the parotid tumor or parotid 
gland) with a work RVU of 19.53 as a more appropriate crosswalk as it 
is a more intense procedure than our proposed crosswalk CPT code 69930.
    Response: Our proposed work RVU of 17.73 is not solely derived from 
time ratios. Our analysis included comparisons to other codes of 
similar time values as well as to codes with similar numbers of the 
total number of post-op visits, as well as a consideration of the RUC-
recommended key reference services. These factors all indicated a work 
RVU lower than the recommended 20.00. Comparison of relative intensity 
values further indicates this RVU is somewhat overvalued. Our proposed 
value of 17.73 produces an intensity value of 0.066, which is very 
similar to the intensity value for our crosswalk CPT code 69930, which 
is 0.067. We disagree that the patient populations of these two codes 
are too different; the description and vignettes of CPT code 69930 do 
not indicate that this is primarily a pediatric procedure. Further, we 
reiterate that, although codes that describe clinically similar 
services are sometimes stronger comparator codes, we do not agree that 
codes must share the same site of service, patient population, or 
utilization level to serve as an appropriate crosswalk. We continue to 
believe the time values and relative intensity of this procedure 
indicate that a work RVU of 17.73 is a more accurate valuation, and we 
are finalizing this work RVU as proposed.
    After consideration of the public comments, we are finalizing as 
proposed a work RVU of 17.73, as well as the RUC-recommended direct PE 
inputs without refinement.
(18) Computer-Aided Mapping of Cervix Uteri (CPT Code 57465)
    In September 2019, the addition of CPT code 57465 (Computer-aided 
mapping of cervix uteri during colposcopy, including optical dynamic 
spectral imaging and algorithmic quantification of the acetowhitening 
effect (List separately in addition to code for primary procedure)) was 
approved by the CPT Editorial Panel to report computer-aided mapping of 
cervix uteri during colposcopy. The RUC recommended the survey median 
work RVU of 0.81 for this service.
    We proposed the RUC-recommended value of 0.81 for CPT code 57465. 
We also proposed the RUC-recommended direct PE inputs for this code.
    We solicited comment on a new medical supply indicated on the PE 
spreadsheet submitted by the RUC. A ``computer aided spectral imaging 
system (colposcopy) disposal speculum'' was noted in the RUC PE meeting 
materials. This name suggests it is digital. However, on the actual 
invoice submitted, the supply item in question was listed as a 
``disposable medium speculum'' with no mention of a spectral imaging 
system or a digital component. We researched this speculum and could 
not find any evidence that it has a digital component. Therefore, we 
proposed to change the name of this new supply item to ``disposable 
speculum, medium'' (SD337) to reflect the actual product on the invoice 
submitted. We sought clarification as to what aspect of the

[[Page 84616]]

speculum is digital or if a cheaper, non-digital speculum would 
suffice. We noted for example that the vaginal specula (SD118) supply 
has a CY 2021 price of $1.12 and we were able to find disposable medium 
specula readily available online for a price of roughly $1.00. We 
proposed the new SD337 supply at the $5.80 price as listed on the 
invoice submitted in the RUC materials and sought comment as to why 
other disposable speculums at a lower price would not be typical for 
this procedure.
    We received public comments on the Computer-Aided Mapping of Cervix 
Uteri code family (CPT code 57465). The following is a summary of the 
comments we received and our responses.
    Comment: Commenters were overall in support and appreciated CMS 
proposing the RUC-recommended work RVU and the direct PE inputs for 
code 57465. We also received comments with additional information on 
the SD337 supply item in question. Commenters stated that in order for 
the map to be successfully generated, there are stringent technical 
requirements of the vaginal speculum that require it to be attached to 
the optical head of the system. Commenters stated that the specula are 
therefore custom designed to meet performance standards, and are an 
integral part of the imaging system. One commenter noted that the 
speculum referenced is typical. The coating on the plastic that 
enhances the image is necessary, and without its light reflection on 
plastic interferes with the image processing.
    Response: We appreciate the additional information provided from 
commenters and the commenters' agreement with the proposed name change 
and that the item referenced is typical for the service noted.
    After consideration of the public comments, we are finalizing the 
RUC-recommended work RVU of 0.81 for CPT code 57465. We are also 
finalizing the proposed RUC-recommended direct PE inputs for this code. 
We are finalizing the new SD337 supply at the $5.80 price as listed on 
the invoice submitted in the RUC materials based on the public comments 
submitted. To clarify the nature of the supply, we are renaming SD337 
to ``digital imaging speculum'' to reflect what the commenters stated 
would be more accurate.
(19) Colpopexy (CPT Codes 57282 and 57283)
    The CPT codes 57282 (Colpopexy, vaginal; extra-peritoneal approach 
(sacrospinous, iliococcygeus)) and 57283 (Colpopexy, vaginal; intra-
peritoneal approach (uterosacral, levator myorrhaphy)) were identified 
by the RUC Relativity Assessment Workgroup as services performed less 
than 50 percent of the time in the inpatient setting yet include 
inpatient hospital E/M services within the global period and the 2018 
Medicare utilization is over 5,000. This code family was surveyed and 
reviewed for the January 2020 RUC meeting. For CY 2021, the RUC 
recommended a work RVU of 13.48 for CPT code 57282, and a work RVU of 
13.51 for CPT code 57283.
    We disagreed with the RUC-recommended work RVUs for the CPT code 
family of 57282 and 57283. We proposed a work RVU of 11.63 for CPT code 
57282, and also proposed to maintain the current work RVU of 11.66 for 
CPT code 57283. For CPT code 57283, we based our disagreement on the 
total time ratio between the current time of 349 minutes and the 
recommended time established by the survey of 231 minutes. This ratio 
equals 66 percent, and 66 percent of the current work RVU of 11.66 for 
CPT code 57283 equals a work RVU of 7.70. When we reviewed CPT code 
57283, we found that the recommended work RVU was higher than other 
codes with similar time values. This is supported by the reference CPT 
codes we compared to CPT code 57283 with 90 minutes of intraservice 
time; reference CPT code 19350 (Nipple/areola reconstruction) has a 
work RVU of 9.11 with 229 minutes of total time, and reference CPT code 
47563 (Laparoscopy, surgical; cholecystectomy with cholangiography) 
which has a work RVU of 11.47 with 238 minutes of total time. Although 
we did 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 noted that 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. The recommendation from the RUC 
acknowledged that the time had decreased for CPT code 57283, and also 
noted that there has been an increase in intensity due to a change in 
technique and knowledge necessary to perform the service. In the case 
of CPT code 57283, we noted that we believe it would be more accurate 
to propose maintaining the current work RVU of 11.66 instead of the 
RUC-recommended work RVU of 13.51 to account for these decreases in the 
surveyed work time while still accounting for the increase in 
intensity. We also noted that the intensity of CPT code 57283 would 
nearly double by maintaining the proposed work RVU of 11.66, due to the 
significant decreases in surveyed work time, which we believe supported 
the RUC's contention that the intensity of this code has increased over 
time.
    For CPT code 57282, we disagreed with the RUC-recommended RVU of 
13.48. We noted that the significant decrease in total time for code 
57282 suggests an RVU lower than 13.48. Although we disagreed with the 
RUC-recommended work RVU, we concurred that the relative difference in 
work between CPT codes 57282 and 57283 is equivalent to the RUC-
recommended interval of 0.03 RVUs. We noted that we believe the use of 
an incremental difference between these CPT codes is a valid 
methodology for setting values, especially in valuing services within a 
family of revised codes where it is important to maintain appropriate 
intra-family relativity. Therefore, we proposed a work RVU of 11.63 for 
CPT code 57282, based on the RUC-recommended interval of 0.03 RVUs 
below our proposed work RVU of 11.66 for CPT code 57283.
    We proposed the RUC-recommended direct PE inputs for the CPT code 
family of 57282 and 57283 without refinement.
    We received public comments on the Colpopexy code family (CPT codes 
57282 and 57283). The following is a summary of the comments we 
received and our responses.
    Comment: The commenters disagreed with our proposal to value CPT 
code 57282 using an incremental methodology, and stated that the 
proposal inaccurately treats all components of the physician time as 
having identical intensity. The commenters would prefer that CMS 
finalize the RUC-recommended value rather than values derived by 
increments. Moreover, commenters stated that CMS proposed the RUC work 
RVU increment (0.03) between CPT codes 57282 and 57283 for this code 
family, yet disagreed with the RUC-recommended work RVU.
    Response: We believe the use of an incremental difference between 
codes is a valid methodology for setting values, especially in valuing 
services within a family of revised codes where it is important to 
maintain appropriate intra-family relativity. Historically, we have 
frequently utilized an incremental methodology in which we value a code 
based upon its incremental difference between another code or another 
family of codes. We noted that the RUC has also used the same 
incremental methodology on occasion when it was unable to produce valid 
survey data for a service.

[[Page 84617]]

    Comment: Commenters stated that the RUC recommendation for CPT code 
57282 was based on robust survey results and requested that CMS adopt 
the RUC-recommended work values. The commenters stated that the current 
work value and time for CPT code 57282 were derived from the Harvard 
studies, and therefore, are not resource based. Commenters stated that 
they could not support comparing the original Harvard value of this 
service, which is over 25 years old and whose source is unknown, to 
time and work derived from a recent survey. Commenters stated that CPT 
code 57282 has never been surveyed by the RUC and the IWPUT for the 
current times and work RVU (0.014) are inappropriately low for this 
intense major surgical procedure, not that much higher than the 
intensity for pre-service scrub/dress/wait time, which strongly implies 
the current total times are inflated relative to the current work RVU 
and not valid for comparison to the new times. Commenters stated that 
the increased intra-service time can be attributed to the support 
sutures being placed at multiple points of attachment, which was not 
done in the past. Commenters stated that the largest difference in the 
total time comes from the hospital visit time assigned by Harvard in 
1992.
    Response: We agree that it is important to use the recent data 
available regarding time, and we acknowledge that when many years have 
passed between when work time is measured, significant discrepancies 
can occur. However, we also believe that our operating assumption 
regarding the validity of the existing values as a point of comparison 
is critical to the integrity of the relative value system as currently 
constructed. The times currently associated with codes play a very 
important element in PFS ratesetting, both as points of comparison in 
establishing work RVUs and in the allocation of indirect PE RVUs by 
specialty. If we were to operate under the assumption that previously 
recommended work times had routinely been underestimated or 
overestimated, this would undermine the relativity of the work RVUs on 
the PFS in general, given the process under which codes are often 
valued by comparisons to codes with similar times and it undermine the 
validity of the allocation of indirect PE RVUs to physician specialties 
across the PFS.
    Instead, we believe that it is crucial that the code valuation 
process take place with the understanding that the existing work times, 
used in the PFS ratesetting processes, are accurate. We recognize that 
adjusting work RVUs for changes in time is not always a straightforward 
process and that the intensity associated with changes in time is not 
necessarily always linear, which is why we apply various methodologies 
to identify several potential work values for individual codes. 
However, we want to reiterate that we believe it would be irresponsible 
to ignore changes in time based on the best data available and that we 
are statutorily obligated to consider both time and intensity in 
establishing work RVUs for PFS services. For additional information 
regarding the use of old work time values in our methodology, we refer 
readers to our discussion of the subject in the CY 2017 PFS final rule 
(81 FR 80273 through 80274).
    Comment: We received several comments regarding the decrease in 
total times for CPT codes 57282 and 57283. For CPT code 57282, a few 
commenters stated that the largest difference in the total time comes 
from the hospital visit time assigned by Harvard in 1992, which makes 
CMS' rationale to recommend a lower work RVU based on the ``significant 
decrease in total time'' completely flawed and unjustified. For CPT 
code 57283, the commenters disagreed that the decreased total time 
should result in a lower work RVU than the RUC recommendation, and 
stated that although the current times for CPT code 57283 have 
decreased according to the RUC survey data, the overall intensity and 
complexity has increased significantly.
    Response: For CPT codes 57282 and 57283, we disagree with the 
commenters and continue to believe that the use of time ratios is one 
of several appropriate methods for identifying potential work RVUs for 
particular PFS services, particularly when the alternative values 
recommended by the RUC and other commenters do not account for 
information provided by surveys that suggests the amount of time 
involved in furnishing the service has changed significantly. We 
reiterate that, consistent with the statute, we are required to value 
the work RVU based on the relative resources involved in furnishing the 
service, which include time and intensity. When our review of 
recommended values reveals that changes in the resource of time have 
been unaccounted for in a recommended RVU, then we believe we have the 
obligation to account for that change in establishing work RVUs since 
the statute explicitly identifies time as one of the two elements of 
the work RVUs. We recognize that it would not be appropriate to develop 
work RVUs solely based on time given that intensity is also an element 
of work, but in applying the time ratios, we are using derived 
intensity measures based on current work RVUs for individual 
procedures. Were we to disregard intensity altogether, the work RVUs 
for all services will be developed based solely on time values and that 
is definitively not the case, as indicated by the many services that 
share the same time values but have different work RVUs. Furthermore, 
we reiterate that we use time ratios to identify potentially 
appropriate work RVUs, and then use other methods (including estimates 
of work from CMS medical personnel and crosswalks to key reference or 
similar codes) to validate these RVUs. For more details on our 
methodology for developing work RVUs, we direct readers to the 
discussion CY 2017 PFS final rule (81 FR 80272 through 80277).
    Comment: Some comments stated that the proposed rule did not 
discuss the RUC's compelling evidence rationale for why CPT codes 57282 
and 57283 are presently undervalued, suggesting that CMS missed 
considering this rationale. Commenters stated that there has been a 
change in the physician work necessary to perform these services based 
on a change in technique and knowledge of the problem. Commenters 
stated that there has been a change in technology due to functional MRI 
studies which have increased what is known about pelvic organ prolapse 
and what structures are important to successful repair. Some commenters 
went on to describe the extent of dissection required and the change in 
technique which is now standardized when performing CPT codes 57282 and 
57283.
    Response: We agree with the commenters that due to changes in 
technology for CPT codes 57282 and 57283 we had reason to believe that 
practitioners are becoming more efficient at performing these 
procedures. While the incorporation of new technology can sometimes 
make services more complex and difficult to perform, it can also have 
the opposite effect by making services less reliant on manual skill and 
technique. We do not agree with the commenters that a change in the 
work pattern, and more dissections and greater use of sutures, would 
necessarily be grounds for increasing the work RVUs as recommended by 
the RUC, as improvements in technology are commonplace across many 
different services and are not specific to these procedures. We also 
have reason to

[[Page 84618]]

believe that the improved technology has led to greater efficiencies in 
these procedures which, under the resource-based nature of the RVU 
system, lends further support for the proposed work RVU of 11.63 for 
CPT code 57282 and 11.66 for CPT code 57283. Also, compelling evidence 
is not part of our statutory guidelines which require that the 
valuation of codes should be based on time and intensity. We do 
consider changes in technology, patient population, etc. insofar as 
they affect the time and intensity of the service under review. 
However, we do not specifically address the RUC's compelling evidence 
criteria in our rulemaking since it is outside the purview of the code 
valuation process stipulated by statute.
    Comment: Several commenters stated that CMS is incorrect in 
proposing a work RVU of 11.66 for CPT code 57283 based on referencing 
codes 19350 and 47563. CPT code 19350, involves an incision made 
externally on the breast to dissect a small amount of tissue at the 
site where the nipple will be made. The surgical site is external to 
the body without proximate anatomical structures that would be affected 
by a subcutaneous incision. Also, CPT code 19350 can be performed under 
local anesthesia and is performed in the office setting 19 percent of 
the time. CPT code 47563 does not include the amount of dissection and 
tissue reattachment that CPT code 57283 does, and the radiographic work 
included in CPT code 47563 is not comparable to the intensity or risk 
of CPT code 57283.
    Response: We continue to believe that the nature of the PFS 
relative value system is such that all services are appropriately 
subject to comparisons to one another. Although codes that describe 
clinically similar services are sometimes stronger comparator codes, we 
do not agree that codes must share the same site of service, patient 
population, or utilization level to serve as an appropriate code 
comparison or an appropriate crosswalk.
    Comment: Commenters appreciated that CMS proposed to accept the 
RUC-recommended direct PE inputs for CPT codes 57282 and 57283.
    Response: We appreciated the commenters for their support.
    After consideration of the public comments, we are finalizing the 
proposed work RVU of 11.63 for CPT code 57282 and the work RVU of 11.66 
for CPT code 57283. We are also finalizing the RUC-recommended direct 
PE inputs for the codes in the Colpopexy family of codes (CPT codes 
57282 and 57283) without refinement.
    (20) Laparoscopic Colpopexy (CPT code 57425)
    The CPT code 57425 (Laparoscopy, surgical, colpopexy (suspension of 
vaginal apex)) was identified by the RUC Relativity Assessment 
Workgroup as a service performed less than 50 percent of the time in 
the inpatient setting yet includes inpatient hospital E/M services 
within the global period and the 2018 Medicare utilization is over 
5,000. This service was surveyed and reviewed for the January 2020 RUC 
meeting.
    We disagreed with the RUC-recommended work RVU of 18.02 for CPT 
code 57425 and proposed to maintain the current RVU of 17.03 based on 
the total time ratio between the current time of 404 minutes and the 
recommended time established by the survey of 351 minutes. This was 
supported by the reference CPT codes we compared to CPT code 57425 with 
the same intraservice time; reference CPT code 26587 (Reconstruction of 
polydactylous digit, soft tissue and bone) which has a work RVU of 
14.50, and reference CPT code 20696 (Application of multiplane (pins or 
wires in more than 1 plane), unilateral, external fixation with 
stereotactic computer-assisted adjustment (e.g., spatial frame), 
including imaging; initial and subsequent alignment(s), assessment(s), 
and computation(s) of adjustment schedule(s)) which has a work RVU of 
17.56. Both CPT codes 26587 and 20696 have 180 minutes of intraservice 
time, which is equal to the 180 minutes of intraservice time in the RUC 
recommendation for CPT code 57425, and over 400 minutes of total time. 
The total time for CPT code 57425 decreased from 404 to 351 minutes and 
the RUC did not appear to take this into account. Therefore, we 
proposed to maintain the current work RVU of 17.03.
    We proposed the RUC-recommended direct PE inputs for CPT code 57425 
without refinement.
    We received public comments on the Laparoscopic Colpopexy code 
family (CPT code 57425). The following is a summary of the comments we 
received and our responses.
    Comment: The commenters disagreed that a decrease in total time for 
CPT code 57425 should result in a lower work RVU than the RUC 
recommendation since the intraservice time required to perform CPT code 
57425 increased significantly. The commenters also stated that using a 
total time ratio approach in lieu of the RUC survey data for CPT code 
57425 is erroneous.
    Response: For CPT code 57425, we disagree with the commenters and 
continue to believe that the use of time ratios is one of several 
appropriate methods for identifying potential work RVUs for particular 
PFS services, particularly when the alternative values recommended by 
the RUC and other commenters do not account for information provided by 
surveys that suggests the amount of time involved in furnishing the 
service has changed significantly. We reiterate that, consistent with 
the statute, we are required to value the work RVU based on the 
relative resources involved in furnishing the service, which include 
time and intensity. When our review of recommended values reveals that 
changes in the resource of time have been unaccounted for in a 
recommended RVU, then we believe it is appropriate to account for that 
change in establishing work RVUs since the statute explicitly 
identifies time as one of the two elements of the work RVUs. We 
recognize that it would not be appropriate to develop work RVUs solely 
based on time given that intensity is also an element of work, but in 
applying the time ratios, we are using derived intensity measures based 
on current work RVUs for individual procedures. Were we to disregard 
intensity altogether, the work RVUs for all services would be developed 
based solely on time values and that is definitively not the case, as 
indicated by the many services that share the same time values but have 
different work RVUs. Furthermore, we reiterate that we use time ratios 
to identify potentially appropriate work RVUs, and then use other 
methods (including estimates of work from CMS medical personnel and 
crosswalks to key reference or similar codes) to validate these RVUs. 
For more details on our methodology for developing work RVUs, we direct 
readers to the discussion CY 2017 PFS final rule (81 FR 80272 through 
80277).
    Comment: Commenters stated that CMS did not discuss the RUC's 
compelling evidence rationale in the proposed rule text for why CPT 
code 57425 is presently undervalued, and suggested CMS missed 
considering this rationale. The commenters further stated that the 
surgical techniques and technology for CPT code 57425 have changed 
drastically. Specifically, commenters stated that the technique has 
been refined and is now much more standardized than when CPT code 57425 
was last surveyed in 2003. This decreased the complication rate and has 
changed the physician work. In addition, commenters stated that there 
is a change in technology due to functional MRI studies which have 
increased what is known about pelvic

[[Page 84619]]

organ prolapse and what is important for a successful repair. Some 
commenters stated that the dissection is difficult and requires more 
time, as shown in the RUC survey, for CPT code 57425.
    Response: We agree with the commenters that due to a change in 
technology for CPT code 57425 we had reason to believe that 
practitioners are becoming more efficient at performing the procedure. 
While the incorporation of new technology can sometimes make services 
more complex and difficult to perform, it can also have the opposite 
effect by making services less reliant on manual skill and technique. 
We do not agree with the commenters that a change in the work practice 
and new technology would necessarily be grounds for increasing the work 
RVU to 18.02 as recommended by the RUC, as improvements in technology 
are commonplace across many different services and are not specific to 
this procedure. We also have reason to believe that the improved 
technology has led to greater efficiencies in the procedure which, 
under the resource-based nature of the RVU system, lends further 
support for maintaining the current work RVU value of 17.03 for CPT 
code 57425 as proposed. Also, compelling evidence is not part of our 
statutory guidelines which require that the valuation of codes should 
be based on time and intensity. We do consider changes in technology, 
patient population, etc., insofar as they affect the time and intensity 
of the service under review. However, we do not specifically address 
the RUC's compelling evidence criteria in our rulemaking since it is 
outside the purview of the code valuation process stipulated by 
statute.
    Comment: Some commenters stated that CMS is incorrect in proposing 
the current work RVU of 17.03 for CPT code 57425 when referencing CPT 
codes 26587 and 20696 because both procedures are performed on an 
external part of the body. Commenters went on to describe how the 
difficulty performing CPT codes 26587 and 20696 is not as great as 
performing CPT code 57425. For CPT code 26587, the physician is 
removing an external amount of tissue that includes bone and could be 
considered a sixth toe or finger, and has little risk to other organs 
or permanent disability. Commenters stated that there are not any close 
major blood vessels or an entire nerve plexus that must be avoided with 
CPT code 26587, while CPT code 57425 involves the placement of a 
synthetic mesh which must be performed properly to avoid erosion into a 
viscus, causing permanent long-term harm and multiple follow up 
surgeries. In addition, commenters stated that CPT code 26587 is a low 
volume Medicare procedure and was last reviewed by the RUC in 2001. CPT 
code 20696 is fixating an external metal frame onto someone's leg, 
which involves less risk and more space and visualization to perform 
than CPT code 57425.
    Response: We continue to believe that the nature of the PFS 
relative value system is such that all services are appropriately 
subject to comparisons to one another. Although codes that describe 
clinically similar services are sometimes stronger comparator codes, we 
do not agree that codes must share the same site of service, patient 
population, or utilization level to serve as an appropriate code 
comparison or an appropriate crosswalk. We looked to CPT codes 26587 
and 20696 as reference codes for comparison to CPT code 57425 based on 
their total time ratios. Few other supporting codes with similar 
intraservice time and total time were found. The current work RVU of 
17.03 is closer to the higher end of the RVUs within this reference 
code bracket that uses 26587 on the low end, and 20696 on the high end.
    Comment: Commenters supported the CMS proposal of the RUC-
recommended direct PE inputs for CPT code 57425.
    Response: We thank the commenters for their support.
    After consideration of the public comments, we are finalizing 
maintaining the current work RVU of 17.03 as proposed for CPT code 
57425. We are also finalizing the RUC-recommended direct PE inputs for 
the codes in the Laparoscopic Colpopexy family of codes (CPT code 
57425) without refinement.
(21) Intravitreal Injection (CPT Code 67028)
    CPT code 67028 (Intravitreal injection of a pharmacologic agent) 
was identified via the RUC's Relativity Assessment Workgroup as a code 
where the original valuation was based on a crosswalk code that had 
since been revalued. The RUC recommended that CPT code 67028 should be 
surveyed for the April 2019 RUC meeting. We proposed the RUC-
recommended work RVU of 1.44 for CPT code 67028.
    For the direct PE inputs, we proposed to refine the clinical labor 
time for the ``Clean room/equipment by clinical staff'' (CA024) 
activity from the RUC-recommended 5 minutes to 3 minutes for CPT code 
67028, because 3 minutes is the standard time for this clinical labor 
activity code, and we disagree that there would typically be a need for 
2 additional minutes for cleaning, sterilizing, and re-packaging a 
reusable eyelid speculum in a sterile package to prepare for its next 
case. Additionally, 3 minutes is the standard time for cleaning the 
room and cleaning the equipment; although we agreed that these cleaning 
tasks would take place, we do not believe that the removal of the same 
day E/M visit would result in the need for 2 additional minutes of 
cleaning time. We noted that we are proposed to maintain the current 
time for this clinical labor activity, which was previously finalized 
in the CY 2011 PFS final rule at the standard value of 3 minutes (75 FR 
73353). We also proposed to refine the equipment times to match the 
change in clinical labor time.
    We received public comments on CPT code 67028. The following is a 
summary of the comments we received and our responses.
    Comment: A commenter stated that they agreed with the CMS proposal 
of the RUC-recommended work RVU of 1.44. However, the commenter 
disagreed with the proposal to refine the clinical labor time for the 
``Clean room/equipment by clinical staff'' (CA024) activity from the 
RUC-recommended 5 minutes to 3 minutes. The commenter stated that the 5 
minutes listed for time to clean the room/equipment was not increased 
because of the absence of a same day E/M visit; rather, it was 
increased to appropriately reflect the current time it takes to clean/
disinfect the room and equipment. The commenter stated that the eyelid 
speculum is soaked in an antiseptic solution for a fixed period of 
time, then scrubbed, repackaged, and sterilized in an autoclave, and 
that an infection from an unsterile piece of equipment for this 
intraocular procedure can directly lead to endophthalmitis which is 
permanently blinding. The commenter also stated that they disagreed 
with the CMS refinement of the equipment time for the vaccine 
refrigerator (ED043) equipment since the medication must be logged into 
an inventory tracking system and it is now typical for each physician 
to hire a private temperature monitoring service that requires a 
recurring fee.
    Response: We disagree with the commenter regarding the refinements 
to the direct PE inputs for CPT code 67028. As we stated in the 
proposed rule, 3 minutes is the standard time for cleaning the room as 
well as cleaning the equipment, not one or the other. Although we 
appreciate the additional information stating that this cleaning time 
is not associated with an E/M visit, we do not agree that 2 minutes of 
additional clinical time would be

[[Page 84620]]

typical for this procedure, especially given that CPT code 67028 
currently allocates the standard 3 minutes of clinical labor time for 
cleaning activities. For the vaccine refrigerator (ED043) equipment, 
the refinement to the equipment time was made to conform to the 
refinement in clinical labor time associated with cleaning the room. We 
also note that any fees associated with a monitoring service for the 
refrigerator's temperature would be an indirect cost akin to office 
rent and therefore would not be included in the direct PE inputs.
    After consideration of the public comments, we are finalizing our 
proposed work RVU of 1.44 and our proposed direct PE inputs for CPT 
code 67028.
(22) Dilation of Eustachian Tube (CPT Codes 69705 and 69706)
    In September 2019, the CPT Editorial Panel created two new codes, 
CPT code 69705 (Nasopharyngoscopy, surgical, with dilation of 
eustachian tube (i.e., balloon dilation); unilateral) and CPT code 
69706 (Nasopharyngoscopy, surgical, with dilation of eustachian tube 
(i.e., balloon dilation); bilateral) to describe the dilation of the 
eustachian tube via surgical nasopharyngoscopy, unilateral and 
bilateral. We proposed the RUC-recommended work RVUs of 3.00 and 4.27 
for CPT codes 69705 and 69706, respectively. For the direct PE inputs, 
we proposed the RUC-recommended values without refinement.
    We received public comments on the Dilation of Eustachian Tube (CPT 
codes 69705 and 69706). The following is a summary of the comments we 
received and our responses.
    Comment: Several commenters stated their support for CMS proposing 
the RUC-recommended values without refinement.
    Response: We thank commenters for their feedback and support.
    After consideration of the public comments, we are finalizing the 
work RVUs and direct PE inputs for the codes in the Dilation of 
Eustachian Tube family as proposed.
(23) X-Ray of Eye (CPT Code 70030)
    CPT code 70030 (Radiologic examination, eye, for detection of 
foreign body) was identified through an updated screen of CMS/Other 
source codes with Medicare utilization over 20,000. We proposed the 
RUC-recommended work RVU of 0.18 for this service. We proposed the RUC-
recommended direct PE inputs without refinement.
    We received public comments on the X-Ray of Eye family (CPT code 
70030). The following is a summary of the comments we received and our 
responses.
    Comment: A commenter appreciated CMS' acceptance of the RUC 
recommendation for this code.
    Response: We appreciate the support for our proposals.
    After consideration of the public comments, we are finalizing the 
proposed work RVU of 0.18 as well as the proposed direct PE inputs for 
CPT code 70030.
(24) CT Head-Brain (CPT Codes 70450, 70460, and 70470)
    In the CY 2019 PFS final rule (83 FR 59500 through 59503), a 
stakeholder nominated CPT code 70450 (Computed tomography, head or 
brain; without contrast material) as potentially misvalued, citing GAO 
and MedPAC reports that suggest that work RVUs are overstated for 
procedures such as these, and the specialty society surveyed family 
codes 70460 (Computed tomography, head or brain; with contrast 
material(s)) and 70470 (Computed tomography, head or brain; without 
contrast material, followed by contrast material(s) and further 
sections). We proposed the RUC recommendation to maintain the current 
work RVUs of 0.85, 1.13, and 1.27 for CPT codes 70450, 70460, and 
70470, respectively. For CPT code 70450, we note that the surveyed 
times are nearly identical to the current times for these services, and 
we believe that the RUC's reference to CPT code 70486 (Computed 
tomography, maxillofacial area; without contrast material), which has 
similar physician time and the same work RVU, is appropriate. For CPT 
code 70460, we noted that the surveyed times are nearly identical to 
the current times for these services, and we believe that the RUC's 
reference to CPT code 70487 (Computed tomography, maxillofacial area; 
with contrast material(s)), which has similar physician time and the 
same work RVU is appropriate. Similarly, for CPT code 70470, we noted 
that the surveyed times are nearly identical to the current times for 
these services, and we believe that the RUC's reference to CPT code 
70488 (Computed tomography, maxillofacial area; without contrast 
material, followed by contrast material(s) and further sections), which 
has similar physician time and the same work RVU, is appropriate. We 
also noted that these codes are relatively consistently valued compared 
to other codes with similar time values and a global period of XXX. We 
proposed the RUC-recommended direct PE inputs without refinement.
    We received public comments on the CT Head-Brain (CPT codes 70450, 
70460, and 70470). The following is a summary of the comments we 
received and our responses.
    Comment: Commenters supported our proposal to adopt the RUC-
recommended work RVUs and PE inputs.
    Response: We appreciate the support for our proposals from the 
commenters.
    After consideration of the public comments, we are finalizing as 
proposed work RVUs of 0.85, 1.13, and 1.27 for CPT codes 70450, 70460, 
and 70470 respectively.
(25) Screening CT of Thorax (CPT Codes 71250, 71260, 71270, and 71271)
    In October 2018, AMA staff identified the CMS/Other Source codes 
with 2017 Medicare utilization over 30,000. HCPCS code G0297 (Low dose 
ct scan (ldct) for lung cancer screening) was identified. In January 
2019, the RUC recommended to refer to CPT Editorial Panel to establish 
a permanent code for this procedure. In May 2019, the CPT Editorial 
Panel revised three codes and added one code to distinguish diagnostic 
computed tomography, thorax from computed tomography, thorax, low dose 
for lung cancer screening.
    For CPT code 71250 (Computed tomography, thorax; without contrast 
material), we did not propose the RUC recommendation to maintain the 
current work RVU of 1.16 as we believe this does not accurately reflect 
the reduction in physician work time, and because an analysis of all 
XXX-global period codes with similar time values indicates that this 
service is overvalued. Instead, we recommended proposing a work RVU of 
1.08 based on the ratio of current to RUC-recommended intraservice 
time. As support for this value, we note that it falls slightly below 
CPT code 76391 (Magnetic resonance (e.g., vibration) elastography), 
which has a work RVU of 1.10 and also has higher physician time values.
    Similarly, for CPT code 71260 (Computed tomography, thorax; with 
contrast material(s)), we did not propose the RUC recommendation to 
maintain the current work RVU of 1.24 as we believe this does not 
accurately reflect the reduction in physician time, and proposed a work 
RVU of 1.16 based the ratio of current to RUC-recommended intraservice 
time. Although we disagreed with the RUC-recommended work RVU, we 
concurred that the relative difference between CPT codes 71250 and 
71260 is equivalent to the RUC-recommended interval of 0.08 RVUs. As 
stated previously, we noted

[[Page 84621]]

that we believe the use of an incremental difference between these CPT 
codes is a valid methodology for setting values, especially in valuing 
services within a family of revised codes where it is important to 
maintain appropriate intra-family relativity. We noted that the 
proposed work RVU of 1.16 maintains the RUC-recommended interval of 
0.08 additional RVUs above our proposed work RVU of 1.08 for CPT code 
71250.
    For CPT code 71270 (Computed tomography, thorax; without contrast 
material, followed by contrast material(s) and further sections), we 
did not propose the RUC recommendation to maintain the current work RVU 
of 1.38 as we believed this does not accurately reflect the reduction 
in physician time, and instead, we proposed a work RVU of 1.25 with a 
crosswalk to CPT code 93284 (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 transvenous implantable 
defibrillator system) and we supported this value by noting that it is 
slightly higher than values suggested by the ratio of current to RUC-
recommended intraservice time For CPT code 71271 (Computed tomography, 
thorax, low dose for lung cancer screening, without contrast 
material(s)), we did not propose the RUC-recommended work RVU of 1.16, 
but proposed a work RVU of 1.08 so that the value of this code is 
consistent with that of CPT code 71250 as current code G0297 is valued 
based on the value of CPT code 71250, and to maintain the relative 
relationship among these codes. In the CY 2016 PFS final rule (80 FR 
70974) we finalized that CPT code G0297 should be identically valued to 
CPT code 71250.
    We proposed the RUC-recommended direct PE inputs without refinement 
for CPT codes 71250, 71260, and 71270. For the direct PE inputs for CPT 
code 71271, we proposed 2 minutes for the clinical labor activity 
CA011: ``Provide education/obtain consent'' rather than the RUC-
recommended 3 minutes to be consistent with other non-contrast 
screening codes, and we proposed 4 minutes for the clinical labor 
activity CA038 ``Coordinate post-procedure services'' rather than the 
RUC-recommended 6 minutes to be consistent with other screening 
services, and because we did not see any compelling evidence that this 
service has changed significantly since G0297 was implemented for CY 
2015 to warrant the recommended 2 additional minutes.
    We received public comments on the codes in the Screening CT of 
Thorax family. The following is a summary of the comments we received 
and our responses.
    Comment: A commenter disagreed with the use of intraservice time 
ratios to account for changes in time, arguing that it negates CMS' 
longstanding position that 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.
    A commenter attributed the decreases in intra-service times for CPT 
codes 71250 and 71270 to survey variation. The commenter stated that 
reductions in pre and post-service time values do not necessarily 
justify a reduction in physician work value as intraservice work has a 
higher intensity than pre-service and post-service work. Additionally, 
the commenter stated that at these lower ends of time in the RBRVS, it 
is unreliable to draw conclusions based on single minute increments, 
which may simply be a result of rounding to whole integers.
    Response: While we agree that the surveyed intraservice times are 
not substantially lower than they are currently, we disagree that the 
differences in total time values are negligible or that they should not 
be accounted for in work RVU. In addition, we note that we considered 
the RUC-recommended values based on the relationship between work RVU 
and time as well as through comparisons to other CPT codes of similar 
time values. We continue to believe that in light of this analysis, the 
RUC-recommended values are overestimations.
    Comment: For CPT code 71250, a commenter disagreed with the use of 
a comparison to a magnetic resonance (MR) code with higher physician 
times, CPT code 76391 (Magnetic resonance (e.g., vibration) 
elastography). The commenter stated that this is a suboptimal 
comparison as CPT code 76391 involves work predominantly focused on a 
single organ (the liver) with, in general, a single pathology 
(fibrosis). In contrast, the commenter stated that CPT code 71250 
requires evaluation of numerous structures in the thorax including the 
heart, lungs, mediastinum, pleura and pleural space, bones, etc. which 
can be affected by a multitude of pathologies. For CPT code 71260, the 
RUC objected to the CMS statement that the proposed work RVUs maintain 
the RUC-recommended relative difference between CPT codes 71250 and 
71260, stating that time survey data and comparison codes, not ratios 
and intervals, were used in arriving at the value of 1.24 for CPT code 
71260.
    Response: We reiterate that a comparison to all XXX-global period 
codes with similar time values indicated that the RUC-recommended work 
RVU was overestimated for CPT code 71250. While we recognize that the 
RUC did not base its recommended valuation for CPT code 71260 on an 
incremental relationship, we continue to believe the use of an 
incremental difference between codes is a valid methodology for 
considering appropriate values, especially in valuing services within a 
family of revised codes where it is important to maintain appropriate 
intra-family relativity.
    Comment: For CPT code 71270, a commenter disagreed with the use of 
a crosswalk to CPT code 93284 (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 transvenous implantable 
defibrillator system) because these codes describe completely different 
clinical work.
    Response: We do consider clinical information associated with 
physician work intensity provided by the RUC and other stakeholders as 
part of our review process, although we remind readers that we do not 
agree that codes must share the same site of service, patient 
population, or utilization level to serve as an appropriate crosswalk.
    Comment: For CPT code 71271, the RUC noted that HCPCS code G0297 is 
CMS/Other sourced. Therefore, how the times and values were established 
is unknown or flawed. The RUC also agreed that the physician work 
involved in the new code for low-dose screening exam is comparable to 
the diagnostic exam performed in CPT code 71250. While CMS finalized a 
policy that HCPCS code G0297 should be identically valued to CPT code 
71250 in the CY 2016 PFS final rule (80 FR 70974-70975), the G-code is 
currently not valued the same. CPT code 71250 is currently valued 
higher than HCPCS code G0297 because CPT code 71250 was revalued in 
2016; its work RVU increasing from 1.02 to 1.16, however HCPCS code 
G0297 was not revalued at that time and remains currently valued at 
1.02. The RUC suggested CMS to accept a work RVU of 1.16 for CPT code 
71271 and requests deletion of HCPCS code G0297. In the event this G-
code is

[[Page 84622]]

not deleted, the RUC requests that HCPCS code G0297 be crosswalked to 
71271 and the same value and inputs be assigned.
    Response: Our proposed work RVU of 1.08 for HCPCS code 71271 is 
partly based on our assumption that this code has an identical work RVU 
to CPT code 71250. Our proposed values will restore parity between the 
two codes by increasing the work RVU for the former to match our 
proposed value for the latter.
    After consideration of the public comments, we are finalizing the 
work RVUs and direct PE inputs for the codes in the Screening CT of 
Thorax family as proposed.
(26) X-Ray Bile Ducts (CPT Codes 74300, 74328, 74329, and 74330)
    CPT codes 74300 (Cholangiography and/or pancreatography; 
intraoperative, radiological supervision and interpretation) and 74328 
(Endoscopic catheterization of the biliary ductal system, radiological 
supervision and interpretation) were identified through a screen of 
CMS/Other Source codes with 2017 Medicare utilization over 30,000. CPT 
codes 74329 (Endoscopic catheterization of the pancreatic ductal 
system, radiological supervision and interpretation) and 74330 
(Combined endoscopic catheterization of the biliary and pancreatic 
ductal systems, radiological supervision and interpretation) were 
included as part of the same code family and the family was surveyed. 
The codes describe x-rays of the liver, pancreas, and bile ducts. They 
are performed in facilities and have no direct PE inputs.
    We disagreed with the RUC-recommended work RVU of 0.32 for CPT code 
74300. We proposed a work RVU of 0.27 based on a crosswalk to CPT code 
74021 (Radiologic examination, abdomen; 3 or more views), one of the 
reference services from the RUC survey and that has an intraservice 
time of 4 minutes, nearly identical to the RUC's recommendation of 5 
minutes of intraservice time for CPT code 74300. The proposal was 
supported by CPT code 93922 (Limited bilateral noninvasive physiologic 
studies of upper or lower extremity arteries) with a work RVU of 0.25 
and an intraservice time of 5 minutes and a total time of 10 minutes. 
These times are nearly identical to the RUC's recommended intraservice 
of 5 minutes and total time of 10 minutes for CPT code 74300.
    We proposed the RUC-recommended work RVU of 0.47 for CPT code 74328 
(Endoscopic catheterization of the biliary ductal system, radiological 
supervision and interpretation), with an intraservice time of 10 
minutes and a total time of 20 minutes.
    We disagreed with the RUC's recommended work RVU of 0.50 for CPT 
code 74329 (Endoscopic catheterization of the pancreatic ductal system, 
radiological supervision and interpretation). We proposed a crosswalk 
to CPT code 74328 at a work RVU of 0.47 because the intraservice and 
total times for both codes are identical and we noted that we believe 
the work involved in the biliary ductal and pancreatic ductal systems 
is similar.
    We disagreed with the RUC's recommended work RVU of 0.70 for CPT 
code 74330 (Combined endoscopic catheterization of the biliary and 
pancreatic ductal systems, radiological supervision and interpretation) 
and we proposed a work RVU of 0.56 based on the proposal of the RUC's 
recommendation for CPT code 74328 to create internal consistency within 
the code family, based on our time ratio methodology and further 
supported by a reference to CPT code 93228 (External mobile 
cardiovascular telemetry with electrocardiographic recording, 
concurrent computerized real time data analysis and greater than 24 
hours of accessible ECG data storage (retrievable with query) with ECG 
triggered and patient selected events transmitted to a remote attended 
surveillance center for up to 30 days; review and interpretation with 
report by a physician or other qualified health care professional) with 
nearly identical and total time values to CPT code 74330.
    The RUC did not recommend and we did not propose any direct PE 
inputs for these codes.
    We received public comments on the X-Ray Bile Ducts code family. 
The following is a summary of the comments we received and our 
responses.
    Comment: A few commenters did not support the proposal of 0.27 work 
RVUs for CPT code 74300, stating that based on the RUC survey data, the 
overall intensity and complexity to perform CPT code 74300 is greater 
than that required to perform the key reference service of CPT code 
74021. Commenters also stated that the crosswalk to CPT code 74021 was 
inappropriate due to the service time difference between the codes.
    Response: Based on the survey results, we disagree that the overall 
intensity and complexity to perform CPT code 74300 is greater than that 
required to perform CPT code 74021. Based on the survey results, only 
the technical skill component of intensity suggested that CPT code 
74300 may be more intense than CPT code 74021, with 67 percent of 
respondents stating that CPT code 74300 was more intense. Comparing CPT 
code 74300 to its key reference service CPT code 74321, 50 percent of 
survey respondents reported that CPT code 74300 had identical 
intensity, 50 percent of survey respondents reported physical effort as 
having identical or less intensity, and 67 percent of survey 
respondents reported psychological stress as having identical or less 
intensity. We also disagree that the crosswalk to CPT code 74021 was 
inappropriate because the RUC used CPT code 74021 as a key reference 
survey in its survey. Thus, we are finalizing 0.27 work RVUs for CPT 
code 73400 as proposed.
    Comment: A few commenters supported the CMS proposal of 0.47 work 
RVUs for CPT code 74328.
    Response: We appreciate commenters' support and are finalizing 0.47 
work RVUs for CPT code 74328 as proposed.
    Comment: A few commenters did not support the proposal of 0.47 work 
RVUs for CPT code 74329. These commenters asserted that the work 
associated with assessing the pancreatic ductal system in CPT code 
74329 and is more intense and complex than CPT code 74328. They also 
stated that codes with identical times are not assigned the same RVU 
because both the AMA RUC and CMS recognize that procedures with 
equivalent times do not have equivalent intensities.
    Response: While it may be true that codes that have identical times 
can have different intensities, because the survey did not use CPT code 
74328 as a key reference service for the valuation of CPT code 74329, 
we do not believe the survey results provided sufficient evidence to 
support the assertion that CPT code 74329 is more intense. Thus, we are 
finalizing 0.47 work RVUs for CPT code 74329 as proposed.
    Comment: A few commenters did not support the proposal of 0.56 work 
RVUs for CPT code 74330. These commenters were concerned that we did 
not apply our time ratio methodology correctly. The commenters also 
disagreed with the use of time ratio methodologies for work valuation 
for these services. Commenters stated that this use of time ratios is 
not a valid methodology for the valuation of physician services.
    Response: To clarify, we used an intraservice time ratio and not a 
total time ratio. We disagree with the commenters and continue to 
believe that the use of time ratios is one of several appropriate 
methods for identifying potential work RVUs for PFS services.
    We have responded to concerns about our methodology earlier in this 
section

[[Page 84623]]

of this final rule. For additional information regarding the use of use 
of time ratios in our methodology, we refer readers to our discussion 
of the subject in the Methodology for Establishing Work RVUs section of 
this rule (section II.N.2), as well as a longer discussion in the CY 
2017 PFS final rule (81 FR 80273 through 80274). Thus, we are 
finalizing 0.56 work RVUs for CPT code 74330 as proposed.
    After consideration of the public comments, we are finalizing the 
work RVUs for the codes in the X-Ray Bile Ducts family as proposed. We 
did not propose and we are not finalizing any direct PE inputs for 
these codes.
(27) Venography (CPT Codes 75820 and 75822)
    The review of CPT code 75820 (Venography, extremity, unilateral, 
radiological supervision and interpretation) was prompted by the 
Relativity Assessment Workgroup Medicare utilization screen of over 
20,000 claims in a year. CPT code 75820 currently has a work RVU of 
0.70 with 14 minutes of total time. This service involves the 
supervision and interpretation of a contrast injection and imaging of 
either the upper or lower extremity. For CPT code 75820, the RUC 
recommended 12 minutes preservice time, 20 minutes intraservice time, 
10 minutes postservice time and 42 minutes of total time. The specialty 
societies' survey at the 25th percentile yielded a 1.05 work RVU, and 
it is the RUC's recommended work value. We proposed the RUC-recommended 
value for CPT code 75820.
    CPT code 75822 (Venography, extremity, bilateral, radiological 
supervision and interpretation) is reviewed as part of the family of 
codes included with CPT code 75820. CPT code 75822 has a current 1.06 
work RVU and 21 minutes of total time. The RUC recommended 15 minutes 
preservice time, 30 minutes intraservice time, 12 minutes postservice 
time and 57 minutes of total time, and the survey's 25th percentile 
work RVU of 1.48. The service is similar to CPT code 75820, except that 
this CPT code is bilateral, involving the supervision and 
interpretation of a contrast injection and imaging of both of either 
the upper or lower extremities. The RUC recommended 1.48 work RVU and 
57 minutes of total time for CPT code 75822. We proposed these RUC-
recommended values for CPT code 75822.
    We received public comments on the Venography services CPT codes 
75820 and 75822. The following is a summary of the comments we received 
and our responses.
    Comment: The commenters appreciated CMS' proposal of the AMA RUC 
recommended RVU values.
    Response: We appreciate the commenters' support for our proposal to 
adopt the RUC recommendations for CPT codes 75820 and 75822.
    After consideration of the public comments, we are finalizing the 
RUC recommendations for CPT codes 75820 and 75822, as proposed.
(28) Introduction of Catheter or Stent (CPT Code 75984)
    The RUC recommended reviewing CPT code 75984 (Change of 
percutaneous tube or drainage catheter with contrast monitoring (e.g., 
genitourinary system, abscess) radiological supervision and 
interpretation) after more utilization data was available, which 
resulted in this service being surveyed and reviewed for the April 2019 
RUC meeting. We proposed the work RVU of 0.83 as recommended by the 
RUC. We proposed the RUC-recommended direct PE inputs for CPT code 
75984 without refinement.
    We received public comments on the Introduction of Catheter or 
Stent family (CPT code 75984). The following is a summary of the 
comments we received and our responses.
    Comment: Commenters supported the CMS proposal of 0.83 for the work 
RVU as recommended by the RUC, as well as the proposal of the direct PE 
inputs without refinements.
    Response: We appreciate the commenters' support for our proposal to 
adopt the RUC recommendations for CPT code 75984.
    After consideration of the public comments, we are finalizing the 
RUC-recommended work RVU of 0.83 for CPT code 75984. We are also 
finalizing the RUC-recommended direct PE inputs for CPT code 75984 
without refinement.
(29) Medical Physics Dose Evaluation (CPT Code 76145)
    The CPT Editorial Panel created CPT code 76145 (Medical physics 
dose evaluation for radiation exposure that exceeds institutional 
review threshold, including report), which is a new PE-only code. 
Because of the high amount of clinical staff time and the fact that 
there are not analogous services, the PE Subcommittee requested that 
the specialty societies conduct a PE survey. In addition, they stated 
that the service is stand-alone, meaning that the medical physicist 
works independently from a physician and there are no elements of the 
PE that are informed by time from a physician work survey. Following 
the meeting, the specialty societies developed a PE survey which was 
reviewed and approved by the Research Subcommittee. We proposed the 
RUC-recommended direct PE inputs for CPT code 76145 without refinement.
    The following is a summary of the comments we received and our 
responses.
    Comment: Commenters supported the proposal to implement the RUC-
recommended direct PE inputs for CPT code 76145 without refinement.
    Response: We appreciate the support for our proposals from the 
commenters.
    Comment: Commenters recommended that CMS remove the Deficit 
Reduction Act (DRA) cap designation for CPT code 76145, stating that 
this is not an imaging service but a patient-specific organ dose 
assessment and evaluation performed by a medical physicist that can be 
utilized across a broad spectrum of cardiology and interventional 
radiology services. These dose calculations are commonly associated 
with interventional procedures and not diagnostic imaging studies.
    Response: We are persuaded by the commenters that this service does 
not describe an imaging service as defined for purposes of the ``DRA 
cap,'' also known as the ``OPPS cap,'' under section 1848(b)(4)(B) of 
the Act. We note it is more akin to physics consultation services 
similar to those described by CPT codes 77331 (Special dosimetry (e.g., 
TLD, microdosimetry) (specify), only when prescribed by the treating 
physician), 77336 (Continuing medical physics consultation, including 
assessment of treatment parameters, quality assurance of dose delivery, 
and review of patient treatment documentation in support of the 
radiation oncologist, reported per week of therapy), and 77370 (Special 
medical radiation physics consultation). Therefore, we are not 
including CPT code 76145 within the codes that are subject to the 
adjustment under section 1848(b)(4) will not be subject to the OPPS 
cap.
    After consideration of the public comments, we are finalizing the 
direct PE inputs for CPT code 76145 as proposed and removing this code 
from the OPPS Cap List.
(30) Ophthalmic Ultrasound Anterior Segment (CPT Code 76513)
    CPT code 76513 (Ophthalmic ultrasound, diagnostic; anterior segment 
ultrasound, immersion (water bath) B-scan or high resolution 
biomicroscopy) was identified by the RUC due to volume growth, 
attributed to improved equipment. The CPT Editorial Panel has

[[Page 84624]]

since revised this code to clarify that it is either unilateral or 
bilateral (it was previously unilateral). It was then surveyed. The 
code describes a test for glaucoma and is performed on the same day as 
an office/outpatient evaluation and management (O/O E/M) visit. The CPT 
and RUC removed CPT code 76513 from its former code family, creating a 
family of 1 service.
    In reviewing this code, we noted that the recommended total time is 
decreasing from 19 minutes to 15 minutes (21 percent) while the RUC-
recommended work RVU is decreasing from 0.66 to 0.60 (9 percent). We 
did not believe the RUC-recommended work RVU appropriately accounts for 
the substantial reductions in the surveyed work times for the 
procedure. Although we did 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 noted 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 76513, we noted that we believe that 
it would be more accurate to propose a work RVU of 0.53 based on a 
crosswalk to CPT code 74230 (Radiologic examination, swallowing 
function, with cineradiography/videoradiography, including scout neck 
radiograph(s) and delayed image(s), when performed, contrast (e.g., 
barium) study) with identical intraservice and total times.
    For the direct PE inputs, we proposed to make two refinements to 
the clinical labor times of CPT code 76513. We proposed a reduction of 
1 minute for the clinical labor task CA009: ``Greet patient, provide 
gowning, ensure appropriate medical records are available'' because the 
EHR information should already be linked from the preceding O/O E/M 
visit and the entry of information would be redundant and paid under 
indirect PE. We also proposed a reduction of 1 minute for the clinical 
labor task CA011: ``Provide education/obtain consent'' to be consistent 
with the time for this clinical labor task for the services in CPT code 
76513's former code family.
    We received public comments on CPT code 76513. The following is a 
summary of the comments we received and our responses.
    Comment: A few commenters disagreed with the CMS proposed work RVU 
of 0.53 and stated that CMS should finalize the RUC-recommended work 
RVU value of 0.60. Commenters stated that CPT code 76513 is more 
complex and intense than the proposed crosswalk of CPT code 74320 due 
to a wider number of potential diagnoses, and requires placing a probe 
with water bath on the patient's cornea, which is more uncomfortable 
than swallowing contrast, requiring extra skill and effort to obtain 
appropriate images.
    Response: We appreciate the additional information from the 
commenters regarding the intensity of CPT codes 76513 and 74320. In 
light of this additional information, we agree with the commenters that 
the diagnostic ophthalmic ultrasound service described by 76513 may 
have a higher intensity than the radiologic examination service 
described by CPT code 74320. Therefore, we are finalizing the RUC-
recommended work RVU of 0.60 for CPT code 76513.
    Comment: A few commenters stated that the crosswalk or methodology 
used in the original valuation of CPT code 76513 is unknown and not 
resource-based, and therefore, it was invalid for CMS to compare the 
current time and work to the surveyed time and work.
    Response: We appreciate the commenters' concerns regarding our 
interpretation of older work time sources and their use in the code 
valuation process for establishing work RVUs for these services. We 
agree that it is important to use the most recent data available 
regarding work times, and we acknowledge that when many years have 
passed between when time is measured, significant discrepancies can 
occur. However, we also believe that our operating assumption regarding 
the validity of the existing values as a point of comparison is 
critical to the integrity of the relative value system as currently 
constructed. We have responded to concerns about our methodology 
earlier in this section. For additional information regarding the use 
of old work time values that were established many years ago and have 
not since been reviewed; we refer readers to our discussion of the 
subject in the Methodology for Establishing Work RVUs section of this 
rule (section II.N.2. of this final rule), as well as a longer 
discussion in the CY 2017 PFS final rule (81 FR 80273 through 80274).
    Comment: A few commenters disagreed with our reduction of 1 minute 
of clinical labor task CA009: ``Greet patient, provide gowning, ensure 
appropriate medical records are available'' and stated that our 
assumption that the EHR information should already be linked from the 
preceding O/O E/M visit was incorrect. Commenters stated that it is not 
typical for the EHR and the ultrasound equipment to be linked and that 
staff time is required to enter the data into the ultrasound equipment 
software and ensure that it matches the information in the main EHR and 
therefore it would be inappropriate to reduce the RUC-recommended staff 
time.
    Response: While we appreciate the additional information that the 
EHR and the ultrasound equipment are not linked, we believe that the 
staff time required to enter the data into the equipment constitutes a 
data entry task and paid under indirect PE. Therefore, we are 
finalizing our proposed reduction of 1 minute of clinical staff time 
for CPT code 76513.
    Comment: A few commenters also disagreed with our proposed 
reduction of 1 minute for the clinical labor task CA011: ``Provide 
education/obtain consent.'' Commenters stated that this test involves 
placement of a device directly onto the ocular surface, with a risk of 
corneal abrasion and associated loss of vision. Thus, a clear and 
detailed explanation of what to expect was necessary to reduce patient 
anxiety and increase the patient's ability to cooperate with the exam. 
Thus, patient consent would require the RUC-recommended 3 minutes.
    Response: We appreciate the additional information from the 
commenters regarding the steps that are involved in providing education 
and obtaining consent and we agree with the commenters that the 
additional minute of time would be required. Thus, we are finalizing 
the RUC-recommended 3 minutes of clinical staff time.
    After consideration of the public comments, we are not finalizing 
our proposed work RVU of 0.53 for CPT code 76513 and are instead 
finalizing the RUC-recommended work RVU of 0.60. We are finalizing the 
direct PE inputs as proposed, with the exception of the proposed 
reduction of 1 minute for the clinical labor task CA011 as detailed 
above.
(31) Dual-Energy X-Ray Absorptiometry (CPT Code 77080)
    We did not make any proposals regarding CPT code 77080 (Dual-energy 
X-ray absorptiometry (DXA), bone density study, 1 or more sites; axial 
skeleton (e.g., hips, pelvis, spine)) in the proposed rule. Following 
the publication of the CY 2021 PFS proposed rule, a stakeholder 
contacted CMS and stated that Medicare payment for the CPT code 77080 
has declined in the nonfacility setting from $140 in 2006 to 
approximately $40 in 2020. The stakeholder stated that due to policies 
proposed in the CY 2021 PFS proposed rule, payment for DXA would be 
subject to an eight percent decrease bringing the payment rate to 
$36.78. The stakeholder

[[Page 84625]]

suggested CMS to address DXA payment in the CY 2021 PFS final rule.
    In response to the stakeholder, we note that the payment decreases 
for CPT code 77080 were produced by two factors: The adoption of the 
current PE methodology during CY 2007-2010 and the code's last RUC 
review in CY 2014. Payment for CPT code 77080 has been stable at 
approximately $40 for the last 6 years. We also note that our 
ratesetting methodology proposed a modest increase in total RVUs for CY 
2021 for CPT code 77080. However, the proposed decrease of 10.6 percent 
to the CF resulted in the proposed payment for CPT code 77080 
decreasing by approximately eight percent. This decrease would result 
from implementation of budget neutrality adjustment to the PFS 
conversion factor, and would not be caused by any policy changes 
associated with CPT code 77080. We remind stakeholders that, in 
accordance with section 1848(c)(2)(B)(ii)(II) of the Act, if revisions 
to the RVUs under the PFS cause expenditures for the year to change by 
more than $20 million, we are statutorily obligated to make budget 
neutrality adjustments to ensure that expenditures do not increase or 
decrease by more than $20 million. For additional information, we 
direct readers to the Regulatory Impact Analysis (section VIII.) of 
this rule. We may consider future rulemaking regarding CPT code 77080 
under the misvalued code initiative if there is continued stakeholder 
concern regarding the valuation of this service.
(32) Radiation Treatment Delivery (CPT Code 77401)
    CPT code 77401 (Radiation treatment delivery, superficial and/or 
ortho voltage, per day) was identified by the RUC Relativity Assessment 
Workgroup through a screen of high-volume growth, for services with 
2017 Medicare utilization of 10,000 or more that has increased by at 
least 100 percent from 2012 through 2017. In January 2019, the RUC 
recommended to refer to this service to the CPT Editorial Panel to 
better define the set of services associated with delivery of 
superficial radiation therapy (SRT).
    We proposed the following direct PE refinements: A reduction of 2 
minutes for the clinical labor task CA024: ``Clean room/equipment by 
clinical staff,'' to the standard 3 minutes, and we did not propose to 
include the new equipment item ER119 ``Lead Room,'' as we noted that we 
did not have enough information on what this equipment item contains, 
and we are requesting more information to allow us to determine if it 
is more accurately priced as direct or indirect PE. CPT code 77401 is a 
PE only code and we proposed to maintain the current work RVU of 0.00.
    We received public comments on the Radiation Treatment Delivery 
(CPT code 77401). The following is a summary of the comments we 
received and our responses.
    Comment: Many commenters stated that while they still believe more 
should be done with regard to the work RVUs for 77401 in order to make 
this treatment option more fair and equitable, the commenters greatly 
appreciate CMS' willingness to increase the PE RVUs for SRT. The 
commenters stated that this is a much needed increase for the modality 
as a whole and should result in an increase in availability for 
patients that truly need access to this technology for non-melanoma 
skin cancer and keloids.
    Response: We appreciate the support for our proposals from the 
commenters.
    Comment: Commenters provided information on the recommended new 
equipment item ER 119 (``Lead Room''), noting that all states require a 
lead shielded room for radiation therapy. Some commenters said that 
physicians can also utilize this room for other services when not using 
the SRT. Some commenters stressed that although the lead lined room may 
be used for other services when there is no patient receiving 
superficial radiation therapy (SRT), there should not be payment for 
the lead room when SRT is not being performed.
    Response: We continue to believe that, given the fact that the 
lead-shielded room may be used for other types of services as indicated 
by commenters, this item is not allocable specifically to CPT code 
77401, but is rather a general practice cost akin to office rent 
expenses. Therefore, we consider the lead-shielded room to be indirect 
PE, and we are finalizing the direct PE inputs as proposed, without 
including the lead lined room.
    Comment: Commenters disagreed with the proposed reduction of 2 
minutes for the clinical labor task CA024: ``Clean room/equipment by 
clinical staff'', to the standard 3 minutes. Commenters stated that the 
2 minutes were added by the RUC because the room and the equipment must 
be cleaned after each use and this has increased at least 5 fold under 
COVID. Commenters stated that the standard 3 minutes is for the room 
only and is insufficient to do both and that CMS should restore the 2 
minutes that were removed.
    Response: The commenters stated that 5 minutes are necessary to 
clean both the room and the equipment; however, the standard time of 3 
minutes already assumes that both the room and equipment will be 
cleaned. Therefore, we are finalizing this PE refinement as proposed.
    After consideration of the public comments, we are finalizing the 
direct PE inputs for this service as proposed.
(33) Proton Beam Treatment Delivery (CPT Codes 77520, 77522, 77523, and 
77525)
    In April 2018, the RUC's Relativity Assessment Workgroup (RAW) 
identified CPT code 77522 (Proton treatment delivery; simple, with 
compensation) and CPT code 77523 (Proton treatment delivery; 
intermediate) as contractor-priced Category I CPT codes with 2017 
estimated Medicare utilization over 10,000 services. Although the RAW 
agreed with the specialty society that this family of codes should 
remain contractor priced, the RUC determined that these services should 
be surveyed for PE. CPT codes 77520 (Proton treatment delivery; simple, 
without compensation) and 77525 (Proton treatment delivery; complex) 
were added to the family and the group was surveyed for PE for the 
April 2019 RUC meeting.
    We noted in the proposed rule that we encountered significant 
difficulties in reviewing the recommended direct PE inputs for the 
codes in the Proton Beam Treatment Delivery family. These difficulties 
were largely associated with determining a price for the two new 
equipment items in the code family, the Proton Treatment Vault (ER115) 
and the Proton Treatment Delivery System (ER116). These equipment items 
had extraordinarily high prices of $19,001,914 and $30,400,000 
respectively on the invoices submitted with the code family. By way of 
comparison, the highest equipment price currently existing in our 
database for CY 2021 is the ``SRS system, Linac'' (ER082) equipment 
item at $4,233,825. We noted concerns that establishing equipment 
pricing for the proton treatment vault and delivery system at a rate 
that is so much higher than anything else in our equipment database 
could distort relativity.
    We also noted concerns about the information provided on the 
submitted invoices used for the pricing of these two new equipment 
items. The invoices for both the Proton Treatment Vault and the Proton 
Treatment Delivery System contained building construction costs such as 
asphalt paving, masonry and carpentry expenses, drywall packaging, and 
the installation of electrical

[[Page 84626]]

systems. We noted that we understood that these proton treatment 
equipment items are extremely capital-intensive and require the 
construction of custom-built offices to house the equipment. However, 
the expenses associated with constructing new office facilities fall 
outside of our direct PE methodology, and would be more accurately 
classified as a form of building maintenance or office rent under 
indirect PE. We did not agree that construction costs should be 
included as a form of direct PE because they are not individually 
allocable to a particular patient for a particular service. Although we 
agreed that the proton beam treatment practitioners do need to bear the 
costs associated with the storage of this equipment, we noted that this 
is a form of indirect PE under our methodology. Therefore, we noted 
that we did not believe that it would serve the interests of relativity 
to include these building construction costs for the proton treatment 
equipment as a type of direct PE expense.
    As a result, we proposed to maintain contractor pricing for CPT 
codes 77520, 77522, 77523, and 77525 instead of proposing active 
pricing for these services. We noted that we believe that maintaining 
contractor pricing will allow the limited providers of these very 
expensive services to adapt more quickly to shifts in the market-based 
costs associated with the proton treatment equipment. The RUC similarly 
expressed concern in its recommendations about the extremely high cost 
of this equipment, agreed that these services were extremely hard to 
value, and noted the difficulties that had taken place in surveying the 
family of codes. The recommendations from the RUC also noted that 
proton treatment is a rapidly changing technology and the change in the 
treatment equipment often requires extensive modification to the vault. 
We also noted that we believe that these frequent changes can be more 
accurately captured through contractor pricing as opposed to the need 
to update the pricing of the proton treatment equipment on an annual 
basis.
    As discussed in the proposed rule, if we were to propose active 
pricing for the codes in this family, we believe that we would need to 
remove the building construction costs from the Proton Treatment Vault 
and the Proton Treatment Delivery System as forms of indirect PE, which 
would substantially lower their overall equipment prices. We would also 
refine the equipment times to the standard formula for highly technical 
equipment, which would result in 3 minutes less time for each equipment 
item (such as 14 minutes for all three equipment items in CPT code 
77522).
    We received public comments on the codes in the Proton Beam 
Treatment Delivery family. The following is a summary of the comments 
we received and our responses.
    Comment: Many commenters supported the proposal to maintain 
contractor pricing for CPT codes 77520, 77522, 77523, and 77525 instead 
of proposing active pricing for these services. Commenters stated that 
they applauded CMS for carefully considering the unintended 
consequences of pricing high equipment cost items using the current CMS 
methodology and agreed that contractor pricing will allow proton 
therapy practitioners to adapt quickly to shifts in the market-based 
costs associated with the proton treatment equipment. Commenters stated 
that until there is a way to accurately reflect the price of this 
advanced technology, they agreed with the proposal and requested that 
CMS maintain contractor pricing for the proton treatment delivery 
codes.
    Response: We appreciate the support for our proposals from the 
commenters.
    Comment: One commenter stated that although they currently 
supported the continuation of contractor pricing, the commenter also 
could envision proton beam treatment pricing at some percentage of OPPS 
rates (e.g., 95 percent of OPPS payment amount) as CMS looks to 
potentially value PE RVUs using OPPS rates. The commenter stated that 
while this rate might not adequately cover the PE component in some 
larger facilities, it would allow continued support for other 
facilities showing significant positive patient outcomes.
    Response: We appreciate the feedback from the commenter regarding 
the potential use of OPPS payment rates for PFS pricing.
    Comment: One commenter disagreed with the CMS proposal to maintain 
contractor pricing for CPT codes 77520, 77522, 77523, and 77525 and 
recommended that CMS finalize the RUC recommendations. The commenter 
stated that although it is not the purview of the RUC to make 
recommendations about pricing and useful life of equipment, CMS should 
accept the direct PE inputs for CPT codes 77520, 77522, 77523, and 
77525 as submitted by the RUC.
    Response: We disagree with the commenter and continue to believe 
that the unique nature of the equipment costs associated with these 
services poses problems for our PE methodology. We believe that 
maintaining contractor pricing will incorporate these costs into the 
payment rate while also allowing the limited practitioners of these 
very expensive services to adapt more quickly to shifts in the market-
based costs associated with the proton treatment equipment.
    After consideration of the comments, we are finalizing our proposal 
to maintain contractor pricing for CPT codes 77520, 77522, 77523, and 
77525.
(34) Immunization Administration (CPT Codes 90460, 90461, 90471, 90472, 
90473, and 90474 and HCPCS Codes G0008, G0009, and G0010)
    Especially in the context of the current PHE for COVID-19, it is 
evident that consistent beneficiary access to vaccinations is vital to 
public health. Many stakeholders have raised concerns regarding the 
reductions in payment rates for vaccine administration services over 
the past several years. The codes that describe these services have 
generally been valued based on a direct crosswalk to CPT code 96372 
(Therapeutic, prophylactic, or diagnostic injection (specify substance 
or drug); subcutaneous or intramuscular). Because we proposed and 
finalized reductions in valuation for that code for CY 2018 and because 
the reductions in overall valuation have been subject to the multi-year 
phase-in of significant reductions in RVUs, the payment rate for the 
vaccine administration codes has been concurrently reduced.
    In the CY 2020 PFS final rule, we acknowledged that it is in the 
public interest to ensure appropriate resource costs are reflected in 
the valuation of the immunization administration services that are used 
to deliver vaccines, and noted that we planned to review the valuations 
for these services in future rulemaking. For CY 2020, we maintained the 
CY 2019 national payment amount for immunization administration 
services described by HCPCS codes G0008 (Administration of influenza 
virus vaccine), G0009 (Administration of pneumococcal vaccine), and 
G0010 (Administration of hepatitis b vaccine) in the interim.
    The RUC has recently resubmitted recommendations from 2009 
regarding the appropriate valuation for the broader range of vaccine 
administration services, including CPT codes 90460 (Immunization 
administration through 18 years of age via any route of administration, 
with counseling by physician or other qualified health care 
professional; first or only component of each vaccine or toxoid 
administered), 90471 (Immunization administration (includes 
percutaneous, intradermal, subcutaneous, or intramuscular

[[Page 84627]]

injections); 1 vaccine (single or combination vaccine/toxoid)), and 
90473 (Immunization administration by intranasal or oral route; 1 
vaccine (single or combination vaccine/toxoid)). In its recommendation, 
the RUC noted that the current RVUs assigned are directly crosswalked 
from CPT code 96372 (like the vaccine administration G-codes had been) 
and the resulting payment rates are substantially lower than current 
Centers for Disease Control and Prevention (CDC) regional maximum 
charges. The RUC also pointed out that appropriate payment for 
immunization administration that reflects resource cost is critical in 
maintaining high immunization rates in the United States, as well as 
having the capacity to respond quickly to vaccinate against preventable 
disease outbreaks.
    We agreed with the RUC's assertions regarding the importance of 
appropriate resource-based valuations for vaccine administration 
services. We also recognized that the importance of these services is 
increased in the context of the current PHE for COVID-19, especially 
should there be a vaccine for this particular disease.
    We reviewed and considered the 2009 RUC-recommended direct PE 
inputs for CPT codes 90460-90474 (as well as the related G-codes) in 
place of the existing policy, based on a crosswalk to CPT code 96372. 
However, the RUC-recommended direct PE inputs from 2009 would result in 
significant decreases in valuation for these 6 CPT codes, even compared 
to the current crosswalk. At the time of the proposed rule, we did not 
believe that either the existing crosswalk or the RUC recommendations 
from over a decade ago reflect the relative resource costs associated 
with these services. Without updated information to use in developing 
rates specific to these codes based on direct PE inputs, and in 
consideration of the importance of these services for Medicare 
beneficiaries, as well as the public health concerns raised by 
commenters, we believed that it would be most appropriate to value 
these services using a crosswalk methodology that better reflects the 
relative resources involved in furnishing all of these services.
    Therefore, we proposed to crosswalk the valuation of CPT codes 
90460, 90471, and 90473 and HCPCS codes G0008, G0009, and G0010 to CPT 
code 36000 (Introduction of needle or intracatheter, vein). CPT code 
36000 is a service with a nearly identical work RVU (0.18 as compared 
to 0.17 for CPT codes 90460, 90471, and 90473) and a similar clinical 
vignette. We noted that we believe that the additional clinical labor, 
supply, and equipment resources associated with the furnishing of CPT 
code 36000 more accurately capture the costs associated with these 
immunization codes. We also noted that this crosswalk would result in 
payment rates for vaccine administration services at approximately the 
same CY 2017 rates that were paid prior to the revaluation of CPT code 
96372, which had previously served as the basis of the crosswalk. We 
noted that we believe that the proposed crosswalk is the most accurate 
valuation of these services and would also serve to ensure the 
appropriate relative resources involved in furnishing all of these 
services is reflected in the payment for these critical immunization 
and vaccination services in the context of the health needs of Medicare 
beneficiaries.
    Regarding the add-on codes associated with these services, CPT 
codes 90461 (Immunization administration through 18 years of age via 
any route of administration, with counseling by physician or other 
qualified health care professional; each additional vaccine or toxoid 
component administered), 90472 (Immunization administration (includes 
percutaneous, intradermal, subcutaneous, or intramuscular injections); 
each additional vaccine (single or combination vaccine/toxoid)), and 
90474 (Immunization administration by intranasal or oral route; each 
additional vaccine (single or combination vaccine/toxoid)), we noted 
that the previous valuation methodology set their RVUs at approximately 
half of the valuation for the associated base codes, described above. 
Absent additional information, we proposed to maintain that approach by 
valuing the three add-on codes at half of the RVUs of the 
aforementioned crosswalk to CPT code 36000.
    Finally, we proposed this valuation to apply to all of these 
existing vaccine administration codes, using the valuation of CPT code 
90471 for base codes and CPT code 90472 for add-on codes. We also noted 
that should a vaccine for COVID-19 or other infectious disease become 
available during CY 2021, we would anticipate applying the same 
approach to valuing the administration of such vaccines, regardless of 
whether separate coding for such services would need to be introduced.
    We received public comments on the codes in the Immunization 
Administration family. The following is a summary of the comments we 
received and our responses.
    Comment: Many commenters supported the proposal to crosswalk the 
valuation of CPT codes 90460, 90471, and 90473 and HCPCS codes G0008, 
G0009, and G0010 to CPT code 36000. Commenters stated that the current 
vaccine administration rates do not adequately cover the costs of 
purchasing, storing, monitoring, and administering vaccines and that 
appropriate valuation and reimbursement for these services is critical 
to ensuring widespread access to vaccines. Commenters agreed that the 
current crosswalk does not recognize the resources needed to provide 
the immunization procedure and that the proposed crosswalk to CPT code 
36000 more accurately captures the direct clinical labor and resources 
needed to perform immunizations.
    Response: We appreciate the support for our proposals from the 
commenters.
    Comment: Many commenters supported the proposal to crosswalk the 
valuation of CPT codes 90460, 90471, and 90473 and HCPCS codes G0008, 
G0009, and G0010 to CPT code 36000 while also disagreeing with the 
proposal to value the three add-on codes (CPT codes 90461, 90472, and 
90474) at half of the RVUs of the aforementioned crosswalk to CPT code 
36000. Commenters stated that the value of the work RVU for the add-on 
Immunization Administration codes is not half of the base codes but 
rather 88 percent of the value of the base codes. Commenters requested 
that CMS apply the same magnitude relationship between the base and 
add-on codes as in the previous valuation.
    Response: We appreciate the feedback from the commenters regarding 
the relationship between the base codes and add-on codes in this 
family. After reviewing the issue and looking at the historic 
relationship in payment rates for the base codes and add-on codes, we 
agree with the commenters that the add-on codes have typically been 
valued at 88 percent of the RVU of the base codes, not half of the 
value. Therefore, we are finalizing the value of the three add-on codes 
at 88 percent of the RVUs assigned to the immunization administration 
codes.
    Comment: Several commenters stated that they supported the 
proposals for this code family; however, they noted that there has been 
some confusion about the actual payment amount because RVUs for the 
CMS-issued immunization administration HCPCS ``G'' codes are not listed 
in the files sent to the contractors nor made available to the public. 
The commenters suggested CMS to include the crosswalked values for the 
immunization codes in the RVU files to ensure that the crosswalk is 
accurately implemented, and that stakeholders can identify the rate

[[Page 84628]]

Medicare will pay for vaccine administration.
    Response: HCPCS codes G0008, G0009, and G0010 are used to bill 
Medicare for administration of the preventive vaccines described under 
section 1861(s)(10) of the Act. They are not technically valued under 
the PFS, as they do not fit within the statutory definition of 
physicians' services in section 1848(j)(3) of the Act. CMS established 
HCPCS codes G0008, G0009, and G0010 to describe the administration of 
these preventive vaccines. As a result, no RVUs or payment amounts are 
shown for these codes in the PFS tables, and payment for them is not 
made under the PFS. While it is true that we have established payment 
rates for these codes using a crosswalk to the values of codes listed 
on the PFS, these three HCPCS codes do not have PFS rates themselves.
    Comment: Several commenters requested that in the future CMS should 
ensure a long-term sustainable valuation for vaccine administration by 
severing any linkage to other non-related CPT codes. The commenters 
recommend CMS consider determining the value of vaccine administration 
codes based on actual, updated physician time and PE inputs for vaccine 
administration.
    Response: We agree with the commenters that it would be helpful to 
be able to value the vaccine administration codes using direct PE 
inputs instead of relying on crosswalks to other services; however, as 
we mentioned in the proposed rule, we reviewed and considered the 2009 
RUC-recommended direct PE inputs and found that they would result in 
significant decreases in valuation for the six vaccine administration 
CPT codes, even compared to the current crosswalk. We would welcome the 
results of an updated formal review of these services as well as any 
additional information that may be helpful for improved valuation.
    Comment: Several commenters supported the proposal and further 
suggested CMS to use its available authority to make this proposed 
change in vaccine administration valuation effective prior to January 
1, 2021. Commenters stated that timely and appropriate payment for 
immunization administration that reflects resource cost is critical in 
maintaining high immunization rates in the United States as well as 
having the capacity to respond quickly to vaccinate against preventable 
disease outbreaks.
    Response: While we share the concerns of the commenters regarding 
the importance of appropriate payment for vaccine administration, this 
final rule takes effect beginning for CY 2021. We did not propose to 
modify payment policies for these services for any earlier timeframe 
and we continue to believe that the payment policies that we finalized 
last year were appropriate for these services.
    Comment: One commenter stated that Medicare pays a travel allowance 
to cover the transportation and personnel expenses for specimen 
collection from an individual or a patient in an inpatient facility 
other than a hospital. The commenter recommended that CMS establish a 
travel fee for providers/practitioners of current adult vaccines and 
for COVID-19 vaccinations to support access to immunizations, following 
the same approach and with the same value as established for specimen 
collection.
    Response: Travel and transportation fees are considered to be a 
form of indirect PE under our methodology and would not be included as 
a direct cost. Therefore, we do not believe it would be appropriate to 
establish a separate payment for these costs under the PFS or 
otherwise.
    Comment: One commenter disagreed with the rationale that CMS 
provided to crosswalk the PE RVUs for this set of codes to equal those 
for CPT code 36000. The commenter stated that CPT code 36000 is a 
bundled service that is not recognized for payment by CMS, nor has it 
ever been reviewed by the RUC; and this code includes a multispecialty 
visit pack that would be a duplication of resources for the vaccination 
codes, and that also includes an angiocatheter, which would never be 
used for vaccine administration. The commenter stated that arbitrarily 
assigning a specific PE RVU to this set of vaccination codes was 
another example of CMS's failure to consistently apply the same 
standards to all codes in the PFS, and as such, takes payment for 
resources away from one group of health care providers and assigns it 
to another group of health care providers.
    Response: We note that our proposal to crosswalk valuation for the 
vaccine administration services was based on methodological approaches 
that have long been used for valuation under the PFS and reflect our 
best estimate of resource cost for these services at the time of the 
proposal. As we mentioned in the proposed rule, we reviewed and 
considered the 2009 RUC-recommended direct PE inputs and found that 
they would result in significant decreases in valuation for the six 
vaccine administration CPT codes, even compared to the current 
crosswalk. We would welcome the results of an updated formal review of 
these services as well as any additional information that may be 
helpful for improved valuation.
    After considering the comments, we are not finalizing our proposal 
to crosswalk the valuation of CPT codes 90460, 90471, and 90473 and 
HCPCS codes G0008, G0009, and G0010 to CPT code 36000. We are instead 
finalizing a policy to maintain the CY 2019 payment for all nine of the 
services in this family, including the add-on codes. We note that 
maintaining the CY 2019 rates for these services will also maintain the 
historical relationship between the base administration codes and the 
add-on CPT codes 90461, 90472, and 90474, instead of our proposal to 
value the add-on codes at 50 percent of the base codes. As previously 
discussed, in our proposal, we approximated a cost for these services, 
but acknowledge the concerns that were raised in the comments we 
received and will continue to seek additional information that 
specifically reflects the resource costs and inputs that should be 
considered to establish payment for these services on a long-term 
basis. Again, we would welcome the results of an updated formal review 
of these services as well as any additional information that may be 
helpful for valuation in the immediate future.
(35) Liver Elastography (CPT Code 91200)
    CPT code 91200 (Liver elastography, mechanically induced shear wave 
(e.g., vibration), without imaging, with interpretation and report) was 
targeted for review through the RUC's new technology/new services 
screen. The RUC reviewed 3 years of available Medicare claims data 
(2016, 2017 and 2018) and surveyed the code for the January 2020 
meeting.
    We proposed the RUC-recommended work RVU of 0.21. We also proposed 
the RUC-recommended direct PE inputs for CPT code 91200 without 
refinement.
    We received public comments on CPT code 91200. The following is a 
summary of the comments we received and our responses.
    Comment: Several commenters supported the proposal of the RUC-
recommended work RVU and direct PE inputs for CPT code 91200.
    Response: We appreciate the support for our proposals from the 
commenters.
    Comment: Several commenters discussed the clinical benefits of 
liver elastography treatments using Fibroscan equipment. Commenters 
stated that this service expedites patient diagnosis and keeps care 
centered in the office while allowing for non-invasive screenings of 
this population to identify those

[[Page 84629]]

patients with advanced fibrosis and cirrhosis who are at high risk for 
complications and costly care, allowing for earlier successful 
outpatient intervention. Commenters recommended that Fibroscan 
reimbursement should be increased, not decreased, which will allow 
expanded utilization and access for more GI physicians providing more 
widespread use of this effective and non-invasive practice based 
technology.
    Response: We appreciate the additional information provided by 
commenters regarding the clinical benefits of the technology. However, 
the PFS is a resource-based payment system and we agree with the RUC 
that the resources associated with furnishing this service have 
decreased over time as the technology has become more widespread.
    Comment: Several commenters disagreed with the proposed price for 
the Fibroscan with printer (ER101) equipment. Commenters stated that 
the proposed price of $102,495 is not supported by customer invoices or 
StrategyGen's market research and that there is no available data that 
supports a 31 percent reduction in equipment pricing. The commenters 
recommended pricing the ER101 equipment at $136,449 based on the 
submission of seven new invoices. The commenters stated that the 
average cost on the invoices was $180,000, which included hardware 
costs and service contracts, and their recommended pricing of $136,449 
included the cost for CAP, which is an integral FibroScan component and 
not an optional addition. This price also included training and an S+ 
probe.
    Response: We appreciate the additional information provided by the 
commenters, especially the submission of invoices for use in pricing 
the Fibroscan equipment. Based on this additional information, we agree 
with the commenters that the CAP is an integral part of the Fibroscan 
equipment and should be included in the price of the equipment. 
However, training expenses are an indirect cost under our PE 
methodology and therefore are not included in the price of the 
equipment. We also noted that the S+ probe was only included on 2 of 
the 7 submitted invoices and as a result we do not believe that this is 
typically part of the cost of the Fibroscan equipment. (By contrast, 
the CAP option was present in all cases.) Therefore, we are finalizing 
an update in the price of the Fibroscan (ER101) to $125,096.21 based on 
an average of six invoices, as we were unable to use one invoice since 
it did not have individually itemized costs.
    Comment: Several commenters stated that Medicare and commercial 
payor utilization data for CPT code 91200 demonstrate that the usage of 
FibroScan in the physician office setting is well below 50 percent. 
Commenters stated that at a 50 percent usage rate, each FibroScan would 
generate 6,250 exams per year, or 24 per day, resulting in 3,656,250 
total national exams per year but the Medicare database identifies 
39,556 actual in-office claims in 2018 and 51,000 in 2019, resulting in 
less than 1 scan per day. Commenters stated that CMS can assign an 
equipment utilization rate of lower than 50 percent and the change is 
warranted by actual claims data. Commenters requested that CMS 
establish an equipment utilization rate of 10 percent for CPT code 
91200.
    Response: We disagree with the commenters that an equipment 
utilization rate of 10 percent would be typical for the Fibroscan. 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. It would distort relativity to assign 
a utilization rate of 10 percent for the Fibroscan equipment which 
would have the same effect as a fivefold increase in the price of the 
equipment. We continue to agree with the RUC's recommended direct PE 
inputs for CPT code 91200.
    After considering the comments, we are finalizing the RUC-
recommended work RVU of 0.21 and the RUC-recommended direct PE inputs 
for CPT code 91200. We are also finalizing an update in the price of 
the Fibroscan (ER101) equipment to $125,096.21.
(36) Remote Retinal Imaging (CPT Codes 92227, 92228, and 92229)
    The AMA CPT Editorial Panel revised CPT code 92227 (Imaging of 
retina for detection or monitoring of disease; with remote clinical 
staff review and report, unilateral or bilateral) and CPT code 92228 
(Imaging of retina for detection or monitoring of disease; with remote 
physician or qualified health professional review and report, 
unilateral or bilateral) that are reported for the treatment of 
diabetic retinopathy. Two practice sites are involved in these 
services: The acquiring site (for example, a primary care practice) and 
the reading site (for example, the ophthalmology practice). Both codes 
can be used to report diagnostic and monitoring services and the 
distinction is in whom provides the service: Physician (CPT code 92228) 
or clinical staff only (CPT code 92227). Thus, only CPT code 92228 
includes work, accounting for the physician at the reading site. For 
both CPT codes 92227 and 92228, direct PE pays for the clinical staff 
at both sites.
    The AMA CPT Editorial Panel also created CPT code 92229 (Imaging of 
retina for detection or monitoring of disease; with point-of-care 
automated analysis with diagnostic report; unilateral or bilateral) for 
point-of-care automated analysis that uses innovative artificial 
intelligence technology to perform the interpretation of the eye exam, 
without requiring that an ophthalmologist interpret the results. CPT 
code 92229 can be used at a primary care practice site and the 
artificial intelligence technology interprets the test instead of a 
remotely located ophthalmologist. Because no physician is involved, 
this service is PE only. We considered CPT code 92229 to be a 
diagnostic service under the PFS and are created separate payment for 
it.
    For CPT code 92228, we proposed the RUC's recommended work RVU of 
0.32. CPT codes 92227 and 92229 are PE only codes, and proposed a work 
RVU of 0.00 for both codes.
    For both CPT codes 92227 and 92228, we proposed the AMA RUC's 
recommended direct PE inputs. We proposed two refinements to the direct 
PE inputs for CPT code 92229. We proposed a reduction of 1 minute for 
the clinical labor task CA009, ``Greet patient, provide gowning, ensure 
appropriate medical records are available,'' to be consistent with the 
amount of clinical labor for this task in CPT codes 92228 and 92227. We 
did not propose the RUC's recommendation of a $25 ``per click'' 
analysis fee for remote imaging because we considered this a service 
fee that constitutes a form of indirect PE and that this cost is 
appropriately captured via the indirect PE methodology as opposed to 
being included as a separate direct PE input. We did not believe that 
the analysis fee would be allocated to the use of an individual patient 
for an individual service, and can be better understood as an indirect 
cost similar to other administrative expenses.
    We received public comments on the Remote Retinal Imaging family. 
The following is a summary of the comments we received and our 
responses.
    Comment: For CPT code 92228, a few commenters supported our 
proposals for 0.32 work RVUs with no refinements to the direct PE 
inputs.
    Response: We appreciate the commenters' support and are finalizing 
0.32 work RVUs and no refinements to the direct PE inputs as proposed.

[[Page 84630]]

    Comment: For CPT code 92227, a few commenters supported our 
proposals for 0.00 work RVUs with no refinements to the direct PE 
inputs.
    Response: We appreciate the commenters' support and are finalizing 
0.00 work RVUs with no refinements to the direct PE inputs as proposed.
    Comment: We received no comments on our proposal for 0.00 work RVU 
for CPT code 92229.
    Response: We are finalizing 0.00 work RVUs for CPT code 92229 as 
proposed.
    Comment: Several commenters disagreed with our proposals for the 
direct PE inputs for CPT code 92229. A few commenters disagreed with 
our reduction of 1 minute of clinical labor task CA009: ``Greet 
patient, provide gowning, ensure appropriate medical records are 
available.'' Commenters stated that it is not typical for the EHR and 
the imaging and analyzing software to be linked and that staff time is 
required to enter the data into the imaging and analyzing software and 
ensure that it matches the information in the main EHR and therefore it 
would be inappropriate to reduce the RUC-recommended staff time.
    Response: While we appreciate the additional information that the 
EHR and the imaging and analyzing software are not linked, we believe 
that the staff time required to enter the data into the imaging and 
analyzing constitutes a data entry task and is paid under indirect PE. 
Therefore, we are finalizing our proposed reduction of 1 minute of 
clinical staff time for CPT code 92229.
    Comment: Several commenters also disagreed with the elimination of 
the analysis fee for remote imaging. They asserted that the analysis 
fee is a direct cost because it is directly attributable to a specific 
patient and incurred for each patient. The commenters also stated that 
because the analysis is conducted by artificial intelligence (AI) 
software, there would be no service if the software was not used on a 
per patient basis.
    Response: As the PE data have aged and AI applications are 
emerging, we recognize that issues involving the use of AI are complex. 
While we agree that the costs for AI applications should be accounted 
for in payment, AI applications are not well accounted for in our PE 
methodology. In recent years, we have considered other services that 
use algorithms or artificial intelligence components to render key 
portions of a service. For example, in the CY 2018 OPPS final rule (82 
FR 59284), we discussed the fractional flow reserve computed tomography 
(FFRCT) service. We noted that that the service, which we considered to 
be separate and distinct from the original coronary computed tomography 
angiography service is not an image processing service but rather, the 
diagnostic output from the FFRCT reports functional flow values that 
can only be obtained using FFRCT. We found FFRCT to be similar to other 
technologies that use algorithms, artificial intelligence, or other new 
forms of analysis to determine a course of treatment, where the 
analysis portion of the service cannot adequately be reflected under 
the PFS payment methodology. Accordingly, we established contractor 
pricing for the service and have continued to gather information from 
stakeholders on payment that appropriately reflects resource cost for 
this service under the PFS payment methodology for the codes below. Our 
recent reviews of the overall cost for the service and specifically for 
the analysis component of the service related to the analysis services 
listed below have shown the costs to be similar, to the costs reflected 
in payment under the CY 2021 OPPS final rule for CPT code 0503T 
(analysis of fluid dynamics and simulated maximal coronary hyperemia, 
generation of estimated FFR model).
    We look forward to continuing to seek out new data sources and 
ongoing conversations with stakeholders to help in updating the PE 
methodology and the underlying data to better reflect such services. In 
the meantime, we are finalizing payment based on contractor pricing for 
CPT code 92229.
    After consideration of the comments, we are finalizing the work 
RVUs and direct PE inputs for CPT codes 92227 and 92228 as proposed and 
are finalizing contractor pricing for CPT code 92229 as detailed above.
(37) Auditory Evoked Potentials (CPT Codes 92584, 92650, 92651, 92652, 
and 92653)
    CPT codes 92585 (Auditory evoked potentials for evoked response 
audiometry and/or testing of the central nervous system; comprehensive) 
and 92586 (Auditory evoked potentials for evoked response audiometry 
and/or testing of the central nervous system; limited) were identified 
through a RAW requested screen of CMS/Other Source codes with 2017 
Medicare utilization over 30,000. Since these codes were last valued, 
audiologists, the primary reporter of these services, can now report 
Medicare services independently. As a result, the audiologist work for 
these services is moving from PE to work.
    To better describe tests of auditory function, the CPT created CPT 
code 92584 (Electrocochleography) and replaced CPT codes 92585 and 
92586 with four new services. We proposed the RUC-recommended work RVUs 
of 1.00 for CPT code 92584, 1.00 for CPT code 92651 (Auditory evoked 
potentials; for hearing status determination, broadband stimuli, with 
interpretation and report), 1.50 for CPT code 92652 (Auditory evoked 
potentials; for threshold estimation at multiple frequencies, with 
interpretation and report), and 1.05 for CPT code 92653 (Auditory 
evoked potentials; neurodiagnostic, with interpretation and report). 
CPT code 92650 (Auditory evoked potentials; screening of auditory 
potential with broadband stimuli, automated analysis) is a screening 
service and is not payable by Medicare. Therefore, we did not propose a 
valuation for this code; however, we noted we will display RUC-
recommended values associated with the code.
    We proposed the RUC-recommended direct PE inputs for this code 
family without refinement.
    We received public comments on the Auditory Evoked Potentials codes 
(CPT codes 92584, 92650, 92651, 92652, and 92653). The following is a 
summary of the comments we received and our responses.
    Comment: Commenters uniformly expressed support for our proposal to 
accept the RUC-recommended work RVUs and direct PE inputs for CPT codes 
92584, 92651, 92652, and 92653.
    Response: We appreciate the commenters' support.
    Comment: Commenters requested that CMS publish the RUC-recommended 
work, PE, and malpractice RVUs for CPT code 92650. CPT code 92650 is a 
key component of universal newborn hearing screening programs that are 
widely furnished across the country. As such, it is critical for CMS to 
display the total RVUs--to include the RUC's recommended work, PE, and 
MP RVUs--to allow state Medicaid agencies, newborn hearing programs, 
and commercial insurers to appropriately value 92650.
    Response: We did not propose values for CPT code 92650 because it 
is not a covered Medicare service. However, we will post the RUC-
recommended RVUs for this code.
    Comment: Commenters also noted a discrepancy between Addendum B--
which indicates 92650 is an active code (status indicator ``A'')--and 
the narrative in the proposed rule, which states that 92650 is a 
screening code and not payable by Medicare.
    Response: We acknowledge the error and have corrected it in 
Addendum B.
    Comment: Commenters requested that CMS create a professional and 
technical

[[Page 84631]]

component (PC/TC) split for CPT codes 92650, 92651, 92652, and 92653. 
Other audiology codes including CPT codes 92585 and 92586, which are 
being replaced by 92650-92651, also included the PC/TC split.
    Response: We appreciate commenters' suggestion that we create PC/TC 
splits for CPT codes 92650, 92651, 92652, and 92653. When we reviewed 
the code descriptors and the RUC recommendations for the codes, we 
noted that the direct PE for the new codes no longer includes clinical 
staff time. We also noted that the now deleted codes included clinical 
staff time that was assigned to an audiologist. We understood that the 
new codes represented changes to the service; audiologists were now 
able to bill independently for the work. During our review, we did not 
consider a PC/TC split and were surprised by the commenters' 
suggestion. Looking forward, we may consider this suggestion during 
future rulemaking.
    After considering the comments, we are finalizing the work RVUs and 
direct PE inputs for the codes in the Auditory Evoked Potentials family 
as proposed.
(38) Vestibular Evoked Myogenic Potential Testing (CPT Codes 92517, 
92518, and 92519)
    In response to a 2017 RAW request, AMA staff compiled a list of 
CMS/Other codes with Medicare Utilization of 30,000 or more. CPT code 
92585 (Auditory evoked potentials for evoked response audiometry and/or 
testing of the central nervous system; comprehensive) was identified as 
one of the codes. In 2018, the AMA/RUC referred CPT code 92585 and its 
family member CPT code 92586 (Auditory evoked potentials for evoked 
response audiometry and/or testing of the central nervous system; 
limited) to the February 2019 CPT Editorial Panel meeting to clarify 
code descriptors and define the terms ``limited'' and ``comprehensive'' 
auditory evoked potentials.
    During the discussion of CPT codes 92585 and 92586 at the February 
2019 CPT Editorial Panel meeting, specialty societies introduced a new 
procedure, Vestibular Evoked Myogenic Potential (VEMP), and suggested 
new coding. As a result, the CPT Editorial Panel created 3 new codes: 
CPT code 92517 (Vestibular evoked myogenic potential testing, with 
interpretation and report; cervical (cVEMP)); CPT code 92518 
(Vestibular evoked myogenic potential testing, with interpretation and 
report; ocular (oVEMP)); and CPT code 92519 (Vestibular evoked myogenic 
potential testing, with interpretation and report; cervical and 
ocular). The RUC reviewed the three codes at its April 2019 meeting.
    We proposed the RUC-recommended work RVU of 0.80 for CPT codes 
92517 and 92518. For CPT code 92519, we proposed the RUC-recommended 
work RVU of 1.20. We also proposed the RUC-recommended direct PE inputs 
without refinement for these three VEMP codes.
    We received public comments on the Vestibular Evoked Myogenic 
Potential Testing family (CPT codes 92517, 92518, and 92519). The 
following is a summary of the comments we received and our responses.
    Comment: Commenters wrote to express support for our proposal to 
accept the RUC-recommended work RVUs.
    Response: We appreciate the support of commenters.
    Comment: Commenters requested that CMS create a professional and 
technical component (PC/TC) split for the new codes. These commenters 
noted that audiologists who perform services in a facility setting 
require a mechanism to accurately report the professional component for 
their services. Commenters cited other vestibular testing codes such as 
CPT codes 92548 and 92549 that have a PC/TC split.
    Response: We appreciate commenters' interest in the creation of a 
PC/TC split for CPT codes 92517, 92518, and 92519. When we reviewed the 
code descriptors and the RUC recommendations, we noted that the direct 
PE for this set of new codes did not include clinical staff time. As a 
result, we did not consider a PC/TC split. However, as a result of the 
commenters' suggestion, we may consider the PC/TC split a topic of 
future rulemaking.
    After consideration of public comments, we are finalizing the work 
RVUs and direct PE inputs for the codes in the Vestibular Evoked 
Myogenic Potential Testing family as proposed.
(39) Complete Electrocardiogram (CPT Codes 93000, 93005, and 93010)
    In the CY 2019 PFS final rule (83 FR 59452), CPT code 93000 was 
nominated for review under the potentially misvalued code initiative. 
The RUC reviewed these services at the April 2019 meeting where the 
specialty societies explained that the family of electrocardiogram 
(ECG) codes were relatively unique in that CPT code 93000 
(Electrocardiogram, routine ECG with at least 12 leads; with 
interpretation and report) is the global service which is billed in the 
hospital setting, CPT code 93005 (Electrocardiogram, routine ECG with 
at least 12 leads; tracing only, without interpretation and report) is 
the technical component and CPT code 93010 is the professional 
component.
    We proposed the RUC-recommended work RVU of 0.17, which is the 
current value for both codes, for CPT codes 93000 and 93010. CPT code 
93005 is a PE only technical component code, and we proposed to 
maintain the current work RVU of 0.00.
    For the direct PE inputs, we proposed the RUC-recommended values 
without refinement.
    We did not receive public comments on this code family, and 
therefore, we are finalizing as proposed.
(40) External Extended ECG Monitoring (CPT Codes 93224, 93225, 93226, 
93227, 93241, 93242, 93243, 93244, 93245, 93246, 93247, and 93248)
    In September 2019, the CPT Editorial Panel replaced four Category 
III codes with 8 new Category I codes to report external 
electrocardiographic (ECG) recording by continuous rhythm recording and 
storage for periods longer than 48 hours. The existing Holter monitor 
codes (CPT codes 93224 through 93227) that include up to 48 hours of 
continuous recording were also reviewed as part of this family of 
services at the January 2020 RUC meeting.
    We proposed the RUC-recommended work RVU for all 12 codes in the 
family. We proposed a work RVU of 0.39 for CPT codes 93224 (External 
electrocardiographic recording up to 48 hours by continuous rhythm 
recording and storage; includes recording, scanning analysis with 
report, review and interpretation by a physician or other qualified 
health care professional) and 93227 (External electrocardiographic 
recording up to 48 hours by continuous rhythm recording and storage; 
review and interpretation by a physician or other qualified health care 
professional); a work RVU of 0.50 for CPT codes 93241 (External 
electrocardiographic recording for more than 48 hours up to 7 days by 
continuous rhythm recording and storage; includes recording, scanning 
analysis with report, review and interpretation) and 93244 (External 
electrocardiographic recording for more than 48 hours up to 7 days by 
continuous rhythm recording and storage; review and interpretation); 
and a work RVU of 0.55 for CPT codes 93245 (External 
electrocardiographic recording for more than 7 days up to 15 days by 
continuous rhythm recording and storage; includes recording, scanning 
analysis with report, review and interpretation) and 93248 (External 
electrocardiographic recording for more

[[Page 84632]]

than 7 days up to 15 days by continuous rhythm recording and storage; 
review and interpretation).
    The other six codes in the family are technical component codes 
that do not have a work RVU; we proposed a work RVU of 0.00 for CPT 
codes 93225 (External electrocardiographic recording up to 48 hours by 
continuous rhythm recording and storage; recording (includes 
connection, recording, and disconnection)), 93226 (External 
electrocardiographic recording up to 48 hours by continuous rhythm 
recording and storage; scanning analysis with report), 93242 (External 
electrocardiographic recording for more than 48 hours up to 7 days by 
continuous rhythm recording and storage; recording (includes connection 
and initial recording)), 93243 (External electrocardiographic recording 
for more than 48 hours up to 7 days by continuous rhythm recording and 
storage; scanning analysis with report), 93246 (External 
electrocardiographic recording for more than 7 days up to 15 days by 
continuous rhythm recording and storage; recording (includes connection 
and initial recording)), and 93247 (External electrocardiographic 
recording for more than 7 days up to 15 days by continuous rhythm 
recording and storage; scanning analysis with report).
    For the direct PE inputs, we proposed to refine the clinical labor 
time for the ``Perform procedure/service--NOT directly related to 
physician work time'' (CA021) activity for CPT codes 93241, 93243, 
93245, and 93247. We proposed to reduce the clinical labor time by 5 
minutes for each code as the description of the tasks taking place in 
the recommended materials includes activities that are considered to be 
indirect PE under our methodology. The recommended materials stated 
that ``incoming patch deliveries are sorted and distributed to work 
queues. The return box is opened, diary book removed, top housing is 
removed using a custom tool to expose USB connection, and device is 
plugged in to extract serial number and diagnostic logs.'' These 
unboxing and filing activities are classified as administrative 
expenses under our PE methodology, and therefore, do not constitute 
clinical labor as a direct expense. We proposed to remove 5 minutes 
from the clinical labor to reflect these activities, which are indirect 
as opposed to direct costs. We also proposed to refine the equipment 
time for the desktop computer (ED021) to reflect these changes in the 
clinical labor time.
    We noted an inconsistency in the RUC-recommended direct PE inputs 
for CPT codes 93241 and 93245. Both of these codes are the ``global 
component'' for their respective group of codes, such that the direct 
costs for CPT codes 93242-93244 must sum up to the direct cost of CPT 
code 93241 and the direct costs for CPT codes 93246 through 93248 must 
sum up to the direct cost of CPT code 93245. However, CPT codes 93241 
and 93245 each contained 2 pairs of non-sterile gloves (SB022) whereas 
their constituent technical component codes (93242 and 93246 
respectively) only contained a single pair of non-sterile gloves. 
Therefore, we proposed to refine the quantity of the non-sterile gloves 
down to 1 pair for CPT codes 93241 and 93245 to correct this 
inconsistency. We noted we also considered increasing the quantity of 
the gloves to 2 as in CPT codes 93224 through 93227. However, we 
believed that only 1 pair of gloves would typically be needed to attach 
the ECGs, as the patient does not return to have the ECGs removed in 
CPT codes 93241 through 93248 as opposed to CPT codes 93224 through 
93227 where the patient does return for ECG removal.
    We proposed the RUC-recommended equipment time of 1,474 minutes for 
the Holter monitor (EQ127) equipment included in CPT codes 93224 and 
93226, based on an equipment time of 34 minutes during the procedure 
along with 1,440 minutes (24 hours) of equipment time thereafter. We 
noted that an external stakeholder wrote to request that the number of 
minutes of equipment time for the Holter monitor be increased from 
1,440 minutes (24 hours) to 2,160 minutes (36 hours) to reflect the 
average length of equipment time. The stakeholder wrote that the 24-
hour and 48-hour test were each performed approximately 50 percent of 
the time and stated that the most accurate number of equipment minutes 
would be the average time. The RUC disagreed with the stakeholder's 
request in its review because it concluded that there was insufficient 
evidence to warrant a change from the current 24 hours of equipment 
time; the RUC-recommended equipment time for the Holter monitor was 
based on the typical rather than the average service. We proposed the 
RUC-recommended equipment time of 1,474 minutes because our PE 
methodology is indeed based on the typical case, specifically what 
would be typical and reasonable and necessary for the procedure in 
question. Although we appreciated the feedback from the stakeholder, 
our previously finalized PE methodology establishes pricing based on 
the typical case. For a detailed explanation of the direct PE 
methodology, including examples, we refer readers to the 5-year review 
of work RVUs under the PFS and proposed changes to the PE methodology 
CY 2007 PFS proposed notice (71 FR 37242) and the CY 2007 PFS final 
rule with comment period (71 FR 69629).
    The recommendations for this family of codes contain one new supply 
item, the ``extended external ECG patch, medical magnetic tape 
recorder'' (SD339). We did not receive a traditional invoice to 
establish a price for this supply item, instead receiving pricing 
information from two sources: A weighted median of claims data with the 
cost of the other direct PE inputs removed, and a top-down approach 
calculating the cost of the supply per service based on summing the 
total costs of the health care provider and dividing by the total 
number of tests furnished. The former methodology yielded a supply 
price of approximately $440 while the latter methodology produced an 
estimated supply price of $416.85. Stakeholders also submitted a series 
of invoices from the clinical study marketplace with a price of $595. 
Although we are appreciative of the data provided by the stakeholder, 
we require an invoice representative of commercial market pricing to 
establish a national price for a new supply or equipment item. Although 
we are aware of the unusual circumstances surrounding the ``extended 
external ECG patch, medical magnetic tape recorder'' in terms of how it 
uploads data to the health care provider, we cannot establish supply 
pricing based on an analysis of claims data and in absence of a 
representative invoice.
    Therefore, we proposed to employ a crosswalk to an existing supply 
for use as a proxy price until we have an invoice to use for the 
``extended external ECG patch, medical magnetic tape recorder'' item. 
We proposed to use the ``kit, percutaneous neuro test stimulation'' 
(SA022) supply as our proxy item at a price of $413.24. Although this 
kit is not clinically similar to the extended external ECG patch, we 
believe that it is the closest match from a pricing perspective to 
employ as a proxy until we are able to arrive at an invoice that is 
representative of commercial market pricing. We welcomed the submission 
of invoices or other additional information for use in pricing the 
``extended external ECG patch, medical magnetic tape recorder'' supply.
    We received public comments on the codes in the External Extended 
ECG Monitoring family. The following is a

[[Page 84633]]

summary of the comments we received and our responses.
    Comment: Several commenters supported the proposal of the RUC-
recommended work RVUs for all of the codes in the External Extended ECG 
Monitoring family.
    Response: We appreciate the support for our proposals from the 
commenters.
    Comment: One commenter supported the proposal to refine the 
quantity of the non-sterile gloves down to 1 pair for CPT codes 93241 
and 93245 to correct an inconsistency in the RUC recommendations. The 
commenter agreed that this corrected a summing error.
    Response: We appreciate the support for our proposals from the 
commenter.
    Comment: Several commenters disagreed with the proposal to reduce 
the clinical labor time for the ``Perform procedure/service--NOT 
directly related to physician work time'' (CA021) activity for CPT 
codes 93241, 93243, 93245, and 93247 by 5 minutes. Commenters stated 
that delivery and assignment tasks may be fair to characterize as 
administrative, but accessing the device, connecting it, and 
downloading data is more akin to the CA032 activity code (``Scan exam 
documents into PACS. Complete exam in RIS system to populate images 
into work queue.'') when clinical data is put into the system. 
Commenters recommended that CMS reduce clinical staff time by 1 minute, 
not 5, to account for the delivery sorting, distribution, and box 
opening.
    Response: We continue to disagree with the commenters and maintain 
that the proposed reduction of 5 minutes of clinical labor time is 
warranted as the activities listed by commenters are forms of indirect 
PE. Data entry tasks such as connecting a device and downloading data 
are typically considered to be forms of indirect PE unless they are 
directly allocable to a particular patient for a particular service. We 
do not agree that the suggested comparison to the CA032 activity code 
would be accurate for these services, as the CA032 activity code 
requires the use of a PACS workstation, which is not present in any of 
these CPT codes.
    Comment: Several commenters disagreed with CMS' position regarding 
equipment time for the wearable holter monitor (EQ127) device. 
Commenters stated that they had presented evidence to the RUC 
demonstrating that about half of the services described by CPT code 
93226 involve 24 hours of monitoring and about half are for 48 hours; 
based on this, the commenter suggested that the ``typical'' service was 
36 hours--the average of 24 and 48 hours. The commenter stated that the 
RUC and CMS did not agree as both take the view that the ``typical'' 
service requires a binary choice between 24 and 48 hours. The commenter 
stated that they believe a more accurate methodology for valuing 
equipment time is to look to objective and quantifiable data such as 
the average number of hours of use rather than the ``either/or'' 
methodology which inevitably undervalues approximately 50 percent of 
tests.
    Response: Although we appreciated the feedback from the 
stakeholder, as we stated in the proposed rule, our previously 
finalized PE methodology establishes pricing based on the typical case 
and not the average result. For a detailed explanation of the direct PE 
methodology, including examples, we refer readers to the 5-year review 
of work RVUs under the PFS and proposed changes to the PE methodology 
CY 2007 PFS proposed notice (71 FR 37242) and the CY 2007 PFS final 
rule with comment period (71 FR 69629).
    Comment: We received many comments regarding our proposal to price 
the ``extended external ECG patch, medical magnetic tape recorder'' 
(SD339) supply via a proxy item at a price of $413.24. Several 
commenters supported the proposed proxy pricing, stating that because 
the independent diagnostic testing facilities that furnish the extended 
ECG services are also the manufacturers of the devices, there are no 
invoices that reflect the sale or purchase of this supply item or the 
related software required to scan and analyze the extended ECG data 
recorded on this patch. These commenters stated that CMS should 
finalize the pricing as proposed and advised caution when reviewing 
pricing for what appear to be extended ECG system components, and to 
assess whether the invoiced items represent the supplies and equipment 
required to furnish the typical case of the service described by the 
new codes.
    Other commenters strongly disagreed with the proposed proxy pricing 
for the SD339 supply. Commenters stated that they were alarmed that 
CMS's proposal would result in payment rates far in excess of the costs 
incurred when performing these services in direct violation of CMS's 
stated principles for reimbursement rates. One commenter stated that 
CMS proposed rates at more than four times where they should be valued 
under its standard PE cost accounting methodology. Several commenters 
stated that the SD339 patch was available for purchase at roughly $100 
to $120 if bought in bulk quantities, which the commenters stated made 
sense because these ECG patches are not high tech equipment. Several 
commenters were concerned that CMS had not followed its traditional 
methodology for supply pricing by valuing the SD339 patch without 
receiving an invoice submission. Commenters stated that the proposed 
proxy pricing incorporated the research and development costs 
associated with developing the patch, which are typically indirect 
costs under the PE methodology, and CMS was therefore double-paying for 
these expenses by including them as a direct cost. Commenters also 
raised concerns that providers of these services might be able to make 
up to $200 per patient through the sale of discounted patch kits by 
profiting from the spread between the CMS payment and the much lower 
cost of the product. Commenters stated that this could create an 
incentive for significant overutilization of these services. One 
commenter submitted a lengthy report suggesting that CMS reject the 
proxy supply input approach and value the external ECG patch not as a 
supply but as a form of reusable equipment. This commenter submitted a 
series of invoices to support their contention that the external ECG 
patch would be more accurately priced as a reusable form of equipment 
at a much lower reimbursement rate.
    One commenter who supported the proposed proxy pricing later 
submitted a second comment responding to the commenters' criticisms of 
the proposal. This commenter stated that the devices and systems 
described by the invoices presented by other commenters were not 
consistent with the diagnostic system typically used to furnish the 
services described by these new codes. The commenter stated that there 
were systemic differences between the extended external ECG patch and 
the items described by the invoices referenced by other commenters. The 
commenter reiterated that the proposed proxy price should be finalized 
as it is supported by peer-reviewed clinical evidence from the 
specialty societies.
    Response: Given the conflicting information and assertions provided 
by commenters, we are unable to identify accurate national pricing for 
the ``extended external ECG patch, medical magnetic tape recorder'' 
(SD339) supply. To allow additional time to receive more pricing 
information, we are finalizing contractor pricing for CY 2021 for the 
four codes that include this supply input (CPT codes 93241, 93243, 
93245, and 93247). We will retain the SD339 supply in our pricing 
database while removing the proxy price pending additional information. 
We welcome the

[[Page 84634]]

submission of additional invoices or other pricing information to 
assist us to determine the most accurate values for these services.
    After consideration of the comments, we are finalizing the work 
RVUs and direct PE inputs for CPT codes 93224, 93225, 93226, 93227, 
93242, 93244, 93246, and 93248. We are finalizing contractor pricing 
for CPT codes 93241, 93243, 93245, and 93247 as detailed above.
(41) Complete Transthoracic Echocardiography (TTE) With Doppler (CPT 
Code 93306)
    In the CY 2019 PFS final rule (83 FR 59500), a submitter nominated 
CPT code 93306 (Echocardiography, transthoracic, real-time with image 
documentation (2D), includes M-mode recording, when performed, 
complete, with spectral Doppler echocardiography, and with color flow 
Doppler echocardiography) as potentially misvalued, citing GAO, MedPAC, 
and Urban Institute reports that suggest the work RVUs are overstated. 
Although the code was most recently surveyed in 2016, the specialty 
societies and the RUC stated that there has been a change in the 
technique and technology used to perform the procedure, so they 
resurveyed the code. The RUC recommended decreasing the work RVU from 
1.50 to 1.46 and we proposed this value.
    Although we proposed the RUC-recommended direct PE inputs without 
refinement, we noted that the RUC's recommendation included both 25 mL 
and 50 mL of ultrasound transmission gel. We proposed a supply quantity 
of 25 mL and sought clarification on the correct amount.
    We received public comments on the proposed valuation of CPT code 
93306. The following is a summary of the comments we received and our 
responses.
    Comment: A few commenters were supportive of our proposals for the 
work RVUs and direct PE inputs for the codes in this family.
    Response: We appreciate the support for our proposals from the 
commenters.
    Comment: A few commenters confirmed that the correct supply 
quantity of the ultrasound transmission get was 25 mL.
    Response: We appreciate the clarification and are finalizing the 
ultrasound transmission gel supply quantity as proposed.
    After consideration of the public comments, we are finalizing the 
work RVUs and direct PE inputs for CPT code 93306 as proposed.
(42) Pacing Heart Stimulation (CPT Code 93623)
    Review of CPT code 93623 (Programmed stimulation and pacing after 
intravenous drug infusion (List separately in addition to code for 
primary procedure)), was prompted by the Relativity Assessment 
Workgroup Medicare utilization screen of over 30,000 claims in a year. 
This service is to create an arrhythmia by an intravenous drug infusion 
and it is an add-on code with 60 minutes of total time and a current 
work RVU of 2.85.
    The RUC recommended the 25th percentile survey value of 2.04 work 
RVUs and 20 minutes of intraservice time.
    The revision of CPT code 93623 physician's time adjusting from the 
current 60 minutes to 20 minutes is a significant change. We noted that 
we do not believe the RUC-recommended work RVU appropriately accounts 
for the substantial reductions in the surveyed work times for the 
procedure. 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 noted that 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 93623, we believed that it would be 
more accurate to propose a work RVU of 0.98 based on CPT code 76810 
(Ultrasound, pregnant uterus, real time with image documentation, fetal 
and maternal evaluation, after first trimester ( or = 14 
weeks 0 days), transabdominal approach; each additional gestation (list 
separately in addition to code for primary procedure)) with 20 minutes 
of intraservice time. We proposed a work RVU of 0.98 with 20 minutes of 
intraservice time for CPT code 93623.
    This CPT code is a facility-only service and has no direct PE 
inputs.
    We received public comments on the Pacing Heart Stimulation CPT 
code 93623. The following is a summary of the comments we received and 
our responses.
    Comment: Commenters disagreed with our selection of CPT code 76810 
as an equivalent comparator to CPT code 93623 in regard to the work 
RVUs and the number of total minutes derived from the `CMS Other' 
category listed in CMS's physician time file. Commenters stated that 
the nature of the type of work and intensity for the service described 
by CPT code 76810 are vastly different from Pacing Heart Stimulation. 
The commenters strongly suggested that CMS accept the 25th percentile 
work RVU of 2.04 from their recent survey of 46 cardiologists.
    Response: We continue to believe that CPT code 76810 is a valid 
reference for purposes of valuing CPT code 93623, and that the 
physician time change from the current 60 minutes to 20 minutes 
indicates a reduction in work RVUs. As we have discussed in previous 
rules, we continue to believe that our use of the existing time values 
as a point of comparison is critical to the integrity of the current 
relative value system and we do not accept the characterizing of a time 
source as ``CMS-Other'' as being less valid. As for CPT code 76810 
having only total time instead of intraservice time, for add-on codes, 
total time is almost always the equivalent of intraservice time, and 
both of these add-on codes have 20 minutes of total time. We do not 
regard the 20 minutes of physician time assigned to CPT code 76810 to 
be any different from the 20 minutes of physician time with CPT code 
93623. While the clinical nature of the work for CPT code 76810 is 
different from the clinical nature of the work for CPT code 93623, our 
review of the assigned RVU is based on a comparison of the physician 
times and intensity assigned to each code, which are the same.
    After consideration of the public comments, we are finalizing the 
work and time values for CPT code 93623 as proposed.
(43) Intracardiac Echocardiography (ECG) (CPT Code 93662)
    The review of CPT code 93662 (Intracardiac echocardiography during 
therapeutic/diagnostic intervention, including imaging supervision and 
interpretation (List separately in addition to code for primary 
procedure), was prompted by the Relativity Assessment Workgroup 
Medicare utilization screen of over 10,000 claims in a year that had an 
increase in volume by 100 percent between the 2012 to 2017. This 
procedure has since changed from its last review, in its reduced use of 
fluoroscopy, now replaced with ultrasound that create arrhythmia 
mapping systems with intracardiac echo images processed to produce 3-
dimensional electroanatomical maps. The physician can now visualize 
better and have more accurate details for more effective catheter 
ablation for a wide range of arrhythmias. CPT code 93662 currently has 
a work RVU of 2.80 with 5 minutes of preservice evaluation time, 55 
minutes of intraservice time, 10 minutes of immediate postservice time, 
and 70 minutes of total time.

[[Page 84635]]

    The survey resulted in a median intraservice time of 25 minutes, a 
significant shift from the current intraservice time of 55 minutes. The 
RUC recommended a work RVU of 2.53 and 25 minutes of intraservice time 
for add-on CPT code 93662. We noted that we do not believe the RUC-
recommended work RVU appropriately accounts for the substantial 
reductions in the surveyed work times for the procedure. 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 believed that since the two components of work are time and 
intensity, significant decreases in time should be appropriately 
reflected in decreases to work RVUs. CPT code 92979 (Endoluminal 
imaging of coronary vessel or graft using intravascular ultrasound 
(ivus) or optical coherence tomography (oct) during diagnostic 
evaluation and/or therapeutic intervention including imaging 
supervision, interpretation and report; each additional vessel (list 
separately in addition to code for primary procedure)), with 1.44 work 
RVUs and 25 minutes of intraservice time, is a good equivalent 
comparator code in light of the significant physician time reduction 
from 55 minutes. A similarly proportioned reduction of physician 
intraservice time from the current 55 minutes to the surveyed 25 
minutes, if applied to the current work RVU would result in a value 
much lower than our reference CPT code 92979's work RVU, so we proposed 
a work RVU of 1.44 and 25 minutes of intraservice time for add-on CPT 
code 93662.
    This CPT code is a facility only service and has no direct PE 
inputs.
    We received public comments on the service of Intracardiac 
Echocardiography (ECG) CPT code 93662. The following is a summary of 
the comments we received and our responses.
    Comment: The AMA RUC disagreed with our selection of CPT code 92979 
as an equivalent comparator code to CPT code 93662 because of ECG's 
higher technical nature, and its use of anesthesia which supports a 
higher intensity and a difference in the nature of the work. As in 
their AMA RUC recommendation, they referenced their selection of CPT 
code 34713 (Percutaneous access and closure of femoral artery for 
delivery of endograft through a large sheath (12 French or larger), 
including ultrasound guidance, when performed, unilateral (List 
separately in addition to code for primary procedure)) with a work RVU 
of 2.50 and an intraservice time of 20 minutes. The commenters strongly 
suggested that CMS accept their comparison code and the 25th percentile 
work RVU of 2.53 from their recent survey of 42 cardiologists.
    Response: We consider CMS' selection of CPT code 92979 to be a more 
appropriate comparator to value CPT code 93662, than the AMA RUC's 
selection of comparator CPT code 34713, and believe that the physician 
time change from the current 55 minutes to 25 minutes indicates a 
reduction in work RVUs of greater than 0.27. We also do not agree with 
the AMA RUC that the increase in ECG's work intensity supports the AMA 
RUC recommended 2.53 work RVUs (90% of the current value). The 
substantial reduction in physician time (45%) and increase in work 
intensity, is not reflected in the AMA RUC-recommended reduction of 
work RVUs. CPT code 92979's intraservice time of 25 minutes and 1.44 
work RVUs is a better equivalent that reflects the halving on the 
physician's current time and we do not believe that the work intensity 
has substantial change enough to justify the AMA RUC's recommended work 
value. We note that CPT code 93662's work value is for the professional 
component (26) that is set in the fee schedule and that CPT code 
93622's technical component and global are also add-on codes and are 
carrier-priced, meaning that if the health care provider performs both 
components, their final payment will be more than the work RVUs 
finalized here.
    After consideration of the public comments, we are finalizing a 
work RVU of 1.44 with 25 minutes of intraservice time for CPT code 
93662 as proposed.
(44) Ventricular Assist Device (VAD) Interrogation (CPT Code 93750)
    The review of CPT code 93750, (Interrogation of ventricular assist 
device (VAD), in person, with physician or other qualified health care 
professional analysis of device parameters (e.g., drivelines, alarms, 
power surges), review of device function (e.g., flow and volume status, 
septum status, recovery), with programming, if performed, and report) 
was prompted by the Relativity Assessment Workgroup Medicare 
utilization screen of over 10,000 claims in a year and had had an 
increased in volume by 100 percent between the 2012 to 2017. CPT code 
93750 currently has a work RVU of 0.92 with 30 minutes of intraservice 
time.
    For physician times, the societies' survey for CPT code 93750 
yielded 6 minutes preservice time, 10 minutes intraservice time, 7 
minutes immediate post-service time, and 23 minutes of total time. The 
25th percentile surveyed work RVU was 0.96. The RUC compared the survey 
code to CPT code 78598 (Quantitative differential pulmonary perfusion 
and ventilation (e.g., aerosol or gas), including imaging when 
performed) (0.85 work RVU and 5 minutes of preservice time, 10 minutes 
of intraservice time, 9 minutes of immediate postservice time, and 
total time of 24 minutes). The RUC recommended crosswalking the work 
RVU of 0.85 from CPT code 78598 to 93750.
    CPT code 93289 (Interrogation device evaluation (in person) with 
analysis, review and report by a physician or other qualified health 
care professional, includes connection, recording and disconnection per 
patient encounter; single, dual, or multiple lead transvenous 
implantable defibrillator system, including analysis of heart rhythm 
derived data elements), with 0.75 work RVUs and 5 minutes of preservice 
time, 10 minutes of intraservice time, 8.5 minutes of immediate 
postservice time, and total time of 23.5 minutes, we noted we believe 
is a more precise comparator code. CPT code 93289's intraservice times, 
pre and post times, and total times are almost identical to CPT code 
93750's survey times; therefore, we proposed a work RVU of 0.75 and 23 
minutes of total time for CPT code 93750.
    The PE Subcommittee corrected the equipment times based on the 
formulas as provided by CMS. In addition, the PE Subcommittee changed 
the clinical staff type for direct labor item ID CA013 Prepare Room, 
Equipment and Supplies, from an RN to the RN/LPN/MTA blend and the 
direct equipment item ID EQ168 light, exam was removed from CPT code 
93750. We proposed to accept the RUC-recommended direct PE inputs.
    We received public comments on the Ventricular Assist Device (VAD) 
Interrogation CPT code 93750. The following is a summary of the 
comments we received and our responses.
    Comment: The AMA RUC surveyed CPT code 93750 and initially reviewed 
their surveyed 25th percentile recommendation of 0.96 work RVUs for 
this code, finding it to be overestimated, since the current work RVU 
value is 0.92 for the current 30 minutes of physician time. Instead, 
they selected CPT code 78598 as a comparator code with a work RVU of 
0.85. Commenters disagreed with our selection of CPT code 93289 with a 
work RVU of 0.75 as inappropriately low, but they noted that they had 
originally reviewed CPT code

[[Page 84636]]

93289 only to abandon this code on the basis that it did not involve 
device programming.
    Response: We disagree with commenters that our selection of 
comparator CPT code 93289 is inappropriate. The reduction in time from 
30 minutes to 23 minutes suggests that the work RVUs should be 
decreasing, and the survey's 25th percentile reflects an increase. We 
do not believe the RUC-recommended work RVU appropriately accounts for 
the substantial reductions in the work times for the procedure. 
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 continue to 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; and 
that CPT code 93289 is a more appropriate comparator to CPT code 93750.
    After consideration of the public comments, we are finalizing a 
work RVU of 0.75 with a total time of 23 minutes for CPT code 93750, as 
proposed.
(45) Spirometry (CPT Codes 94010 and 94060)
    CPT code 94010 (spirometry, including graphic record, total and 
timed vital capacity, expiratory flow rate measurement(s), with or 
without maximal voluntary ventilation) and CPT code 94060 
(Bronchodilation responsiveness, spirometry as in 94010, pre- and post-
bronchodilator administration) were identified as part of a Relativity 
Assessment Workgroup (RAW) review of action plans on the status of 
services that were RUC referrals to develop CPT Assistant articles. 
These codes were recommended to be surveyed.
    We proposed the RUC-recommended work RVU of 0.17 for CPT code 94010 
(spirometry, including graphic record, total and timed vital capacity, 
expiratory flow rate measurement(s), with or without maximal voluntary 
ventilation) and the RUC-recommended work RVU of 0.22 for CPT code 
94060 (Bronchodilation responsiveness, spirometry as in 94010, pre- and 
post-bronchodilator administration). We proposed the RUC-recommended 
direct PE inputs for this code family without refinements.
    We did not receive public comments on this code family, and are 
finalizing as proposed.
(46) Exercise Test for Bronchospasm (CPT Codes 94619, 94617, 94618, and 
94621)
    In 2018, the CPT Editorial Panel created CPT code 94617 (Exercise 
test for bronchospasm, including pre- and post-spirometry, 
electrocardiographic recording(s), and pulse oximetry), and CPT code 
94618 (Pulmonary stress testing (e.g., 6-minute walk test), including 
measurement of heart rate, oximetry, and oxygen titration, when 
performed) from the now deleted CPT code 94620 (Pulmonary stress 
testing; simple (e.g., 6-minute walk test, prolonged exercise test for 
bronchospasm with pre- and post-spirometry and oximetry)), and revised 
CPT code 94621 (Cardiopulmonary exercise testing, including 
measurements of minute ventilation, co2 production, o2 uptake, and 
electrocardiographic recordings) to better describe the specialty's 
pulmonary exercise test. Shortly after the creation and revision of 
these codes, the specialty society became aware of some health care 
providers performing CPT code 94617 without ECG monitoring, so to more 
accurately account for this work without the ECG monitoring, the CPT 
Editorial Panel proposed to establish CPT code 94619 with the 
descriptor, (Exercise test for bronchospasm, including pre- and post-
spirometry and pulse oximetry; without electrocardiographic 
recording(s)). For the October 2019 RUC meeting, the specialty 
societies surveyed CPT code 94619, and included a request to reaffirm 
the values of the rest of the codes in the code family.
    For CPT code 94619, the surveyed physician time yielded 5 minutes 
of preservice time, 9 minutes of intraservice time, followed by 10 
minutes of immediate post-service time, for a total time of 24 minutes. 
This distribution of physician times is of course very similar to the 
times for CPT code 94617, total time of 26 minutes, except without the 
task of including an electrocardiographic recording. The RUC 
recommended the survey's median work RVU of 0.49 for CPT code 94619.
    We proposed the RUC's recommendation of a work RVU of 0.49 and a 
total physician time of 24 minutes for CPT code 94619.
    This CPT family of codes that includes CPT code 94619, are CPT 
codes 94617, 94618, and 94621 and there are no changes to their 
physician service times, no change to their descriptors, nor their work 
RVUs, and remain as they currently are. The specialty societies 
reaffirmed these current valuations and we proposed to accept them 
without change.
    We proposed the RUC-recommended PE changes without refinement.
    We did not receive public comments on this provision, and are 
finalizing as proposed.
(47) Evaluation of Wheezing (CPT Codes 94640, 94667, 94668, and 94669)
    At the April 2019 RUC meeting, four PE only CPT codes from the 
Evaluation of Wheezing code family were reviewed. The codes included 
CPT codes 94640 (Pressurized or nonpressurized inhalation treatment for 
acute airway obstruction for therapeutic purposes and/or for diagnostic 
purposes such as sputum induction with an aerosol generator, nebulizer, 
metered dose inhaler or intermittent positive pressure breathing (IPPB) 
device), 94667 (Manipulation chest wall, such as cupping, percussing, 
and vibration to facilitate lung function; initial demonstration and/or 
evaluation), 94668 (Manipulation chest wall, such as cupping, 
percussing, and vibration to facilitate lunch function; subsequent), 
and 94669 (Mechanical chest wall oscillation to facilitate lung 
function, per session).
    We proposed the RUC-recommended direct PE inputs for the four PE 
only codes. The RUC did not recommend work RVUs and we proposed to 
maintain the current work RVU of 0.00 for all four codes.
    We did not receive public comments on this code family, and are 
finalizing as proposed.
(48) Exhaled Nitric Oxide Measurement (CPT Code 95012)
    In January 2019, the RAW reviewed services with 2017 Medicare 
utilization of 10,000 or more that had increased by at least 100 
percent from 2012 through 2017. The RUC recommended that CPT code 95012 
(Nitric oxide expired gas determination) be surveyed for the April 2019 
meeting. We proposed the direct PE inputs for CPT code 95012 without 
refinement. CPT code 95012 is a PE-only code with no work RVU, and we 
proposed to maintain the current work RVU of 0.00.
    We did not receive public comments on this code family and are 
finalizing as proposed.
(49) Acupuncture Services (CPT Codes 97810, 97811, 97813, and 97814)
    The CPT Editorial Panel created two new codes and two new add-on 
codes in 2004 to describe the appropriate time or additional time and 
levels of service that can be performed using acupuncture and 
electroacupuncture,

[[Page 84637]]

acupuncture therapy with electrical stimulation. These codes were 
designated as noncovered services since Medicare did not reimburse for 
acupuncture services at the time. In January 2020, we issued a decision 
memo stating that Medicare will cover acupuncture for chronic low back 
pain under section 1862(a)(1)(A) of the Act (CAG-00452N). This was 
reflected in the April 2020 PFS Quarterly Update which changed CPT 
codes 97810 through 97814 to active payment status (CMS Change Request 
11661). Because we had never conducted a review of these four 
acupuncture codes, the CY 2020 payment rate consisted of the work RVUs 
recommended by the RUC in 2004.
    For CY 2021, we proposed to establish work RVUs for these four 
acupuncture codes based on a pair of crosswalks to two recently 
reviewed codes in the Dry Needling family. We proposed a work RVU of 
0.48 for CPT codes 97810 (Acupuncture, 1 or more needles; without 
electrical stimulation, initial 15 minutes of personal one-on-one 
contact with the patient) and 97813 (Acupuncture, 1 or more needles; 
with electrical stimulation, initial 15 minutes of personal one-on-one 
contact with the patient) based on a crosswalk to CPT code 20561 
(Needle insertion(s) without injection(s); 3 or more muscles). We 
proposed a work RVU of 0.32 for CPT codes 97811 (Acupuncture, 1 or more 
needles; without electrical stimulation, each additional 15 minutes of 
personal one-on-one contact with the patient, with re-insertion of 
needle(s)) and 97814 (Acupuncture, 1 or more needles; with electrical 
stimulation, each additional 15 minutes of personal one-on-one contact 
with the patient, with re-insertion of needle(s)) based on a crosswalk 
to CPT code 20560 (Needle insertion(s) without injection(s); 1 or 2 
muscle(s)).
    CPT codes 20560 and 20561 are clinically similar services 
associated with dry needling that were reviewed last year for CY 2020. 
We finalized work RVUs of 0.32 and 0.48 respectively for these two 
codes following our review of their associated RUC recommendations, 
while noting that dry needling services were non-covered by Medicare 
unless otherwise specified through a national coverage determination 
(NCD) (84 FR 62722 through 62724). Like the acupuncture codes, CPT 
codes 20560 and 20561 were updated to active payment status in the 
April 2020 PFS Quarterly Update to reflect the Medicare coverage of 
acupuncture for chronic low back pain. We noted that CPT codes 97810 
and 97813 share the identical work time values with CPT code 20561, and 
that CPT codes 97811 and 97814 differ from CPT code 20560 by only 1 
minute of work time, 15 minutes as compared to 16 minutes. Although we 
did not imply that codes with similar work times must equate to a one-
to-one or linear relationship in the valuation of work RVUs, we 
believed that, since the two components of work are time and intensity, 
clinically related services with similar intensities and work times 
should, generally speaking, be valued similarly. Due to the similar 
clinical nature of these services and their nearly identical work 
times, we believed that it is more accurate to propose crosswalking CPT 
codes 97810 through 97814 to the work RVUs of the Dry Needling codes, 
which were finalized last year, as opposed to proposing work RVUs from 
2004, which were never reviewed by CMS.
    The RUC did not make any recommendations and we did not propose any 
changes to the direct PE inputs for CPT codes 97810 through 97814.
    We received public comments on the codes in the Acupuncture 
Services family. The following is a summary of the comments we received 
and our responses.
    Comment: A few commenters supported the proposed work RVUs assigned 
to the acupuncture codes and appreciated CMS' recent coverage 
determination. The commenters stated that it is important for CMS to 
provide coverage and adequate reimbursement to a broad array of 
services that provide non-opioid pain management alternatives.
    Response: We appreciate the support for our proposals from the 
commenters.
    Comment: Many commenters were supportive of the Medicare decision 
to provide coverage for acupuncture services but disagreed with the 
proposed valuation crosswalk to two recently reviewed codes in the Dry 
Needling family. Commenters stated that the dry needling services were 
not clinically similar to the acupuncture codes as CMS had claimed in 
the proposed rule, as the dry needling codes do not reflect the 
training or expertise required to perform an acupuncture treatment. 
Commenters stated that acupuncture is more physically and mentally 
intensive than inserting a dry needle into a tender muscle. Commenters 
stated that the higher skill and knowledge set that is required to 
perform acupuncture therapy is evidenced in the licensure requirements 
to perform these services, whereas there are no standardized training 
curriculums or accreditation programs for dry needling. Commenters 
stated that the current acupuncture therapy codes are specifically 
intended to include pre- and post-service intervention assessment/
evaluation, as per the CPT guidelines, which is lacking in the dry 
needling codes. Many commenters stated that if Medicare rates are 
reduced for acupuncture services then providers of acupuncture services 
will not be able to afford to treat Medicare beneficiaries and this 
would create additional barriers to care.
    Response: We appreciate the detailed feedback from the commenters 
detailing the differences between acupuncture and dry needling 
services. After reviewing the comments, we agree that there are 
significant differences between these services and it would not be 
appropriate to use the proposed crosswalk for valuation. Therefore, we 
are not finalizing our proposal to establish work RVUs for these four 
acupuncture codes based crosswalks to CPT codes 20560 and 20561. We are 
instead finalizing the current CY 2020 work RVUs of 0.60 for CPT code 
97810, 0.50 for CPT code 97811, 0.65 for CPT code 97813, and 0.55 for 
CPT code 97814. As this valuation is based on a RUC review that took 
place in 2005, we welcome the prospect of an updated formal review or 
other new information regarding the valuation of these services for 
potential future rulemaking.
(50) Interim Final Rule With Comment Period for Coding and Payment for 
Personal Protective Equipment (PPE) (CPT Code 99072)
a. Background
    Following the publication of the CY 2021 PFS proposed rule, the CPT 
Editorial Panel approved the creation of CPT code 99072 (Additional 
supplies, materials, and clinical staff time over and above those 
usually included in an office visit or other non-facility service(s), 
when performed during a Public Health Emergency, as defined by law, due 
to respiratory-transmitted infectious disease). During the comment 
period for the proposed rule, stakeholders contacted CMS and stated 
that practices have incurred significant costs of maintaining safe 
offices, particularly in implementing specific infection control 
measures related to screening patients, purchasing personal protective 
equipment (PPE), and implementing office redesign measures to ensure 
social distancing. Stakeholders requested that CMS immediately consider 
implementation of relative values and payment (outside of budget 
neutrality) for the newly created CPT code 99072 in recognition of 
these costs.

[[Page 84638]]

    Stakeholders submitted recommended direct PE inputs associated with 
CPT code 99072 designed to capture the additional supplies, materials, 
and clinical staff time over and above the PE inputs included in an 
office visit or other nonfacility service(s) when the office visit or 
other non-facility service(s) are rendered during a public health 
emergency (PHE). Stakeholders submitted more than 500 invoices 
associated with PPE supplies and requested that CMS use them to update 
their pricing, as well as requested that N95 masks should be added to 
the direct PE supply list. Stakeholders stated that payment for these 
additional costs should be fully funded and not be subject to budget 
neutrality, and that CMS could use remaining money from the CARES Act 
funding to pay physicians for these costs and/or recognize the 
decreased expenditures during the early months of the pandemic to waive 
budget neutrality. Stakeholders also stated that CMS should review the 
utilization assumptions for equipment due to decreased practice 
capacity during the PHE for COVID-19 and that any modifications to the 
equipment utilization during the PHE should not be subject to budget 
neutrality.
b. Interim Final Policy
    We appreciate the submission of this additional information 
regarding CPT code 99072, especially the large number of invoice 
submissions for use in updating the pricing of PPE supplies. We share 
in the concerns of the stakeholders regarding the additional costs 
borne by providers during the public health emergency. After reviewing 
the information provided by the stakeholders, we are finalizing CPT 
code 99072 as a bundled service on an interim basis. We believe that 
use of these additional forms of PPE would be inherent to the 
furnishing of separately paid services under these practitioner/patient 
interactions. We agree with the stakeholders that there have been 
additional costs for providers as part of the PHE for COVID-19; however 
payment for the services as described under CPT code 99072 are always 
bundled into payment for other services and payment for them is 
subsumed by the payment for the services to which they are incident.
    In recognition of the increased market-based costs for certain 
types of PPE, we are finalizing on an interim basis several supply 
pricing increases using the invoices submitted along with CPT code 
99072. We did not previously include the N95 mask in our supply 
database and we are finalizing on an interim basis its addition under 
supply code SD344 at the median price of $2.36 based on 94 submitted 
invoices. We are also finalizing on an interim basis an increase in the 
price of the surgical mask (SB033) supply to the median price of $0.43 
based on 259 submitted invoices and an increase in the price of the 
surgical mask with face shield (SB034) supply to the median price of 
$3.40 based on 49 submitted invoices. We are using the median price as 
opposed to the average price of the submitted invoices as the median 
was more typical of market-based pricing and avoided the effect of 
outlier prices. The increased cost associated with these forms of PPE 
will be reflected in payment for services that include these supply 
inputs.
    We also received additional invoices associated with non-sterile 
gloves (SB022), nitrile gloves (SB023), patient gowns (SB026), and 
sterile surgical gowns (SB028). We are not finalizing changes in the 
prices of these supplies at this time due to concerns that we had 
regarding the data on the submitted invoices. The non-sterile gloves 
and nitrile gloves contained median prices which were significantly 
lower than their CY 2021 prices, $0.05 as compared to $0.25 for the 
non-sterile gloves and $0.06 as compared to $1.01 for the nitrile 
gloves. The sterile surgical gowns followed the same pattern with a 
median invoice price of $3.39 as compared to the CY 2021 price of 
$5.02. We do not believe that the typical price for these supplies has 
undergone significant decreases as a result of the PHE and we are not 
finalizing any price changes at this time pending additional discussion 
with stakeholders. For the patient gown (SB026) supply, the median 
price of the 43 submitted invoices was $0.51 and the average price was 
$0.67. We believe that this additional data supports the current CY 
2021 price of $0.58 and we are not finalizing a price change since the 
invoice data suggested that the current price remains typical during 
the PHE. We also received a small quantity of invoices associated with 
other PPE supplies but we did not believe that we had enough data in 
these cases to determine typical pricing and therefore we are not 
finalizing any additional price changes to supply items.
    As described in section VIII. of this final rule, Regulatory Impact 
Analysis, 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. We do not have 
authority to waive the budget neutrality provision for CPT code 99072 
unless explicitly stated by statute. In addition, as described in 
section II.B. of this rule (PE section), we also disagree with the 
stakeholders that utilization assumptions for equipment should be 
revisited as part of the public health emergency. While we agree that 
many services had a reduced volume of Medicare beneficiaries at times 
during CY 2020, we note that equipment costs under the PFS are 
amortized across the full useful life of the equipment, which in the 
vast majority of cases is 5-10 years. We believe that it would distort 
relativity to apply a temporary decrease in utilization caused by the 
PHE to the pricing structure of the equipment's full useful life 
duration. We also note that we do not have statutory authority to 
exempt any modifications to the equipment utilization assumptions from 
budget neutrality calculations.
c. Waiver of Proposed Rulemaking Provisions
    Under the Administrative Procedure Act (APA), 5 U.S.C. 553(b), an 
agency is generally required to publish a notice and solicit comment on 
a proposed rule in the Federal Register before issuing a final rule. 
Similarly, section 1871(b)(1) of the Act requires the Secretary to 
provide for notice of a proposed rule in the Federal Register and 
provide a period of not less than 60 days for public comment. The APA 
provides for exceptions from the notice and comment requirements, see 5 
U.S.C. 553(b)(B); in cases in which the APA exceptions apply, section 
1871(b)(2)(C) of the Act provides for exceptions from the notice and 
60-day comment period requirements of the Act as well. Section 
553(b)(B) of Title 5 and section 1871(b)(2)(C) of the Act authorize an 
agency to dispense with normal rulemaking requirements if the agency 
for good cause finds that the notice and comment process is 
impracticable, unnecessary, or contrary to the public interest.
    We find that there is good cause to waive the notice and comment 
requirements under sections 553(b)(B) of the APA and section 
1871(b)(2)(C) due to the September 2020 creation of CPT code 99072 
which did not allow for its inclusion in the proposed rule. We believe 
that establishing payment for this service on an interim basis will 
allow for its provision as a bundled service during the public health 
emergency. We find that it would be impracticable and contrary to the 
public interest to undergo notice and comment procedures before 
finalizing these

[[Page 84639]]

payment policies on an interim basis. We also find that delaying 
implementation of these policies is unnecessary because the impact on 
other PFS services for 2021 is negligible and the practical alternative 
for this treatment is no payment under Medicare Part B. In either case, 
payments for 2022 and beyond would be informed by public comments.
    Therefore, we find good cause to waive the notice of proposed 
rulemaking as provided under section 1871(b)(2)(C) of the Act and 
section 533(b)(B) of the APA and to issue this interim final rule with 
an opportunity for public comment. We are providing a 60-day public 
comment period as specified in the DATES section of this document. We 
are seeking interim final comment on our general approach to CPT code 
99072, as well as how to think about services that may not include 
these specific PPE items but for which there are incurred costs as 
described by the stakeholders. Additionally, we will consider the 
market cost for these supply items relative to the changing conditions 
in the market, as appropriate.
(51) Chronic Care Management Services (CPT Code 99439 and HCPCS Code 
G2058)
    We established payment for HCPCS code G2058 (Chronic care 
management services, each additional 20 minutes of clinical staff time 
directed by a physician or other qualified healthcare professional, per 
calendar month) in the CY 2020 PFS final rule (84 FR 62690). At the 
January 2020 RUC meeting, specialty societies requested a temporary 
crosswalk through CY 2021 between the value established by CMS for 
HCPCS code G2058 and the value of new CPT code 99439 (with a descriptor 
identical to G2058). The Chronic Care Management code family will be 
resurveyed during CY 2020 and is expected to be presented for review as 
part of the 2022 RUC review process.
    For CY 2021, we proposed the RUC-recommended work RVU of 0.54 and 
the RUC-recommended direct PE inputs for CPT code 99439.
    We received several public comments all in support of our proposed 
valuations for Chronic Care Management Services (CPT code 99439 and 
G2058). After consideration of the comments, we are finalizing as 
proposed.
(52) External Counterpulsation (HCPCS Code G0166)
    In the CY 2020 PFS proposed rule (84 FR 40516), an external 
stakeholder nominated HCPCS code G0166 as potentially misvalued due to 
concerns that the PE RVUs for this code did not fully reflect the total 
resources required to deliver the service and CMS proposed G0166 as 
potentially misvalued. The RUC reviewed the direct PE inputs for HCPCS 
code G0166 at the October 2019 RUC meeting.
    We proposed the RUC-recommended preservice period, service period 
and postservice period with refinements. We proposed to replace CA010 
(obtain vital signs) during the postservice of service period with 
CA023 (monitor patient following procedure/service, no multitasking).
    For the equipment items, we proposed to update the price of the 
``EECP, external counterpulsation system'' (EQ012) equipment to 
$101,247.50 based on an average of the five invoices submitted along 
with the recommendations. We noted that the EQ012 equipment is the only 
current equipment item in our direct PE database with an equipment 
utilization rate of 25 percent and the only equipment item with a 
utilization rate under 50 percent. Although we did not propose to 
change the equipment utilization rate, we solicited feedback from 
commenters regarding the utilization rate for the EQ012 equipment to 
help us understand why it should differ from all other medical 
equipment.
    We also received invoices for a series of additional equipment 
items: An EECP service contract, an EECP compression equipment package, 
and an EECP electrical equipment package. We did not propose to 
establish a price for the EECP service contract, as service contracts 
are considered to be an administrative expense and a form of indirect 
PE under our methodology. As for the two equipment packages, there were 
a number of unusual factors involving these items that created 
difficulties for our equipment methodology. Both equipment packages had 
a suggested utilization rate of 25 percent, half of our typical 
utilization rate of 50 percent, and both had a suggested useful life 
duration of only 3 months. As we stated in section II.B. of the 
proposed rule (85 FR 50082-50083), Determination of Practice Expense 
RVUs, we have concerns that assigning very low useful life durations to 
this type of equipment would fail to maintain relativity with other 
equipment on the PFS. We also noted that the equipment cost per minute 
formula was designed under the assumption that each equipment item 
would remain in use for a period of several years and depreciate over 
that span of time. Our current equipment formula is not designed to 
address cases in which equipment is replaced multiple times per year, 
and we noted that we believe that applying a multi-year depreciation in 
these situations would not be reflective of market pricing. Although we 
agreed that these costs should be reflected in the pricing of HCPCS 
code G0166, we believed that the very frequent replacement of the items 
in the two equipment packages makes them a poor fit under our equipment 
methodology.
    Therefore, we proposed to treat the two EECP equipment packages as 
supplies instead of treating them as equipment. We proposed to 
establish the EECP compression equipment package (SD341) as a supply 
with a cost of $645 based on an average of the submitted invoices, and 
proposed to establish the EECP electrical equipment package (SD342) as 
a supply with a cost of $500 again based on an average of the submitted 
invoices. Based on information provided by stakeholders, we proposed a 
supply quantity of 1/325 for these two items (0.00308) based on the 
supply being used on average five times per day and replaced every 3 
months (5 uses * 5 days * 13 weeks = 325). We noted that we believe 
that assigning these two items as supplies rather than equipment more 
accurately captures the unusual circumstances associated with providing 
this service.
    We received public comments on External Counterpulsation. The 
following is a summary of the comments we received and our responses.
    Comment: Several commenters disagreed with CMS's proposal to move 3 
minutes of clinical labor time for checking vitals at the end of the 
session to post-procedure monitoring, stating this is not monitoring in 
the sense of the CA023 activity code but taking vitals to evaluate the 
effectiveness of the treatment and the patient's condition.
    Response: We disagree with the commenters and continue to believe 
our proposal to replace CA010 (obtain vital signs) during the 
postservice of the service period with CA023 (monitor patient following 
procedure/service, no multitasking) was appropriate. We understand that 
the clinical labor taking place is not a monitoring activity, however 
the CA010 activity code is used to describe clinical labor that takes 
place before the service occurs, not afterward. We proposed to use the 
CA023 activity code as the closest proxy available to describe this 
clinical labor. We note that there is no change in valuation for the 
service as we proposed the same 3 minutes for the CA023 activity code 
as the RUC recommended under the CA010 activity code.
    Comment: Several commenters disagreed with the proposal to price 
the

[[Page 84640]]

``EECP, external counterpulsation system'' (EQ012) equipment at 
$101,247.50. Commenters stated that one of the previous invoices used 
for pricing the EQ012 equipment reflected a discount of $10,000 and was 
not for the purchase of a new ECP system. Commenters stated that 
although it was not explicitly listed, it was highly likely that 
another invoice used for pricing was either the result of a trade-in 
credit or reflected a refurbished system. Commenters submitted a new 
invoice for the EQ012 equipment with a listed price of $130,890 and 
requested that CMS use this invoice for pricing while disregarding the 
prior invoices.
    Response: We disagree with the commenters that the previous 
invoices used for pricing the EQ012 equipment should be disregarded for 
pricing. We do not agree that invoices from 2015 and 2017 have no 
validity; while we prefer to use current invoices wherever possible, we 
also believe in the importance of using multiple data points as opposed 
to relying on a single invoice. We also note that the same commenter 
submitted invoices for pricing the supply packages, which ranged in 
date from 2012 to 2020. We have no indication that the previous 
invoices were part of trade-in programs, and our pricing methodology 
uses the actual market rate for supplies/equipment, which does include 
discounts. We also do not agree with the commenter that the use of new 
equipment would be typical in all cases as it is clear that providers 
of these services can and do purchase used versions of the EQ012 
equipment. As a result, we are employing our standard policy for 
invoice submissions and averaging together the previously submitted 
invoices with the new invoice submission, which results in a price of 
$111,128.30 for the EQ012 equipment. We are finalizing this as the new 
price for the EECP, external counterpulsation system.
    Comment: Several commenters supported the current equipment 
utilization rate of 25 percent for the EQ012 equipment. Commenters 
stated that this rate reflected 80 minutes (proposed nonfacility time) 
x 1.57 services per day x 5 days per week x 50 weeks = 31,400 minutes 
for a total utilization rate of 20.9 percent (31,400 divided by 
150,000). Commenters stated that the utilization rate was accurate 
based on their experience delivering this service and their discussions 
with other ECP therapy providers in different regions across the 
country. One commenter disagreed with the proposed equipment 
utilization rate of 25 percent and requested that CMS review the 
equipment utilization for this service and explain why it differs from 
all other medical equipment.
    Response: We appreciate the additional information provided by the 
commenters regarding the utilization rate for the EQ012 equipment. 
Based on the information supplied by the commenters, we continue to 
believe that the current equipment utilization rate of 25 percent is 
the most accurate value for this unique type of equipment.
    Comment: Several commenters provided feedback on the proposal to 
establish the EECP compression equipment package (SD341) and the EECP 
electrical equipment package (SD342) as disposable supplies. Commenters 
were supportive of the concept of treating these items as supplies 
instead of as equipment and provided additional details regarding the 
supply contents and supply quantities. Commenters stated that the EECP 
compression equipment package (SD341) supply should contain eight total 
inputs consisting of cuffs, bladders, hoses, straps, connectors, and 
specialized treatment pants. Several commenters stated that the total 
cost for the SD341 supply package summed to $847.00 while other 
commenters stated the cost of the same supply to be $826.75. For the 
EECP electrical equipment package (SD342), commenters stated that CMS 
accurately captured the finger plethysmograph and ECG cable in this 
package while omitting the Spo2 probe. Commenters stated that the Spo2 
probe is a required item needed to perform the pulse oximetry and the 
price of the SD342 package should be updated to $752.00. Commenters 
submitted an extensive list of invoices to support these requested 
prices.
    Response: We appreciate the additional information provided by the 
commenters regarding these supply packages, especially the pricing data 
contained in the submitted invoices. For the SD341 compression 
equipment package, we note that the invoices show that the two sets of 
cuffs are often sold together at a price of $220 instead of separately 
at $245. This accounts for the difference between the $847.00 and 
$826.75 prices listed by different commenters, and since the bundling 
of these cuffs appears to be the typical case, we are finalizing an 
update in the price of the EECP compression equipment package (SD341) 
supply at $826.75. For the second supply package, we agree with the 
commenters and we are finalizing an update in the price of the EECP 
electrical equipment package (SD342) at $752.00.
    Comment: Several commenters provided additional details regarding 
the quantities for the two supply packages. Commenters stated that the 
compression package items typically have to be replaced every 13 weeks 
while the electrical package items typically have to be replaced every 
50 weeks. Commenters stated that a provider of these services would be 
highly unlikely to be able to use the same cuffs, bladders, hoses, and 
straps in the SD341 supply package for 325 hours as these items would 
be completely deteriorated by this point and would be likely to lose 
the structural integrity needed to maintain clinical effectiveness. 
Commenters stated that a 100 hour life span would be more accurate for 
the SD341 supply as it reflected the typical wear and tear with 
inflating the compression items at high pressure (300 mm Hg every 
heartbeat) and was consistent with the manufacturer's estimated usage. 
Commenters stated that the electrical package does not experience the 
same level of stress and wear, and instead those items have a 400 hour 
life span.
    Response: We appreciate the additional information provided by the 
commenters regarding the quantities for these two supply packages. 
Given that the intraservice treatment time for HCPCS code G0166 lasts 
for one hour, we are finalizing an update in the quantity of the SD341 
supply pack to 1/100 and an update in the quantity of the SD342 supply 
pack to 1/400. These updated supply quantities reflect how many times 
the service can be performed before the supply package needs to be 
replaced.
    Comment: Several commenters disagreed with the proposal of the RUC-
recommended clinical labor time of 83 minutes. Commenters stated that 
the proposed time omitted 8 minutes of required clinical activities 
consistent with the ECP user manual. Commenters stated that ECP therapy 
providers must check legs, conduct a patient assessment, auscultate/
assess lungs, and review change in baseline. Commenters stated that ECP 
therapy providers also must perform patient checks immediately 
following the service such as assess signs related to blood sugar 
levels (for diabetic patients), assess the patient's lower body for 
redness, blistering, and/or ulceration, and assist patients from the 
treatment area following the service. Commenters stated that these are 
essential safety measures to ensure patients have tolerated the 
treatment well and these activities must be performed every treatment 
and must be captured as part of the clinical labor time. Commenters

[[Page 84641]]

requested that CMS add 8 minutes to the total time under the CA016 
activity code (``Prepare, set-up and start IV, initial positioning and 
monitoring of patient''), increasing the time for this clinical 
activity from 6 minutes to 14 minutes.
    Response: Although we appreciate the additional information 
supplied by the commenters, we continue to agree with the RUC's 
recommendation of 83 minutes of total clinical labor time. The RUC 
reviewed the same information provided by the commenters and concluded 
that this additional clinical labor time would not be typical. We also 
note that the recommended 83 minutes of total clinical labor time 
already represents an increase over the prior total time of 73 minutes 
for the service, with additional clinical labor time for preparing and 
positioning the patient as well as completing post-procedure forms. We 
believe that the typical clinical labor activities for HCPCS code G0166 
are captured in the RUC-recommended clinical labor time.
    After considering the comments, we are finalizing the RUC-
recommended preservice period, service period, and postservice period 
clinical labor times for HCPCS code G0166 along with our proposal to 
replace the CA010 clinical labor time with an equivalent 3 minutes of 
CA023 clinical labor time. We are also finalizing updates in the price 
of the EQ012 equipment and the SD341 and SD342 supply packages, along 
with updates to the supply quantity for the two supply packages.
(53) Molecular Pathology Interpretation (HCPCS Code G0452)
    At the October 2018 RUC meeting, the Relativity Assessment 
Workgroup (RAW) identified HCPCS code G0452 (Molecular pathology 
procedure; physician interpretation and report) as potentially 
misvalued on a CMS/Other screen. The RUC had never reviewed HCPCS code 
G0452 and assumptions regarding work and time were based upon a 1995 
vignette. In addition, the specialty society noted that the technology 
available for furnishing the service, as well as the patient population 
receiving the service, had changed since the code was valued by CMS.
    The RUC requested a physician work survey be completed for the 
October 2019 RUC meeting. It was during the October meeting that the 
work and PE values for HCPCS code G0452 were reviewed and recommended.
    For CY 2021, we proposed the RUC-recommended work RVU of 0.93 and 
the RUC-recommended direct PE inputs for HCPCS code G0452.
    We received several public comments on Molecular Pathology 
Interpretation (HCPCS code G0452) all in support of our proposal to 
adopt the RUC's recommendations for the service.
    After consideration of the comments, we are finalizing the work RVU 
and direct PE inputs as proposed.
(54) Evaluation and Management, Observation and Provision of Self-
Administered Esketamine (HCPCS Codes G2082 and G2083)
    In the CY 2020 PFS final rule (84 FR 63102 through 63104), we 
issued an interim final rule with comment period (IFC) to establish 
coding and payment for E/M, observation, and the provision of self-
administered Esketamine to facilitate beneficiary access to care for 
treatment-resistant depression as efficiently as possible. We created 
two new HCPCS G codes, G2082 and G2083, effective January 1, 2020 on an 
interim final basis. For CY 2020, we established RVUs for these 
services that reflect the relative resource costs associated with the 
E/M, observation and provision of the self-administered esketamine 
product. The HCPCS G-codes are described as follows: HCPCS code G2082 
(Office or other outpatient visit for the evaluation and management of 
an established patient that requires the supervision of a physician or 
other qualified health care professional and provision of up to 56 mg 
of esketamine nasal self-administration, includes 2 hours post-
administration observation) and HCPCS code G2083 (Office or other 
outpatient visit for the evaluation and management of an established 
patient that requires the supervision of a physician or other qualified 
health care professional and provision of greater than 56 mg esketamine 
nasal self-administration, includes 2 hours post-administration 
observation).
    In developing the interim final values for these codes, we used a 
building block methodology that sums the values associated with several 
codes. For the overall E/M and observation elements of the services, we 
incorporated the work RVUs, work time and direct PE inputs associated 
with a level two office/outpatient visit for an established patient, 
CPT code 99212 (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 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), which has a 
work RVU of 0.48 and a total work time of 16 minutes, which is based on 
a pre-service evaluation time of 2 minutes, an intraservice time of 10 
minutes, and a postservice time of 4 minutes.
    We also incorporated CPT codes 99415 (Prolonged clinical staff 
service (the service beyond the typical service time) during an 
evaluation and management service in the office or outpatient setting, 
direct patient contact with physician supervision; first hour (List 
separately in addition to code for outpatient Evaluation and Management 
service)) and 99416 (Prolonged clinical staff service (the service 
beyond the typical service time) during an evaluation and management 
service in the office or outpatient setting, direct patient contact 
with physician supervision; each additional 30 minutes (List separately 
in addition to code for prolonged service))) in which neither code has 
a work RVU, but includes direct PE inputs reflecting the prolonged time 
for clinical staff under the direct supervision of the billing 
practitioner.
    In addition, to account for the cost of the provision of the self-
administered esketamine as a direct PE input, we incorporated the 
wholesale acquisition cost (WAC) data from the most recent available 
quarter. For HCPCS code G2082, we used a price of $590.02 for the 
supply input that describes 56 mg (supply code SH109) and for HCPCS 
code G2083, we used a price of $885.02 for the supply input describing 
84 mg of esketamine (supply code SH110).
    We sought comment on the interim final values we established for 
HCPCS codes G2082 and G2083, including the assigned work RVUs, work 
times, and direct PE inputs. See the CY 2021 PFS proposed rule (85 FR 
50169 through 50172) for a summary of the comments we received and our 
responses.
    After considering the comments we received, we proposed to refine 
the values for HCPCS codes G2082 and G2083 using a building block 
methodology that sums the values associated with several codes. For the 
overall E/M and observation elements of the services, we incorporated 
the work RVUs, work time and direct PE inputs associated with a level 
two office/outpatient visit for an established patient, CPT code 99212. 
We also proposed to include the clinical labor for CPT codes 95076 and 
95079 (in lieu of CPT codes 99415 and 99416 as detailed earlier); and 
to account for the

[[Page 84642]]

cost of the provision of the self-administered esketamine as a direct 
PE input, we proposed to incorporate the wholesale acquisition cost 
(WAC) data from the most recent available quarter. We solicited comment 
on this updated payment proposal and valuation of HCPCS code G2082 and 
G2083.
    We received public comments on the Evaluation and Management, 
Observation and Provision of Self-Administered Esketamine (HCPCS Codes 
G2082 and G2083). The following is a summary of the comments we 
received and our responses.
    Comment: Overall, commenters were in support of our proposal to 
refine the values for HCPCS codes G2082 and G2083.
    Response: We appreciate the support for our proposal to refine the 
direct PE inputs of HCPCS codes G2082 and G2083, in part, by using the 
clinical labor time for CPT codes 95076 and 95079, in lieu of the 
clinical labor time of CPT codes 99415 and 99416, which increased the 
clinical labor time from 30 minutes to 150 minutes.
    Comment: A commenter stated that administering esketamine may on 
occasion necessitate a higher level of E/M from the physician, and 
therefore, encouraged CMS to provide the ability to bill a separate E/M 
service on those occasions where medical necessity dictates a higher 
level of service. The commenter also requested that CMS issue a J-code 
specifically for esketamine treatment and create a HCPCS code that 
separates the clinical work of the service from the cost of the 
medication.
    Response: HCPCS codes G2082 and G2083 are bundled services that 
include, as discussed in the CY 2021 PFS proposed rule (85 FR 50169 
through 50172), the E/M, observation and the provision of self-
administered esketamine. We continue to believe that HCPCS codes G2082 
and G2083 should be a bundled services. We do not believe it would be 
appropriate to create a J-code that could permit esketamine to be 
billed separately, particularly given that the product is only 
available through a restricted distribution system under a REMS; 
patients must be monitored by a health care provider for at least 2 
hours after receiving their Spravato dose; the prescriber and patient 
must both sign a Patient Enrollment Form; and the product will only be 
administered in a certified medical office where the health care 
provider can monitor the patient.\24\ Additionally, we continue to 
believe that the building block methodology we used incorporating CPT 
code 99212 is appropriate for valuing this service. Since HCPCS codes 
G2082 and G2083 already take into account E/M provided as part of these 
services, it would be duplicative for a clinician to bill for a 
separate E/M code along with HCPCS codes G2082 and G2083. We believe 
the direct PE input refinements made for HCPCS codes G2082 and G2083, 
which increased the clinical labor time to 150 minutes, are appropriate 
for the necessary observation associated with esketamine 
administration. However, other reasonable and necessary E/M services 
may be furnished and billed for a patient on dates before and after 
HCPCS codes G2082 and G2083, for example, when the services are 
furnished in the course of treating and diagnosing treatment-resistant 
depression. Additionally, the self-administered esketamine is 
considered a supply item for this bundled service. Therefore, 
esketamine cannot be billed separately along with HCPCS codes G2082 and 
G2033 under the PFS.
---------------------------------------------------------------------------

    \24\ https://www.fda.gov/news-events/press-announcements/fda-approves-new-nasal-spray-medication-treatment-resistant-depression-available-only-certified.
---------------------------------------------------------------------------

    After consideration of public comments, we are finalizing our 
proposal to refine the values for HCPCS codes G2082 and G2083 using a 
building block methodology that sums the values associated with several 
codes.
(55) Bundled Payments Under the PFS for Substance Use Disorders (HCPCS 
Codes G2086, G2087, and G2088)
    In the CY 2020 PFS final rule (84 FR 62673), we finalized the 
creation of new coding and payment describing a bundled episode of care 
for the treatment of Opioid Use Disorder (OUD). The codes and 
descriptors we finalized for CY 2020 were:
     HCPCS code G2086: Office-based treatment for opioid use 
disorder, including development of the treatment plan, care 
coordination, individual therapy and group therapy and counseling; at 
least 70 minutes in the first calendar month.
     HCPCS code G2087: Office-based treatment for opioid use 
disorder, including care coordination, individual therapy and group 
therapy and counseling; at least 60 minutes in a subsequent calendar 
month.
     HCPCS code G2088: Office-based treatment for opioid use 
disorder, including care coordination, individual therapy and group 
therapy and counseling; each additional 30 minutes beyond the first 120 
minutes (List separately in addition to code for primary procedure).
    As noted in the CY 2020 PFS final rule (84 FR 62673), if a 
patient's treatment involves MAT, this bundled payment would not 
include payment for the medication itself. Billing and payment for 
medications under Medicare Part B or Part D would remain unchanged.
    As discussed in the CY 2021 PFS proposed rule (85 FR 50172), we 
received requests to expand these bundled payments to be inclusive of 
other SUDs, not just OUD. We agreed that doing so could expand access 
to needed care. We proposed to expand these bundled payments to be 
inclusive of all SUDs. To accomplish this, we proposed to revise the 
code descriptors for HCPCS codes G2086, G2087, and G2088 by replacing 
``opioid use disorder'' with ``a substance use disorder.'' The payment 
and billing rules would otherwise remain unchanged. We noted that HCPCS 
codes G2086, G2087, and G2088 were added to the Medicare Telehealth 
list in the CY 2020 PFS final rule (84 FR 62628). The revised code 
descriptors are:
     HCPCS code G2086: Office-based treatment for a substance 
use disorder, including development of the treatment plan, care 
coordination, individual therapy and group therapy and counseling; at 
least 70 minutes in the first calendar month.
     HCPCS code G2087: Office-based treatment for a substance 
use disorder, including care coordination, individual therapy and group 
therapy and counseling; at least 60 minutes in a subsequent calendar 
month.
     HCPCS code G2088: Office-based treatment for a substance 
use disorder, including care coordination, individual therapy and group 
therapy and counseling; each additional 30 minutes beyond the first 120 
minutes (List separately in addition to code for primary procedure).
    In addition, in the CY 2020 PFS final rule we stated that we 
anticipated that the services described by HCPCS codes G2086, G2087, 
and G2088 would often be billed by addiction specialty practitioners, 
but note that these codes are not limited to any particular physician 
or NPP specialty. We also noted that consultation was not a required 
condition of payment for these codes, but that consultation with a 
specialist could be counted toward the minutes required for billing 
HCPCS codes G2086, G2087, and G2088 (84 FR 62674). Although it is not a 
requirement for billing the code, we encouraged that practitioners 
consult with specialists in cases where it is warranted and refer the 
patient to specialty care as needed.

[[Page 84643]]

    We noted that while these codes describe treatment for any SUD, 
information about which specific SUDs are being treated would provide 
valuable information that can help assess local, state, and national 
trends and needs. We believe it is important that the diagnosis codes 
listed on the claim form reflect all SUDs being treated; however, we 
also noted that we do not wish to add any additional burden on 
practitioners related to claims submission, and therefore, we solicited 
information on whether there are sources of data we could explore in 
order to provide this information. We also solicited information on 
whether there are differences in the resource costs associated with 
furnishing services for the various SUDs, and accordingly whether there 
is a need for more stratified coding to describe these services. We 
noted that in some instances, the CPT Editorial Panel has created CPT 
codes to replace G codes created by CMS, and that we welcomed such 
input on those services.
    We received public comments on the proposal to expand these bundled 
payments to be inclusive of all SUDs. The following is a summary of the 
comments we received and our responses.
    Comment: Several commenters supported this proposal. Some noted 
that this flexibility would permit practitioners to furnish 
comprehensive services for individuals with SUDs, the majority of whom 
have polysubstance use disorder. One commenter noted that every service 
code can have one or more diagnosis codes connected to it on a claim, 
therefore, a generic SUD treatment code still permits physicians to 
specify which SUDs were treated, allowing CMS to track that information 
without adding additional administration burden. Some commenters also 
stated they were not aware of any significant variation in resource 
costs between SUDs. One stakeholder encouraged CMS to work with the 
medical societies through the CPT Editorial Panel process to examine 
the different resource costs involved in treating different SUDs to 
determine the need for more stratified coding, but advised that in the 
meantime, CMS should finalize the proposal to ensure that more patients 
have access to these critical services. A few commenters suggested that 
these codes should account for risk stratification, noting that some 
patients, such as pregnant or postpartum women have more complex needs 
and require more frequent services. One commenter stated that expanding 
the use of these codes to all SUD diagnoses may present opportunity for 
fraudulent, duplicative coding, were providers to bill the codes for 
each SUD diagnosis, noting that many patients with SUD use multiple 
substances and require treatment for more than one substance, 
therefore, the commenter recommended that CMS limit billing of these 
codes to once per month per patient.
    Response: We thank the commenters for their feedback. After 
consideration of the comments, we are finalizing our proposal to expand 
the bundled payments described by HCPCS codes G2086-G2088 to be 
inclusive of all SUDs. We appreciate the commenter that pointed out 
that duplicative billing could occur in cases where a beneficiary is 
being treated for more than one SUD. We agree that HCPCS codes G2086-
G2088 should not be billed more than once per month per beneficiary 
since these codes describe treatment for one or more SUDs. 
Additionally, we welcome the opportunity to work with the medical 
societies and CPT Editorial Panel to determine whether there is a need 
to stratify this coding to reflect variation in service intensity, 
through future rulemaking.
(56) Initiation of Medication Assisted Treatment (MAT) in the Emergency 
Department (HCPCS Code G2213)
    In the CY 2020 PFS proposed rule (84 FR 40545), we sought comment 
on the use of medication assisted treatment (MAT) in the emergency 
department (ED) setting, including initiation of MAT and the potential 
for either referral or follow-up care, to better understand typical 
practice patterns to help inform whether we should consider making 
separate payment for such services in future rulemaking. We noted that 
the term MAT generally refers to treatment of OUD that includes both an 
FDA-approved medication for the treatment of OUD and behavioral/
psychosocial treatment, but that care provided in the ED typically 
would include medication for the treatment of OUD and referral or 
linkage to primary care or a hospital-based bridge clinic for 
continuation of medication and potentially other services, including 
counseling and other psychosocial services.
    The public comments received in response to the comment 
solicitation were supportive of us making a proposal, several citing 
research that indicates improved outcomes for patients who initiate 
medications for the treatment of OUD in the ED. One commenter noted 
that by implementing this treatment regimen, practitioners can address 
a patient's immediate withdrawal symptoms, which allows time to 
coordinate care and provide a referral to substance use disorder 
specialists and other community resources who can appropriately carry 
out long-term treatment. Another commenter cited that the national rate 
of overdose-related visits seen in EDs nearly doubled between 2005 and 
2014 and noted that hospital-based care represents a critical 
opportunity to initiate treatment and connect patients with OUD to 
care, noting that patients who receive information about drug treatment 
in the hospital post-overdose are more likely to seek treatment.\25\ 
The commenter also cited a randomized clinical trial that showed that 
more patients were engaged in treatment 30 days after buprenorphine was 
initiated in the ED and coupled with a referral, compared to 
interventions that did not include buprenorphine.\26\ Another study 
found that ED induction of buprenorphine was more cost-effective than 
either brief intervention or referral upon discharge.\27\ One commenter 
suggested that CMS institute a G-code to address this coding gap in the 
short term, while a more permanent solution is pursued to address this 
site-of-service specification.
---------------------------------------------------------------------------

    \25\ Agency for Healthcare Research and Quality, ``Statistical 
Brief #219: Opioid-Related Inpatient Stays and Emergency Department 
Visits by State, 2009-2014,'' (2017), https://www.hcup-us.ahrq.gov/reports/statbriefs/sb219-Opioid-Hospital-Stays-ED-Visits-by-State.pdf.
    \26\ Gail D'Onofrio et al., ``Emergency Department--Initiated 
Buprenorphine/Naloxone Treatment for Opioid Dependence Randomized 
Clinical Trial,'' JAMA 16, no. 313 (2015): 2002-2010, https://www.ncbi.nlm.nih.gov/pubmed/25919527.
    \27\ Susan Busch et al., ``Cost Effectiveness of Emergency 
Department--Initiated Treatment for Opioid Dependence,'' Journal of 
Addiction 11, no. 112 (2017), https://www.ncbi.nlm.nih.gov/pubmed/28815789.
---------------------------------------------------------------------------

    We were persuaded by the comments received in response to our 
comment solicitation that this work is not currently accounted for in 
the existing code set. To account for the resource costs involved with 
initiation of medication for the treatment of opioid use disorder in 
the ED and referral for follow-up care, we proposed to create one add-
on G-code to be billed with E/M visit codes used in the ED setting. We 
discussed that this code would include payment for assessment, referral 
to ongoing care, follow-up after treatment begins, and arranging access 
to supportive services, but we note that the drug itself would be paid 
separately. We proposed the following code:
     HCPCS code GMAT1: Initiation of medication for the 
treatment of opioid use disorder in the emergency department setting, 
including assessment, referral to ongoing care, and arranging access to 
supportive

[[Page 84644]]

services (List separately in addition to code for primary procedure).
    To price this service, we proposed to use a direct crosswalk to the 
work and direct PE inputs for HCPCS code G0397 (Alcohol/subs interv 
30 min), which is assigned a work RVU of 1.30. We noted that 
we believe that the work and PE described by this crosswalk code is 
similar in nature and magnitude to the services described in HCPCS code 
GMAT1. We noted that unlike the requirements for reference code, we did 
not propose a required number of minutes to bill HCPCS code GMAT1. We 
welcomed comment on the proposal and whether we should consider a 
different valuation to account for the resource costs involved with 
these services.
    We received public comments on our proposal to create an add-on G-
code to be billed with E/M visit codes used in the ED setting. The 
following is a summary of the comments we received and our responses.
    Comment: Commenters were very supportive of finalizing this 
proposal, noting that payment for this service will encourage hospitals 
to engage in this evidence-based practice. One commenter sought 
clarification on which of these elements were mandatory given that 
``initiation'' of the service for patients will involve a transition of 
care to other health care providers and requested that CMS provide 
guidance on what ``follow-up'' is required of the emergency department 
provider given that post-initiation care is administered by the 
practitioner to whom the ED provider would have transitioned the 
patient care.
    Response: We are finalizing payment for this code as proposed. We 
note that HCPCS code GMAT1 was a placeholder code in the proposed rule. 
The finalized code is HCPCS code G2213 (Initiation of medication for 
the treatment of opioid use disorder in the emergency department 
setting, including assessment, referral to ongoing care, and arranging 
access to supportive services (List separately in addition to code for 
primary procedure)). In response to the request for clarification about 
which elements are required in order to bill for this code, 
practitioners should furnish only those activities that are clinically 
appropriate for the beneficiary that is being treated.
(57) Percutaneous Creation of an Arteriovenous Fistula (AVF) (HCPCS 
Codes G2170 and G2171)
    We received a comment in response to the CY 2020 PFS proposed rule 
(84 FR 40481), as well as inquiries from stakeholders, requesting that 
we establish new coding for the percutaneous creation of an 
arteriovenous fistula (AVF) used for dialysis access.
    For CY 2019, based on two new technology applications for 
arteriovenous fistula creation, we established two new HCPCS codes to 
describe the two modalities of this service. Specifically, we 
established HCPCS code C9754 (Creation of arteriovenous fistula, 
percutaneous; direct, any site, including all imaging and radiologic 
supervision and interpretation, when performed and secondary procedures 
to redirect blood flow (e.g., transluminal balloon angioplasty, coil 
embolization, when performed)) and HCPCS code C9755 (Creation of 
arteriovenous fistula, percutaneous using magnetic-guided arterial and 
venous catheters and radiofrequency energy, including flow-directing 
procedures (e.g., vascular coil embolization with radiologic 
supervision and interpretation, when performed) and fistulogram(s), 
angiography, venography, and/or ultrasound, with radiologic supervision 
and interpretation, when performed). The HCPCS codes were created for 
institutional payment systems, and thus do not allow for payment for 
the physician's work portion of the service. Stakeholders have stated 
that the lack of proper coding to report the physician work associated 
with these procedures is problematic, as physicians are either billing 
an unlisted procedure code, or are billing other CPT codes that do not 
appropriately reflect the resource cost associated with the physician 
work portion of the service. Stakeholders stated that separate coding 
for physician payment will allow billing when the procedures are 
furnished in either a physician office or an institutional setting, and 
be paid under the respective payment systems, as appropriate. We have 
recognized that the lack of appropriate coding for this critical 
physician's service has become an even greater burden given the PHE for 
COVID-19. In order to mitigate potential health risks to beneficiaries, 
physicians and practitioners as a result of having this procedure 
performed in an institutional setting, we created two HCPCS G codes for 
percutaneous creation of an arteriovenous fistula (AVF). The codes are 
contractor priced and effective July 1, 2020. This will allow for more 
accurate billing and coding of a crucial physician service that could 
then be performed in both institutional and office settings, thus 
mitigating unnecessary risk to beneficiaries, physicians and 
practitioners caused by disease transmission. The HCPCS G codes are 
described as follows:
     HCPCS G code G2170 (Percutaneous arteriovenous fistula 
creation (AVF), direct, any site, by tissue approximation using thermal 
resistance energy, and secondary procedures to redirect blood flow 
(e.g., transluminal balloon angioplasty, coil embolization) when 
performed, and includes all imaging and radiologic guidance, 
supervision and interpretation, when performed.)
     HCPCS G code G2171 (Percutaneous arteriovenous fistula 
creation (AVF), direct, any site, using magnetic-guided arterial and 
venous catheters and radiofrequency energy, including flow-directing 
procedures (e.g., vascular coil embolization with radiologic 
supervision and interpretation, when performed) and fistulogram(s), 
angiography, venography, and/or ultrasound, with radiologic supervision 
and interpretation, when performed.)
    We proposed to maintain contractor pricing for these HCPCS codes 
for CY 2021, however, we also solicited information from stakeholders 
on the resource costs involved in furnishing the services described by 
HCPCS codes G2170 and G2171 to ensure proper payment for these 
physician's services, for consideration in future rulemaking. We noted 
that under the OPPS these services are assigned to APC 5193, which for 
CY 2020 has an assigned payment rate of $15,938.20.
    We received public comments on Percutaneous Creation of an 
Arteriovenous Fistula (AVF) (HCPCS code G2170 and G2171).
    The following is a summary of the comments we received and our 
responses.
    Comment: Commenters stated that they were supportive of the 
creation of the HCPCS codes G2170 and G2171. Many commenters stated 
that they believe this will increase access for beneficiaries by 
allowing this service to be performed in outpatient settings. 
Commenters were also appreciative of the creation of these codes for 
use during the PHE.
    Response: We appreciate the commenters' support of the creation of 
HCPCS codes G2170 and G2171.
    Comment: A few commenters stated that they did not understand the 
logic of our proposal to contractor price HCPCS codes G2170 and G2171 
to avoid disease transmission.
    Response: We believe that our statement about reduced risk of 
disease transmission in connection with our proposal to maintain 
contractor pricing

[[Page 84645]]

for calendar year 2021 for HCPCS codes G2170 and G2171 may have been 
confusing to some commenters. We created HCPCS codes G2170 and G2171 to 
facilitate provision of these services outside of institutional 
facility settings. We stated that expanded access to this service 
outside of facility settings, especially in light of the PHE for COVID-
19, could reduce the potential health risks to beneficiaries, 
physicians and other health care practitioners that could occur when 
these services are furnished in higher acuity health care settings. The 
proposal to contractor price these services was not related to risks of 
disease transmission.
    Comment: Commenters stated that they believe HCPCS codes G2170 and 
G2171 should be nationally priced for calendar year 2021 and beyond. 
The commenters stated that they believe contractor pricing creates 
unnecessary variability and unreliable payment.
    Response: CMS routinely contractor prices new HCPCS codes. The 
services described by G2170 and G2171 are new technology and are just 
beginning to be performed outside of the facility setting. As such, we 
anticipate collecting more information for purposes of national 
pricing. We expect to take these comments into consideration for future 
rulemaking and we hope to continue a dialogue with stakeholders on 
these important services.
    Comment: A few commenters stated that they are displeased with the 
publication of a proposed Local Coverage Determination (LCD) that would 
limit coverage for these services.
    Response: We appreciate the concern of some commenters regarding a 
proposed LCD for HCPCS codes G2170 and G2171. We did not address 
coverage policies for these services in the proposed rule. Such local 
coverage policies are not within the scope of the CY 2021 PFS 
rulemaking process.
    Comment: A few commenters responded to our request for information 
from stakeholders on the resource costs involved in furnishing the 
services described by HCPCS codes G2170 and G2171 for consideration in 
future rulemaking. Some commenters submitted invoices for various 
equipment as well as a breakdown of their estimated supply and clinical 
staff costs.
    Response: We appreciate the information commenters provided on the 
resource costs involved in furnishing these services. We will take this 
information into consideration for future rulemaking.
    After consideration of these public comments, we are finalizing our 
proposals for HCPCS codes G2170 and G2171 with contractor pricing as 
proposed, and will consider addressing national pricing through 
potential future rulemaking.
(58) Insertion, Removal, and Removal and Insertion of Implantable 
Interstitial Glucose Sensor System (Category III CPT Codes 0446T, 
0447T, and 0448T)
    Category III CPT codes 0446T, 0447T, and 0448T describe the 
services related to the insertion, removal, and removal and insertion 
of an implantable interstitial glucose sensor from subcutaneous pocket, 
in a subcutaneous pocket via incision. The implantable interstitial 
glucose sensors are part of systems that can allow real-time glucose 
monitoring, provides glucose trend information, and signal alerts for 
detection and prediction of episodes of low blood glucose 
(hypoglycemia) and high blood glucose (hyperglycemia). The codes that 
describe the implantation, removal, and removal and implantation of 
implantable interstitial glucose sensors are currently contractor-
priced.
     Category III CPT code 0446T (Creation of subcutaneous 
pocket with insertion of implantable interstitial glucose sensor, 
including system activation and patient training);
     Category III CPT code 0447T (Removal of implantable 
interstitial glucose sensor from subcutaneous pocket via incision); and
     Category III CPT code 0448T (Removal of implantable 
interstitial glucose sensor with creation of subcutaneous pocket at 
different anatomic site and insertion of new implantable sensor, 
including system activation).
    In the CY 2020 PFS final rule (84 FR 62627), we requested 
information from stakeholders to ensure proper payment for this 
important physician's service and welcomed recommendations on 
appropriate valuation for these services to be considered in future 
rulemaking.
    We proposed to establish national payment amounts for the codes 
describing the insertion, removal, and removal and insertion of an 
implantable interstitial glucose sensor, effective January 1, 2021. We 
proposed a work RVU of 1.14 for Category III CPT code 0446T, a work RVU 
of 1.34 for Category III CPT code 0447T, and work RVU of 1.91 for 
Category III CPT code 0448T based on a crosswalk to the work RVUs, work 
time, and direct PE inputs of CPT codes 11981 (Insertion, non-
biodegradable drug delivery implant), 11982 (Removal, non-biodegradable 
drug delivery implant), and 11983 (Removal with reinsertion, non-
biodegradable drug delivery implant), respectively, due to the similar 
clinical nature of these procedures.
    We also proposed to include one supply and one equipment item to 
the direct PE inputs crosswalked from CPT codes 11981-11983. We added a 
new ``implantable interstitial glucose sensor'' (supply code SD334) for 
Category III CPT codes 0446T and 0448T to include the supply costs of 
the ``implantable interstitial glucose sensor'' (supply code SD334) 
included in these procedures, which we proposed to price at $1,500.00, 
based on information we received from stakeholders. We also proposed to 
include the smart transmitter associated with the use of this 
implantable interstitial glucose sensor. We proposed to price the smart 
transmitter involved in furnishing this service by using a similar 
equipment item finalized in the CY 2019 PFS final rule (83 FR 59624) as 
a proxy, the ``heart failure patient physiologic monitoring equipment 
package'' (EQ392); the EQ392 has a price of $1,000.00, and is similarly 
used for long term remote monitoring of patients. We proposed to use 
the EQ392 equipment as a proxy for the valuation of the smart 
transmitter associated with the implantable interstitial glucose 
sensor, to which we are assigning a time of 25,920 minutes for EQ392 in 
Category III CPT codes 0446T and 0448T. We explained that this time is 
derived from 60 minutes per hour times 24 hours per day times 90 days 
per billing quarter, divided by 1 minute of equipment use out of every 
5 minutes of time. We did not include the implantable interstitial 
glucose sensor or the EQ392 equipment proxy for Category III CPT code 
0447T, as it describes only a removal procedure.
    We solicited comment on the proposed values for these Category III 
CPT codes (0446T, 0447T, and 0448T), and we solicited comment on the 
appropriateness and accuracy of the proposed work RVUs, work times, and 
direct PE inputs.
    We received public comments on the Insertion, Removal, and Removal 
and Insertion of Implantable Interstitial Glucose Sensor System code 
family. The following is a summary of the comments we received and our 
responses.
    Comment: Commenters supported the proposed work RVUs for the 
Category III CPT codes, 1.14 for Category III CPT code 0446T, 1.34 for 
Category III CPT code 0447T, and 1.91 for Category III CPT code 0448T.
    Response: We appreciate the support for the proposed work RVUs for 
these Category III CPT codes (0446T, 0447T, and 0448T).
    Comment: Several commenters stated that they agreed with the 
inclusion of

[[Page 84646]]

the ``implantable interstitial glucose sensor'' supply (SD334) for 
Category III CPT codes 0446T and 0448T, which should include the supply 
costs of the implantable interstitial glucose sensor at the proposed 
price of $1,500.00. However, the commenters stated that the cost of the 
smart transmitter equipment (EQ392) associated with the use of the 
implantable interstitial glucose sensor should be included only for 
Category III CPT code 0446T and not be included as part of the cost of 
Category III CPT code 0448T. A commenter stated that the 90-day 
implantable sensor will be implanted for the first time and linked to 
the transmitter device in the first procedure, Category III CPT code 
0446T. The commenter stated that there is no need to report the cost of 
the transmitter with Category III CPT 0448T as the sensor will be 
removed and replaced, but the patient will not receive a new smart 
transmitter during this visit.
    Response: We appreciate the additional information supplied by the 
commenter regarding the use of the smart transmitter equipment in 
Category III CPT codes 0446T and 0448T. Given that there is no need to 
report the cost of the transmitter with Category III CPT 0448T because 
the sensor will be removed and replaced, but the patient will not 
receive a new smart transmitter during this visit, we are finalizing 
the removal of the heart failure patient physiologic monitoring 
equipment package (EQ392) from Category III CPT code 0448T.
    After consideration of public comments, we are finalizing the work 
RVUs as proposed for Category III CPT codes 0446T, 0447T, and 0448T, 
and finalizing the direct PE inputs as proposed except that we are 
removing the equipment package (EQ392) from the Category III CPT code 
0448T in response to comments as explained above.
BILLING CODE 4120-01-P

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[[Page 84682]]


BILLING CODE 4120-01-C

I. Modifications Related to Medicare Coverage for Opioid Use Disorder 
(OUD) Treatment Services Furnished by Opioid Treatment Programs (OTPs)

1. Background
    Section 2005 of the Substance Use-Disorder Prevention that Promotes 
Opioid Recovery and Treatment for Patients and Communities (SUPPORT) 
Act established a new Medicare Part B benefit category for OUD 
treatment services furnished by OTPs during an episode of care 
beginning on or after January 1, 2020. In the CY 2020 PFS final rule 
(84 FR 62630 through 62677), we implemented coverage requirements and 
established new codes describing the bundled payments for episodes of 
care for the treatment of OUD furnished by OTPs. We established new 
codes for and finalized bundled payments for weekly episodes of care 
that include methadone, oral buprenorphine, implantable buprenorphine, 
injectable buprenorphine or naltrexone, and non-drug episodes of care, 
as well as add-on codes for intake and periodic assessments, take-home 
dosages for methadone and oral buprenorphine, and additional 
counseling. We are monitoring Medicare enrollment by OTPs and 
utilization of the new benefit to ensure that Medicare beneficiaries 
have appropriate access to care. For CY 2021, we proposed several 
refinements and also provided clarification of certain issues that 
stakeholders have brought to our attention.
2. Definition of OUD Treatment Services
    In the CY 2020 PFS final rule (84 FR 62631 through 62635), we 
finalized a definition of ``OUD treatment services'' that reflects the 
statutory definition in section 1861(jjj)(1)(A) of the Act, which 
defines covered OUD treatment services to include oral, injected, and 
implanted opioid agonist and antagonist treatment medications approved 
by the Food and Drug Administration (FDA) under section 505 of the 
Federal Food, Drug, and Cosmetic Act (FFDCA) for use in the treatment 
of OUD. There are three drugs currently approved by FDA for the 
treatment of opioid dependence: Buprenorphine; methadone; and 
naltrexone. In the CY 2020 PFS final rule, we noted that we had 
received comments supporting the proposed definition of OUD treatment 
services but also requesting that CMS include naloxone to treat opioid 
overdose in that definition as a medication used in treatment of OUD. 
Although we did not finalize including naloxone in the definition of 
OUD treatment services in that final rule, we indicated that as we 
continue to work on refining this new Medicare benefit, we would 
consider including additional drugs in the definition of OUD treatment 
services under our discretionary authority in section 1861(jjj)(1)(F) 
of the Act to include other items and services the Secretary determines 
are appropriate. As explained in the CY 2021 PFS proposed rule (85 FR 
50203), we determined, after further consideration, that it would be 
appropriate to propose to extend the definition of OUD treatment 
services to include opioid antagonist medications, such as naloxone, 
that are approved by FDA under section 505 of the FFDCA for emergency 
treatment of opioid overdose.
    Naloxone is an opioid antagonist indicated for the emergency 
treatment of known or suspected opioid overdose, as manifested by 
respiratory and/or central nervous system depression.\28\ \29\ Naloxone 
should be given to a person who shows signs of an opioid overdose or 
when an overdose is suspected. FDA-approved naloxone products for 
overdose reversal are effective in reversing opioid overdose, including 
fentanyl-involved opioid overdoses, although overdoses involving potent 
(for example, fentanyl) or large quantities of opioids may require 
higher-than-normal doses of naloxone or repeated administration to 
reverse overdose.\30\
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    \28\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208411lbl.pdf.
    \29\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/209862lbl.pdf.
    \30\ https://store.samhsa.gov/sites/default/files/d7/priv/sma18-4742.pdf.
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    Naloxone attaches to opioid receptors and reverses and blocks the 
effects of other opioids.\31\ FDA has approved injectable naloxone, 
intranasal naloxone, and naloxone auto-injector as emergency treatments 
for opioid overdose. The nasal spray is a prefilled, needle-free device 
that requires no assembly and can deliver a single dose into each 
nostril with two sprays. The auto-injector is injected into the outer 
thigh to deliver naloxone to the muscle (intramuscular). Both the nasal 
spray and naloxone auto-injector are packaged in a carton containing 
two doses to allow for repeat dosing if needed.\32\ \33\ These forms of 
naloxone can easily be administered by persons who do not have medical 
training and they may be prescribed to a patient who is receiving 
medication-assisted treatment (MAT) for OUD, especially if the patient 
is considered to be at risk for opioid overdose.\34\ However, it is 
important to understand how to administer naloxone properly. A doctor 
or pharmacist can show patients, their family members, or caregivers 
how to administer naloxone.\35\ We expect that a treating practitioner 
that is prescribing naloxone will also educate the patient, as 
appropriate, on how to administer the specific form of naloxone 
prescribed.
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    \31\ https://www.drugabuse.gov/publications/drugfacts/naloxone.
    \32\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208411lbl.pdf.
    \33\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/209862lbl.pdf.
    \34\ https://www.samhsa.gov/medication-assisted-treatment/treatment/naloxone.
    \35\ https://www.samhsa.gov/medication-assisted-treatment/medications-counseling-related-conditions/naloxone.
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    The U.S. Surgeon General Jerome M. Adams, M.D., M.P.H. has released 
a public health advisory stating that, ``Research shows that when 
naloxone and overdose education are available to community members, 
overdose deaths decrease in those communities. Therefore, increasing 
the availability and targeted distribution of naloxone is a critical 
component of our efforts to reduce opioid-related overdose deaths and, 
when combined with the availability of effective treatment, to ending 
the opioid epidemic.'' \36\
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    \36\ https://www.hhs.gov/surgeongeneral/priorities/opioids-and-addiction/naloxone-advisory/index.html.
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    In the CY 2021 PFS proposed rule, we proposed to add naloxone to 
the definition of OUD treatment services in order to increase access to 
this important emergency treatment and to allow OTPs to be paid under 
Medicare for dispensing naloxone to Medicare beneficiaries who are 
receiving other OUD treatment services from the OTP. Under the 
proposal, beneficiaries receiving OUD treatment services from the OTP 
would be able to receive naloxone from the OTP under the OUD treatment 
services benefit, to the extent it is medically reasonable and 
necessary as part of their OUD treatment. We noted that naloxone is 
already covered under Medicare Part D. In 2017, 72.5 percent of all 
Medicare beneficiaries were enrolled in Medicare Part D plans.\37\ 
However, as we explained in the proposed rule, we believe allowing 
beneficiaries to access this important emergency treatment at the OTP 
may help to decrease barriers to access because there currently are no 
copayments for services furnished by OTPs and beneficiaries would not 
need to visit a separate provider to access naloxone.
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    \37\ http://www.medpac.gov/docs/default-source/reports/mar18_medpac_ch14_sec.pdf.
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    Accordingly, to align with efforts to end the opioid epidemic, 
under the discretionary authority in section

[[Page 84683]]

1861(jjj)(1)(F) of the Act, we proposed to amend the definition of OUD 
treatment services at Sec.  410.67(b) by adding Sec.  410.67(b)(8) to 
include opioid antagonist medications that are approved by FDA under 
section 505 of the FFDCA for the emergency treatment of known or 
suspected opioid overdose. We proposed to amend the definition of OUD 
treatment services under the discretionary authority in section 
1861(jjj)(1)(F) of the Act rather than the authority under section 
1861(jjj)(1)(A) of the Act because section 1861(jjj)(1)(A) of the Act 
pertains to opioid agonist and antagonist treatment medications 
(including oral, injected, or implanted versions) that are approved by 
FDA under section 505 of the FFDCA for use in the treatment of opioid 
use disorder. As we explained in the CY 2021 PFS proposed rule, 
naloxone is not one of the three drugs currently approved by FDA for 
the treatment of opioid dependence (buprenorphine, methadone, and 
naltrexone); \38\ and, as a result, we do not believe naloxone fits the 
criteria of section 1861(jjj)(1)(A) of the Act. We sought comment on 
our proposal to expand the definition of OUD treatment services.
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    \38\ https://www.fda.gov/drugs/information-drug-class/information-about-medication-assisted-treatment-mat.
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    Additionally, we noted that we agree with the public health 
advisory quoted previously that community education related to overdose 
prevention is needed to address the opioid crisis. We believe that 
prevention and community education efforts would increase awareness of 
treatment options and could play a role in decreasing opioid overdose 
deaths. We solicited comments on whether the definition of OUD 
treatment services should be further revised to include overdose 
education. Additionally, we also solicited comments on whether payment 
for providing overdose education to the beneficiary and/or the 
beneficiary's family or partner should be considered to be included in 
the current weekly bundled payments for episodes of care or whether we 
should consider establishing an add-on payment for education related to 
overdose prevention when such services are furnished by OTPs. We 
specifically sought information related to what inputs we might 
consider in developing the payment rate for such a service, such as 
payment amounts for similar services under the PFS, if we were to 
include this type of education as part of the proposed new add-on codes 
for naloxone discussed later in this section (HCPCS codes GOTP1 and 
GOTP2), For example, in order to establish a payment rate for education 
related to overdose prevention for the beneficiary and/or the 
beneficiary's family or partner, we could consider a crosswalk to the 
Medicare payment rate for CPT code 96161 (Administration of caregiver-
focused health risk assessment instrument (e.g., depression inventory) 
for the benefit of the patient, with scoring and documentation, per 
standardized instrument). The current non-facility payment rate under 
the PFS for CPT code 96161 is $2.53.
a. Adjustment to the Bundled Payments for OUD Treatment Services
    Consistent with the proposal to expand the definition of OUD 
treatment services to include opioid antagonist medications indicated 
for the emergency treatment of known or suspected opioid overdose, we 
noted that we believed it would be appropriate to propose changes to 
the payment rates for the bundled payments to reflect the costs of 
these medications. Therefore, we proposed to adjust the bundled payment 
rates through the use of add-on codes to account for instances in which 
OTPs provide Medicare beneficiaries with naloxone. We explained that we 
believe beneficiaries receiving naloxone will need a supply at the 
start of treatment and would only require refills later if the supply 
is used in an emergency. As a result, we noted that we would not expect 
naloxone to be provided weekly to all patients, but only on an as-
needed basis. Accordingly, we noted that we believed that making 
payment for naloxone through the use of an add-on code would be the 
most accurate approach to pricing rather than including the costs of 
these medications as part of the bundled payment rates for all episodes 
of care.
    We proposed to adopt the following add-on G codes:
     HCPCS code GOTP1: Take-home supply of nasal naloxone 
(provision of the services by a Medicare-enrolled Opioid Treatment 
Program); List separately in addition to code for primary procedure.
     HCPCS code GOTP2: Take-home supply of auto-injector 
naloxone (provision of the services by a Medicare-enrolled Opioid 
Treatment Program); List separately in addition to code for primary 
procedure.
    We proposed to adopt an approach similar to the pricing methodology 
that was used to price the drug component of the bundled payments in 
the CY 2020 PFS final rule to determine the payment rate for these 
proposed new add-on codes for naloxone. In the CY 2020 PFS proposed 
rule (84 FR 40530), we explained that payment structures that are 
closely tailored to the provider's actual acquisition cost reduce the 
likelihood that a drug will be chosen primarily for a reason that is 
unrelated to the clinical care of the patient, such as the drug's 
profit margin for a provider. Therefore, we noted that we believe it 
would be appropriate to use a methodology similar to the one we adopted 
in the CY 2020 PFS final rule (84 FR 62650 through 62657), for purposes 
of determining the payment rate for the drug component of the bundled 
payments to determine the payment rates for the add on codes for 
naloxone because this methodology would provide the best estimate of an 
OTP's cost in dispensing naloxone.
    In the CY 2020 PFS final rule, we adopted a policy under which we 
apply the methodology set forth in section 1847A of the Act to 
determine the payment amount for the drug component of the bundled 
payment for an episode of care that includes implantable or injectable 
medications, except that the payment amount shall be 100 percent of the 
average sales price (ASP), if ASP is used. For oral medications, the 
payment for the drug component is based on 100 percent of ASP, if ASP 
data are available. However, if ASP is not available, the payment 
amount for methadone will be based on the TRICARE rate and the payment 
amount for oral buprenorphine is calculated using the national average 
drug acquisition cost (NADAC).
    We received public comments on the proposed adjustment to the 
bundled payments for OUD treatment services to account for instances in 
which OTPs provide Medicare beneficiaries with naloxone. The following 
is a summary of the comments we received and our responses.
    Comment: Commenters were overwhelmingly supportive of extending the 
definition of OUD treatment services to include opioid antagonist 
medications, such as naloxone.
    Response: We thank commenters for their support of extending the 
definition of OUD treatment services to include opioid antagonist 
medications, such as naloxone. Because we continue to believe that the 
availability of emergency treatment medications is an important 
component of treatment for OUD, we are finalizing our proposal to amend 
the definition of OUD treatment service in Sec.  410.67 to add 
paragraph (b)(8) to include opioid antagonist medications approved by 
the FDA under section 505 of the FFDCA for emergency treatment of known 
or suspected opioid overdose.

[[Page 84684]]

    Comment: Overall, commenters were in support of revising the 
definition of OUD treatment services to include overdose education. 
Several commenters indicated that overdose education should be included 
in the currently established bundled payment. Some other commenters 
suggested creating a separate add-on code and payment for providing 
overdose prevention education. Some commenters supported including 
community education for naloxone as an add-on service, but disagreed 
with the example provided in the proposed rule (85 FR 50203 and 50204) 
of using the CY 2020 Medicare payment rate for CPT code 96161 of $2.53 
to determine the additional payment amount. Rather, a commenter stated 
that CPT code 96161 is not commensurate with the cost of the service 
nor reflective of the required staff involvement and overhead cost and 
recommended a payment rate of $20 at 15-minute increments. While 
another commenter thought the clinical activities are more aligned with 
98960 (Education and training for patient self-management by a 
qualified, nonphysician health care professional using a standardized 
curriculum, face-to-face with the patient (could include caregiver/
family) each 30 minutes; individual patient). Another commenter 
indicated that overdose education was proposed for Medicare Part D 
plans for contract year 2021 as part of Medication Therapy Management 
(MTM) and Drug Management Programs (DMP). However, no additional 
payment was proposed for these services when delivered in Medicare Part 
D. Another commenter stated that all patients receiving treatment at an 
OTP as well as their families should receive overdose education and 
urged CMS to include this payment in the add-on payments for intake 
activities and periodic assessments, and in the bundled payment for the 
initial month of substance use disorder treatment. One commenter stated 
that the availability of naloxone and other medications that can 
rapidly reverse an opioid overdose, along with education on its proper 
use, will save lives. The commenter also recommended that, whether 
reimbursement for overdose education is included as part of the bundled 
payment or billed as an add-on service, CMS include guardrails on what 
services OTPs are permitted to code as education to prevent waste and 
abuse, including specific requirements regarding the quality of 
services.
    Response: After consideration of comments, we are revising the 
definition of OUD treatment services to include overdose education. We 
continue to agree with the U.S. Surgeon General's public health 
advisory discussed above that community education related to overdose 
prevention is needed to address the opioid crisis. Overdose education 
includes educating patients and caregivers on how to recognize 
respiratory depression, the signs and symptoms of a possible opioid 
overdose, how to administer naloxone in the event of an overdose, and 
the importance of calling 911 or getting emergency medical help right 
away, even if naloxone is administered.\39\ Providing naloxone and 
teaching people to use it is an effective means of preventing deaths 
among people who misuse opioids. With brief training, most adults can 
learn to administer life-saving naloxone.\40\ We are modifying the 
proposed provision at Sec.  410.67(b)(8) to include a reference to 
overdose education that is furnished in conjunction with opioid 
antagonist medications. After considering the commenters' 
recommendations regarding the payment rate for this type of education, 
which ranged from a payment rate of $20 for each 15 minutes of 
education, to no separate payment for this education, we have 
determined that it would be appropriate to use a crosswalk to the CY 
2020 Medicare payment rate for CPT code 96161 (Administration of 
caregiver-focused health risk assessment instrument (e.g., depression 
inventory) for the benefit of the patient, with scoring and 
documentation, per standardized instrument), which is assigned a non-
facility payment rate under the PFS of $2.53. We believe this reference 
code describes a similar level of service intensity and amount of 
clinical staff time involved in furnishing overdose education. We 
believe establishing a separate add-on code for overdose education to 
be billed in 15-minute increments is unnecessary and may result in 
overpayment for this service. As noted in the CY 2017 PFS final rule 
(81 FR 80331), we recognize that practitioners' interactions with 
caregivers or family members are an integral part of treatment for some 
patients. Overdose education and naloxone distribution programs have 
reduced opioid-related overdose for over 20 years.\41\ Therefore, as 
naloxone and overdose education complement one another, we are 
finalizing add-on codes for naloxone that consist of both a drug 
component and a non-drug component that would account for overdose 
education furnished by the OTP. Therefore, the overdose education add-
on will be included each time naloxone is furnished by the OTP. We will 
consider for future rulemaking whether separate coding is needed to 
allow payment for overdose education when it is furnished separate from 
the OTP furnishing the patient with naloxone.
---------------------------------------------------------------------------

    \39\ https://www.fda.gov/media/140360/
download#:~:text=%E2%80%A2%20Naloxone%20is%20an%20FDA-
approved%20medicine%20used%20to,Signs%20of%20an%20opioid%20overdose%2
0include%20breathing%20problems%2C.
    \40\ https://www.samhsa.gov/homelessness-programs-resources/hpr-resources/useful-resources-opioid-overdose-prevention.
    \41\ https://www.japha.org/article/S1544-3191(17)30002-X/
fulltext.
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    Comment: Several commenters were in support of creating a new code 
for auto-injector naloxone and nasal naloxone. One commenter stated 
that the generic version of the auto-injector naloxone is currently not 
available in the marketplace.
    Response: We thank the commenters for their support for creating 
new codes for the auto-injector naloxone and nasal naloxone. After 
consideration of the comments, we are finalizing our proposal to 
establish an add-on code for nasal naloxone that is dispensed in 
conjunction with an episode of care for treatment of OUD. We believe 
establishing an add-on code for nasal naloxone to allow OTPs to receive 
payment when they dispense this medication will allow beneficiaries 
access to this important emergency treatment at OTPs and may help 
decrease barriers to access because there are currently no copayments 
for services furnished by OTPs and beneficiaries would not need to 
visit a separate provider to access naloxone. We note that both the 
brand and authorized generic formulation of the auto-injector naloxone 
have been discontinued with obsolete dates effective September 4, 
2020.\42\ Therefore, we are not finalizing our proposal to create an 
add-on code for auto-injector naloxone.
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    \42\ https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209862.
---------------------------------------------------------------------------

    After consideration of comments, we are extending the definition of 
OUD treatment services to include short acting opioid antagonist 
medications, such as naloxone. We are further revising the definition 
of OUD treatment services to include overdose education furnished in 
conjunction with providing an opioid antagonist medication. We are also 
finalizing our proposal to create a code for nasal naloxone: HCPCS code 
G2215 (Take-home supply of nasal naloxone (provision of the services by 
a

[[Page 84685]]

Medicare-enrolled Opioid Treatment Program)); List separately in 
addition to code for primary procedure.), which will include both a 
drug component and a non-drug component for overdose education. The 
payment for the non-drug component of this code will be determined 
using a crosswalk to the Medicare payment rate for CPT code 96161 of 
$2.53.
Drug Pricing for Nasal Naloxone
    Consistent with the approach that we adopted for pricing the drug 
component of the weekly bundled payments, we proposed to price the add-
on code describing the take home supply of nasal naloxone, using the 
same methodology we previously adopted for pricing the drug component 
of episodes of care that include implantable or injectable medications. 
Accordingly, the payment methodology would be based upon the 
methodology set forth in section 1847A of the Act, except that payment 
amounts determined based on ASP and wholesale acquisition cost (WAC) 
would not include any add-on percentages. In the CY 2021 PFS proposed 
rule (85 FR 50204), we acknowledged that nasal naloxone is not an oral, 
implantable or injectable medication; however, ASP data are available. 
We explained that, as noted in the CY 2020 PFS final rule (84 FR 
62653), we believe using ASP provides a transparent and public 
benchmark for manufacturers' pricing as it reflects the manufacturers' 
actual sales prices to all purchasers (with limited exceptions as noted 
in section 1847A(c)(2) of the Act) and is the only pricing methodology 
that includes off-invoice rebates and discounts as described in section 
1847A(c)(3) of the Act. Therefore, we believe ASP to be the most 
market-based approach to set drug prices. We sought public comment on 
our proposal to use ASP+0 to price the add-on payment for nasal 
naloxone and other potential sources of pricing data for nasal naloxone 
either generally or specifically with respect to acquisition by OTPs.
    We received public comments on the proposed drug pricing for nasal 
naloxone. The following is a summary of the comments we received and 
our responses.
    Comment: Several commenters opposed the proposed ASP + 0 payment 
for nasal naloxone and asserted that if payment for nasal naloxone is 
below cost, OTPs would not be able to offer this medication to Medicare 
beneficiaries. A commenter indicated that this product is made by one 
manufacturer that does not offer volume discounts. Commenters generally 
recommended including an add-on payment similar to other drugs. A 
couple of commenters stated that the cost for OTPs to purchase nasal 
naloxone is $125. Accordingly, they recommended a payment of cost + 6 
percent for nasal naloxone ($125 + 6 percent). A commenter indicated 
the cost + 6 percent payment rate would avoid imposing a financial loss 
on OTPs for providing naloxone and take into account OTP overhead costs 
(for example, training, security), thereby encouraging OTPs to provide 
this critical medication. A few commenters were in support of the 
proposed ASP + 0 payment for nasal naloxone. One commenter agreed that 
setting the payment rate for nasal naloxone at ASP is a reasonable 
approach.
    Response: After review of the comments, we are finalizing our 
proposal to apply the payment methodology set forth in section 1847A of 
the Act to determine the payment for the nasal naloxone. However, as 
proposed, payment amounts for nasal naloxone, determined based on ASP 
and wholesale acquisition cost (WAC) will not include any add-on 
percentages. The use of ASP provides a transparent and public benchmark 
for the acquisition cost of a drug as it reflects the manufacturers' 
actual sales prices to all purchasers (with limited exceptions) and is 
the only pricing methodology that includes off-invoice rebates and 
discounts as described in section 1847A(c)(3) of the Act. We believe 
this approach is most consistent with the approach we adopted in the CY 
2020 PFS final rule for pricing the drug component of an episode of 
care that includes implantable or injectable medications. For the 
reasons discussed in the CY 2020 PFS final rule (84 FR 62652 and 
62653), we continue to believe that limiting the payment amount to 100 
percent of the volume-weighted ASP for a HCPCS code instead of 106 
percent of the volume-weighted ASP for a HCPCS code will incentivize 
the use of the most clinically appropriate drug for a given patient. We 
understand that many OTPs purchase medications directly from drug 
manufacturers, thereby limiting the markup from distribution channels. 
We continue to believe that the selection of drugs purchased by most 
OTPs is quite limited, which theoretically limits the utility of third-
parties, such as wholesalers, and their associated costs and increases 
the purchase volume for OTPs and accompanying manufacturer discounts. 
We believe that this situation could lend itself to an OTP drug channel 
for purchasing at discounted rates either directly or through the use 
of buying groups as is the standard in the pharmacy industry today. We 
believe that our proposed approach of paying for nasal naloxone based 
on ASP offers the most appropriate balance between ensuring OTPs 
receive appropriate reimbursement for their drug acquisition costs, 
while also preserving the incentive to use the most clinically 
appropriate drug for the treatment of individual beneficiaries.
    We are interested in continuing to obtain feedback regarding access 
concerns related to naloxone payment. We will monitor utilization of 
these codes in the claims data to determine whether CMS should consider 
proposing changes in the future to the payment policies finalized in 
this rule.
Drug Pricing for Auto-Injector Naloxone
    We proposed to price the add-on code describing the take-home 
supply of auto-injector naloxone, using the lowest pricing available 
(the lower of ASP + 0, WAC + 0, or NADAC). Currently, there is no ASP 
or NADAC reported or calculated for auto-injector naloxone. 
Accordingly, we proposed to use WAC + 0 to determine the pricing for 
the add-on payment for auto-injector naloxone. We explained that we 
believe 100 percent of WAC is a closer estimate of the actual 
acquisition cost for OTPs compared to WAC with an add-on percentage 
because, as defined in section 1847A(c)(6)(B) of the Act, WAC does not 
include prompt pay discounts, rebates or reductions in price. Thus, 
there should be no need to pay an add-on percentage to ensure OTPs are 
reimbursed for their acquisition costs for auto-injector naloxone. 
However, we also noted that in the future, using the lowest pricing 
available for auto-injector naloxone may be most appropriate, because 
if ASP and/or NADAC pricing were to become available for auto-injector 
naloxone, they would be more reflective of actual costs than a list 
price.
    We noted that auto-injector naloxone was available in both a 
generic and brand name version. We explained that we had considered 
comparing the Medicare Part D utilization for each formulation to 
determine the frequency with which the generic and brand name versions 
might dispensed by OTPs. However, because the generic auto-injector 
naloxone was rather new to the marketplace \43\, we acknowledged that 
there were limited utilization data available for the generic product. 
Based on historical information reflecting a

[[Page 84686]]

trend of increased generic utilization uptake,\44\ we explained that we 
believed that in most cases where the auto-injector naloxone would be 
prescribed and dispensed by OTPs to beneficiaries, it would be the 
generic formulation of the product. Therefore, we noted that we 
believed using the price for the generic formulation would be a 
reasonable approach to pricing the proposed add-on code for auto-
injector naloxone and would ensure that beneficiaries who need this 
drug as part of their treatment for OUD would have access to it and 
that OTPs would receive a reasonable payment for dispensing the drug. 
Accordingly, we proposed to use the price of the generic formulation, 
determined as WAC + 0, to pay for auto-injector naloxone when the drug 
is provided by an OTP as part of an episode of care. We sought comment 
on our proposed pricing methodology to pay for auto-injector naloxone 
and other potential sources of pricing data for auto-injector naloxone 
either generally or specifically with respect to acquisition by OTPs.
---------------------------------------------------------------------------

    \43\ https://kaleo.com/in-the-news/authorized-generic-for-evzio-naloxone-hcl-injection-to-be-available-at-a-reduced-list-price-of-178/.
    \44\ In 2015, approximately 87 percent of prescriptions filled 
under Part D were for generic drugs, compared with 61 percent in 
2007. http://www.medpac.gov/docs/default-source/reports/mar18_medpac_ch14_sec.pdf.
---------------------------------------------------------------------------

    We received public comments on the proposed drug pricing for auto-
injector naloxone. The following is a summary of the comments we 
received and our response.
    Comment: One commenter pointed out that generic auto-injector 
naloxone is not currently available in the marketplace and stated that 
the brand name auto-injector naloxone costs about $4,000. The commenter 
stated that the proposed payment rate for auto-injector naloxone is 
inadequate and should be revised to accurately reflect the true 
acquisition cost of the drug. Another commenter recommended a payment 
rate of cost plus 6 percent for auto-injector naloxone. Some other 
commenters also recommended including an add-on of plus 6 percent to 
the payment rate, similar to other drugs.
    Response: As previously discussed, both the brand name auto-
injector (Evzio) and authorized generic naloxone auto-injector were 
recently discontinued with obsolete dates effective September 4, 2020. 
Because auto-injector naloxone is no longer available in the 
marketplace, we are not finalizing the proposed code and pricing for 
auto-injector naloxone.
Frequency Limit
    In the CY 2021 PFS proposed rule (85 FR 50205), we noted that 
Medicare Part D allows prescription drug plans to place quantity limits 
(QL) on most drugs, including on naloxone. While most Medicare Part D 
plans do not limit the amount of naloxone a beneficiary is able to 
receive in a given month, when they do, they most frequently allow a 
plan enrollee a maximum of 4 units per 30 days (2 boxes of 2 units). In 
the current contract year (2020) only 22 percent of Medicare Part D 
formularies apply a QL to naloxone (115/535 formularies), while for the 
2021 contract year only 19 percent of Medicare Part D formularies plan 
to apply a QL to this product (106/564 formularies). However, a review 
of Medicare Part D claims data shows that beneficiaries who use 
naloxone most frequently use only one box (2 units) within a 30-day 
period even though nearly all plans would have permitted additional 
doses. We also noted that under TRICARE, auto-injector naloxone is 
covered for a maximum quantity of one carton at retail network 
pharmacies for up to a 30-day supply.\45\ We explained our belief that 
it would be appropriate to apply a similar limit on the frequency of 
the add-on payment for naloxone dispensed by OTPs. We stated that 
applying a frequency limit would assist in enhancing patient safety and 
discourage misuse, waste and abuse. Furthermore, we noted that such a 
limitation was reasonable because there are other services that OTPs 
should already be performing, and which are already included in the 
weekly bundled payments for episodes of care, such as counseling and 
individual and group therapy, that should limit the need for this 
emergency treatment. However, we noted that we do not want to limit 
access to naloxone when it is a medically reasonable and necessary part 
of the treatment for OUD. Therefore, we proposed to limit Medicare 
payment to OTPs for naloxone to one add-on code (HCPCS code GOTP1 or 
GOTP2) every 30 days to the extent that it is medically reasonable and 
necessary. We sought comment on whether this proposed limit was 
reasonable and whether special circumstances may arise under which more 
frequent payment would be medically reasonable and necessary and the 
types of circumstances that should qualify for more frequent payment. 
However, we noted that we also expect OTPs and their treating 
practitioners will use their clinical judgment as to whether there may 
be cases in which a referral to a higher level of care may be needed 
for some beneficiaries in order to reduce the risk of overdose and the 
need for more frequent emergency treatment. We proposed to add Sec.  
410.67(d)(4)(i)(E) to describe payment for a take-home supply of opioid 
antagonist medications that are approved by FDA under section 505 of 
the FFDCA for the emergency treatment of known or suspected opioid 
overdose.
---------------------------------------------------------------------------

    \45\ https://www.express-scripts.com/static/formularySearch/2.9.6/#/formularySearch/drugSearch.
---------------------------------------------------------------------------

    We invited public comments on the proposed pricing for nasal 
naloxone and auto-injector naloxone. We also sought comment on the 
proposal to limit payment for the proposed add-on codes for take-home 
supplies of these medications to once every 30 days to the extent that 
it is medically reasonable and necessary.
    We received public comments on the proposed frequency limit. The 
following is a summary of the comments we received and our responses.
    Comment: Several commenters did not support imposing frequency 
limits on the provision of naloxone to once per month and stated that 
clinicians should determine medical necessity, noting that naloxone is 
a life-saving drug and patient access should not be limited. One 
commenter recommended that exceptions be allowed for patients with a 
recent (within the last 30 days) overdose. Other commenters supported 
the proposed frequency limit and found it reasonable.
    Response: After consideration of the comments, we are finalizing a 
frequency limit on Medicare payments to OTPs for naloxone to one add-on 
code (HCPCS code G2215 or G2216) every 30 days. However, we agree with 
commenters that access to naloxone should not be limited when it is a 
medically reasonable and necessary part of the treatment for OUD. 
Therefore, we will allow exceptions to this limit in the case where the 
beneficiary overdoses and uses the initial supply of naloxone dispensed 
by the OTP to the extent that it is medically reasonable and necessary 
to furnish additional naloxone. We note that section 1862(a)(1)(A) of 
the Act requires that in order for payment to made for most Part A and 
Part B services furnished to Medicare beneficiaries, those services 
must be reasonable and necessary for the diagnosis or treatment of 
illness or injury or to improve the malfunctioning of a malformed body 
member. If an additional supply of naloxone is needed within 30 days of 
the original supply being provided, OTPs must document in the medical 
record the reason for the exception. Additionally, CMS will monitor 
utilization of these codes in the claims data and will refer cases of 
disproportionate use for further review.
    Additionally, we sought comment on whether we should consider 
creating a

[[Page 84687]]

code and establishing an add-on payment for injectable naloxone. We 
noted that all three forms of naloxone (injectable, auto-injector, and 
nasal spray) are FDA-approved and may be considered as options for 
community distribution.
    It is important to understand how to administer naloxone properly, 
therefore, we defer to the clinical judgment of practitioners in the 
OTP as to which formulation of naloxone would be the most appropriate 
to dispense to a patient. Brief education on how to administer naloxone 
using a syringe can be obtained from the provider of the naloxone kit 
or from http://prescribetoprevent.org/.\46\ Additionally, we note that 
in this final rule, we are including overdose education in the non-drug 
component of the payment rate for both of the new add-on codes for 
naloxone (HCPCS codes G2215 and G2216), and expect that when OTPs 
provide beneficiaries with a supply of naloxone, they will also inform 
them about how to use the medication they are being given.
---------------------------------------------------------------------------

    \46\ https://store.samhsa.gov/sites/default/files/d7/priv/sma18-4742.pdf.
---------------------------------------------------------------------------

    We stated in the CY 2021 PFS proposed rule (85 FR 50205) that if we 
were to establish an add-on payment for injectable naloxone, we would 
consider using the same methodology we adopted for pricing the drug 
component of an episode of care that includes implantable or injectable 
medications, as described in Sec.  410.67(d)(2)(i)(A).
    We received public comments in response to our request for input on 
whether we should create a code and establish an add-on payment for 
injectable naloxone. The following is a summary of the comments we 
received and our responses.
    Comment: Commenters supported the creation of coding and payment 
for injectable naloxone. Some commenters stated that ensuring payment 
for all three forms of FDA-approved naloxone would allow providers to 
select the most appropriate form of naloxone for the particular 
Medicare beneficiary and provide options in the case of drug shortages. 
The commenters also noted that traditionally, injectable naloxone is 
the least expensive form, but can be more difficult to administer in an 
overdose emergency. Another commenter stated that they believe 
formulations of naloxone that are intended for use by medical 
professionals (that is, injectable naloxone) are also valuable in the 
prevention and treatment of opioid overdose. The commenter stated that 
given that it is highly probable that OTP providers will be in a 
position to provide care to a beneficiary who has overdosed, the 
availability of injectable naloxone at these facilities can facilitate 
timely opioid overdose reversal. Some commenters stated that the 
payment rate for injectable naloxone must be adequate and another 
stated that they believe payment should align with payment for other 
Medicare Part B medications (that is, ASP plus 6 percent).
    Response: We agree with the commenters that providing for Medicare 
payment to OTPs for all available forms of FDA-approved naloxone will 
allow practitioners in OTPs to select the most appropriate form of 
naloxone for the beneficiary, provide options in the case of drug 
shortages, and expand access to treatment for opioid overdoses. 
Although we acknowledge that individuals experiencing an opioid 
overdose will not be able to use injectable naloxone to treat an 
overdose themselves,\47\ self-administration of naloxone is not 
necessarily a goal of overdose death prevention training. A safer, more 
reliable approach may be to prescribe naloxone to at-risk patients and 
train and also equip members of their household and social networks in 
overdose prevention and response.\48\
---------------------------------------------------------------------------

    \47\ https://www.samhsa.gov/medication-assisted-treatment/medications-counseling-related-conditions/opioid-overdose.
    \48\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4019939/.
---------------------------------------------------------------------------

    After consideration of the comments received, we are finalizing a 
second new add-on code to cover the cost of providing patients with a 
supply of injectable naloxone. We recognize the importance of making 
injectable naloxone available to Medicare beneficiaries. Additionally, 
creating a new add-on code for injectable and nasal naloxone will 
provide options in the case of drug shortages or in the event a drug is 
no longer available in the market, as occurred with auto-injector 
naloxone.
    The add-on code for injectable naloxone is HCPCS code G2216 (Take-
home supply of injectable naloxone (provision of the services by a 
Medicare-enrolled Opioid Treatment Program); List separately in 
addition to code for primary procedure.), which will include both a 
drug component and a non-drug component. As stated in previous 
rulemaking (84 FR 62650), we use the typical maintenance dose to 
calculate the drug component for the OTP benefit. According to the 
package insert,\49\ \50\ an initial dose of 0.4 mg to 2 mg of 
injectable naloxone may be administered through intravenous, 
intramuscular, or subcutaneous routes. If needed, it may be repeated at 
two- to three-minute intervals up to a total dose of 10mg. Because the 
information we have is not based upon a typical dose, we are contractor 
pricing this code for CY 2021. This will provide beneficiaries access 
to injectable naloxone under the OTP benefit and will also allow us the 
opportunity to obtain more information to better understand the typical 
dosage of injectable naloxone, in order to potentially establish 
national pricing for injectable naloxone through future rulemaking. The 
payment for the non-drug component of this code will be determined 
using a crosswalk to the Medicare payment rate for CPT code 96161 of 
$2.53, as discussed previously in conjunction with the new code for 
nasal naloxone (HCPCS G2215).
---------------------------------------------------------------------------

    \49\ http://labeling.pfizer.com/ShowLabeling.aspx?id=4541.
    \50\ https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=f0932877-1f3b-4d5e-82d2-dd6c53db4730&type=display.
---------------------------------------------------------------------------

    Table 34 details the new add-on codes for nasal naloxone and 
injectable naloxone, and the accompanying payment amounts, which 
reflect the cost of the drug plus an additional $ 2.53 for overdose 
education, as discussed previously in this section.

[[Page 84688]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.079

Duplicative Payment
    Section 1834(w)(1) of the Act, added by section 2005(c) of the 
SUPPORT Act, requires the Secretary to ensure, as determined 
appropriate by the Secretary, that no duplicative payments are made 
under Medicare Part B or Part D for items and services furnished by an 
OTP. In the CY 2021 PFS proposed rule (85 FR 50206), we noted that 
under the proposal, OTPs would be able to provide naloxone to Medicare 
beneficiaries and bill for it as an add-on to the bundled payment for 
the episode of care. Consistent with Sec.  410.67(e), the beneficiary's 
copayment amount would remain zero. We also noted that naloxone may 
also be appropriately available to beneficiaries through other Medicare 
benefits, including, for example, Medicare Part D, under which the 
beneficiary would be responsible for the applicable cost sharing. As 
discussed in the CY 2020 PFS final rule (84 FR 62664) and codified at 
Sec.  410.67(d)(5), we define duplicative payment to involve only those 
circumstances where medications that are delivered, administered or 
dispensed to a beneficiary are paid as part of the OTP bundled payment, 
and where the delivery, administration or dispensing of the same 
medication (that is, same drug, dosage and formulation) is also 
separately paid under Medicare Part B or Part D for the same 
beneficiary on the same date of service. Because we proposed to pay for 
naloxone as an add-on to the weekly bundled payment, any payment to an 
OTP for naloxone would be duplicative if the same medication is 
separately paid under Medicare Part B or Part D for the same 
beneficiary on the same date of service. Consistent with Sec.  
410.67(d)(5), CMS would recoup any duplicative payment made to an OTP 
for naloxone.
    Additionally, we noted that we understand some OTPs negotiate 
arrangements whereby community pharmacies supply MAT-related 
medications to OTPs. However, we reiterated that, as stated in the CY 
2020 PFS final rule, if the OTP provides reasonable and necessary MAT-
related medications as part of an episode of care, we would expect the 
OTP to take measures to ensure that there is no claim for payment for 
these drugs other than as part of the OTP bundled payment. Thus, 
naloxone billed by an OTP as an add-on to the bundled payment should 
not be reported to or paid under a Medicare Part D plan. We noted that 
we expect OTPs will take reasonable steps to prevent duplicative 
payment for naloxone furnished under their care by ensuring it is not 
reported or billed under a different Medicare benefit. We also noted 
that we intend to monitor for duplicative payments, and would take 
appropriate action as needed when and if such duplicative payments are 
identified.
    We received public comments on the discussion of duplicative 
payment for naloxone. The following is a summary of the comments we 
received and our responses.
    Comment: Several commenters opposed recoupment of duplicative 
payments made to OTPs for naloxone. One commenter noted that OTPs do 
not have the capacity to be aware of or prevent other providers from 
prescribing naloxone through Medicare Part D. A commenter recommended 
that CMS inform health plans if a member is receiving services from an 
OTP, but acknowledged this may be difficult due to privacy laws. A 
commenter stated that CMS should either establish a means of 
coordination or recoup payment from Medicare Part D plans and other 
healthcare providers if naloxone is provided outside of the OTP. 
Another commenter stated that if the proposal to establish an add-on 
payment for naloxone is finalized, CMS will need to provide 
instructions to guard against duplicative payment.
    Response: As we are finalizing the proposal to pay for naloxone as 
an add-on to the weekly bundled payment, we reiterate that consistent 
with Sec.  410.67(d)(5), any payment to an OTP for naloxone would be 
duplicative if a claim for the same medication is separately paid under 
Medicare Part B or Part D for the same beneficiary on the same date of 
service, and CMS would recoup any duplicative payment made to an OTP 
for naloxone. Section 1834(w)(1) of the Act, added by section 2005(c) 
of the SUPPORT Act, requires the Secretary to ensure, as determined 
appropriate by the Secretary, that no duplicative payments are made 
under Medicare Part B or Part D for items and services furnished by an 
OTP. Therefore, for purposes of implementing section 1834(w)(1) of the 
Act, payment for medications delivered, administered or dispensed to 
the beneficiary as part of the OTP bundled payment is considered 
duplicative if delivery, administration or dispensing of the same 
medication was also separately paid under Medicare Part B or D. CMS 
would recoup any duplicative payment made to an OTP for naloxone 
because OTPs will be in the best position to know whether naloxone that 
is included as part of the beneficiary's treatment plan is being 
furnished by the OTP or by another provider or supplier given that the 
OTP is responsible for managing the beneficiary's overall OUD 
treatment. OTPs should make a good faith effort to ensure that no 
duplicative payments are made for naloxone, for example, by inquiring 
whether the beneficiary has already received a supply of naloxone 
through Medicare Part B or D. Please see the CY 2020 PFS final rule (84 
FR 62663 and 62664) for a more detailed discussion of our policy on 
duplicative payments.
3. WAC Pricing
    Section 1834(w) of the Act gives the Secretary significant 
discretion to establish bundled payment rates for OUD treatment 
services. In the CY 2020 PFS final rule, we finalized a payment 
methodology for the drug component of

[[Page 84689]]

the bundled payment rates for OUD treatment services, under which we 
use the payment methodology set forth in section 1847A of the Act 
(which bases most payment on ASP) to set the payment rates for 
implantable and injectable drugs and limited the payment amount for 
these drugs to 100 percent of the volume-weighted ASP for a drug 
category or code, if ASP is used. We codified this payment methodology 
at Sec.  410.67(d)(2)(i)(A).
    Section 1847A of the Act provides for the use of other payment 
methodologies in certain circumstances, including payment based on WAC 
or average manufacturer price (AMP). In the CY 2020 PFS final rule, we 
limited payments to OTPs for injectable and implantable drugs to 100 
percent of ASP, but did not otherwise diverge from the payment 
methodology that would apply under section 1847A of the Act. In the CY 
2021 PFS proposed rule (85 FR 50206), we noted our belief that it was 
necessary to amend the OTP drug pricing methodology in order to limit 
WAC-based payments to 100 percent of WAC. As discussed previously, we 
proposed to use WAC pricing to determine the payment rate for the add-
on code for the auto-injector naloxone. Although none of the drugs that 
are currently included in the drug component of an episode of care is 
currently paid based on WAC, we also noted that it is possible that we 
may use WAC to determine the payment for the drug component of an 
episode of care in the future, and we wanted to establish, in advance, 
the methodology that would apply for purposes of determining the 
payment rate.
    As authorized under section 1847A of the Act, some Medicare Part B 
drugs are paid based on WAC. For example, for single source drugs, 
payment is 106 percent of the lesser of WAC or ASP (section 1847A(b)(4) 
of the Act), and in cases where ASP is unavailable during the first 
quarter of sales (section 1847A(c)(4) of the Act), 103 percent of WAC 
is used. Additionally, there are some instances where drugs lack ASP 
data for reasons other than being new, for example, in cases where the 
manufacturer had no sales in a reporting quarter. In those situations, 
the Medicare payment method varies, but in some cases, the payment may 
be 106 percent of the WAC.\51\ As we stated in the CY 2020 PFS final 
rule (84 FR 62651), payment structures that are closely tailored to the 
provider's actual acquisition cost reduce the likelihood that a drug 
will be chosen primarily for a reason that is unrelated to the clinical 
care of the patient, such as the drug's profit margin for a provider. 
The WAC is defined in section 1847A(c)(6)(B) as the manufacturer's list 
price for a drug to wholesalers or direct purchasers in the United 
States, not including prompt pay or other discounts, rebates, or 
reductions in price. A drug's WAC is ultimately controlled by the 
manufacturer. Unlike ASP, a drug's WAC does not incorporate prompt-pay 
or other discounts. If discounts are available on drugs reimbursed by 
Medicare at 106 percent of WAC, then Medicare is paying more for drugs 
than it otherwise would under the ASP-based formula.\52\ Therefore, 
consistent with our existing policy to set the payment amount at 100 
percent of the ASP, if ASP is used to determine the payment for the 
drug component of an episode of care, we proposed that when WAC-based 
pricing is used, the payment amount shall be WAC + 0. We proposed to 
amend the provision at Sec.  410.67(d)(2)(i)(A) to reflect this 
limitation.
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    \51\ http://www.medpac.gov/-blog-/requiring-reporting-of-sales-price-data/2019/06/14/payment-for-part-b-drugs.
    \52\ http://medpac.gov/docs/default-source/reports/jun17_ch2.pdf.
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    We solicited comments on this proposed alternative pricing 
methodology when the payment for an implantable or injectable 
medication included in the drug component of an episode of care is 
determined using the methodology set forth in section 1847A of the Act, 
and ASP pricing data are not available.
    We received public comments on the WAC pricing proposal. The 
following is a summary of the comments we received and our responses.
    Comment: A commenter expressed concern with CMS establishing 
payment rates for medications that deviate from the standard 
methodology under Medicare Part B of paying for drugs at the current 
rate of ASP plus 6 percent. The commenter also stated that they were 
concerned that limiting payment to Wholesale Acquisition Cost (WAC) 
when ASP is not available would limit OTPs' ability to treat Medicare 
beneficiaries effectively. Another commenter supported the use of WAC + 
0 and stated, in reference to auto-injector naloxone, that any payments 
above WAC would likely only serve to encourage price increases in the 
market more broadly.
    Response: We thank the commenters for their feedback on our 
proposal that when the payment for an implantable or injectable 
medication included in the drug component of an episode of care is 
determined using the methodology set forth in section 1847A of the Act, 
and ASP pricing data are not available, and WAC-based pricing is used, 
the payment amount shall be WAC + 0. We continue to believe that 
payment structures that are closely tailored to the provider's 
acquisition cost reduce the likelihood that a drug will be chosen 
primarily for a reason that is unrelated to the clinical care of the 
patient, such as the drug's profit margin for a provider. Because WAC 
does not include prompt pay discounts, rebates or price reductions, we 
believe WAC could be a much higher than acquisition cost. However, we 
continue to believe that 100 percent of WAC is a closer estimate of the 
actual acquisition cost for OTPs compared to WAC with an add-on 
percentage. Therefore, we are finalizing our proposal that when WAC-
based pricing is used, the payment amount shall be WAC + 0. We are also 
finalizing the proposed amendment to the provision at Sec.  
410.67(d)(2)(i)(A) to reflect this pricing methodology.
4. Billing and Payment Policies
a. Institutional Claim Forms
    As discussed in the CY 2021 PFS proposed rule (85 FR 50207), we 
have received several requests to allow OTPs to bill on an 
institutional claim form. We were informed by representatives from the 
state of New York that all OTPs in New York state bill on institutional 
claim forms, not just those that are part of a hospital system. Given 
the public health need related to the opioid epidemic, we explained 
that we were exploring claims processing flexibilities requested by 
some OTPs that would allow them to bill services on institutional 
claims. See also section III.B. of this final rule, OTP Provider 
Enrollment Regulation Updates for Institutional Claim Submissions, for 
a discussion related to OTP enrollment as it relates to institutional 
claims. As we explained in the CY 2021 PFS proposed rule, there would 
be no differences in coverage or payment between services billed on the 
institutional claim form versus the professional claim form. We noted 
that the National Uniform Billing Committee (NUBC) approved a new Type 
Of Bill (087x) for Freestanding Non-residential Opioid Treatment 
Program provider billing, as well as a new condition code (89) for 
Opioid Treatment Program/Indicates claim for opioid treatment program 
services, to be used on hospital based OTP claims (TOB 013x and 085x). 
We sought information on the reasons this claims-processing flexibility 
is necessary for OTPs, and stated that we would address any changes to 
provider billing policies

[[Page 84690]]

in subsequent claims processing instructions.
    We received public comments on allowing OTPs to bill on an 
institutional claim form. The following is a summary of the comments we 
received and our response.
    Comment: Several commenters expressed support for allowing this 
flexibility. One commenter noted that they anticipate there will be a 
significant increase in OTP enrollment as a result of this flexibility, 
especially in states that have a significant number of hospital-based 
OTPs. Another commenter noted that allowing OTPs to submit claims on 
the institutional claim form (837i) will help to facilitate the 
processing of crossover claims between Medicare and Medicaid.
    Response: We are continuing to explore how best to implement these 
flexibilities. We will provide notice of any relevant changes through 
claims processing instructions.
b. Periodic Assessments
    In the CY 2020 PFS final rule (84 FR 62634), we stated that we 
understood that intake activities and periodic assessments are integral 
services for the establishment and maintenance of OUD treatment for a 
beneficiary at an OTP, and therefore, we believed it was reasonable to 
include these services in the definition of OUD treatment services. 
Accordingly, we finalized a definition of OUD treatment services in 
Sec.  410.67(b) that reflected the required intake activities and 
periodic assessments. We stated it was our understanding that these 
services are furnished much less frequently than the other services 
included in the weekly bundled payments; therefore, we created add-on G 
codes to describe these services, which would allow us to make more 
targeted payments for these services. We noted that the add-on code 
describing intake activities should only be billed for new patients 
(that is, patients starting treatment at the OTP). We agreed with the 
commenters that the level 4 office/outpatient E/M visits for new and 
established patients are a good approximation of the services provided 
at intake and during periodic assessments at OTPs based on the expected 
acuity of patients with OUD receiving services at OTPs, who are likely 
to have multiple co-morbidities and present with problems that are of 
moderate to high severity and require medical decision making of 
moderate complexity. The finalized add-on codes are HCPCS code G2076 
(Intake activities; including initial medical examination that is a 
complete, fully documented physical evaluation and initial assessment 
conducted by a program physician or a primary care physician, or an 
authorized health care professional under the supervision of a program 
physician or qualified personnel that includes preparation of a 
treatment plan that includes the patient's short-term goals and the 
tasks the patient must perform to complete the short-term goals; the 
patient's requirements for education, vocational rehabilitation, and 
employment; and the medical, psycho-social, economic, legal, or other 
supportive services that a patient needs, conducted by qualified 
personnel) and HCPCS code G2077 (Periodic assessment; assessing 
periodically by qualified personnel to determine the most appropriate 
combination of services and treatment). The medical services described 
by these add-on codes can be furnished by a program physician, a 
primary care physician or an authorized healthcare professional under 
the supervision of a program physician or qualified personnel such as 
nurse practitioners (NPs) and physician assistants (PAs). The other 
assessments, including psychosocial assessments can be furnished by 
practitioners who are eligible to do so under state law and their scope 
of licensure. We noted that to bill for the add-on code, the services 
need to be medically reasonable and necessary and that OTPs should 
document the rationale for billing the add-on code in the patient's 
medical record (84 FR 62647).
    As we explained in the CY 2021 PFS proposed rule (85 FR 50207), we 
have received inquiries from stakeholders related to what activities 
would qualify to bill the add-on code for periodic assessments, HCPCS 
code G2077. In the CY 2020 PFS final rule (84 FR 62647), we noted that 
the add-on code describing periodic assessments can be billed for each 
periodic assessment performed for patients that require multiple 
assessments during an episode of care, such as patients who are 
pregnant or postpartum. We noted that in order to bill for the add-on 
code, the services would need to be medically reasonable and necessary 
and that OTPs should document the rationale for billing the add-on code 
in the patient's medical record. Based on our understanding of the 
typical resources costs involved in furnishing periodic assessments, we 
priced HCPCS code G2077 based on a crosswalk to a level 4 office/
outpatient E/M visit. Consistent with our understanding of the expected 
acuity of patients with OUD receiving services at OTPs, including the 
likelihood of the patient having multiple co-morbidities and presenting 
with problems that are of moderate to high severity and requiring 
medical decision making of moderate complexity, as well as the 
associated payment rate assigned to this code, we explained that we 
believe it is important for the clinician to be able to visually assess 
the patient as part of any periodic assessment. Therefore, for CY 2021, 
we proposed that in order to bill for HCPCS code G2077, a face-to-face 
medical exam or biopsychosocial assessment would need to have been 
performed. Accordingly, we proposed to amend the definition of periodic 
assessment in Sec.  410.67(b)(7) to provide that the definition is 
limited to a face-to-face encounter.
    Additionally, we noted that in the May 8th COVID-19 IFC, CMS 
revised Sec.  410.67(b)(7) on an interim final basis to allow periodic 
assessments to be furnished during the PHE for COVID-19 via two-way 
interactive audio-video communication technology and, in cases where 
beneficiaries do not have access to two-way audio-video communication 
technology, to permit the periodic assessments to be furnished using 
audio-only telephone calls rather than via two-way interactive audio-
video communication technology, provided all other applicable 
requirements are met. We explained our belief that allowing periodic 
assessments to be furnished via two-way interactive audio-video 
communication technology beyond the conclusion of the PHE for COVID-19 
would help to expand access to care for patients who may have a 
difficult time getting to the OTP in person. Therefore, in the proposed 
rule, we proposed to revise Sec.  410.67(b)(7) to allow periodic 
assessments to be furnished via two-way interactive audio-video 
communication technology, provided all other applicable requirements 
are met. We noted that we are currently permitting the use of audio-
only telephone calls to furnish these services during the PHE for 
COVID-19, because we believe it is important to maintain access to 
these services while the public is following infection control 
guidelines to stay at home and practice social distancing, and not all 
beneficiaries receiving OUD treatment services from OTPs may have 
access to interactive audio-video communication technology. However, we 
did not believe this flexibility would be needed in order to ensure 
access after the PHE for COVID-19 ends. Therefore, we did not propose 
to extend the flexibility to use audio-only telephone services to 
furnish periodic assessments once the PHE for COVID-19 has ended.

[[Page 84691]]

We noted that we would consider payment for any periodic assessment-
related services furnished via audio-only telephone calls to be 
included in the bundled payment for a weekly episode of care, but that 
audio-only telephone services would not qualify for billing HCPCS code 
G2077 after the end of the PHE for COVID-19. We sought input from the 
public on whether we should consider continuing to make add-on payments 
for audio-only periodic assessments furnished by OTPs after the 
conclusion of the PHE for COVID-19, and if so, whether the payment rate 
for audio-only services should reflect any differences in resource 
costs.
    We received public comments on the proposals related to periodic 
assessments. The following is a summary of the comments we received and 
our responses.
    Comment: Commenters supported our proposal to allow OTPs to utilize 
two-way interactive audio-video communication to satisfy the proposed 
requirement that periodic assessments include a face-to-face encounter. 
Several commenters requested that CMS allow audio only communication to 
continue to be used for periodic assessments beyond the PHE for 
beneficiaries who do not have video capabilities, noting that many 
individuals who receive treatment at OTPs do not have access to devices 
with audio-video capability and beneficiaries in rural areas may not 
have broadband internet access.
    Response: While we believe it is important to allow the flexibility 
to furnish periodic assessments via audio-only telephone calls during 
the PHE for COVID-19, we continue to have concerns about continuing 
this flexibility after the end of the PHE. For example, we are 
concerned that the effectiveness and/or quality of the care furnished 
during these interactions may be lower when practitioners cannot 
observe visual cues while furnishing these assessments. Therefore, 
after consideration of the comments, we are finalizing our proposal 
that in order to bill for HCPCS code G2077, a face-to-face medical exam 
or biopsychosocial assessment would need to have been performed. 
Additionally, we are finalizing our proposal to revise Sec.  
410.67(b)(7) to provide that periodic assessments must be furnished 
during a face-to-face encounter, but may be furnished via two-way 
interactive audio-video communication technology, as clinically 
appropriate, provided all other applicable requirements are met. We 
plan to analyze differences in utilization in the claims data during 
and after the PHE for COVID-19, and are interested in feedback related 
to differences in frequency, effectiveness, and quality of care 
furnished by OTPs when services are furnished via audio-only 
communication in order to help assess whether we should consider making 
any changes to our current policies regarding the use of communication 
technology in future rulemaking.
c. Date of Service
    In the CY 2020 PFS final rule (84 FR 62641), we defined an episode 
of care as a 1-week (contiguous 7-day) period at Sec.  410.67(b). We 
have received inquiries related to the date of service used on claims 
for the weekly bundles and add-on codes, particularly related to an 
approach that many providers informed us they use, which is to 
establish a ``standard billing cycle'' in which episodes of care for 
all patients at that OTP begin on the same day of the week. We do not 
believe that the definition of an episode of care that was finalized 
for CY 2020 precludes the use of a ``standard billing cycle.'' 
Therefore, OTPs may choose to apply a standard billing cycle by setting 
a particular day of the week to begin all episodes of care. In this 
case, the date of service would be the first day of the OTP's billing 
cycle. If a beneficiary starts treatment at the OTP on a day that is in 
the middle of the OTP's standard weekly billing cycle, the OTP may 
still bill the applicable code for that episode of care provided that 
the threshold to bill for the code has been met. Alternatively, OTPs 
may choose to adopt weekly billing cycles that vary across patients. 
Under this approach, the initial date of service will depend upon the 
day of the week when the patient was first admitted to the program or 
when Medicare billing began. Therefore, under this approach of adopting 
weekly billing cycles that vary across patients, when a patient is 
beginning treatment or re-starting treatment after a break in 
treatment, the date of service would reflect the first day the patient 
was seen and the date of service for subsequent consecutive episodes of 
care would be the first day after the previous 7-day period ends. For 
the codes describing add-on services (HCPCS codes G2076-G2080), the 
date of service should reflect the date that service was furnished; 
however, if the OTP has chosen to apply a standard weekly billing 
cycle, the date of service for codes describing add-on services may be 
the same as the first day in the weekly billing cycle.
    In the CY 2021 PFS proposed rule (50208), we noted that this 
approach is consistent with earlier guidance that was issued in the OTP 
Billing and Payment Fact sheet that is posted on the CMS OTP web page 
(https://www.cms.gov/files/document/otp-billing-and-payment-fact-sheet.pdf).
    We received public comments on the discussion of the date of 
service used on claims in the proposed rule. The following is a summary 
of the comments we received and our responses.
    Comment: Commenters expressed support for the flexibility to use 
either a ``standard billing cycle'' or a weekly billing cycle that 
varies across patients.
    Response: We intend to continue to offer this flexibility to OTPs. 
Additionally, we note that the current policies regarding the date of 
services for add-on codes will apply to the new add-on codes we are 
adopting in this final rule for nasal naloxone and injectable naloxone.
d. Coding
    In the CY 2021 PFS proposed rule (85 FR 50208), we explained that 
we recognize the importance of allowing OTPs to become accustomed to 
billing Medicare using the coding that was established in the CY 2020 
PFS final rule; however, we remain interested in refining the code set 
through future rulemaking, including stratifying the coding and 
associated payment amounts to account for significant differences in 
resource costs among patients, especially in relation to amounts of 
expected counseling. In the CY 2020 PFS final rule (84 FR 62645), we 
finalized an add-on code to describe an adjustment to the bundled 
payment when additional counseling or therapy services are furnished, 
HCPCS code G2080. This add-on code may be billed when counseling or 
therapy services are furnished that substantially exceed the amount 
specified in the patient's individualized treatment plan. We stated 
that we have received feedback from stakeholders noting a range of OTP 
attendance patterns that represent a continuum of care and service 
intensity, noting significant differences in services received during 
the induction phase versus the maintenance phase. We also understand 
that patients' needs for service may fluctuate over time, depending on 
a variety of factors and circumstances. We sought comments on how we 
might better account for differences in resource costs among patients 
over the course of treatment. We noted that we would consider the 
comments received in developing any proposed refinements to our coding 
policies in future rulemaking.
    We received public comments on the discussion of billing and 
payment policies in the proposed rule. The

[[Page 84692]]

following is a summary of the comments we received and our responses.
    Comment: Commenters expressed support for CMS' retaining the coding 
framework that was established in the CY 2020 rulemaking. A few 
commenters stated that CMS should maintain the current bundle structure 
because it has proven to be successful and viable during the first year 
of the new Medicare Part B benefit for OUD treatment services furnished 
by OTPs, and therefore there is no need to overly tinker with a 
functioning reimbursement structure. Another commenter stated that the 
current bundled payment methodology, with the ability to bill for 
additional counseling via add-on codes has worked remarkably well due 
to its simplicity. They stated that the current bundled payments 
reflect the costs associated with treating a patient with average needs 
and that while some patients require greater services and some require 
less, it usually balances out from a reimbursement-to-costs standpoint. 
They also stated that they have found that Medicare beneficiaries 
generally are a more health care service intensive population than non-
Medicare patients, and therefore many OTPs are working to increase 
counseling resources to meet the unique needs of the Medicare 
population. They also stated that changing the current bundled payment 
methodology would undermine the progress OTPs have made in this area 
and therefore recommended that CMS maintain the current bundled payment 
structure.
    Response: We are pleased to hear that the coding and payment 
policies that we established in CY 2020 PFS final rule have been 
effective and well received. We plan to retain the current coding 
structure for 2021, and will continue to consider any refinements to 
that structure for future rulemaking.
5. Annual Updates
    In the CY 2020 PFS final rule (84 FR 62667 through 62669), we 
finalized a policy under which the payment for the drug component of 
episodes of care will be determined using the most recent data 
available at the time of ratesetting for the applicable calendar year. 
The payment for the non-drug component of the bundled payment for OUD 
treatment services will be updated annually based upon the Medicare 
Economic Index. The current payment rates, as finalized in the CY 2020 
PFS final rule, both with and without locality adjustments, can be 
found on the CMS OTP web page under Billing and Payment at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Opioid-Treatment-Program/billing-payment. The list of the payment rates for OUD 
treatment services furnished by OTPs, with the annual update applied 
for CY 2021, is available in the file called CY 2021 PFS final rule OTP 
Payment Rates on the CMS website under downloads for the CY 2021 PFS 
proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices?DLSort=2&DLEntries=10&DLPage=1&DLSortDir=descending.
    Comment: Commenters stated that using the Medicare Economic Index 
(MEI), which focuses more narrowly on physician practices, to update 
the payment rates for the non-drug component of the bundled payments 
does not ensure that Medicare payment rates for OTPs keep pace with 
growing practice costs. The commenters stated that OTPs' cost 
structures are more similar to HOPDs than they are to physician 
offices, in that they employ interdisciplinary teams, including medical 
directors, doctors, counselors, nurses, pharmacists, laboratory 
technicians, social workers, and case managers, to provide care to 
patients. They also noted that like hospitals, OTPs serve patients 7 
days per week and go through extensive accreditation and certification 
process and are subject to thorough inspections by deferral regulators. 
OTPs are also required to employ diversion control systems to ensure 
treatment medication is being used properly, while physicians in the 
office setting who prescribe buprenorphine are not subject to those 
requirements. Commenters stated that given these similarities between 
OTPs and HOPDs, the IPPS market basket update would be a more accurate 
measure of annual price growth in the OTP setting for the non-drug 
component of the OTP bundled payment rates, noting that TRICARE 
increases its payments to OTPs by the IPPS update factor annually.
    Response: We did not propose any changes for CY 2021 to the annual 
update process that was established in the CY 2020 PFS final rule (84 
FR 62667), however, we will consider this feedback for future 
rulemaking.

J. Technical Correction to the Definition of Public Health Emergency

    In the March 31st COVID-19 IFC (85 FR 19285), we amended 42 CFR 
part 400 by adding the definition of ``Public Health Emergency.'' We 
made an inadvertent typographical error in the regulations at Sec.  
400.200 by referring to the authority for the Public Health Emergency 
(PHE) as the ``Public Health Security Act'' rather than the ``Public 
Health Service Act.'' We are correcting this error in this final rule 
and amending Sec.  400.200 by revising the definition. Public Health 
Emergency (PHE) now means the Public Health Emergency determined to 
exist nationwide as of January 27, 2020, by the Secretary pursuant to 
section 319 of the Public Health Service Act on January 31, 2020, as a 
result of confirmed cases of COVID-19, including any subsequent 
renewals. This revised definition has an applicability date of March 1, 
2020, which is the same applicability date as the March 31st COVID-19 
IFC.

III. Summary of the Proposals for Other Part B Provisions, Analysis of 
and Responses to Public Comments, and Provisions of the Final Rule

A. Clinical Laboratory Fee Schedule: Revised Data Reporting Period and 
Phase-In of Payment Reductions, and Comment Solicitation on Payment for 
Specimen Collection for COVID-19 Clinical Diagnostic Laboratory Tests

1. Background on the Clinical Laboratory Fee Schedule
    Prior to January 1, 2018, Medicare paid for clinical diagnostic 
laboratory tests (CDLTs) on the Clinical Laboratory Fee Schedule 
(CLFS), with certain exceptions, under section 1833(a), (b), and (h) of 
the Act. Under the previous payment system, 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 payment 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. Coinsurance and 
deductibles generally do not apply to CDLTs paid under the 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 CDLTs under the CLFS. In the June 23, 
2016 Federal Register (81 FR 41036), we published a final rule entitled 
Medicare Clinical Diagnostic Laboratory Tests

[[Page 84693]]

Payment System (CLFS final rule), that implemented section 1834A of the 
Act at 42 CFR part 414, subpart G.
    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.'' The first data collection period occurred 
from January 1, 2016 through June 30, 2016. The first data reporting 
period occurred from January 1, 2017 through March 31, 2017. On March 
30, 2017, we announced a 60-day period of enforcement discretion for 
the application of the Secretary's potential assessment of Civil 
Monetary Penalties (CMPs) for failure to report applicable information 
with respect to the initial data reporting period. This announcement is 
available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Downloads/2017-March-Announcement.pdf.
    In the CY 2018 PFS proposed rule (82 FR 34089 through 34090), we 
solicited public comments from applicable laboratories and reporting 
entities to better understand the applicable laboratories' experiences 
with data reporting, data collection, and other compliance requirements 
for the first data collection and reporting periods. We discussed these 
comments in the CY 2018 PFS final rule (82 FR 53181 through 53182) and 
stated that we would consider the comments for potential future 
rulemaking or guidance.
    As part of the CY 2019 Medicare PFS rulemaking, we finalized two 
changes to the definition of ``applicable laboratory'' at Sec.  414.502 
(see 83 FR 59667 through 59681, 60074; 83 FR 35849 through 35850; 83 FR 
35855 through 35862). First, we excluded Medicare Advantage (MA) plan 
payments under Part C from the denominator of the Medicare revenues 
threshold calculation, in an effort to broaden the types of 
laboratories qualifying as an applicable laboratory. Specifically, 
excluding MA plan payments 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 an applicable laboratory (if they also meet the 
low expenditure threshold) and report data to CMS during the data 
reporting period. Because MA plan payments are now excluded from the 
total Medicare revenues calculation, the denominator amount (total 
Medicare revenues) would decrease. If the denominator amount decreases, 
the likelihood increases that a laboratory would qualify as an 
applicable laboratory. This is because the laboratory's PFS and CLFS 
revenues are being compared to a lower total Medicare payment amount 
(than what they would have been compared to if MA plan payments 
remained in the denominator). Second, consistent with our goal of 
obtaining a broader representation of laboratories that could 
potentially qualify as an applicable laboratory and report data, we 
also amended the definition of applicable laboratory to include 
hospital outreach laboratories that bill Medicare Part B using the CMS-
1450 14x Type of Bill.
2. Payment Requirements for Clinical Diagnostic Laboratory Tests
    In general, under section 1834A of the Act, 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 CMS 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 for a phase-in of payment reductions, limiting the 
amounts the CLFS rates for each CDLT (that is not a new advanced 
diagnostic laboratory test (ADLT) or new CDLT) can be reduced as 
compared to the payment rates for the preceding year. Under the 
provisions enacted by section 216(a) of PAMA, 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. Under section 1834A(a)(1) and (b) of the Act, as enacted by PAMA, 
for CDLTs that are not ADLTs, the data collection period, data 
reporting period, and payment rate update occur every 3 years. As such, 
the second data collection period for CDLTs that are not ADLTs occurred 
from January 1, 2019 through June 30, 2019, and the next data reporting 
period was scheduled to take place from January 1, 2020 through March 
31, 2020, with the next update to the Medicare payment rates for these 
tests based on that reported applicable information scheduled to take 
effect as of January 1, 2021.
    Section 216(a) of PAMA established a new subcategory of CDLTs known 
as ADLTs, with separate reporting and payment requirements under 
section 1834A of the Act. As defined in Sec.  414.502, an ADLT is a 
CDLT covered under Medicare Part B that is offered and furnished only 
by a single laboratory, and cannot be sold for use by a laboratory 
other than the single laboratory that designed the test or a successor 
owner. Also, an ADLT must meet either Criterion (A), which implements 
section 1834A(d)(5)(A) of the Act, or Criterion (B), which implements 
section 1834A(d)(5)(B) of the Act, as follows:
     Criterion (A): The test is an analysis of multiple 
biomarkers of deoxyribonucleic acid (DNA), ribonucleic acid (RNA), or 
proteins; when combined with an empirically derived algorithm, yields a 
result that predicts the probability a specific individual patient will 
develop a certain condition(s) or respond to a particular therapy(ies); 
provides new clinical diagnostic information that cannot be obtained 
from any other test or combination of tests; and may include other 
assays; or:
     Criterion (B): The test is cleared or approved by the FDA.
    Generally, under section 1834A(d) of the Act, the Medicare payment 
rate for a new ADLT is equal to its actual list charge during an 
initial period of 3 calendar quarters. After the new ADLT initial 
period, ADLTs are paid using the same methodology based on the weighted 
median of private payor rates as other CDLTs. However, under section 
1834A(d)(3) of the Act, updates to the Medicare payment rates for ADLTs 
occur annually instead of every 3 years.
    Additional information on the private payor rate-based CLFS is 
detailed in the CLFS final rule (81 FR 41036 through 41101) and is 
available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/PAMA-regulations.
3. Statutory Revisions to the Data Reporting Period and Phase-In of 
Payment Reductions
    Section 105(a) of the Further Consolidated Appropriations Act, 2020 
(FCAA) (Pub. L. 116-94, enacted on December 20, 2019), and section 3718 
of the Coronavirus Aid, Relief, and Economic Security Act, 2020 (CARES 
Act) (Pub. L. 116-136, enacted on March 27, 2020), made revisions to 
the CLFS requirements for the next data reporting period for CDLTs that 
are not ADLTs under section 1834A of the Act. Additionally, the CARES 
Act made

[[Page 84694]]

revisions to the phase-in of payment reductions under section 1834A of 
the Act. Specifically, section 105(a)(1) of the FCAA amended the data 
reporting requirements in section 1834A(a) of the Act to delay the next 
data reporting period for CDLTs that are not ADLTs by 1 year, so that 
data reporting would be required during the period of January 1, 2021 
through March 31, 2021; the 3-year data reporting cycle for CDLTs that 
are not ADLTs would resume after that data reporting period. Section 
105(a)(1) of the FCAA also specified that the data collection period 
that applies to the data reporting period of January 1, 2021 through 
March 30, 2021 would be the period of January 1, 2019 through June 30, 
2019, which is the same data collection period that would have applied 
absent the amendments. In addition, section 105(a)(2) of the FCAA 
amended section 1834A(b)(3) of the Act regarding the phase-in of 
payment reductions to provide that payments may not be reduced by more 
than 10 percent as compared to the amount established for the preceding 
year through CY 2020, and for CYs 2021 through 2023, payment may not be 
reduced by more than 15 percent as compared to the amount established 
for the preceding year. These statutory changes were consistent with 
our regulations implementing the private payor rate-based CLFS (81 FR 
41036;Sec.  414.507(d)).
    Subsequently, section 3718 of the CARES Act further amended the 
data reporting requirements for CDLTs that are not ADLTs and the phase-
in of payment reductions under the CLFS. Specifically, section 3718(a) 
of the CARES Act amended section 1834A(a)(1)(B) of the Act to delay the 
next data reporting period for CDLTs that are not ADLTs by one 
additional year, to require data reporting during the period of January 
1, 2022 through March 31, 2022. As amended by the CARES Act, section 
1834A(a)(1)(B) of the Act now provides that in the case of reporting 
with respect to CDLTs that are not ADLTs, the Secretary shall revise 
the reporting period under subparagraph (A) such that-(i) no reporting 
is required during the period beginning January 1, 2020, and ending 
December 31, 2021; (ii) reporting is required during the period 
beginning January 1, 2022, and ending March 31, 2022; and (iii) 
reporting is required every 3 years after the period described in 
clause (ii).
    The CARES Act did not modify the data collection period that 
applies to the next data reporting period for these tests. Thus, under 
section 1834A(a)(4)(B) of the Act, as amended by section 105(a)(1) of 
the FCAA, the next data reporting period for CDLTs that are not ADLTs 
(January 1, 2022 through March 31, 2022) will be based on the data 
collection period of January 1, 2019 through June 30, 2019. In Sec.  
414.502, the current definition of data collection period is defined as 
the 6 months from January 1 through June 30 during which applicable 
information is collected and that precedes the data reporting period. 
Additionally, in Sec.  414.502 the data reporting period is defined as 
the 3-month period, January 1 through March 31, during which a 
reporting entity reports applicable information to CMS and that follows 
the preceding data collection period. Unless we revised our current 
definitions of data collection period and data reporting period, the 
definitions would have been incorrect with regard to the data 
collection period that applies to the next data reporting period. 
Therefore, we proposed to revise the definitions of data collection 
period and data reporting period in Sec.  414.502 to reflect that the 
data collection period will be January 1, 2019 through June 30, 2019 
for the data reporting period of January 1, 2022 through March 31, 
2022.
    Section 3718(b) of the CARES Act further amended the provisions in 
section 1834A(b)(3) of the Act regarding the phase-in of payment 
reductions under the CLFS. First, it extended the statutory phase-in of 
payment reductions resulting from private payor rate implementation by 
an additional year, that is, through CY 2024. It further amended 
section 1834A(b)(3)(B)(ii) of the Act to specify that the applicable 
percent for CY 2021 is 0 percent, meaning that the payment amount 
determined for a CDLT for CY 2021 shall not result in any reduction in 
payment as compared to the payment amount for that test for CY 2020. 
Section 3718(b) of the CARES Act further amended section 
1834A(b)(3)(B)(iii) of the Act to state that the applicable percent of 
15 percent will apply for CYs 2022 through 2024, instead of CYs 2021 
through 2023.
4. Conforming Regulatory Changes
    In accordance with section 105(a) of the FCAA and section 3718 of 
the CARES Act, we proposed to make conforming changes to the data 
reporting and payment requirements at part 414, subpart G. 
Specifically, we proposed to revise Sec.  414.502 to update the 
definitions of both the data collection period and data reporting 
period, specifying that for the data reporting period of January 1, 
2022 through March 31, 2022, the data collection period is January 1, 
2019 through June 30, 2019. We also proposed to revise Sec.  
414.504(a)(1) to indicate that initially, data reporting begins January 
1, 2017 and is required every 3 years beginning January 2022. In 
addition, we proposed conforming changes to our requirements for the 
phase-in of payment reductions to reflect the CARES Act amendments. 
Specifically, we proposed to revise Sec.  414.507(d) to indicate that 
for CY 2021, payment may not be reduced by more than 0.0 percent as 
compared to the amount established for CY 2020, and for CYs 2022 
through 2024, payment may not be reduced by more than 15 percent as 
compared to the amount established for the preceding year.
    We received public comments on the revised data reporting 
requirements and phase-in of payment reductions for the CLFS. The 
following is a summary of the comments we received and our responses.
    Comment: Several commenters expressed support for the proposed 
conforming regulatory changes to the data reporting and payment 
requirements.
    Response: We appreciate the commenters' support for these changes 
that reflect the recent statutory revisions required by section 105(a) 
of the FCAA and section 3718 of the CARES Act.
    Comment: One commenter suggested that CMS delay implementation of 
the phase-in of payment reductions under the CLFS.
    Response: We note that the phase-in of payment reductions to the 
CLFS payment amounts is statutory; therefore, we are unable to delay 
implementation. Additionally, we note that there will be a 0.0% payment 
reduction for CY 2021 and, for CYs 2022 through 2024, payment may not 
be reduced by more than 15 percent as compared to the amount 
established for the preceding year.
    In consideration of these public comments and in accordance with 
section 105(a) of the FCAA and section 3718 of the CARES Act, we are 
finalizing the proposed conforming changes to the data reporting and 
payment requirements at part 414, subpart G.
5. Response to the Comment Solicitation on Payment for Specimen 
Collection for COVID-19 Clinical Diagnostic Laboratory Tests
    In the ``Medicare and Medicaid Programs; Policy and Regulatory 
Revisions in Response to the COVID-19 Public Health Emergency'' interim 
final rule with comment period (March 31st COVID-19 IFC), which 
displayed and became effective on March 31, 2020 and

[[Page 84695]]

appeared in the April 6, 2020 Federal Register (85 FR 19230), we 
established that Medicare will pay a nominal specimen collection fee 
and associated travel allowance to independent laboratories for the 
collection of specimens for COVID-19 clinical diagnostic laboratory 
testing for homebound and non-hospital inpatients (85 FR 19256 through 
19258). This policy provides independent laboratories with additional 
resources to provide COVID-19 testing and helps with efforts to limit 
patients' exposure to the general population and alleviate patients' 
unease with leaving the home. To identify specimen collection for 
COVID-19 testing specifically, we established two new level II HCPCS 
codes: Code G2023 (specimen collection for severe acute respiratory 
syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), 
any specimen source); and code G2024 (specimen collection for severe 
acute respiratory syndrome coronavirus 2 (SARS-Cov-2) (Coronavirus 
disease [COVID19]), from an individual in a SNF or by a laboratory on 
behalf of a HHA, any specimen source), for independent laboratories to 
use when billing Medicare for the nominal specimen collection fee for 
COVID-19 testing for the duration of the PHE for COVID-19.
    We indicated in the March 31st COVID-19 IFC that this specimen 
collection fee policy was established for the duration of the PHE for 
COVID-19 (85 FR 19256). In the CY 2021 PFS proposed rule, we requested 
comments on whether we should delete HCPCS codes G2023 and G2024 once 
the PHE for COVID-19 ends (85 FR 50211). We noted that comments 
received may inform a future proposal. Specifically, we sought public 
input on why these codes, and their corresponding payment amounts, 
which are higher than the nominal specimen collection fees for other 
conditions, would be necessary or useful outside of the context of the 
PHE for COVID-19. We stated that we were particularly interested in why 
separate, increased payment for specimen collection specifically for 
COVID-19 tests, in contrast to other tests, may be needed following the 
end of the PHE.
    We received public comments on the specimen collection fees for 
COVID-19 clinical diagnostic laboratory tests. The following is a 
summary of the comments we received and our response.
    Comment: Several commenters expressed support for permanently 
extending payment for specimen collection for COVID-19 tests after the 
PHE, as commenters expect the COVID-19 virus to be present into CY 
2021, thus making it appropriate for CMS to continue to pay for 
specimen collection. Commenters recommended that CMS expand and 
permanently authorize the specimen collection fees under HCPCS codes 
G2023 and G2024 to apply to all CDLTs to compensate for the supplies, 
equipment, and sterilization protocols required for safe and 
uncontaminated specimen collection and handling in the presence of 
COVID-19. Commenters noted that COVID-19 will continue to spread and 
may become an ongoing and/or seasonal infectious disease event, and 
because of this possibility, they expect that the heightened safety 
precautions, the need for personal protective equipment, and the 
requirement for special training for specimen collection will persist 
beyond the immediate PHE.
    Commenters also recommended that CMS confirm that HCPCS code G2023 
applies to any site where clinical laboratory personnel collect 
specimens, and not solely to homebound and nonhospital inpatients. Some 
commenters requested that CMS confirm that when a laboratory receives a 
health care professional's order for COVID-19 test specimen collection 
in a beneficiary's home, the laboratory may consider this order to be a 
determination by the health care professional that the beneficiary is 
homebound, and therefore, the laboratory is eligible for the increased 
specimen collection fee represented by HCPCS code G2023.
    Response: We appreciate the comments regarding the nominal specimen 
collection fees and associated travel allowance to independent 
laboratories for the collection of specimens for COVID-19 clinical 
diagnostic laboratory testing. We plan to take this feedback into 
consideration for possible future rulemaking or guidance.

B. OTP Provider Enrollment Regulation Updates for Institutional Claim 
Submissions

1. Modifications to OTP Enrollment Process
a. Background
    Under 42 CFR 424.510, a provider or supplier must complete, sign, 
and submit to its assigned Medicare Administrative Contractor (MAC) the 
Form CMS-855 (OMB Control No. 0938-0685) application to enroll in the 
Medicare program and obtain Medicare billing privileges. The Form CMS-
855, which can be submitted via paper or electronically through the 
internet-based Provider Enrollment, Chain, and Ownership System (PECOS) 
process (SORN: 09-70-0532, Provider Enrollment, Chain, and Ownership 
System), captures information about the provider or supplier that CMS 
or its MACs reviews and verifies to determine whether the provider or 
supplier meets all Medicare requirements. (The specific Form CMS-855 
application (of which there are several variations) to be completed 
will depend upon the type of provider or supplier submitting said 
application.) This process of enrollment helps ensure that: (1) All 
prospective providers and suppliers are carefully screened and 
reviewed; and (2) unqualified providers and suppliers are kept out of 
the Medicare program, which helps protect the Trust Funds and Medicare 
beneficiaries. Indeed, without this process, billions of taxpayer 
dollars might be paid to fraudulent or otherwise non-compliant parties.
b. Completion of Form CMS-855
    Existing Sec.  424.67 outlines a number of enrollment requirements 
for OTPs. One requirement, addressed in Sec.  424.67(b)(1), is that 
OTPs must complete the Form CMS-855B application (Medicare Enrollment 
Application: Clinics/Group Practices and Certain Other Suppliers; OMB 
#: 0938-0685) to enroll in Medicare. The reference to the Form CMS-855B 
in Sec.  424.67(b)(1) was predicated in part on the assumption that 
OTPs would generally submit the CMS-1500 claim form (Health Insurance 
Claim Form; OMB Control No.: 0938-1197) to receive payment for their 
services. However, as mentioned previously in section II.I.4. of the CY 
2021 PFS proposed rule (85 FR 50074), we have received requests to 
allow OTPs to bill for services on an institutional claim form 
(specifically, the 837I). To do so, these OTPs would have to enroll in 
Medicare via the Form CMS-855A (Medicare Enrollment Application for 
Institutional Providers (OMB #: 0938-0685)). To account for 
circumstances where an OTP wishes to pursue Form CMS-855A enrollment 
for the reason stated above, we proposed the following revisions to 
Sec.  424.67:
     Current Sec.  424.67(b)(1) states that a newly enrolling 
OTP must fully complete and submit the Form CMS-855B application (or 
its successor application). We proposed to revise this paragraph to 
state that the newly enrolling OTP must fully complete and submit, as 
applicable, the Form CMS-855A or Form CMS-855B application (or their 
successor applications).
     Existing Sec.  424.67(b)(1)(ii) requires the OTP to 
certify compliance with the requirements and standards described in 
paragraphs Sec.  424.67(b) and (d) via the Form CMS-855B and/or the 
applicable

[[Page 84696]]

supplement or attachment thereto. We proposed to revise this paragraph 
such that the OTP must certify compliance with the above-referenced 
requirements and standards via the Form CMS-855A or Form CMS-855B (as 
applicable) and/or the applicable supplement or attachment thereto.
     Existing Sec.  424.67(b)(5) requires the OTP to report on 
the Form CMS-855B and/or any applicable supplement all OTP staff who 
meet the definition of ``managing employee'' in Sec.  424.502. We 
proposed to change this to state that the OTP must report on the Form 
CMS-855A or Form CMS-855B (as applicable) and/or any applicable 
supplement all OTP staff who meet this definition.
    We believed these revisions would accomplish two objectives. First, 
they would permit OTPs to submit a Form CMS-855A in lieu of a Form CMS-
855B based on their preferred method of billing. Second, they would 
confirm that the requirements of Sec.  424.67 apply to all OTPs 
regardless of whether they complete the Form CMS-855A or the Form CMS-
855B.
c. Screening Activities Associated With Risk Designation
    Section 424.518 outlines provider enrollment screening categories 
and requirements based on our assessment of the degree of risk of 
fraud, waste, and abuse posed by a particular category of provider or 
supplier. In general, the higher the level of risk that a certain 
provider or supplier type presents, the greater the degree of scrutiny 
with which we will screen and review enrollment applications submitted 
by providers or suppliers within that category. There are three levels 
of screening addressed in Sec.  424.518: Limited; moderate; and high. 
Irrespective of which level a provider or supplier type falls within, 
the MAC performs certain minimum screening functions upon receipt of an 
initial enrollment application, a revalidation application, or an 
application to add a new practice location. These include:
     Verification that the provider or supplier meets all 
applicable federal regulations and state requirements for their 
provider or supplier type.
     State license verifications.
     Database reviews on a pre- and post-enrollment basis to 
ensure that providers and suppliers continue to meet the enrollment 
criteria for their provider or supplier type.
    Providers and suppliers at the moderate and high categorical risk 
levels must also undergo a site visit. Moreover, for those in the high 
categorical risk level, the MAC performs two additional functions under 
Sec.  424.518(c)(2). First, the MAC requires the submission of a set of 
fingerprints for a national background check from all individuals who 
maintain a 5 percent or greater direct or indirect ownership interest 
in the provider or supplier. Second, it conducts a fingerprint-based 
criminal history record check of the Federal Bureau of Investigation's 
(FBI) Integrated Automated Fingerprint Identification System on all 
individuals who maintain a 5 percent or greater direct or indirect 
ownership interest in the provider or supplier. These additional 
verification activities are intended to correspond to the heightened 
risk involved with such provider or supplier types.
    For newly enrolling OTPs, those that have been fully and 
continuously certified by the Substance Abuse and Mental Health 
Services Administration (SAMHSA) since October 23, 2018 fall within the 
moderate level of categorical screening. OTPs that have not been so 
certified since the aforementioned date are subject to the high 
screening level. As discussed in the CY 2021 PFS proposed rule (85 FR 
50074), we recognize that certain providers and suppliers have already 
enrolled as OTPs via the Form CMS-855B--and, accordingly, undergone a 
site visit and, if applicable, fingerprinting--but would seek to newly 
enroll via the Form CMS-855A should our proposals be finalized. (Said 
enrollment would be considered ``new'' for purposes of enrollment 
because the OTP would be enrolling via a different variation of the 
Form CMS-855.) While not seeking to minimize the importance of the 
enhanced screening activities associated with the moderate and high 
categorical levels, we do not wish to unduly burden currently enrolled 
OTPs that would pursue Form CMS-855A enrollment as an OTP. More 
specifically, we noted that we did not believe such OTPs should have to 
undergo another site visit and, if applicable, fingerprinting when they 
previously did so as an OTP via their original Form CMS-855B 
enrollment. This, in our view, would constitute an unnecessary 
expenditure of CMS, MAC, and OTP resources. We add that the same would 
hold true if, in the future, an OTP that is enrolled via the Form CMS-
855A under revised Sec.  424.67(b) decides to change to a Form CMS-855B 
enrollment. In both cases, we believe a duplication of effort should be 
avoided to the extent consistent with safeguarding the integrity of the 
Medicare program.
    Existing Sec.  424.67(b)(3) states that an enrolling OTP must 
successfully complete the assigned categorical risk level screening 
required under, as applicable, Sec.  424.518(b) and (c) (which outline 
the screening requirements for newly enrolling parties in, 
respectively, the moderate and high categorical levels). Given the 
foregoing discussion, we proposed several changes to Sec.  
424.67(b)(3). First, we proposed to redesignate existing Sec.  
424.67(b)(3) as new Sec.  424.67(b)(3)(i), though with an exception to 
its requirements. Second, and to address this exception, we proposed to 
add paragraph (b)(3)(ii) to state that currently enrolled OTPs that are 
changing their OTP enrollment from a Form CMS-855B to a Form CMS-855A, 
or vice versa, must successfully complete the limited level of 
categorical screening under Sec.  424.518(a) if the OTP has already 
completed, as applicable, the moderate or high level of categorical 
screening under Sec.  424.518(b) or (c), respectively. Third, we 
proposed to redesignate existing Sec.  424.518(a)(1)(xii) through 
(xvii) as Sec.  424.518(a)(1)(xiii) through (xviii). Fourth, proposed 
new Sec.  424.518(a)(1)(xii) would add OTPs that fall within the 
purview of new paragraph (b)(3)(ii) to the provider and supplier types 
subject to limited risk categorical screening.
d. Additional OTP Enrollment Clarifications Regarding the Form CMS-855A
    We proposed three additional clarifications related to our 
previously mentioned OTP enrollment provisions. To incorporate these 
into Sec.  424.67, we proposed to redesignate existing paragraphs (c), 
(d), (e), and (f) as paragraphs (d), (e), (f), and (g), respectively. 
The three clarifications would be included in new paragraph (c).
    With the redesignation of existing paragraph (d) as paragraph (e), 
we also proposed to change the reference to:
     Paragraph (d) in existing paragraph (b)(1)(ii) to 
paragraph (e).
     Paragraph (d)(1) in existing paragraph (d)(2)(i) to 
paragraph (e)(1) in redesignated paragraph (e)(2)(i).
(1) Single Enrollment
    We proposed in new Sec.  424.67(c)(1) that an OTP may only be 
enrolled as such via the Form CMS-855A or the Form CMS-855B but not 
both. The OTP, in other words, must opt for either Form CMS-855A 
enrollment or Form CMS-855B enrollment. This is to help ensure that the 
OTP does not bill twice for the same service via separate claim 
vehicles (specifically, the CMS-1500 and the 837I).

[[Page 84697]]

(2) Effective Date of Billing
    Section 424.520(d) outlines the effective date of billing 
privileges for newly enrolling OTPs (and certain other provider and 
supplier types). This date is the later of: (1) The date of the OTP's 
filing of a Medicare enrollment application that was subsequently 
approved by a Medicare contractor; or (2) the date that the OTP first 
began furnishing services at a new practice location. In a similar 
vein, Sec.  424.521(a) states that OTPs (and certain other provider and 
supplier types) may retrospectively bill for services when the OTP has 
met all program requirements (including state licensure requirements), 
and services were provided at the enrolled practice location for up 
to--
     30 days prior to their effective date if circumstances 
precluded enrollment in advance of providing services to Medicare 
beneficiaries; or
     90 days prior to their effective date if a Presidentially-
declared disaster under the Robert T. Stafford Disaster Relief and 
Emergency Assistance Act, 42 U.S.C. 5121 through 5206 (Stafford Act) 
precluded enrollment in advance of providing services to Medicare 
beneficiaries.
    In light of proposed Sec.  424.67(c)(1) (and as further explained 
in the collection of information section of this proposed rule), we 
anticipate that a number of OTPs would end their existing enrollment 
and apply as a new OTP via, as applicable, the Form CMS-855A or Form 
CMS-855B. Given this, we believe it is important to clarify for 
stakeholders the new enrollment's effective date of billing. 
Accordingly, at Sec.  424.67, we proposed in new paragraph (c)(2) that 
if a Form CMS-855B-enrolled OTP changes to a Form CMS-855A enrollment, 
or vice versa, the effective date of billing that was established for 
the OTP's prior enrollment under Sec. Sec.  424.520(d) and 424.521(a) 
would be applied to the OTP's new enrollment. This would allow OTPs 
that have been unable to bill for furnished services via their 
preferred claim form (and have consequently chosen to delay the 
submission of these claims for services) to do so retroactive to the 
effective billing date of its prior enrollment. To illustrate, suppose 
an OTP initially enrolled via the Form CMS-855B in 2020. The effective 
date of billing was April 1, 2020. Wishing to submit an 837I claim form 
for the services it has provided since April 1, 2020, the OTP elects to 
end its Form CMS-855B enrollment and enroll via the Form CMS-855A 
pursuant to revised Sec.  424.67. It successfully does the latter in 
March 2021. Under Sec.  424.67(c)(2), the billing effective date of the 
Form CMS-855A enrollment would be retroactive to April 1, 2020. 
However, we noted in the proposed rule that the time limits for filing 
claims found in Sec.  424.44 would continue to apply. Specifically, all 
Medicare Part A and Part B claims must be filed within 1 calendar year 
after the date of service unless one of a very limited number of 
exceptions applies. Switching from a Form CMS-855B enrollment to a Form 
CMS-855A enrollment, or vice versa, is not grounds for an exception.
    We recognized that not every OTP that seeks to change its 
enrollment will have chosen to withhold submission of all of its claims 
under its prior enrollment. (Using our example in the previous 
paragraph, the OTP may have submitted some claims via the CMS-1500 
while planning to eventually submit the remaining ones via the 837I.) 
Irrespective of this, CMS has long had operational safeguards in place 
to prevent double-billing for the same service. Said protections would 
be used in the scenario described in proposed Sec.  424.67(c)(2) so 
that claims submitted under the prior enrollment could not be 
resubmitted under the new one.
(3) Application Fee
    As stated in Sec.  424.514, prospective and revalidating 
institutional providers that are submitting a Medicare enrollment 
application generally must pay the applicable application fee in 
accordance with Sec.  424.514. (For CY 2020, the fee amount is $595.) 
The term ``institutional provider'' is defined in Sec.  424.502 as any 
provider or supplier that submits a paper Medicare enrollment 
application using the Form CMS-855A, Form CMS-855B (not including 
physician and NPP organizations, which are exempt from the fee 
requirement if they are enrolling as a physician or NPP organization), 
Form CMS-855S, Form CMS-20134, or an associated internet-based PECOS 
enrollment application.
    As stated previously, OTPs currently complete the Form CMS-855B to 
enroll in Medicare. They are considered ``institutional providers'' (as 
defined in Sec.  424.502) and must pay an application fee, a 
requirement addressed in existing Sec.  424.67(b)(2). Since the 
existing OTPs referenced in new paragraph (c)(2) would be enrolling as 
new providers via the Form CMS-855A or Form CMS-855B (as applicable), 
we stated our belief in the proposed rule that they would fall within 
the scope of both (1) the aforementioned definition of ``institutional 
provider'' and (2) Sec.  424.514(a)(1); as described therein, Sec.  
424.514(a)(1) applies to prospective institutional providers that are 
submitting an initial application. To clarify this issue for the OTP 
community, we proposed to add language to Sec.  424.67(b)(2) stating 
that compliance with the application fee requirements in Sec.  424.514 
would also apply to those OTPs enrolling under the circumstances 
described in Sec.  424.67(c)(2).
    We emphasized that the flexibilities described in this section 
III.B. are complementary to those in section II.I. (``Medicare Coverage 
for Opioid Use Disorder (OUD) Treatment Services Furnished by Opioid 
Treatment Programs (OTPs))'' regarding OTP billing via the 837I. Our 
OTP enrollment revisions are intended to facilitate greater flexibility 
for OTPs.
    We received the following public comment on our OTP provider 
enrollment proposals:
    Comment: Several commenters supported our proposal to permit an OTP 
to enroll via the Form CMS-855B or the Form CMS-855A. One commenter 
also questioned whether this applies to a Medicare OTP Part B provider 
sharing the same clinical space as a Medicare Part A provider.
    Response: We appreciate the commenters' support. However, we 
emphasize that an OTP may only enroll as such via the Form-855B or the 
Form-855A, not both. In the situation the OTP appears to describe, the 
OTP operating in the clinical space in question would have to elect 
which of the two available enrollment mechanisms to pursue.
    Based on the comments received, we are finalizing our provisions 
pertaining to OTP enrollment as proposed.

C. Payment for Principal Care Management (PCM) Services in Rural Health 
Clinics (RHCs) and Federally Qualified Health Centers (FQHCs)

1. Background
a. RHC and FQHC Payment Methodologies
    RHC and FQHC visits generally are face-to-face encounters between a 
patient and one or more RHC or FQHC practitioners during which time one 
or more RHC or FQHC qualifying services are furnished. RHC and FQHC 
practitioners are physicians, nurse practitioners (NPs), physician 
assistants (PA), certified nurse midwives (CNMs), clinical 
psychologists (CPs), 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 
(TCM) service can also be an RHC or FQHC

[[Page 84698]]

visit. In addition, a Diabetes Self-Management Training (DSMT) service 
or a Medical Nutrition Therapy (MNT) service furnished by a certified 
DSMT or MNT program may also count as an FQHC visit. Only medically 
necessary medical, mental health, or qualified preventive health 
services that require the skill level of an RHC or FQHC practitioner 
are RHC or FQHC billable visits. Services furnished by auxiliary 
personnel (for example, 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.
    RHCs are paid an all-inclusive rate (AIR) for all medically 
necessary medical and mental health services and qualified preventive 
health services furnished on the same day (with some exceptions). In 
general, the A/B Medicare Administrative Contractor (MAC) calculates 
the AIR for the year for each RHC by dividing total allowable costs by 
the total number of visits for all patients. Productivity, payment 
limits, and other factors are also considered in the calculation. 
Allowable costs must be reasonable and necessary and may include 
practitioner compensation, overhead, equipment, space, supplies, 
personnel, and other costs incident to the delivery of RHC services. 
The AIR is subject to a payment limit, except for certain provider-
based RHCs that have an exception to the payment limit.
    FQHCs were paid under the same AIR methodology until October 1, 
2014 when, in accordance with section 1834(o) of the Act (as added by 
section 10501(i)(3) of the Affordable Care Act), they began to 
transition to an FQHC PPS system in which they are paid based on the 
lesser of the FQHC PPS rate or their actual charges. The FQHC PPS rate 
is adjusted for geographic differences in the cost of services by the 
FQHC PPS geographic adjustment factor (GAF).
b. Care Management Services in RHCs and FQHCs
    In the CY 2018 PFS final rule with comment period (82 FR53180), we 
finalized revisions to the payment methodology for Chronic Care 
Management (CCM) services furnished by RHCs and FQHCs and established 
requirements for general Behavioral Health Integration (BHI) and 
psychiatric Collaborative Care Management (CoCM) services furnished in 
RHCs and FQHCs, beginning on January 1, 2019. Specifically, we revised 
Sec.  405.2464(c) to permit RHCs and FQHCs to bill for care management 
services (HCPCS codes G0511 and G0512).
    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 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).
    In the CY 2019 PFS final rule with comment period (83 FR 59687), we 
added CPT code 99491 (30 minutes or more of CCM furnished by a 
physician or other qualified health care professional) as a general 
care management service and included it in the calculation of HCPCS 
code G0511. Beginning January 1, 2019, the payment for HCPCS code G0511 
is set at the average of the national non-facility PFS payment rates 
for CPT codes 99490, 99487, 99484, and 99491 and is updated annually 
based on the PFS amounts. Additional information on CCM requirements is 
available on the CMS Care Management web page at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Care-Management.html, and on the CMS RHC and FQHC web pages at https://www.cms.gov/Center/Provider-Type/Rural-Health-Clinics-Center.html and 
https://www.cms.gov/Center/Provider-Type/Federally-Qualified-Health-Centers-FQHC-Center.html.
2. Requirements for PCM Services in RHCs and FQHCs
    In the CY 2020 PFS final rule with comment (84 FR 62692), we 
established a separate payment for PCM services. PCM services include 
comprehensive care management services for a single high-risk disease 
or complex condition, typically expected to last at least 3 months and 
may have led to a recent hospitalization, and/or placed the patient at 
significant risk of death. Beginning January 1, 2020, practitioners 
billing under the PFS can bill for PCM services using HCPCS codes G2064 
or G2065.
    HCPCS code G2064 is for at least 30 minutes of PCM services 
furnished by physicians or NPPs during a calendar month with the 
following elements: One complex chronic condition lasting at least 3 
months, which is the focus of the care plan; the condition is of 
sufficient severity to place patient at risk of hospitalization or have 
been the cause of a recent hospitalization; the condition requires 
development or revision of disease-specific care plan; the condition 
requires frequent adjustments in the medication regimen; and/or the 
management of the condition is unusually complex due to comorbidities.
    HCPCS code G2065 is for at least 30 minutes of PCM services 
furnished by clinical staff under the direct supervision of a physician 
or NPP with the following elements: One complex chronic condition 
lasting at least 3 months, which is the focus of the care plan; the 
condition is of sufficient severity to place patient at risk of 
hospitalization or have been cause of a recent hospitalization; the 
condition requires development or revision of disease-specific care 
plan; the condition requires frequent adjustments in the medication 
regimen; and/or the management of the condition is unusually complex 
due to comorbidities.
    In the CY 2021 PFS proposed rule (85 FR 50214), we stated that a 
national stakeholder organization representing rural health clinics 
requested that RHCs be allowed to furnish and bill for PCM services. We 
agreed that there can be significant resources involved in care 
management for a single high-risk disease or complex chronic condition, 
and that the requirements for the new PCM codes are similar to the 
requirements for the care management services described by HCPCS code 
G0511. We explained that these are services that do not currently meet 
the requirements for an RHC or FQHC billable visit, and they provide an 
array of care management services that are not generally included in 
the RHC AIR or the FQHC PPS. Therefore, we proposed to add HCPCS codes 
G2064 and G2065 to G0511 as a comprehensive care management service for 
RHCs and FQHCs starting January 1, 2021. The payment rate for HCPCS 
G0511 is set at the average of the national non-facility PFS payment 
rate for the RHC and FQHC care management and general behavioral health 
codes (CPT codes 99490, 99487, 99484, and 99491), and we proposed that 
these 2 new codes be added to the calculation of the G0511 payment 
rate.
3. Other Options Considered
    In the CY 2021 PFS proposed rule (85 FR 50214), we stated that we 
also considered creating a separate G code for PCM services. We did not 
propose this approach because PCM and CCM are similar services and 
grouping them together is consistent with an integrated approach to 
care with reduced reporting

[[Page 84699]]

requirements. As we stated in the CY 2018 PFS final rule, if a new care 
management code is proposed and subsequently finalized for 
practitioners billing under the PFS, we would review the new code to 
determine if it should be included in the calculation of the RHC and 
FQHC General Care Management Code. The determination of whether a new 
care management code should be added to the codes used to determine the 
payment rate is based on the applicability of the service in RHCs and 
FQHCs, and may result in either an increase or decrease in the payment 
amount for HCPCS code G0511.
4. Implementation
    In the CY 2021 PFS proposed rule (85 FR 50214), we explained that 
if this proposal is finalized as proposed, RHCs and FQHCs that furnish 
PCM services would also be able to bill the services using HCPCS code 
G0511, either alone or with other payable services on an RHC or FQHC 
claim for dates of service on or after January 1, 2021. The payment 
rate for HCPCS code G0511 would continue to be the average of the 
national non-facility PFS payment rates for the RHC/FQHC care 
management and general behavioral health codes (CPT codes 99484, 99487, 
99490, and 99491). HCPCS G2064 and G2065 would be added to G0511 to 
calculate a new average for the national non-facility PFS payment rate. 
The payment rate for HCPCS code G0511 would be updated annually based 
on the PFS amounts for these codes.
    We received approximately 27 public comments on the proposed 
requirements for PCM services in RHCs and FQHCs from a mix of 
stakeholders, including individuals, associations, advocate groups, and 
provider groups. The following is a summary of the comments we received 
and our responses.
    Comment: All commenters supported the proposal to add the PCM HCPCS 
codes to the general care management HCPCS code (G0511) for care 
management services furnished in RHCs and FQHCs. One commenter 
recommended we create two new G codes for PCM services furnished in 
RHCs and FQHCs. A few commenters suggested that CMS waive the 
coinsurance for PCM services.
    Response: Per the comment that recommended that we create two new G 
codes, we considered creating new G codes for PCM services as we stated 
in the CY 2021 PFS proposed rule (85 FR 50214); however, we explained 
that since the requirements for PCM services are similar to the 
requirements for care management services furnished in an RHC and FQHC, 
grouping them together is consistent with an integrated approach to 
care with reduced reporting requirements.
    Regarding the comment suggesting that CMS waive the coinsurance for 
PCM services, we remind commenters that we have no authority to waive 
coinsurance for care management services. Coinsurance for care 
management services is 20 percent of lesser of submitted charges or the 
payment rate for general care management HCPCS code.
    Comment: We received several public comments that were out-of-scope 
for this rule. Commenters requested that CMS expand certain 
flexibilities provided during the PHE for COVID-19, including the 
addition of services to the Medicare Telehealth Services List. In 
addition, several commenters requested that CMS create a separate G 
code for remote physiologic monitoring (RPM) services and add RPM 
treatment management services (RPMTMS) to the general care management 
services.
    Response: We appreciate the feedback from commenters, and will 
continue to monitor Medicare telehealth services during the PHE for 
COVID-19. RHCs are paid an AIR when a medically-necessary, face-to-face 
visit is furnished by an RHC practitioner. FQHCs are paid the lesser of 
their charges or the FQHC PPS rate when a medically-necessary, face-to-
face visit is furnished by an FQHC practitioner. Both the RHC AIR and 
the FQHC PPS rate include all services and supplies furnished incident 
to the visit. Services such as RPM are not separately billable because 
they are already included in the RHC AIR or FQHC PPS payment. We may 
consider analyzing the RPMTMS services and how they would impact the 
payment for general care management services in future rulemaking; 
however, we note that we did not specifically make any proposals 
associated with these subjects in the CY 2021 PFS proposed rule.
    In consideration of these public comments, we are finalizing the 
proposal to add the PCM HCPCS codes, G2064 and G2065, to the general 
care management code, G0511, as a comprehensive care management service 
for RHCs and FQHCs, starting January 1, 2021 as proposed. We are also 
finalizing that when RHCs and FQHCs furnish PCM services, they will 
also be able to bill the services using HCPCS code G0511, either alone 
or with other payable services on an RHC or FQHC claim for dates of 
service on or after January 1, 2021. The payment rate for HCPCS code 
G0511 will be the average of the national non-facility PFS payment 
rates for the RHC/FQHC care management and general behavioral health 
codes (CPT codes 99484, 99487, 99490, and 99491) with the addition of 
HCPCS G2064 and G2065. That is, the PCM services will be added to G0511 
to calculate a new average for the national non-facility PFS payment 
rate. The payment rate for HCPCS code G0511 will be updated annually 
based on the PFS amounts for these codes.

D. Changes to the Federally Qualified Health Center Prospective Payment 
System (FQHC PPS) for CY 2021: Rebasing and Revising of the FQHC Market 
Basket

1. Background
    Section 10501(i)(3)(A) of the Affordable Care Act added section 
1834(o) of the Act to establish a payment system for the costs of FQHC 
services under Medicare Part B based on prospectively set rates. In the 
Prospective Payment System (PPS) for FQHC final rule published in the 
May 2, 2014 Federal Register (79 FR 25436), we implemented a 
methodology and payment rates for the FQHC PPS. Beginning on October 1, 
2014, FQHCs began to transition to the FQHC PPS based on their cost 
reporting periods, and as of January 1, 2016, all FQHCs have been paid 
under the FQHC PPS.
    Section 1834(o)(2)(B)(ii) of the Act requires that the payment for 
the first year after the implementation year be increased by the 
percentage increase in the Medicare Economic Index (MEI). Therefore, in 
CY 2016, the FQHC PPS base payment rate was increased by the MEI. The 
MEI is based on 2006 data from the American Medical Association (AMA) 
for self-employed physicians and was used in the PFS sustainable growth 
rate (SGR) formula to determine the CF for physician service payments. 
(See the CY 2014 PFS final rule (78 FR 74264) for a complete discussion 
of the 2006-based MEI.) Section 1834(o)(2)(B)(ii) of the Act also 
requires that beginning in CY 2017, the FQHC PPS base payment rate will 
be increased by the percentage increase in a market basket of FQHC 
goods and services, or if such an index is not available, by the 
percentage increase in the MEI.
    Beginning with CY 2017, FQHC PPS payments were updated using a 
2013-based market basket reflecting the operating and capital cost 
structures for freestanding FQHC facilities (hereafter referred to as 
the FQHC market basket). A complete discussion of the 2013-based FQHC 
market basket can be found in the CY 2017 PFS final rule (81 FR 80393 
through 80403).
    In the CY 2021 PFS proposed rule (85 FR 50214 through 50223), we 
proposed

[[Page 84700]]

to rebase and revise the 2013-based FQHC market basket to reflect a 
2017 base year. The proposed 2017-based FQHC market basket is primarily 
based on Medicare cost report data for FQHCs for 2017, which are for 
cost reporting periods beginning on and after October 1, 2016, and 
prior to September 31, 2017. We proposed to use data from cost reports 
beginning in FY 2017 because these data are the latest available 
complete data for purposes of calculating cost weights for the market 
basket at the time of rulemaking.
    In the following discussion, we provide an overview of the proposed 
FQHC market basket, describe the proposed methodologies for developing 
the 2017-based FQHC market basket, and provide information on the 
proposed price proxies. We then describe any comments received, 
responses to these comments, and our final decision for this final 
rule.
2. Overview of the 2017-Based FQHC Market Basket
    Similar to the 2013-based FQHC market basket, the proposed 2017-
based FQHC market basket is a fixed-weight, Laspeyres-type price index. 
A Laspeyres price index measures the change in price, over time, of the 
same mix of goods and services purchased in the base period. Any 
changes in the quantity or mix (that is, intensity) of goods and 
services purchased over time are not measured. The index itself is 
constructed using three steps. First, a base period is selected (we 
proposed to use 2017 as the base period) and total base period 
expenditures are estimated for a set of mutually exclusive and 
exhaustive spending categories, with the proportion of total costs that 
each category represents being calculated. These proportions are called 
``cost weights'' or ``expenditure weights.'' Second, each expenditure 
category is matched to an appropriate price or wage variable, referred 
to as a ``price proxy.'' In almost every instance, these price proxies 
are derived from publicly available statistical series that are 
published on a consistent schedule (preferably at least on a quarterly 
basis). Finally, the expenditure weight for each cost category is 
multiplied by the level of its respective price proxy. The sum of these 
products (that is, the expenditure weights multiplied by their price 
levels) for all cost categories yields the composite index level of the 
market basket in a given period. Repeating this step for other periods 
produces a series of market basket levels over time. Dividing an index 
level for a given period by an index level for an earlier period 
produces a rate of growth in the input price index over that timeframe. 
As noted above, the market basket is described as a fixed-weight index 
because it represents the change in price over time of a constant mix 
(quantity and intensity) of goods and services needed to furnish FQHC 
services. The effects on total expenditures resulting from changes in 
the mix of goods and services purchased subsequent to the base period 
are not measured. For example, a FQHC hiring more nurse practitioners 
to accommodate the needs of patients would increase the volume of goods 
and services purchased by the FQHC, but would not be factored into the 
price change measured by a fixed-weight FQHC market basket. Only when 
the index is rebased would changes in the quantity and intensity be 
captured, with those changes being reflected in the cost weights. 
Therefore, we rebase the market basket periodically so that the cost 
weights reflect a recent mix of goods and services that FQHCs purchase 
(FQHC inputs) to furnish inpatient care.
3. Development of the 2017-Based FQHC Market Basket Cost Categories and 
Weights
    We solicited public comments on the proposed methodology for 
deriving the 2017-based FQHC market basket.
a. Use of Medicare Cost Report Data
    We proposed a 2017-based FQHC market basket that consists of eleven 
major cost categories and a residual derived from the 2017 Medicare 
cost reports (CMS Form 224-14, OMB Control Number 0938-1298) for FQHCs, 
hereafter referred to as the 2014 Medicare Cost Report form. The eleven 
cost categories are FQHC Practitioner Wages and Salaries, FQHC 
Practitioner Employee Benefits, FQHC Practitioner Contract Labor, 
Clinical Staff Wages and Salaries, Clinical Staff Employee Benefits, 
Clinical Staff Contract Labor, Non-Health Staff Compensation, Medical 
Supplies, Pharmaceuticals, Fixed Capital and Moveable Capital. The 
residual category reflects all remaining costs not captured in the 11 
cost categories such as non-medical supplies and utilities for example. 
We noted that for the 2013-based FQHC market basket, we estimated six 
cost categories from the Medicare cost reports (CMS Form 222-92, OMB 
Control Number 0938-0107), hereafter referred to as the 1992 Medicare 
cost report form: FQHC Practitioner Compensation, Clinical Staff 
Compensation, Non-Health Staff Compensation, Pharmaceuticals, Fixed 
Capital and Moveable Capital.
    The resulting 2017-based FQHC market basket cost weights reflect 
Medicare allowable costs. We proposed to define Medicare allowable 
costs for freestanding FQHC facilities as the total expenses reported 
on: Worksheet A, columns 1 and 2, lines 1 through 7 and lines 9 through 
12; Worksheet A, column 1, lines 23 through 36; and Worksheet S3 Part 
II, columns 1 and 2, lines 2 through 14. We noted that we continue to 
exclude Professional Liability Insurance (PLI) costs from the total 
Medicare allowable costs because FQHCs that receive section 330 grant 
funds also are eligible to apply for medical malpractice coverage under 
Federally Supported Health Centers Assistance Act (FSHCAA) of 1992 
(Pub. L. 102-501) and FSHCAA of 1995 (Pub. L. 104-73 amending section 
224 of the Public Health Service Act).
    The following is a summary of how we proposed to derive the eleven 
major cost category weights. Prior to estimating any costs, we remove 
any providers that did not report any total gross patient revenues as 
reported on the FQHC cost report Worksheet F-1, line 1, column 4.
(1) FQHC Practitioner Wages and Salaries Costs
    A FQHC practitioner is defined as one of the following occupations: 
Physicians; nurse practitioners (NPs); physician assistants (PAs); 
certified-nurse midwife (CNMs); clinical psychologist (CPs); and 
clinical social workers (CSWs). We proposed to derive FQHC Practitioner 
Wages and Salaries costs as the sum of direct care costs salaries as 
reported on Worksheet A, column 1, lines 23, 25, 26, 29, 30, and 31. 
These lines represent the wages and salaries costs for physicians, PAs, 
NPs, CNMs, CPs, and CSWs. For the 2013-based FQHC market basket, we 
estimated FQHC Practitioner Total Compensation costs based on a similar 
methodology using cost data reported on Worksheet A of the 1992 
Medicare cost report form (81 FR 80394) for specific details on the 
prior methodology.
(2) FQHC Practitioner Employee Benefits Costs
    Effective with the implementation of the 2014 Medicare cost report 
form, we began collecting Employee Benefits and Contract Labor data on 
Worksheet S-3, part II and proposed to derive FQHC Practitioner 
Employee Benefits costs using data obtained from that worksheet. 
Approximately 66 percent of FQHCs included in the sample of FQHCs 
reporting Salary costs also reported data on Worksheet S-3, part II for 
2017. We continue to encourage all providers to report these data on 
the

[[Page 84701]]

Medicare cost report. Therefore, we proposed to calculate FQHC 
Practitioner Employee Benefits costs using Worksheet S-3, part II data. 
Specifically, we proposed to use data from Worksheet S-3, part II, 
column 2, lines 2, 3, 4, 7, 8, and 9 to derive FQHC Practitioner 
Employee Benefits costs. These lines represent the employee benefits 
costs for physicians, PAs, NPs, CNMs, CPs, and CSWs. Our analysis of 
the Worksheet S-3, part II data submitted by these FQHCs indicates that 
we had a large enough sample to enable us to produce a reasonable 
Employee Benefits cost weight.
    For the 2013-based FQHC market basket, we did not have data at the 
level of detail to separately estimate FQHC Practitioner Employee 
Benefits costs, and instead computed FQHC Practitioner Total 
Compensation costs, which reflected costs for wages and salaries, 
employee benefits, and contract labor together. Anytime direct costs 
can be obtained for a cost category directly from the Medicare Cost 
Reports we consider that to be a technical improvement to the market 
basket weight methodology as it allows the index to reflect the 
relative shares specific to the provider type. Therefore, as discussed 
in the CY 2021 PFS proposed rule, we noted that we believe the proposed 
method of separately estimating FQHC Practitioner Employee Benefits is 
a technical improvement over the 2013-based FQHC market basket.
(3) FQHC Practitioner Contract Labor Costs
    FQHC Practitioner Contract labor costs are primarily associated 
with direct patient care services. Contract labor costs for services 
such as accounting, billing, and legal are estimated using other 
government data sources as described below. Approximately 60 percent of 
FQHCs reported contract labor costs on Worksheet S-3, part II, which we 
noted that we believe is an adequate sample size to enable us to 
produce a reasonable FQHC Practitioner Contract Labor cost weight. 
Therefore, we proposed to derive the FQHC Practitioner Contract Labor 
costs for the proposed 2017-based FQHC market basket from data reported 
on Worksheet S-3, part II, column 1, lines 2, 3, 4, 7, 8, and 9. These 
lines represent the contract labor costs for physicians, PAs, NPs, 
CNMs, CPs, and CSWs. We would also add in the costs for physician 
services under agreement as reported on Worksheet A, column 2, line 24 
to derive the total FQHC Practitioner Contract Labor cost weight in the 
2017-based FQHC market basket.
    For the 2013-based FQHC market basket, we did not have data at the 
level of detail to separately estimate FQHC Practitioner Contract Labor 
costs and instead computed FQHC Practitioner Total Compensation costs, 
which reflected costs for wages and salaries, employee benefits, and 
contract labor together. As noted previously, anytime direct costs can 
be obtained for a cost category directly from the Medicare Cost Reports 
we consider that to be a technical improvement to the market basket 
weight methodology as it allows the index to reflect the relative 
shares specific to the provider type. Therefore, we noted that we 
believe the proposed method of separately estimating FQHC Practitioner 
Contract Labor is a technical improvement over the 2013-based FQHC 
market basket.
(4) Clinical Staff Wages and Salaries Costs
    Clinical Compensation includes any health-related clinical staff 
who does not fall under the definition of a FQHC Practitioner described 
in paragraph. We proposed to derive Clinical Staff Wages and Salaries 
costs as the sum of direct care costs salaries as reported on Worksheet 
A, column 1, lines 27, 28, 32, 33, 34, 35, and 36. These lines 
represent the wages and salaries costs for visiting registered nurses 
(RNs), visiting licensed practical nurses (LPNs), laboratory 
technicians, registered dietician/Certified DSMT/MNT educators, 
physical therapists (PTs), occupational therapists (OTs), and other 
allied health personnel.
     For the 2013-based FQHC market basket, we estimated a 
clinical staff total compensation cost based on a similar methodology 
using cost data reported on Worksheet A of Medicare Cost Report Form 
CMS-222-92, (see 81 FR 80394 for specific details on the prior 
methodology).
(5) Clinical Staff Employee Benefits Costs
    Effective with the implementation of the 2014 Medicare cost report 
form, we began collecting employee benefits and contract labor data on 
Worksheet S-3, part II and proposed to derive clinical staff employee 
benefits costs using data obtained from that worksheet. Approximately 
64 percent of FQHCs included in the sample of FQHCs reporting salary 
expenses also reported data on Worksheet S-3, part II for 2017. We 
noted that we continue to encourage all providers to report these data 
on the Medicare cost report. Therefore, we proposed to calculate 
clinical staff employee benefits costs using Worksheet S-3, part II, 
column 2, lines 5, 6, 10, 11, 12, 13, and 14. These lines represent the 
employee benefits costs for visiting RNs, visiting LPNs, laboratory 
technicians, registered dietician/Certified DSMT/MNT educators, PTs, 
OTs, and other allied health personnel.
     For the 2013-based FQHC market basket, we did not have 
data at the level of detail to separately estimate clinical staff 
employee benefits costs and instead computed clinical staff total 
compensation costs, which reflected costs for wages and salaries, 
employee benefits, and contract labor together. We noted that we 
believe the proposed method of separately estimating clinical staff 
employee benefits is a technical improvement over the 2013-based FQHC 
market basket.
(6) Clinical Staff Contract Labor Costs
    We proposed to derive the clinical staff contract labor costs for 
the proposed 2017-based FQHC market basket from data reported on 
Worksheet S-3, part II, column 1, lines 5, 6, 10, 11, 12, 13, and 14 to 
derive clinical staff contract labor costs. These lines represent the 
contract labor costs for visiting RNs, visiting LPNs, laboratory 
technicians, registered dietician/Certified DSMT/MNT educators, PTs, 
OTs, and other allied health personnel.
    For the 2013-based FQHC market basket, we did not have data at the 
level of detail to separately estimate clinical staff contract labor 
costs and instead computed clinical staff total compensation costs, 
which reflected costs for wages and salaries, employee benefits, and 
contract labor together. We noted that we believe the proposed method 
of separately estimating FQHC clinical staff contract labor is a 
technical improvement over the 2013-based FQHC market basket.
(7) Non-Health Staff Compensation Costs
    Non-Health Staff Compensation includes wage and salary costs for 
personnel in general service cost centers including: Employee Benefits 
department; Administrative & General; Plant Operation & Maintenance; 
Janitorial; Medical Records; Pharmacy; Transportation; and Other 
General Services. Specifically, non-health staff compensation costs are 
derived as the sum of compensation costs as reported on Worksheet A, 
column 1 for lines 3, 4, 5, 6, 7, 9, 10, 11, and 12. Additionally, we 
add a portion of employee benefit costs reported on Worksheet A, line 
3, column 2 accounting for the non-health staff. We

[[Page 84702]]

estimate the ratio of non-health staff related wages and salaries as a 
percentage of total wages and salaries. We then apply the percentage of 
non-health staff related wages and salary costs to the total employee 
benefits costs (Worksheet A, line 3, column 2) for each FQHC. We noted 
that we believe this is a reasonable estimate of non-health staff 
employee benefits. We proposed to only use the costs from column 1 for 
most of the general service cost centers other than employee benefits 
since we believe that there are noncompensation costs reported in 
column 2 (such as maintenance and janitorial supplies). The remaining 
other costs for the general service categories are reflected in the 
remaining proposed cost categories as explained in more detail below.
(8) Pharmaceuticals Costs
    We proposed to calculate pharmaceuticals costs using the non-salary 
costs for the pharmacy cost center reported on Worksheet A, column 2, 
line 9. We proposed to exclude the costs for drugs charged to patients 
as reported on Worksheet A, line 67 since these drugs are not included 
in the Medicare allowable costs for the FQHC PPS and are separately 
reimbursed. For the 2013-based FQHC market basket we were not able to 
exclude non-reimbursable drug costs (such as drugs charged to patient 
costs) from the pharmacy cost weight as the 1992 Medicare cost report 
form did not capture these costs separately. We noted that we believe 
our proposed methodology is a technical improvement as it is more 
consistent with the FQHC PPS reimbursement.
(9) Medical Supplies
    We proposed to calculate medical supplies costs using the non-
salary costs for the medical supplies cost center reported on Worksheet 
A, column 2, line 10. The medical supplies cost weight for the 2013-
based FQHC market basket was derived based on the relative share of the 
medical supply costs in the MEI since these costs were not separately 
reported on the 1992 Medicare cost report form (81 FR 80395 through 
80396). Since these costs are now directly reported by FQHC providers 
we noted that we believe that the proposed method is a technical 
improvement to the method used in the 2013-based FQHC market basket.
(10) Fixed Capital
    We proposed that fixed capital costs be equal to costs reported on 
Worksheet A, line 1, column 2 of the Medicare Cost Report. A similar 
methodology was used for the 2013-based FQHC market basket.
(11) Moveable Capital Costs
    We proposed that moveable capital costs be equal to the capital 
costs as reported on Worksheet A, line 2, column 2. A similar 
methodology was used for the 2013-based FQHC market basket.
    Comment: Several commenters expressed support, as well as some 
concerns with the proposed use of the Medicare cost reports. 
Specifically, the commenters supported the proposed use of the Medicare 
cost report data to derive eleven major cost categories in the 2017-
based FQHC market basket--an increase from 6 cost categories used in 
the 2013-based FQHC market basket. They stated this calculation will 
give a broader base to more accurately compute the increasing costs of 
providing FQHC services.
    The commenters also agreed with the proposed lines included in the 
calculation of the Medicare Allowable total expenses (Worksheet A, 
columns 1 and 2, lines 1 through 7 and lines 9 through 12; Worksheet A, 
column 1, lines 23 through 36; and Worksheet S3 Part II, columns 1 and 
2, lines 2 through 14). However, they disagreed with the use of columns 
1 and 2 from Worksheet A to capture a health center's expenses because 
they reflect their internal accounting records in accordance with 
generally accepted accounting principles (GAAP). The commenters noted 
that the net expenses as listed in Worksheet A, column 7 of the 
Medicare cost report most accurately reflects Medicare allowable cost 
for a community health center as these reflect the reclassification 
entries which are common on the Medicare cost report, particularly for 
expenses related to compensation and drugs. They also noted that CMS 
must factor in the reclassification and adjustment entries that are 
recorded on health center Medicare cost reports to accurately calculate 
a 2017-based market basket that reflects the change in Medicare 
allowable costs. Furthermore, the commenters noted that the costs that 
are used to calculate the costs per visits in Worksheet B reflect the 
reclassifications and adjustments and so the 2017-based FQHC market 
basket should be calculated using the same cost information.
    Response: Using the data from the net cost column (column 7) 
presents unique challenges because a detailed breakdown of the net 
expenses is not provided on the FQHC cost report, particularly for 
employee benefits, which is why we proposed to utilize the data from 
Worksheet A column 1 and 2 to estimate salary and all other costs. 
Specifically, the FQHC cost report does not have a detailed step down 
of the net expenses allocated to each General Service cost center like 
other provider cost reports such as the hospice cost report (CMS Form 
1984-14). This means that for some categories, particularly Employee 
Benefits cost center, we must make assumptions on how the total 
employee benefit costs are allocated across cost centers. On the other 
hand, Worksheet B on the hospice cost report gives a detailed 
allocation of General Service cost centers' net expenses (including 
employee benefits) across the patient-care cost centers.
    Based on the commenters' concerns, we reviewed the FQHC Medicare 
cost report data and found that a large percentage of providers had 
reclassifications and adjustments and these had an impact on the 
distribution of total expenses among the major cost weight categories, 
particularly pharmaceuticals and FQHC practitioner salaries. Therefore, 
based on public comments, for this final rule we are revising our 
methodology from the proposed rule to reflect the use of net expenses 
as reported on Worksheet A, column 7 rather than the proposed Worksheet 
A, column 1 and column 2 to derive the FQHC cost share weights. Below 
we provide the revised detailed methodology for the major market basket 
cost weights in response to public comment.
    In response to public comments to use net costs rather than total 
costs to derive the FQHC market basket cost weights, we are defining 
Medicare allowable costs for freestanding FQHC facilities as the total 
expenses reported on: Worksheet A, column 7, for lines 1 through 7, 
lines 9 through 12, and lines 23 through 36. These are the same cost 
centers that were used in the proposed market basket for which the 
commenters agreed was appropriate.
(1-3) FQHC Practitioner Compensation (Wages & Salaries, Benefits, and 
Contract Labor)
    In response to public comment to use net costs rather than total 
costs to derive the FQHC market basket cost weights, we are defining 
the FQHC Practitioner Compensation as the sum of net expenses (that is, 
costs after reclassifications and adjustments) as reported on Worksheet 
A, column 7, lines 23, 25, 26, 29, 30, and 31. These lines represent 
the total net costs for physicians, PAs, NPs, CNMs, CPs, and CSWs--the 
same lines that were used for the proposed methodology for which the 
commenters agreed was appropriate. Using this finalized methodology, we 
derive a 2017-based FQHC market

[[Page 84703]]

basket FQHC Practitioner Compensation cost weight of 28.4 percent 
compared to the proposed rule with 30.0 percent.
    To further divide the FQHC Practitioner Compensation costs into 
FQHC Practitioner Wages and Salaries, Benefits, and Contract Labor 
costs, we are using the shares derived for each of these costs using 
the proposed methodologies for each FQHC provider as described in 
sections III.D.3.a.1, D.3.a.2 and D.3.a.3 of this final rule. 
Specifically, for each line included in the FQHC Practitioner category, 
the FQHC Practitioner Wages and Salaries costs is equal to the FQHC 
Practitioner Compensation costs as described above multiplied by the 
FQHC Practitioner Wages and Salaries costs (described in section 
III.D.3.a.1 of this final rule) as a percent of FQHC Practitioner 
Compensation costs. This revised methodology reflects the net expenses 
(Worksheet A, column 7) to address the commenters' concerns while also 
using the Medicare cost report data to reflect the split among the 
types of compensation costs: Wages and salaries, employee benefits, and 
contract labor.
    Therefore, for this final rule, in response to public comment to 
use net costs rather than total costs to derive the FQHC market basket 
cost weights, the FQHC Practitioner Wages and Salaries cost weight is 
19.4 percent, and accounts for 68 percent of the FQHC Practitioner 
Compensation cost weight. The FQHC Practitioner Employee Benefit cost 
weight is 4.5 percent, and accounts for 16 percent of the FQHC 
Practitioner Compensation cost weight. The FQHC Practitioner Contract 
Labor cost weight is 4.6 percent, and accounts for 16 percent of the 
FQHC Practitioner Compensation cost weight.
(4-6) Clinical Staff Compensation (Wages & Salaries, Benefits, and 
Contract Labor)
    In response to public comment to use net costs rather than total 
costs to derive the FQHC market basket cost weights, we are defining 
Clinical Staff Compensation costs as the sum of net expenses (that is, 
costs after reclassifications and adjustments) as reported on Worksheet 
A, column 7, lines 27, 28, 32, 33, 34, 35, and 36. These lines 
represent the net expenses for visiting RNs, visiting LPNs, laboratory 
technicians, registered dietician/Certified DSMT/MNT educators, PTs, 
OTs, and other allied health personnel--the same lines that were used 
for the proposed methodology for which the commenters agreed was 
appropriate. Using this finalized methodology, we derive a 2017-based 
FQHC market basket Clinical Staff Compensation cost weight of 16.8 
percent compared to the proposed rule with 16.2 percent.
    To further divide the Clinical Staff Compensation costs into 
Clinical Staff Wages and Salaries, Clinical Staff Employee Benefits, 
and Clinical Staff Contract Labor costs, we are using the shares 
derived for each of these costs using the proposed methodologies for 
each FQHC provider as described in sections III.D.3.a.4, D.3.a.5 and 
D.3.a.6. of this final rule. Specifically, for each line included in 
the Clinical Staff Compensation category, the Clinical Staff Wages and 
Salaries costs is equal to the Clinical Staff Compensation costs as 
described above multiplied by the Clinical Staff Wages and Salaries 
costs (described in section III.D.3.a.4. of this final rule) as a 
percent of Clinical Staff Compensation costs. This same methodology is 
being used for the FQHC Practitioner Wages and Salaries, Employee 
Benefits, and Contract Labor, which again reflects the net expenses 
(Worksheet A, column 7) to address the commenters concerns. Therefore, 
for this final rule, the Clinical Staff Wages and Salaries cost weight 
is 12.9 percent, which accounts for 77 percent of the Clinical Staff 
Compensation cost weight. The Clinical Staff Employee Benefit cost 
weight is 3.1 percent, which accounts for 18 percent of the Clinical 
Staff Compensation cost weight. The Clinical Staff Contract Labor cost 
weight is 0.8 percent, which accounts for 5 percent of the Clinical 
Staff Compensation cost weight.
(7) Non-Health Staff Compensation Costs
    As stated above, the Non-Health Staff Compensation costs are for 
personnel in general service cost centers including: Employee Benefits 
department; Administrative & General; Plant Operation & Maintenance; 
Janitorial; Medical Records; Pharmacy; Medical Supplies; 
Transportation; and Other General Services.
    In response to public comment to use net costs rather than total 
costs to derive the FQHC market basket cost weights, we are defining 
Non-Health Staff Compensation costs using net expenses (that is, costs 
after reclassifications and adjustments) as the estimated share of 
compensation costs from Worksheet A, column 7 for lines 3, 4, 5, 6, 7, 
9, 10, 11, and 12. Since the net expenses for the General Service Cost 
centers include both compensation and other costs we estimate the share 
of net expenses for each general service cost center that reflects 
compensation costs.
    First, we estimate a share of Non-Health Staff Wages and Salaries 
costs for each general service cost center as reported on Worksheet A, 
column 1 for lines 3, 4, 5, 6, 7, 9, 10, 11, and 12 divided by 
Worksheet A, column 1 and 2 for lines 3, 4, 5, 6, 7, 9, 10, 11, and 12. 
Then, we multiply the Non-Health Staff Net expenses (that is, costs 
after reclassifications and adjustments) by the Non-Health Staff Wages 
and Salaries share to derive estimated Non-Health Staff Wages and 
Salaries for each general service cost center (lines 3-7 and lines 9-
12).
    Second, we estimate Non-Health Staff Employee Benefit costs by 
multiplying the Non-Health Staff Wages and Salaries costs (step one) by 
the facility benefit to salary ratio. Finally, we add the derived Non-
Health Staff Wages and Salaries costs and the derived Non-Health Staff 
Employee Benefits costs for each general service cost center (line 3-7 
and lines 9-12). The results is the 2017-based FQHC market basket Non-
health Staff Compensation cost weight of 27.2 percent compared to the 
proposed rule with 25.4 percent.
(8) Pharmaceuticals Costs
    In response to public comment to use net costs rather than total 
costs to derive the FQHC market basket cost weights, we are calculating 
Pharmaceuticals costs as the non-compensation costs for the pharmacy 
cost center. We define this as Worksheet A, column 7, line 9 less 
derived Pharmacy compensation costs. Similar to the methodology used 
for the Non-Health Staff compensation, we derive estimated Pharmacy 
compensation costs.
    First we derive the share of pharmacy wages and salaries as 
Worksheet A, column 1, line 9 divided by the sum of Worksheet A, Column 
1 & 2, for line 9. Then, we multiply the pharmacy wages and salaries 
share by pharmacy net expenses (Worksheet A, column 7, line 9).
    Second, we estimate Pharmacy employee benefits by multiplying the 
derived Pharmacy wages and salaries by the facility benefit to salary 
ratio. The derived Pharmacy compensation costs are equal to the sum of 
the estimated pharmacy wages and salaries and pharmacy benefits costs. 
Using this finalized methodology, we derive a 2017-based FQHC market 
basket Pharmacy cost weight of 2.4 percent compared to the proposed 
rule with 3.9 percent.
(9) Medical Supplies
    In response to public comment to use net costs rather than total 
costs to derive the FQHC market basket cost weights, we are calculating 
medical supplies costs as the non-compensation costs for

[[Page 84704]]

the Medical Supplies costs center. We define this as Worksheet A, 
column 7, line 10 less derived Medical Supplies compensation costs. 
Similar to the methodology used for the Non-Health Staff compensation, 
we estimate Medical Supplies compensation costs.
    First, we derive the share of medical supplies wages and salaries 
as Worksheet A, column 1, line 10 divided by the sum of Worksheet A, 
Column 1 & 2, line 10. Then, we multiply the medical supplies wages and 
salaries share by the medical supplies net expense (Worksheet A, column 
7, line 10).
    Second we estimate Medical Supplies employee benefits by 
multiplying the derived Medical Supplies wages and salaries by the 
facility benefit to salary ratio. The derived Medical Supplies 
compensation costs are equal to the sum of the estimated medical 
supplies wages and salaries and medical supplies benefits costs. Using 
this finalized methodology, we derive a 2017-based FQHC market basket 
Medical Supplies cost weight of 2.2 percent compared to the proposed 
rule with 2.4 percent.
(10) Fixed Capital
    In response to public comment to use net costs rather than total 
costs to derive the FQHC market basket cost weights, we are defining 
fixed capital costs to be equal to costs reported on Worksheet A, line 
1, column 7 of the Medicare Cost Report. Using this finalized 
methodology, we derive a 2017-based FQHC market basket fixed capital 
cost weight of 4.4 percent compared to the proposed rule with 4.6 
percent.
(11) Moveable Capital Costs
    In response to public comment to use net costs rather than total 
costs to derive the FQHC market basket cost weights, we are defining 
moveable capital costs to be equal to the capital costs as reported on 
Worksheet A, line 2, column 7. Using this finalized methodology, we 
derive a 2017-based FQHC market basket Moveable Capital cost weight of 
2.0 percent compared to the proposed rule with 1.9 percent.
b. Major Cost Category Computation
    After we derive costs for the major cost categories for each 
provider using the Medicare cost report data as previously described, 
we proposed to trim the data for outliers. For each of the eleven major 
cost categories, we proposed to divide the calculated costs for the 
category by total Medicare allowable costs calculated for the provider 
to obtain cost weights for the universe of FQHC providers. For the 
2017-based FQHC market basket (similar to the 2013-based FQHC market 
basket), we proposed that total Medicare allowable costs would be equal 
to the total costs as reported on Worksheet A, columns 1 and 2, lines 1 
through 7 and lines 9 through 12; Worksheet A, column 1, lines 23 
through 36; and Worksheet S3 Part II, columns 1 and 2, lines 2 through 
14. In response to public comment to use net costs rather than total 
costs to derive the FQHC market basket cost weights, we are defining 
Medicare allowable costs for freestanding FQHC facilities as the total 
net expenses (after reclassifications and adjustments) reported on: 
Worksheet A, column 7, for lines 1 through 7, lines 9 through 12; and 
lines 23 through 36. These are the same cost centers that were used in 
the proposed market basket for which the commenters agreed was 
appropriate.
    For the FQHC Practitioner Wages and Salaries, FQHC Practitioner 
Employee Benefits, FQHC Practitioner Contract Labor, Clinical Staff 
Wages and Salaries, Clinical Staff Employee Benefits, Clinical Staff 
Contract Labor, Non-Health Staff Compensation, Pharmaceuticals, Medical 
Supplies, Fixed Capital, and Moveable Capital cost weights, after 
excluding cost weights that are less than or equal to zero, we proposed 
to then remove those providers whose derived cost weights fall in the 
top and bottom 5 percent of provider-specific derived cost weights to 
ensure the exclusion of outliers. A 5 percent trim is the standard trim 
applied to the mean cost weights in all CMS market baskets and is 
consistent with the trimming used in the 2013-based FQHC market basket. 
After the outliers have been excluded, we add the costs for each 
category across all remaining providers. We proposed to then divide 
this by the sum of total Medicare allowable costs across all remaining 
providers to obtain a cost weight for the 2017-based FQHC market basket 
for the given category. This trimming process is done for each cost 
weight separately. We did not receive any comments on this proposal, 
and therefore, we are going to use the same trimming methodology to 
remove outliers as proposed but with the revised cost weights 
reflecting the new methodology in response to public comment.
    Finally, we proposed to calculate the residual ``All Other'' cost 
weight that reflects all remaining costs that are not captured in the 
eleven major cost categories listed. We referred readers to Table 35 
for the resulting cost weights for these major cost categories.
    Table 35 also shows the proposed and final 2017-based FQHC market 
basket cost weights compared to the 2013-based FQHC market basket cost 
weights.

[[Page 84705]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.080

    The total compensation cost weight of 72.5 percent (sum of FQHC 
Practitioner Compensation, Clinical Compensation, Non-health Staff 
Compensation) calculated from the Medicare cost reports for the final 
2017-based FQHC market basket is approximately 4.0 percentage point 
higher than the total compensation cost weight for the 2013-based FQHC 
market basket (68.6 percent). The 2017-based cost weight for FQHC 
Practitioner Compensation are about 3 percentage points lower compared 
to the 2013-based FQHC market basket, while the clinical staff 
compensation cost weight is about 7 percentage points higher. Part of 
the reason for the shift in the weights between compensation categories 
may be due to the change to the FQHC Medicare cost report form. On the 
1992 Medicare cost report form (used for the 2013-based FQHC market 
basket), there were four open ended ``fill-in'' categories for 
healthcare staff costs and costs under agreement. Since we were unable 
to determine what specific category the ``other health care staff'' 
costs should be allocated to (that is, either FQHC practitioner, or 
clinical staff) we used a methodology where we applied the expenses for 
the ``other health care staff costs'' between the categories for FQHC 
practitioner and clinical staff, based on the relative shares of 
expenses for both categories, excluding the open-ended fill in lines of 
Worksheet A, lines 9-11 and line 15. This may have resulted in an over 
allocation of some of the 2013 expenses to the FQHC Practitioner 
category relative to the clinical staff. On the 2014 Medicare cost 
report form, there is no longer an ambiguous category for other direct 
patient care staff costs.
    The final 2017-based Pharmaceuticals cost weight is roughly 2.7 
percentage points lower than the cost weight in the 2013-based FQHC 
market basket. The pharmaceutical costs included in the weight for 
2017-based FQHC market basket includes only non-compensation costs 
reported in Pharmacy (under general services). We believe the cost 
share is lower with the new data because there is more specificity on 
where to report reimbursable and non-reimbursable drugs. Additionally, 
using the net expense data (that is after reclassifications and 
adjustments) results in a lower share for pharmacy expenses relative to 
if total costs are used. This implies that there are notable 
reclassifications and adjustments to the Medicare Allowable pharmacy 
expenses as mentioned by commenters as a reason for the concern for not 
using Net expense data.
    As we did for the 2013-based FQHC market basket, we proposed to 
allocate the contract labor cost weight to the Wages and Salaries and 
Employee Benefits cost weights based on their relative proportions 
under the assumption that contract labor costs comprise both Wages and 
Salaries and Employee Benefits for both FQHC Practitioners and Clinical 
Staff. The contract labor allocation proportion for Wages and Salaries 
is equal to the Wages and Salaries cost weight as a percent of the sum 
of the Wages and Salaries cost weight and the Employee Benefits cost 
weight. This rounded percentage based on the proposed cost weights was 
82 percent for FQHC Practitioners and 80 percent for clinical staff. 
Therefore, we proposed to allocate 82 percent of the FQHC Practitioner 
Contract Labor cost weight to the FQHC Practitioner Wages and Salaries 
cost weight and 18 percent to the FQHC Practitioner Employee Benefits 
cost weight. Similarly, we proposed to allocate 80 percent of the 
clinical staff contract labor cost weight to the Clinical Staff Wages 
and Salaries cost weight and 20 percent to the clinical staff employee 
benefits cost weight. In response to comment, in the final 2017-based 
FQHC market basket, we are allocating 81 percent of the FQHC 
Practitioner Contract Labor to FQHC Practitioner Wages and Salaries and 
19 percent to the FQHC Practitioner Employee Benefits. We are also 
allocating 81 percent of the Clinical Staff Contract Labor to Clinical 
Staff Wages and Salaries and 19 percent to

[[Page 84706]]

the Clinical Staff Employee Benefits. We refer readers to Table 36 that 
shows the final Wages and Salaries and Employee Benefits cost weights 
after Contract Labor cost weight allocation for the final 2017-based 
FQHC market basket.
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    [GRAPHIC] [TIFF OMITTED] TR28DE20.081
    
c. Derivation of the Detailed Operating Cost Weights
    To further divide the ``All Other'' residual cost weight estimated 
from the 2017 Medicare cost report data into more detailed cost 
categories, we proposed to use the 2012 Benchmark Input-Output (I-O) 
``Use Tables/Before Redefinitions/Purchaser Value'' for NAICS 621100, 
Offices of Physicians, published by the Bureau of Economic Analysis 
(BEA). We note that the BEA benchmark I-O data is used to further 
disaggregate residual expenses in other CMS market baskets. Therefore, 
we noted that we believe the data from this industry are the most 
technically appropriate for disaggregation of the residual expenses 
since both physician offices and FQHCs provide similar types of care. 
These data are publicly available at https://www.bea.gov/industry/input-output-accounts-data. For the 2013-based FQHC market basket, we 
used the relative shares of certain categories from the 2006-based MEI 
(81 FR 80396).
    The BEA Benchmark I-O data are scheduled for publication every 5 
years with the most recent data available for 2012. The 2012 Benchmark 
I-O data are derived from the 2012 Economic Census and are the building 
blocks for BEA's economic accounts. Therefore, they represent the most 
comprehensive and complete set of data on the economic processes or 
mechanisms by which output is produced and distributed.\53\ BEA also 
produces Annual I-O estimates. However, while based on a similar 
methodology, these estimates reflect less comprehensive and less 
detailed data sources and are subject to revision when benchmark data 
becomes available. Instead of using the less detailed Annual I-O data, 
we proposed to inflate the 2012 Benchmark I-O data forward to 2017 by 
applying the annual price changes from the respective price proxies to 
the appropriate market basket cost categories that are obtained from 
the 2012 Benchmark I-O data. We repeated this practice for each year. 
We then calculated the cost shares that each cost category represents 
of the 2012 data inflated to 2017. These resulting 2017 cost shares 
were applied to the ``All Other'' residual cost weight to obtain the 
detailed cost weights for the proposed 2017-based FQHC market basket. 
For example, the cost for Medical Equipment represents 7.2 percent of 
the sum of the ``All Other'' 2012 Benchmark I-O Offices of Physicians 
Expenditures inflated to 2017. Therefore, the proposed Medical 
Equipment cost weight represents 7.2 percent of the proposed 2017-based 
FQHC market basket's ``All Other'' cost category (16.5 percent), 
yielding a Medical Equipment cost weight of 1.2 percent in the 2017-
based FQHC market basket (0.072 x 16.5 percent = 1.2 percent).
    Using this methodology, we proposed to derive six detailed FQHC 
market basket cost category weights from the proposed 2017-based FQHC 
market basket residual cost weight (15.5 percent). These categories 
are: (1) Utilities; (2) Medical Equipment; (3) Miscellaneous Products; 
(4) Professional, Scientific, and Technical Services; (5) 
Administrative Support and Waste Management Services; (6) All Other 
Services. We note that for the 2013-based FQHC market basket, we had 
Telephone and Postage cost weights. For the 2017-based FQHC market 
basket, we proposed to include Telephone and Postage costs in the 
Miscellaneous Products cost weight due to the small amount of costs in 
this category (each were less than .05 percent).
    We did not receive any comments on our proposed derivation of the 
detailed operating cost weights. Therefore, we are finalizing our 
methodology as proposed. In response to public comment to use net costs 
rather than total costs to derive the FQHC market basket cost weights, 
the ``All Other'' residual cost weight was revised from the proposed 
rule to reflect the revised methodology as explained in section 
III.D.3.a of this final rule. The ``All Other'' residual cost weight is 
16.5 percent compared to the proposed 15.5 percent weight.
d. 2017-Based FQHC Market Basket Cost Categories and Weights
    Table 37 shows the cost categories and weights for the Final 2017-
based FQHC market basket compared to the proposed 2017-based FQHC 
market basket and the 2013-based FQHC market basket.

[[Page 84707]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.082

4. Selection of Price Proxies
    After developing the cost weights for the 2017-based FQHC market 
basket, we selected the most appropriate wage and price proxies 
currently available to represent the rate of price change for each 
expenditure category. For the majority of the cost weights, we base the 
price proxies on U.S. Bureau of Labor Statistics (BLS) data, as they 
produce indexes that best meet the criteria of reliability, timeliness, 
availability, and relevance, and group them into one of the following 
BLS categories:
     Employment Cost Indexes. Employment Cost Indexes (ECIs) 
measure the rate of change in employment wage rates and employer costs 
for employee benefits per hour worked. These indexes are fixed-weight 
indexes and strictly measure the change in wage rates and employee 
benefits per hour. ECIs are superior to Average Hourly Earnings (AHE) 
as price proxies for input price indexes because they are not affected 
by shifts in occupation or industry mix, and because they measure pure 
price change and are available by both occupational group and by 
industry. The industry ECIs are based on the North American Industry 
Classification System (NAICS) and the occupational ECIs are based on 
the Standard Occupational Classification System (SOC).
     Producer Price Indexes. Producer Price Indexes (PPIs) 
measure the average change over time in the selling prices received by 
domestic producers for their output. The prices included in the PPI are 
from the first commercial transaction for many products and some 
services (https://www.bls.gov/ppi/).
     Consumer Price Indexes. Consumer Price Indexes (CPIs) 
measure the average change over time in the prices paid by urban 
consumers for a market basket of consumer goods and services (https://www.bls.gov/cpi/). CPIs are only used when the purchases are similar to 
those of retail consumers rather than purchases at the producer level, 
or if no appropriate PPIs are available.
    We evaluate the price proxies using the criteria of reliability, 
timeliness, availability, and relevance:
     Reliability. Reliability indicates that the index is based 
on valid statistical methods and has low sampling variability. Widely 
accepted statistical methods ensure that the data were collected and 
aggregated in a way that can be replicated. Low sampling variability is 
desirable because it indicates that the sample reflects the typical 
members of the population. (Sampling variability is variation that 
occurs by chance because only a sample was surveyed rather than the 
entire population.)
     Timeliness. Timeliness implies that the proxy is published 
regularly, preferably at least once a quarter. The market baskets are 
updated quarterly, and therefore, it is important for the

[[Page 84708]]

underlying price proxies to be up-to-date, reflecting the most recent 
data available. We believe that using proxies that are published 
regularly (at least quarterly, whenever possible) helps to ensure that 
we are using the most recent data available to update the market 
basket. We strive to use publications that are disseminated frequently, 
because we believe that this is an optimal way to stay abreast of the 
most current data available.
     Availability. Availability means that the proxy is 
publicly available. We prefer that our proxies are publicly available 
because this will help ensure that our market basket updates are as 
transparent to the public as possible. In addition, this enables the 
public to be able to obtain the price proxy data on a regular basis.
     Relevance. Relevance means that the proxy is applicable 
and representative of the cost category weight to which it is applied.
    The CPIs, PPIs, and ECIs that we have selected meet these criteria. 
Therefore, we believe that they continue to be the best measure of 
price changes for the cost categories to which they would be applied.
    Table 38 lists all price proxies we proposed to use in the 2017-
based FQHC market basket. Below is a detailed explanation of the price 
proxies we proposed for each cost category, many of which are the same 
as those used for the 2013-based FQHC market basket.
a. Price Proxies for the 2017-Based FQHC Market Basket
(1) FQHC Practitioner Wages and Salaries
    We proposed to use the ECI for Wages and Salaries for Private 
Industry Workers in Professional and Related (BLS series code 
CIU2010000120000I) to measure price growth of this category. There is 
no specific ECI for physicians or FQHC Practitioners, and therefore, we 
proposed to use an index that is based on professionals that receive 
advanced training similar to those performing at the FQHC Practitioner 
level of care. This index is consistent with the price proxy used to 
measure wages and salaries inflation pressure for physicians own time 
in the Medicare Economic Index (MEI) and is based on the MEI technical 
panel recommendation from 2012 (78 FR 74266 through 74271). 
Additionally, this price proxy is consistent with the proxy used for 
FQHC practitioner compensation in the 2013-based FQHC market basket (81 
FR 80397). We noted that the 2013-based FQHC market basket has a single 
cost category for Total Compensation reflecting both wages and salaries 
and employee benefits costs for FQHC Practitioners and this single 
compensation category uses the similar price proxy, the ECI Total 
Compensation for Private Industry Workers in Professional and Related, 
reflecting both types of compensation costs together rather than 
separately (81 FR 80397).
(2) FQHC Practitioner Employee Benefits
    We proposed to use the ECI for Total Benefits for Private Industry 
Workers in Professional and Related to measure price growth of this 
category. This ECI is calculated using the ECI for Total Compensation 
for Private Industry Workers in Professional and Related (BLS series 
code CIU1016220000000I) and the relative importance of wages and 
salaries within total compensation. The 2013-based FQHC market basket 
did not include a separate category for FQHC Practitioner employee 
benefit costs.
(3) Clinical Staff Wages and Salaries
    We proposed to use the ECI for Wages and Salaries for all Civilian 
Workers in Health Care and Social Assistance (BLS series code 
CIU1026200000000I) to measure the price growth of this cost category. 
This cost category consists of wage and salary costs for Nurses, 
Laboratory Technicians, and all other healthcare staff not included in 
the FQHC Practitioner compensation categories. Based on the clinical 
staff composition of these workers, we noted that we believe that the 
ECI for health-related workers is an appropriate proxy to measure wage 
and salary price pressures for these workers. We noted that the 2013-
based FQHC market basket has a single cost category for Total 
Compensation reflecting both wages and salaries and employee benefits 
costs for Clinical Staff and this single compensation category uses the 
similar price proxy, the ECI Total Compensation for all Civilian 
Workers in Health Care and Social Assistance, reflecting both types of 
compensation costs together rather than separately (81 FR 80398).
(4) Clinical Staff Employee Benefits
    We proposed to use the ECI for Total Benefits for all Civilian 
Workers in Health Care and Social Assistance to measure price growth of 
this category. This ECI is calculated using the ECI for Total 
Compensation for all Civilian Workers in Health Care and Social 
Assistance (BLS series code CIU1016220000000I) and the relative 
importance of wages and salaries within total compensation. The 2013-
based FQHC market basket did not include a separate category for 
Clinical Staff employee benefit costs.
(5) Non-Health Staff Compensation
    We proposed to continue to use the ECI for Total Compensation for 
Private Industry Workers in Office and Administrative Support (BLS 
series code CIU2010000220000I) to measure the price growth of this cost 
category. The Non-health Staff Compensation cost weight is 
predominately attributable to administrative and facility type 
occupations, as reported in the data from the Medicare cost reports. 
This is the same price proxy used in the 2013-based FQHC market basket 
(81 FR 80398).
(6) Pharmaceuticals
    We proposed to continue to use the PPI Commodities for 
Pharmaceuticals for Human Use, Prescription (BLS series code 
WPUSI07003) to measure the price growth of this cost category. This 
price proxy is used to measure prices of Pharmaceuticals in other CMS 
market baskets, such as 2014-based Inpatient Prospective Payment System 
and 2014-based Skilled Nursing Facility market baskets. This is the 
same proxy used in the 2013-based FQHC market basket (81 FR 80398).
(7) Utilities
    We proposed to continue to use the CPI for Fuel and Utilities (BLS 
series code CUUR0000SAH2) to measure the price growth of this cost 
category. This is the same proxy used in the 2013-based FQHC market 
basket (81 FR 80398).
(8) Medical Equipment
    We proposed to continue to use the PPI Commodities for Surgical and 
Medical Instruments (BLS series code WPU1562) as the price proxy for 
this category. This is the same proxy used in the 2013-based FQHC 
market basket (81 FR 80398).
(9) Medical Supplies
    We proposed to continue to use a 50/50 blended index that comprises 
the PPI Commodities for Medical and Surgical Appliances and Supplies 
(BLS series code WPU156301) and the CPI-U for Medical Equipment and 
Supplies (BLS series code CUUR0000SEMG). The 50/50 blend is used in all 
market baskets where we do not have an accurate split available. We 
noted that we believe FQHCs purchase the types of supplies contained 
within these proxies, including such items as bandages,

[[Page 84709]]

dressings, catheters, intravenous equipment, syringes, and other 
general disposable medical supplies, via wholesale purchase, as well as 
at the retail level. Consequently, we proposed to combine the two 
aforementioned indexes to reflect those modes of purchase. This is the 
same blended price proxy used in the 2013-based FQHC market basket (81 
FR 80398).
(10) Miscellaneous Products
    We proposed to use the CPI for All Items Less Food and Energy (BLS 
series code CUUR0000SA0L1E) to measure the price growth of this cost 
category. We noted that we believe that using the CPI for All Items 
Less Food and Energy is appropriate as it reflects a general level of 
inflation. This is the same proxy used in the 2013-based FQHC market 
basket (81 FR 80398).
(11) Professional, Scientific, and Technical Services
    We proposed to continue to use the ECI for Total Compensation for 
Private Industry Workers in Professional, Scientific, and Technical 
Services (BLS series code CIU2015400000000I) to measure the price 
growth of this cost category. This is the same proxy used in the 2013-
based FQHC market basket (81 FR 80398).
(12) Administrative and Facilities Support Services
    We proposed to continue to use the ECI Total Compensation for 
Private Industry Workers in Office and Administrative Support (BLS 
series code CIU2010000220000I) to measure the price growth of this cost 
category. This is the same proxy used in the 2013-based FQHC market 
basket (81 FR 80398).
(13) All Other Services
    We proposed to continue to use the ECI for Total Compensation for 
Private Industry Workers in Service Occupations (BLS series code 
CIU2010000300000I) to measure the price growth of this cost category. 
This is the same proxy used in the 2013-based FQHC market basket (81 FR 
80398).
(14) Fixed Capital
    We proposed to continue to use the PPI Industry for Lessors of 
Nonresidential Buildings (BLS series code PCU531120531120) to measure 
the price growth of this cost category (81 FR 80398). This is the same 
price proxy used in the 2013-based FQHC market basket. We noted that we 
believe this continues to be the most appropriate price proxy since 
fixed capital expenses in FQHCs should reflect inflation for the rental 
and purchase of business office space.
(15) Moveable Capital
    We proposed to continue to use the PPI Commodities for Machinery 
and Equipment (BLS series code WPU11) to measure the price growth of 
this cost category as this cost category represents nonmedical moveable 
equipment. This is the same proxy used in the 2013-based FQHC market 
basket (81 FR 80398).
    We did not receive any comments on the proposed price proxies in 
the 2017-based FQHC market basket, and therefore, we are finalizing 
this proposal without modification.
c. Summary of Price Proxies of the Final 2017-Based FQHC Market Basket
    Table 38 shows the cost categories and associated price proxies for 
the 2017-based FQHC market basket.
[GRAPHIC] [TIFF OMITTED] TR28DE20.083


[[Page 84710]]


    Comment: Several commenters applauded CMS, both for implementing an 
FQHC[hyphen]specific market basket adjuster, per section 1834(o)(2)(B) 
of the Act, and for taking the initiative to rebase the market basket 
percentage, effective in 2021, using more recent cost data. One 
commenter stated they had been a long[hyphen]term supporter of the FQHC 
specific market basket serving as the annual update method for health 
centers, in both Medicare and Medicaid. The commenter stated that they 
believe that the alternative, the MEI, is outdated and does not 
appropriately capture the services that health centers provide and 
therefore is not an appropriate update factor. The commenters 
appreciated that CMS updates the calculation periodically so that the 
cost weights reflect a current mix of goods and services purchased in 
providing FQHC services. The commenters stated that they did not have 
concerns with the overall structure of the calculation, and they noted 
that they believe the use of a fixed[hyphen]weight, 
Laspeyres[hyphen]type price index that uses cost weights and price 
proxies (based on publicly available cost indexes) is a reasonable way 
to measure the increase in the price over time of goods and services 
needed to furnish FQHC services.
    Response: We appreciate the commenters' support of the FQHC market 
basket and the periodic rebasing and revision of the market basket to 
account for changes in the mix of goods and services purchased in 
providing FQHC services as well as the general methodological approach 
of using Medicare Cost Report data, a Laspeyres-type index formula, and 
the use of publically available price proxies when available and 
appropriate.
    In response to public comment, we are finalizing the 2017-basd FQHC 
market basket with modification effective with CY 2021 FQHC PPS update.
5. CY 2021 Productivity Adjusted Market Basket Update for FQHCs
    For CY 2021 (that is, January 1, 2021 through December 31, 2021), 
we proposed to use the 2017-based FQHC market basket increase factor to 
update the PPS payments to FQHCs. Consistent with CMS practice, we 
estimated the market basket update for the FQHC PPS based on the most 
recent forecast from IGI. IGI is a nationally recognized economic and 
financial forecasting firm with which we contract to forecast the 
components of the market baskets and multifactor productivity (MFP). We 
proposed to use the update based on the most recent historical data 
available at the time of publication of the final rule. For example, 
the final CY 2021 FQHC update would be based on the four-quarter 
moving-average percent change of the 2017-based FQHC market basket 
through the second quarter of 2020 (based on the final rule's statutory 
publication schedule). At the time of the proposed rule, we did not 
have the second quarter of 2020 historical data, and therefore, we 
proposed to use the most recent projection available at the time.
    Based on IGI's third quarter 2020 forecast with historical data 
through the second quarter of 2020, the final 2017-based FQHC market 
basket increase factor for CY 2021 is 2.4 percent. For comparison, the 
2013-based FQHC market basket update is projected to be 2.3 percent in 
CY 2021; this estimate is based on IGI's third quarter 2020 forecast 
(with historical data through the second quarter of 2020). We note that 
the forecast used for the proposed market basket update was developed 
prior to the economic impacts of the COVID-19 pandemic. The lower final 
update (2.4 percent) for CY 2021 relative to the proposed rule (2.5 
percent) is primarily driven by slower anticipated compensation growth 
for both health-related and other occupations as labor markets have 
been significantly impacted during the recession that started in 
February 2020.
    Section 1834(o)(2)(B)(ii) of the Act describes the methods for 
determining updates to FQHC PPS payment. We have included a 
productivity adjustment to the FQHC PPS annual payment update since 
implementation of the FQHC PPS (81 FR 80393) and we proposed to 
continue to include a productivity adjustment to the 2017-based FQHC 
market basket. We proposed to use the most recent estimate of the 10-
year moving average of changes in annual private nonfarm business 
(economy-wide) multifactor productivity (MFP), which is the same 
measure of MFP applied to other CMS Market Basket updates including the 
MEI. The BLS publishes the official measure of private nonfarm business 
MFP (see http://www.bls.gov/mfp for the published BLS historical MFP 
data). For the final FQHC market basket update, we proposed to use the 
most recent historical estimate of annual MFP as published by the BLS. 
Generally, the most recent historical MFP estimate is lagged 2 years 
from the payment year.
    Therefore, we proposed to use the 10-year moving average percent 
change in annual private nonfarm business MFP through 2019 as published 
by BLS in the CY 2021 FQHC market basket update. We noted that MFP is 
derived by subtracting the contribution of labor and capital input 
growth from output growth. Since at the time of development of the 
proposed rule the 2019 MFP was not yet published by BLS, we proposed to 
use IGI's first quarter 2020 forecast of MFP. A complete description of 
the MFP projection methodology is available at http://www.cms.gov/Research-Statistics-Dataand-Systems/Statistics-Trends-andReports/MedicareProgramRatesStats/MarketBasketResearch.html.
    Using IGI's first quarter 2020 forecast, the productivity 
adjustment for CY 2021 (the 10-year moving average of MFP for the 
period ending CY 2019) was projected to be 0.6 percent. Therefore, the 
proposed CY 2021 productivity-adjusted FQHC Market basket update was 
1.9 percent, based on IGI's first quarter 2020 forecast with historical 
data through the fourth quarter of 2019. This reflected a 2.5-percent 
increase in the proposed 2017-based FQHC market basket and a 0.6-
percent adjustment for productivity. Finally, we proposed that if more 
recent data subsequently become available, we would use such data, if 
appropriate, to determine the CY 2021 market basket update and the MFP 
adjustment for the final rule.
    For this final rule, as proposed, we are using the latest 
historical data for MFP as published by the BLS to determine the MFP 
adjustment. The 10-year moving average percent change in MFP for the 
period ending CY 2019 as published by BLS is 0.7 percent. Therefore, 
the final CY 2021 productivity-adjusted FQHC Market basket update is 
1.7 percent, based on IGI's third quarter 2020 forecast with historical 
data through the second quarter of 2020. This reflects a 2.4 percent 
increase in the final 2017-based FQHC market basket less a 0.7 
percentage point adjustment for productivity.

E. Comprehensive Screenings for Seniors: Section 2002 of the Substance 
Use-Disorder Prevention That Promote Opioid Recovery and Treatment for 
Patients and Communities Act (SUPPORT Act)

    Opioid overdose deaths continue to impact communities across the 
United States. In 2018, about 47,000 Americans died as a result of an 
opioid overdose, where 32 percent of these deaths involved a 
prescription opioid.\54\ In addition to the risk of death from 
overdose, opioids carry a number of other health risks, including 
respiratory

[[Page 84711]]

depression, drowsiness, confusion, nausea, increased drug tolerance, 
and physical dependence. An estimated 1.4 million people in the United 
States have substance use disorders (SUDs) involving prescription 
opioid pain relievers.\55\
---------------------------------------------------------------------------

    \54\ Wilson N, Kariisa M, Seth P, et al. Drug and Opioid-
Involved Overdose Deaths--United States, 2017-2018. MMWR Morb Mortal 
Wkly Rep 2020;69:290-297.
    \55\ Substance Abuse and Mental Health Services Administration. 
(2020). Key substance use and mental health indicators in the United 
States: Results from the 2019 National Survey on Drug Use and Health 
(HHS Publication No. PEP20-07-01-001, NSDUH Series H-55). Rockville, 
MD: Center for Behavioral Health Statistics and Quality, Substance 
Abuse and Mental Health Services Administration. Retrieved from 
https://www.samhsa.gov/data/.
---------------------------------------------------------------------------

    CMS has a vital role in addressing opioid use disorder prevention, 
treatment and recovery. The intent of the SUPPORT Act (Pub. L. 115-271, 
enacted on October 24, 2018) is to provide for opioid use disorder 
prevention, treatment and recovery. In section 2002 of the SUPPORT Act, 
Comprehensive Screening for Seniors, the Congress required the Initial 
Preventive Physical Examination (IPPE) and Annual Wellness Visit (AWV) 
to include screening for potential SUDs and a review of any current 
opioid prescriptions. We believe that these provisions are 
complementary to the existing components of the IPPE and AWV. We 
proposed to add these new elements to the IPPE and AWV regulations, to 
draw attention to their importance and fulfil the section 2002 SUPPORT 
Act requirements. In the CY 2021 PFS proposed rule (85 FR at 50224), we 
provided background on the IPPE and AWV, discussed how the requirements 
of the SUPPORT Act are related to the IPPE and AWV, and made proposals 
to implement these provisions.
1. Background: IPPE and AWV
a. IPPE Required Elements
    The IPPE is defined in section 1861(ww) of the Act and codified in 
regulations at Sec.  410.16. The IPPE must be performed within 1 year 
after the effective date of a beneficiary's first Medicare Part B 
coverage period as stated in section 1861(hhh)(4)(G) of the Act. The 
IPPE includes all of the following services furnished to an eligible 
beneficiary by a physician or other qualified NPP with the goal of 
health promotion and disease detection:
     Review of the beneficiary's medical and social history 
with attention to modifiable risk factors for disease, as those terms 
are defined in Sec.  410.16.
     Review of the beneficiary's potential (risk factors) for 
depression, including current or past experiences with depression or 
other mood disorders, based on the use of an appropriate screening 
instrument for persons without a current diagnosis of depression, which 
the physician or other qualified NPP may select from various available 
standardized screening tests designed for this purpose and recognized 
by national professional medical organizations.
     Review of the beneficiary's functional ability, and level 
of safety as those terms are defined in Sec.  410.16 based on the use 
of appropriate screening questions or a screening questionnaire, which 
the physician or other qualified NPP may select from various available 
screening questions or standardized questionnaires designed for this 
purpose and recognized by national professional medical organizations.
     An examination to include measurement of the beneficiary's 
height, weight, body mass index, blood pressure, a visual acuity 
screen, and other factors as deemed appropriate, based on the 
beneficiary's medical and social history, and current clinical 
standards.
     End-of-life planning upon agreement with the individual.
     Education, counseling, and referral, as deemed appropriate 
by the physician or qualified NPP, based on the results of the review 
and evaluation services described in Sec.  410.16.
     Education, counseling, and referral, including a brief 
written plan such as a checklist provided to the individual for 
obtaining an electrocardiogram, as appropriate, and the appropriate 
screening and other preventive services that are covered as separate 
Medicare Part B benefits.
b. AWV Required Elements
    Section 1861(hhh) of the Act expanded Medicare coverage under Part 
B to include an AWV effective for services furnished on or after 
January 1, 2011. We codified the AWV at Sec.  410.15.
    The AWV is a wellness visit that focuses on identification of 
certain risk factors, personalized health advice, and referral for 
additional preventive services and lifestyle interventions (which may 
or may not be covered by Medicare). The elements included in the AWV 
differ from comprehensive physical examination protocols with which 
some providers may be familiar since it is a visit that is specifically 
designed to provide personalized prevention plan services as defined in 
the Act. The AWV includes a health risk assessment (HRA) and the AWV 
takes into account the results of the HRA.
    The AWV may be performed when the beneficiary is no longer within 
12 months after the effective date of his or her first Medicare Part B 
coverage period and when the beneficiary has not received either an 
IPPE or AWV within the past 12 months. The AWV may be performed by a 
physician, NPP (physician assistant, nurse practitioner, or clinical 
nurse specialist), medical professional (including a health educator, a 
registered dietitian, or nutrition professional, or other licensed 
practitioner) or a team of such medical professionals, working under 
the direct supervision of a physician. In summary, the first AWV 
includes the following:
     Review (and administration if needed) of a health risk 
assessment (as defined in Sec.  410.15).
     Establishment of an individual's medical and family 
history.
     Establishment of a list of current providers and suppliers 
that are regularly involved in providing medical care to the 
individual.
     Measurement of an individual's height, weight, body-mass 
index (or waist circumference, if appropriate), blood pressure, and 
other routine measurements as deemed appropriate, based on the 
beneficiary's medical and family history.
     Detection of any cognitive impairment that the individual 
may have, as that term is defined in Sec.  410.15.
     Review of the individual's potential (risk factors) for 
depression, including current or past experiences with depression or 
other mood disorders, based on the use of an appropriate screening 
instrument for persons without a current diagnosis of depression, which 
the health professional may select from various available standardized 
screening tests designed for this purpose and recognized by national 
medical professional organizations.
     Review of the individual's functional ability and level of 
safety, based on direct observation or the use of appropriate screening 
questions or a screening questionnaire, which the health professional 
as defined in Sec.  410.15 may select from various available screening 
questions or standardized questionnaires designed for this purpose and 
recognized by national professional medical organizations.
     Establishment of the following:
    ++ A written screening schedule for the individual such as a 
checklist for the next 5 to 10 years, as appropriate, based on 
recommendations of the United States Preventive Services Task Force 
(USPSTF) and the Advisory Committee on Immunization Practices, and the 
individual's health risk assessment (as that term is defined in Sec.  
410.15), health

[[Page 84712]]

status, screening history, and age-appropriate preventive services 
covered by Medicare.
    ++ A list of risk factors and conditions for which primary, 
secondary or tertiary interventions are recommended or are underway for 
the individual, including any mental health conditions or any such risk 
factors or conditions that have been identified through an IPPE (as 
described under Sec.  410.16), and a list of treatment options and 
their associated risks and benefits.
    ++ Furnishing of personalized health advice to the individual and a 
referral, as appropriate, to health education or preventive counseling 
services or programs aimed at reducing identified risk factors and 
improving self-management, or community-based lifestyle interventions 
to reduce health risks and promote self-management and wellness, 
including weight loss, physical activity, smoking cessation, fall 
prevention, and nutrition.
    ++ At the discretion of the beneficiary, furnish advance care 
planning services to include discussion about future care decisions 
that may need to be made, how the beneficiary can let others know about 
care preferences, and explanation of advance directives which may 
involve the completion of standard forms.
    ++ Any other element determined appropriate through the national 
coverage determination process.
    In summary, subsequent AWVs include the following:
     Review (and administration, if needed) of an updated 
health risk assessment (as defined in Sec.  410.15).
     An update of the individual's medical and family history.
     An update of the list of current providers and suppliers 
that are regularly involved in providing medical care to the individual 
as that list was developed for the first AWV providing personalized 
prevention plan services or the previous subsequent AWV providing 
personalized prevention plan services.
     Measurement of an individual's weight (or waist 
circumference), blood pressure and other routine measurements as deemed 
appropriate, based on the individual's medical and family history.
     Detection of any cognitive impairment that the individual 
may have, as that term is defined in Sec.  410.15.
     An update to the following:
    ++ The written screening schedule for the individual as that 
schedule is defined in paragraph (a) of Sec.  410.15 for the first AWV 
providing personalized prevention plan services.
    ++ The list of risk factors and conditions for which primary, 
secondary or tertiary interventions are recommended or are underway for 
the individual as that list was developed at the first AWV providing 
personalized prevention plan services or the previous subsequent AWV 
providing personalized prevention plan services.
    ++ Furnishing of personalized health advice to the individual and a 
referral, as appropriate, to health education or preventive counseling 
services or programs as that advice and related services are defined in 
paragraph (a) of Sec.  410.15.
    ++ At the discretion of the beneficiary, furnish advance care 
planning services to include discussion about future care decisions 
that may need to be made, how the beneficiary can let others know about 
care preferences, and explanation of advance directives which may 
involve the completion of standard forms.
    ++ Any other element determined appropriate through the national 
coverage determination process.
2. Section 2002 of the SUPPORT Act Requirement
    In section 2002 of the SUPPORT Act, sections 1861(ww) and 
1861(hhh)(2) of the Act were amended to include a review of any current 
opioid prescriptions and screening for potential SUDs as elements of 
the IPPE and AWV, effective January 1, 2020.
3. Revisions to Section 2002 of the SUPPORT Act Requirements
    We proposed to add the requirements of section 2002 of the SUPPORT 
Act to our regulations at Sec. Sec.  410.15 and 410.16 for the AWV and 
IPPE, respectively.
    Section 2002 of the SUPPORT Act, requires a review of any current 
opioid prescriptions as part of the IPPE and AWV. Such review includes 
a review of the potential risk factors to the individual for opioid use 
disorder, an evaluation of the individual's severity of pain and 
current treatment plan, educational information on non-opioid treatment 
options, and a referral to a specialist, as appropriate. Section 2002 
of the SUPPORT Act also requires adding an element to the IPPE and AWV 
to include screening for potential SUDs. Along with the screening for 
SUD, a referral for treatment, as appropriate, was added to the AWV.
    The definitions and conditions for and limitations on coverage of 
the IPPE outlined in Sec.  410.16 includes a review of the 
beneficiary's medical and social history. The medical history is 
defined to include a review of current medications, which would include 
a review of current opioid prescriptions. Furthermore, social history 
is defined to include, at a minimum, a history of alcohol, tobacco, and 
illicit drug use. Illicit drug use may include the non-medical use of 
prescription drugs. The physician or other qualified health 
professional may then provide education, counseling, and referral, as 
deemed appropriate, based on the results of the review and evaluation 
services provided during the IPPE.
    The definitions and conditions for and limitations on coverage of 
the AWV in Sec.  410.15 includes a health risk assessment, which 
entails an evaluation of psychosocial risks, including but not limited 
to, depression/life satisfaction, stress, anger, loneliness/social 
isolation, pain, and fatigue. The patient's substance use, if 
applicable, could be reviewed as part of the health risk assessment. 
The AWV also covers establishment of, or an update to the individual's 
medical and family history. The medical history includes medication 
use, and may have included a review of any opioid prescriptions. The 
health professional may also establish or update a list of risk factors 
and conditions for which primary, secondary or tertiary interventions 
are recommended or are underway for the individual, including any 
mental health conditions or any such risk factors or conditions that 
have been identified through the initial or subsequent AWV or IPPE, and 
a list of treatment options and their associated risks and benefits. If 
the clinician detected, through the above methods for screening, that a 
patient was at high-risk for SUD in the course of the visit, it would 
have been appropriate to note in the patient's IPPE written plan or the 
AWV personalized prevention plan and to have referred the patient for 
further assessment and treatment.
    Awareness of a patient's use of substances, including nonmedical 
use of prescription drugs and illicit drug use, is an important aspect 
of the IPPE and AWV. In general, screening for potential SUDs may 
include screening questions, the use of a specific tool, screening for 
licit and/or illicit drugs (for example, alcohol, non-medical use of 
prescription opioids, methamphetamine, heroin, cocaine, and other 
substances), review of the beneficiary's medical and social history and 
medical records, or prescription drug monitoring program query when 
clinically indicated. Given the existing elements of the IPPE and AWV, 
we do not expect the proposed new regulatory elements to add 
significant burdens on physicians and practitioners who furnish these 
services because review of medical and social

[[Page 84713]]

history, risk factor identification, education, counseling, and 
referrals are already fundamental parts of the IPPE and AWV. The new 
regulatory elements elevate the importance of physicians' and other 
qualified health professionals' vigilance in identifying and addressing 
opioid risks and SUDs in Medicare beneficiaries.
4. Summary of Proposed Regulatory Text Changes
    We proposed to add elements to our regulations to reflect the 
provisions of section 2002 of the SUPPORT Act. Consistent with sections 
1861(ww) and 1861(hhh)(2) of the Act, we proposed to amend Sec. Sec.  
410.15 and 410.16 by: (1) Adding the term ``screening for potential 
substance use disorders''; (2) Adding the term ``a review of any 
current opioid prescriptions'' and its definition; and (3) revising the 
``Initial Preventive Physical Examination,'' ``first annual wellness 
visit providing personalized prevention plan services,'' and 
``subsequent annual wellness visit providing personalized prevention 
plan services''.
a. ``Screening for Potential Substance Use Disorders''
    We proposed to revise Sec. Sec.  410.15 and 410.16 by adding the 
element ``Screening for Potential Substance Use Disorders'' and 
describing the requirement as a review of the individual's potential 
risk factors for SUD and referral for treatment as appropriate.
b. Definition of ``a review of any current opioid prescriptions''
    We proposed to revise Sec. Sec.  410.15 and 410.16 by adding the 
element ``a review of any current opioid prescriptions'' and defining 
such term, consistent with section 1861(ww)(4) of the Act, as a review 
of any current opioid prescriptions, including a review of the 
potential risk factors to the individual for opioid use disorder, an 
evaluation of the individuals' severity of pain and current treatment 
plan, the provision of information on non-opioid treatment options, and 
a referral to a specialist, as appropriate.
c. Proposed Changes to the ``Initial Preventive Physical Examination,'' 
``First Annual Wellness Visit'' and ``Subsequent Annual Wellness 
Visit''
    In Sec. Sec.  410.15 and 410.16, we adopted the components of the 
IPPE and AWV, consistent with the statutory elements described in 
sections 1861(ww) and 1861(hhh)(2) of the Act. The IPPE, first and 
subsequent AWVs are meant to represent a beneficiary visit focused on 
prevention. Among other things, the IPPE and AWV encourage 
beneficiaries to obtain the preventive services covered by Medicare 
that are appropriate for them. First and subsequent AWVs also include 
elements that focus on the furnishing of personalized health advice and 
referral, as appropriate, to health education, preventive counseling 
services, or programs aimed at reducing identified risk factors and 
improving self-management, or community-based lifestyle interventions.
    We proposed to revise ``initial preventive physical examination,'' 
``first annual wellness visit providing personalized prevention plan 
services,'' and ``subsequent annual wellness visit providing 
personalized prevention plan services'' by adding:
     In Sec.  410.15(a):
    ++ A revised paragraph (xi) to the definition of the term ``First 
annual wellness visit providing personalized prevention plan 
services,'' and a revised paragraph (ix) to the definition of the term 
``Subsequent annual wellness visit'' that would add furnishing of a 
review of any current opioid prescriptions as that term is defined in 
this section.
    ++ A new paragraph (xii) to the definition of ``First annual 
wellness visit providing personalized prevention plan services,'' and a 
new paragraph (x) to the definition of ``Subsequent annual wellness 
visit'' that would add screening for potential SUDs including a review 
of the individual's potential risk factors for SUD and referral for 
treatment as appropriate.
    ++ A new paragraph (xiii) to the definition of ``First annual 
wellness visit providing personalized prevention plan services,'' and a 
new paragraph (xi) to the definition of ``Subsequent annual wellness 
visit'' that would add any other element determined appropriate through 
the national coverage determination process.
     In Sec.  410.16:
    ++ A revised paragraph (a)(6) to the definition of ``Initial 
preventive physical examination'' that would include a review of any 
current opioid prescriptions as that term is defined in this section.
    ++ A revised paragraph (a)(7) to the definition of ``Initial 
preventive physical examination'' that would add screening for 
potential SUDs to include a review of the individual's potential risk 
factors for SUD and referral for treatment as appropriate.
    ++ A new paragraph (a)(8) to the definition of ``Initial preventive 
physical examination'' that would add, education, counseling, and 
referral, as deemed appropriate by the physician or qualified NPP, 
based on the results of the review and evaluation services described in 
this section.
    ++ A new paragraph (a)(9) to the definition of ``Initial preventive 
physical examination'' that would include, education, counseling, and 
referral, including a brief written plan such as a checklist provided 
to the individual for obtaining an electrocardiogram, as appropriate, 
and the appropriate screening and other preventive services that are 
covered as separate Medicare Part B benefits as described in sections 
1861(s)(10), (jj), (nn), (oo), (pp), (qq)(1), (rr), (uu), (vv), 
(xx)(1), (yy), (bbb), and (ddd) of the Act.
5. Summary of Public Comments and Responses
    We received public comments on the proposed revisions to the 
requirements under section 2002 of the SUPPORT Act. The following is a 
summary of the comments we received and our responses.
    Comment: The vast majority of commenters supported the proposal to 
add the requirements of section 2002 of the SUPPORT Act to the 
regulations at Sec. Sec.  410.15 and 410.16. Commenters stated that 
they believe these provisions are complementary to the existing 
components of the IPPE and AWV and help underscore the importance of 
prevention and appropriate pain management to stymie the opioid 
epidemic and detect substance use disorders on a regular schedule. 
Furthermore, commenters specifically noted that while Medicare has 
previously emphasized a review of opioid prescriptions is appropriate 
when collecting a patient's medical and social history within the IPPE 
and AWV, adding explicit requirements to the regulations regarding 
opioid prescription review and substance use disorder screening is an 
important distinction and welcomed by the majority of commenters.
    Response: We appreciate the commenters for their support of CMS' 
efforts to include section 2002 of the SUPPORT ACT in the regulations, 
which are intended to strengthen provider engagement with patients on 
appropriate pain management and detection of substance use disorders 
through the IPPE and AWV.
    Comment: According to one commenter a thorough patient assessment 
for pain and opioid use could take 30-90 minutes and such services 
should not be part of the AWV or IPPE but should be a separate 
encounter.

[[Page 84714]]

    Response: We thank the commenter for highlighting the time it can 
take for practitioners to appropriately care for patients with pain. 
Section 2002 of the SUPPORT Act modified the statute to require the 
addition of certain additional services to the AWV and IPPE. We are not 
adopting the commenter's suggestion to only pay for these additional 
services as a separate encounter. We note, however, that there are 
other opportunities throughout the year outside of the AWV and IPPE, 
such as E/M services for practitioners to evaluate their patient's 
pain, consider treatment options and review medications when those 
services would be reasonable and necessary. In addition, other 
medically necessary services may be provided on the same date of 
service as an AWV or IPPE. The Part B deductible and coinsurance or 
copayment obligations would apply to those additional medically 
necessary services.
    Comment: Some commenters advocated for CMS to increase the payment 
rate for the AWV and IPPE as a result of these additional required 
elements. Another commenter stated that the increase in reimbursement 
for CY 2021 will offset the additional work related to these new 
requirements. One commenter agreed with CMS that the new elements are 
aligned and similar to the services already being furnished during the 
visits and, therefore, would not result in significant added burden. 
One commenter disagreed with adding the requirements to the AWV and 
IPPE under section 2002 of the SUPPORT Act because practitioners 
already address prescriptions and substance abuse issues during these 
visits and formally including them adds to the paperwork and 
documentation burden around the visits.
    Response: We note that we are required by law through section 2002 
of the SUPPORT Act to include the new elements in the AWV and IPPE.
    Commenters had various opinions about the appropriate payment rate 
for the AWV and IPPE with the additional requirements. We note for 
commenters that in section III.F. of this final rule, we finalized 
increases in the values of office/outpatient E/M visit codes for CY 
2021. The AWV and IPPE services are valued via direct cross walk from 
the office/outpatient E/M visits. To maintain payment accuracy for the 
IPPE and the AWV, we finalized adjusting the valuation of these 
services to reflect the changes in value for E/M services to which they 
are crosswalked. The payment increase coincides with but is not related 
to the newly required elements in the AWV and IPPE.
    We continue to agree with commenters who believe any additional 
burden for the new required elements will be minimal and we disagree 
with commenters that state the additional work will be a significant 
burden.
    Comment: Commenters requested CMS clarify in more detail what is 
required of practitioners to meet the new required elements of the AWV 
and IPPE. One commenter specifically requested clarification that if a 
patient is found at risk for potential substance use disorder after 
screening that a comprehensive evaluation of that finding is not part 
of the AWV and IPPE. Another commenter specifically requested 
clarification around screening.
    Response: In an effort to minimize burden and allow flexibility, we 
have not been more prescriptive with the regulatory language. We 
believe this allows practitioners to tailor screening to their 
patients. Medically necessary services beyond the scope of those 
required as part of the AWV and IPPE, as discussed in an earlier 
response, may be provided on the same date of service as an AWV or 
IPPE. The deductible and coinsurance or copayment may apply for these 
other medically necessary services.
    Comment: One commenter asked for clarification on how CMS will 
enforce these new requirements.
    Response: We are planning to enforce the new elements of the AWV 
and IPPE in the same manner as other services furnished to Medicare 
beneficiaries.
    Comment: One commenter asked CMS to consider the community pharmacy 
as a provider of screening and referral services.
    Response: We appreciate that the commenter is looking to expand 
access to screening and referral services by including community 
pharmacies as potential suppliers of these services, but this expansion 
would exceed the scope of our proposed rule. We did not seek to amend 
the definition of either ``health professional'' for the AWV or the 
definition of ``qualified nonphysician practitioner'' for the IPPE. The 
types of practitioners that are eligible to furnish the AWV are 
specified in section 1861(hhh)(3) of the Act and defined in our 
regulations in Sec.  410.15(a). For the IPPE, the practitioners 
eligible to furnish these services under certain conditions are based 
on statutory requirements in sections 1861(s)(2)(K) and (ww)(1) of the 
Act and are defined in our regulations at Sec.  410.16(a).
    As a result of the comments, we are finalizing the proposal to add 
explicit requirements to the regulations regarding opioid prescription 
review and substance use disorder screening. Specifically, we are 
adding the requirements of section 2002 of the SUPPORT Act to 
Sec. Sec.  410.15 and 410.16 for the AWV and IPPE, respectively.
    We did not receive public comments on our proposed regulatory text, 
and, therefore, we are finalizing the regulatory language as proposed.

F. 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 incentive payments made to Medicaid EPs and eligible 
hospitals for the adoption, implementation, upgrade, and meaningful use 
of Certified EHR Technology (CEHRT). We have implemented these 
statutory provisions in prior rulemakings to establish the Medicaid 
Promoting Interoperability Program.
    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 CY 2020 PFS final rule (84 FR 62568, 62900), we established 
for 2020 that Medicaid EPs are required to report on any six eCQMs that 
are relevant to the EP's scope of practice, regardless of whether they 
report via attestation or electronically. We also adopted the Merit-
based Incentive Payment System (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 explained 
that if no outcome or high priority measure is relevant to a Medicaid 
EP's scope of practice, the EP may report on any six eCQMs that are 
relevant.

[[Page 84715]]

2. eCQM Reporting Requirements for EPs Under the Medicaid Promoting 
Interoperability Program for 2021

    We annually review and revise the list of eCQMs for each MIPS 
performance year to reflect updated clinical standards and guidelines. 
In Appendix 1 of the CY 2021 PFS proposed rule (85 FR 50412), we 
proposed to amend the list of available eCQMs for the CY 2021 
performance period. In Appendix 1 of this final rule, we list the 
clinical quality measures added (Table Group A), removed (Table Group 
C), and changed (Table Group D) for the CY 2021 performance period. To 
keep eCQM specifications current and minimize complexity, we proposed 
to align the eCQMs available for Medicaid EPs in 2021 with those 
available for MIPS eligible clinicians for the CY 2021 performance 
period. Specifically, we proposed that the eCQMs available for Medicaid 
EPs in 2021 would consist of the list of quality measures available 
under the eCQM collection type on the final list of quality measures 
established for the MIPS CY 2021 performance period.
    In previous years, CMS proposals to align the list of eCQMs for 
MIPS and the Medicaid Promoting Interoperability Program for EPs 
received positive comments that indicated that alignment between these 
two programs would help reduce health care provider reporting burden 
(84 FR 62900; see also 83 FR 59452, 59702). These comments thus suggest 
that aligning the eCQM lists might encourage EP participation in the 
Medicaid Promoting Interoperability Program by giving Medicaid EPs that 
are also MIPS eligible clinicians the ability to report the same eCQMs 
for both programs. Not aligning the eCQM lists could lead to increased 
burden, because EPs might have to report on different eCQMs for the 
Medicaid Promoting Interoperability Program if they opt to report on 
newly added eCQMs for MIPS. In addition, we believe that aligning the 
eCQMs available in each program would help to ensure the most uniform 
application of up-to-date clinical standards and guidelines possible.
    As discussed in the CY 2021 PFS proposed rule (85 FR 50227), we 
anticipate that the 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 would 
report eCQMs to meet the quality performance category of MIPS, and 
therefore, should be prepared to report on the available eCQMs for 
2021. We noted that we expect that the proposal would have only a 
minimal impact on states, by requiring minor adjustments to state 
systems for 2021 to maintain current eCQM lists and specifications.
    For 2021, we proposed to again require (as we did for 2020) that 
Medicaid EPs report on any six eCQMs that are relevant to their scope 
of practice, regardless of whether they report via attestation or 
electronically. This policy of allowing Medicaid EPs to report on any 
six measures relevant to their scope of practice 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 generally 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 
referred readers to Sec.  414.1335(a) for the data submission criteria 
that apply to individual MIPS eligible clinicians and groups that elect 
to submit data with other collection types.
    In addition, as we did for 2020, we proposed that for 2021, EPs in 
the Medicaid Promoting Interoperability Program would be required to 
report on at least one outcome measure (or, if an outcome measure is 
not available or relevant, one other high priority measure). We noted 
that this policy would improve alignment with the MIPS quality 
performance category requirements for eligible clinicians using the 
eCQM collection type. We also proposed that if no outcome or high 
priority measures are relevant to a Medicaid EP's scope of practice, 
the clinician may report on any six eCQMs that are relevant, as was the 
policy in 2020.
    In the CY 2020 PFS final rule (84 FR 62899 and 62900), we 
established the following three methods to identify which of the 
available measures are high priority measures for EPs participating in 
the Medicaid Promoting Interoperability Program. We proposed to use the 
same three methods for identifying high priority eCQMs for the Medicaid 
Promoting Interoperability Program for 2021:
     The same set of measures that are identified as high 
priority measures for reporting on the quality performance category for 
eligible clinicians participating in MIPS.
     All e-specified measures from the previous year's core set 
of quality measures for Medicaid and the Children's Health Insurance 
Program (CHIP) (Child Core Set) or the core set of health care quality 
measures for adults enrolled in Medicaid (Adult Core Set) (hereinafter 
together referred to as ``Core Sets'') that are also included on the 
MIPS list of eCQMs.
    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 are composed 
of measures that specifically focus on populations served by the 
Medicaid and CHIP programs and are of particular importance to their 
care. The MIPS eCQM list includes several, but not all, of the measures 
in the Core Sets. Because the Core Sets are released at the beginning 
of each year, it is not possible to update the list of high-priority 
eCQMs with those added to the current year's Core Sets.
    The eCQMs that would be available for Medicaid EPs to report in 
2021, that are both part of the Core Sets and on the MIPS list of 
eCQMs, and that would be considered high priority measures under the 
proposal are: CMS2, ``Preventive Care and Screening: Screening for 
Depression and Follow-Up Plan''; 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)''; CMS137, 
``Initiation and Engagement of Alcohol and Other Drug Dependence 
Treatment''; 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.''
     Through an amendment to Sec.  495.332(f), we gave each 
state the flexibility to identify which of the eCQMs available for 
reporting in the Medicaid Promoting Interoperability Program are high 
priority measures for Medicaid EPs in that state, with review and 
approval by CMS, through the State Medicaid HIT Plan (SMHP). States are 
thus able to identify high priority measures that align with their 
state health goals or other programs within the state.
    All eCQMs identified via any of these three methods are high 
priority measures for EPs participating in the Medicaid Promoting 
Interoperability Program for 2020. We proposed to use

[[Page 84716]]

the same three methods for identifying high priority eCQMs for the 
Medicaid Promoting Interoperability Program for 2021. We solicited 
comments as to whether any of these methods should be altered or 
removed, or whether any additional methods should be considered for 
2021.
    Finally, we note that the eCQM reporting period in 2021 for EPs in 
the Medicaid Promoting Interoperability Program is a minimum of any 
continuous 90-day period within CY 2021, provided that the end date for 
this period falls before October 31, 2021, or falls before a state-
specific alternative date prior to October 31, 2021 that is specified 
in the SMHP, as described in Sec.  495.332(f)(4). This 2021 eCQM 
reporting period will help ensure that states can issue all Medicaid 
Promoting Interoperability Program payments on or before December 31, 
2021. (See 83 FR 59452, 59704 through 59706).
    We received public comments on our proposals for eCQM reporting 
requirements for EPs under the Medicaid Promoting Interoperability 
Program for 2021. The following is a summary of the comments we 
received and our responses.
    Comment: The overwhelming majority of commenters supported our 
proposals and stated that having the same eCQM specifications for the 
Medicaid Promoting Interoperability program and the MIPS quality 
performance category requirements for eligible clinicians using the 
eCQM collection type would indeed reduce the reporting burden on health 
care providers.
    Response: We appreciate the support for our proposals.
    Comment: Two commenters noted that the accuracy of eCQM data may be 
skewed by the timeline necessitating that EPs submit less than a full 
year of data. They explain that some measures are seasonal, such as 
those related to influenza, and an EP may report data that do not 
represent their true level of care over a full year. We also note that 
both of these commenters supported our proposals.
    Response: We acknowledge and understand that reporting periods of 
less than a year may result in inaccurate or incomplete data. However, 
the applicable meaningful use requirement to receive an incentive 
payment is that an EP must simply report the eCQM data to the state. 
The actual data reported are not used to determine whether an EP is 
eligible for an incentive payment as a meaningful user of CEHRT. 
Furthermore, the length of the eCQM reporting period for Medicaid EPs 
in 2021 is consistent with the length of the eCQM reporting period for 
2020. Therefore, health care providers and states should already be 
aware of issues regarding the statistical validity of partial-year eCQM 
data. Additionally, when we established the 90-day eCQM reporting 
period for 2020, we concluded that, generally, the potential data 
quality issues associated with a shorter eCQM reporting period were 
outweighed by the benefits of that shorter period to all stakeholders 
(including to states preparing for the final year of the Medicaid 
Promoting Interoperability program in 2021), and that establishing 90-
day eCQM reporting periods in both 2020 and 2021 might provide better 
data for comparison across the 2 years (see 84 FR 62901 and 62902). 
Finally, when we established the 90-day eCQM reporting period for 2021, 
we noted that it would help ensure that states can make all incentive 
payments before the statutory deadline (see 83 FR 59705).
    Comment: One health care provider commented that the statutory 
deadline created a shortened time period to update the eCQM 
specifications in their EHR, which could have cost and staff workload 
implications. The commenter suggested that we allow EPs the option to 
report using 2020 specifications or to extend the reporting and payment 
deadlines.
    Response: The December 31, 2021 deadline for payments is statutory 
and we do not have the authority to alter that deadline. In the 2019 
PFS final rule (83 FR 59452), we explained that for states to make 
payments by that deadline, there must be sufficient time after EHR and 
eCQM reporting periods end for Medicaid EPs to attest to states, for 
states to conduct their prepayment processes, and for states to issue 
payments. Therefore, we amended Sec.  495.4 to provide that the EHR 
reporting period in 2021 for all EPs in the Medicaid Promoting 
Interoperability Program will 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 states can issue all 
Medicaid Promoting Interoperability Program payments on or before 
December 31, 2021. We also established that the eCQM reporting period 
in 2021 for EPs in the Medicaid Promoting Interoperability Program will 
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 states can issue all Medicaid Promoting 
Interoperability Program payments on or before December 31, 2021. 
However, we also allowed states the flexibility to set alternative, 
earlier final end dates for EHR or eCQM reporting periods for Medicaid 
EPs in CY 2021, with prior approval from us, through their State 
Medicaid HIT Plans (SMHP). Any alternative end date 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. For more information, see our discussion of the EHR and 
eCQM reporting periods for 2021 at 83 FR 59704-6.
    We believe that allowing some EPs to report eCQMs in 2021 according 
to 2020 specifications, and some to report eCQMs in 2021 according to 
2021 specifications, could cause undue confusion about the requirements 
for providers participating in the Medicaid Promoting Interoperability 
Program and/or MIPS and increase the administrative burden on states to 
determine which EPs submitted data in accordance with which 
specifications. As explained above, we believe that the latest eCQM 
specifications provide the most up-to-date clinical standards and 
guidelines. Furthermore, none of the EHR vendors who submitted comments 
indicated that the accelerated 2021 timeline would pose an obstacle to 
issuing system updates in time for EPs to attest to meaningful use. For 
the reasons explained in our proposal, we believe that maintaining a 
single set of the most up-to-date eCQM specifications for EPs to use in 
2021 reduces the burden on EPs who may be reporting to multiple quality 
programs.
    After considering public comments, we are finalizing the proposals 
in this section as proposed.

G. Medicare Shared Savings Program

    On March 23, 2010, the Patient Protection and Affordable Care Act 
(Pub. L. 111-148) was enacted, followed by enactment of the Health Care 
and Education Reconciliation Act of 2010 (Pub. L. 111-152) on March 30, 
2010, which amended certain provisions of the Patient Protection and 
Affordable Care Act (hereinafter collectively referred to as ``the 
Affordable Care Act''). Section 3022 of the Affordable Care Act amended 
Title XVIII of the Act (42 U.S.C. 1395 et seq.) by adding section 1899 
to the Act to establish the Medicare Shared Savings Program (Shared 
Savings Program) to facilitate coordination and cooperation among 
healthcare 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. (See 42 U.S.C. 1395jjj.) 
Eligible groups of providers and suppliers, including physicians, 
hospitals, and other healthcare

[[Page 84717]]

providers, may participate in the Shared Savings Program by forming or 
participating in an Accountable Care Organization (ACO). Under the 
Shared Savings Program, providers of services and suppliers that 
participate in an ACO continue to receive traditional Medicare FFS 
payments under Parts A and B, but the ACO may be eligible to receive a 
shared savings payment if it meets specified quality and savings 
requirements.
    Section 1899 of the Act has been amended through subsequent 
legislation. The requirements for assignment of Medicare FFS 
beneficiaries to ACOs participating under the program were amended by 
the 21st Century Cures Act (Pub. L. 114-255). The Bipartisan Budget Act 
of 2018 (Pub. L. 115-123, enacted on February 9, 2018), further amended 
section 1899 of the Act to provide for the following: Expanded use of 
telehealth services by physicians or practitioners participating in an 
applicable ACO to furnish services to prospectively assigned 
beneficiaries, greater flexibility in the assignment of Medicare FFS 
beneficiaries to ACOs by allowing ACOs in tracks under retrospective 
beneficiary assignment a choice of prospective assignment for the 
agreement period; permitting Medicare FFS beneficiaries to voluntarily 
identify an ACO professional as their primary care provider and 
requiring that such beneficiaries be notified of the ability to make 
and change such identification, and mandating that any such voluntary 
identification will supersede claims-based assignment; and allowing 
ACOs under certain two-sided models to establish CMS-approved 
beneficiary incentive programs.
    The Shared Savings Program regulations are codified at 42 CFR part 
425. 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''). A final 
rule, ``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; 
Medicaid Promoting Interoperability Program; Quality Payment Program--
Extreme and Uncontrollable Circumstance Policy for the 2019 MIPS 
Payment Year; Provisions From the Medicare Shared Savings Program--
Accountable Care Organizations--Pathways to Success; and Expanding the 
Use of Telehealth Services for the Treatment of Opioid Use Disorder 
Under the Substance Use-Disorder Prevention That Promotes Opioid 
Recovery and Treatment (SUPPORT) for Patients and Communities Act'', 
appeared in the November 23, 2018 Federal Register (83 FR 59452) 
(herein referred to as the ``November 2018 final rule'' or the ``CY 
2019 PFS final rule''). In the November 2018 final rule, we finalized a 
voluntary 6-month extension for existing ACOs whose participation 
agreements would otherwise expire on December 31, 2018; allowed 
beneficiaries greater flexibility in designating their primary care 
provider and in the use of that designation for purposes of assigning 
the beneficiary to an ACO if the clinician they align with is 
participating in an ACO; revised the definition of primary care 
services used in beneficiary assignment; provided relief for ACOs and 
their clinicians impacted by extreme and uncontrollable circumstances 
in performance year 2018 and subsequent years; established a new 
Certified Electronic Health Record Technology (CEHRT) use threshold 
requirement; and reduced the Shared Savings Program quality measure set 
from 31 to 23 measures (83 FR 59940 through 59990 and 59707 through 
59715).
    A final rule redesigning the Shared Savings Program appeared in the 
December 31, 2018 Federal Register (Medicare Program: Medicare Shared 
Savings Program; Accountable Care Organizations-Pathways to Success and 
Uncontrollable Circumstances Policies for Performance Year 2017; final 
rule) (83 FR 67816) (hereinafter referred to as the ``December 2018 
final rule''). In the December 2018 final rule, we finalized a number 
of policies for the Shared Savings Program, including a redesign of the 
participation options available under the program to encourage ACOs to 
transition to two-sided models; new tools to support coordination of 
care across settings and strengthen beneficiary engagement; and 
revisions to ensure rigorous benchmarking.
    In the interim final rule with comment period (IFC) entitled 
``Medicare and Medicaid Programs; Policy and Regulatory Revisions in 
Response to the COVID-19 Public Health Emergency'', which was effective 
on the March 31st date of display and appeared in the April 6, 2020 
Federal Register (85 FR 19230) (hereinafter referred to as the ``March 
31st COVID-19 IFC''), we removed the restriction which prevented the 
application of the Shared Savings Program extreme and uncontrollable 
circumstances policy for disasters that occur during the quality 
reporting period if the reporting period is extended, to offer relief 
under the Shared Savings Program to all ACOs that may be unable to 
completely and accurately report quality data for 2019 due to the PHE 
for COVID-19 (85 FR 19267 and 19268). In the IFC entitled ``Medicare 
and Medicaid Programs; Basic Health Program, and Exchanges; Additional 
Policy and Regulatory Revisions in Response to the COVID-19 Public 
Health Emergency and Delay of Certain Reporting Requirements for the 
Skilled Nursing Facility Quality Reporting Program'' which was 
effective on May 8th and appeared in the May 8, 2020 Federal Register 
(85 FR 27573 through 27587) (hereinafter referred to as the ``May 8th 
COVID-19 IFC''), we modified Shared Savings Program policies to: (1) 
Allow ACOs whose current agreement periods expire on December 31, 2020, 
the option to extend their existing agreement period by 1-year, and 
allow ACOs in the BASIC track's glide path the option to elect to 
maintain their current level of participation for performance year 
2021; (2) adjust program calculations to remove payment amounts for 
episodes of care for treatment of COVID-19; and (3) expand the 
definition of primary care services for purposes of determining 
beneficiary assignment to include telehealth codes for virtual check-
ins, e-visits, and telephonic communication. We also clarified the 
applicability of the program's extreme and uncontrollable circumstances 
policy to mitigate shared losses for the period of the PHE for COVID-19 
starting in January 2020.
    We have also made use of the annual CY PFS rules to address quality 
reporting for the Shared Savings Program and certain other issues. 
Refer to the CY 2020 PFS proposed rule for a summary of policies 
finalized in prior rules (84 FR 40705).

[[Page 84718]]

    Policies applicable to Shared Savings Program ACOs for purposes of 
reporting for other programs have also continued to evolve based on 
changes in the law. The Medicare Access and CHIP Reauthorization Act of 
2015 (Pub. L. 114-10) (MACRA) established the Quality Payment Program. 
In the CY 2017 Quality Payment Program final rule with comment period 
(81 FR 77008), we established regulations for the Merit-Based Incentive 
Payment System (MIPS) and Advanced Alternative Payment Models (APMs) 
and related policies applicable to eligible clinicians who participate 
in the Shared Savings Program. These policies included requirements for 
Shared Savings Program ACOs regarding reporting for the MIPS Quality 
performance category and a policy that gives ACOs full credit for the 
MIPS Improvement Activities performance category based on their 
participation in the Shared Savings Program.
    In the CY 2021 PFS proposed rule (85 FR 50229), we explained our 
belief that the changes we were proposing to the quality reporting 
requirements under the Shared Savings Program for performance year 2021 
and subsequent years would reduce ACO burden by establishing a smaller 
measure set, out of which ACOs would only be required to actively 
report 3 measures. This would represent a significant reduction in 
reporting requirements from the 10 measures on which ACOs are currently 
required to actively report. Under our proposal, reporting for these 
measures would begin in January 2022, for the 2021 performance year. We 
also noted that we believed this timeline would allow organizations 
sufficient time to prepare to report on the new measure set. In 
addition, the reporting options for the three ACO-reported measures 
would leverage existing MIPS collection types and more closely align 
existing CEHRT and registries used by ACOs and their clinicians, 
including use of APIs to submit data.
    In sections III.G.1 through III.G.4 of this final rule, we 
summarize and respond to public comments we received on proposed 
modifications to the Shared Savings Program's policies discussed in 
section III.G. of the CY 2021 PFS proposed rule (85 FR 50228 through 
50252). Some commenters' suggestions for modifications to Shared 
Savings Program policies went beyond the scope of the policies 
addressed in section III.G. of the CY 2021 PFS proposed rule, and will 
not be addressed in this section of this final rule. As a general 
summary, in sections III.G.1 through III.G.4 of this final rule we are 
finalizing the following changes to the Shared Savings Program's 
regulations to:
     Modify the approach to measuring ACO quality performance 
under the Shared Savings Program which includes:
    ++ Applying the Alternative Payment Model (APM) Performance Pathway 
(APP) to Shared Savings Program ACOs for performance years beginning on 
or after January 1, 2021. Specifically, we are finalizing that:
    --For performance year 2021, ACOs will be required to report 
quality data via the APP, and can choose to report either the 10 
measures under the CMS Web Interface or the 3 eCQM/MIPS CQM measures. 
In addition, ACOs will be required to field the CAHPS for MIPS survey, 
and CMS will calculate 2 measures using administrative claims data.
    --For performance year 2022 and subsequent performance years, ACOs 
will be required to actively report quality data on the 3 eCQM/MIPS CQM 
measures via the APP. In addition, ACOs will be required to field the 
CAHPS for MIPS survey, and CMS will calculate two measures using 
administrative claims data.
    ++ Revising the Shared Savings Program Quality Performance 
Standard. ACOs will meet the quality performance standard if:
    --For performance years 2021 and 2022, ACOs achieve a quality 
performance score that is equivalent to or higher than the 30th 
percentile across all MIPS Quality performance category scores; and
    --For performance year 2023 and subsequent performance years, ACOs 
achieve a quality performance score that is equivalent to or higher 
than the 40th percentile across all MIPS Quality performance category 
scores.
    ++ Changing the methodology for determining shared savings and 
shared losses based on ACO quality performance.
    ++ Revising the approach to monitoring ACO quality performance and 
addressing ACOs that fail to meet the Quality Performance Standard.
    ++ Updating the process used to validate ACO Quality Data 
Reporting, where we are finalizing that CMS retains the right to audit 
and validate quality data reported by an ACO via the APP according to 
the MIPS DVA process for performance years beginning on or after 
January 1, 2021.
    ++ Updating the extreme and uncontrollable circumstances policy as 
it relates to quality performance.
     Update the definition of primary care services used in 
beneficiary assignment, and codify in regulations the adjustment that 
is made to an ACO's historical benchmark to reflect any changes to the 
beneficiary assignment methodology specified in part 425, subpart E, 
during an ACO's agreement period, including revisions to the definition 
of primary care services at Sec.  425.402(c).
     Revise the repayment mechanism arrangement policy in the 
following manner:
    ++ To reduce the repayment mechanism amount for certain ACOs 
entering an agreement period starting on January 1, 2022, and in 
subsequent years.
    ++ To allow a one-time opportunity for certain ACOs that renewed 
for a new agreement period beginning on July 1, 2019, or January 1, 
2020, to elect to decrease the amount of their existing repayment 
mechanisms.
    ++ To permit a re-entering ACO that is the same legal entity as an 
ACO that previously participated in the program, to use its existing 
repayment mechanism to support its new agreement period, in a similar 
manner as applies to renewing ACOs.
    In section III.G.5. of this final rule, we summarize and respond to 
public comments received in response to the May 8th COVID-19 IFC, and 
discuss our final policies after taking into consideration the public 
comments.
1. Quality and Other Reporting Requirements
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 establishing the Shared Savings 
Program, we adopted a quality measure set spanning four domains: 
patient experience of care, care coordination/patient safety, 
preventative health, and at-risk population (76 FR 67872 through 
67891). Since then, we have updated the measures that comprise the 
quality performance measure set for the Shared Savings Program through 
rulemaking in the CY 2015, 2016, 2017, and 2019 PFS final rules (79 FR 
67907 through 67920, 80 FR 71263 through 71268, 81 FR 80484 through 
80489, and 83 FR 59707 through 59715 respectively).
    As we stated in the November 2011 final rule (76 FR 67872), our 
principal goal in selecting quality measures for ACOs has been to 
identify measures of success in the delivery of high-quality

[[Page 84719]]

health care at the individual and population levels, with a focus on 
outcomes. In the CY 2019 PFS final rule, we finalized that for 
performance years (or a performance period) starting in 2019 and 
subsequent years, 23 quality measures would be used to determine ACO 
quality performance (83 FR 59707 through 59715). The information used 
to determine ACO performance on these quality measures is submitted by 
the ACO through the CMS Web Interface, calculated by us from 
administrative 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.
    Eligible clinicians who are participating in an ACO and who are 
subject to MIPS (MIPS eligible clinicians) are currently scored under 
the 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, or payment model within a track (Track 1 and Levels A 
through D of the BASIC track) of the Shared Savings Program that is not 
an Advanced APM, as well as those MIPS eligible clinicians 
participating in an ACO in a track, or payment model within a track 
(Track 2, Level E of the BASIC track, and the ENHANCED track, or the 
Medicare ACO Track 1+ Model (Track 1+ Model)) 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.
b. Applying the Alternative Payment Model (APM) Performance Pathway 
(APP) to Shared Savings Program ACOs
    As provided in section 1899(d)(2) of the Act and Sec.  425.502(a) 
of the Shared Savings Program regulations, ACOs must meet a quality 
performance standard to qualify to share in savings. In the CY 2017 PFS 
final rule, we finalized revisions to Sec.  425.502 related to the 
quality performance standard and minimum attainment, including 
clarifying that the quality performance standard is the overall 
standard the ACO must meet to qualify to share in savings; defining the 
minimum attainment level for pay for performance measures at the 30th 
percent or the 30th percentile of the quality performance benchmark and 
for pay for reporting measures at the level of complete and accurate 
reporting; specifying that only pay for performance measures are 
assessed on a sliding scale while pay for reporting measures earn the 
maximum number of points for a measure when the minimum attainment 
level is met (81 FR 80492 through 80494).
    We explained in the CY 2021 PFS proposed rule (85 FR 50230) that 
currently, the quality performance standard is based on an ACO's 
experience in the program rather than its financial track. The quality 
performance standard is currently defined at the level of full and 
complete reporting (pay-for-reporting (P4R)) for the first performance 
year of an ACO's first agreement period under the Shared Savings 
Program. In the second or subsequent years of the ACO's first agreement 
period and all years of subsequent agreement periods, quality measures 
are scored as pay-for-performance (P4P) according to the phase-in 
schedule for the specific measure and the ACO's performance year in the 
Shared Savings Program:
     For all performance years, ACOs must completely and 
accurately report all quality data used to calculate and assess their 
quality performance.
     CMS designates a performance benchmark and minimum 
attainment level for each P4P measure and establishes a point scale for 
the measure. An ACO's quality performance for a measure is evaluated 
using the appropriate point scale, and these measure-specific scores 
are used to calculate the final quality score for the ACO.
     ACOs must meet minimum attainment (defined as 30 percent 
or the 30th percentile of the performance benchmark for P4P measures) 
on at least one measure in each domain to be eligible to share in any 
savings generated (Sec.  425.502(d)(2)(iii)(A)).
    In the CY 2020 PFS proposed rule (84 FR 40709 through 40713), we 
sought comment on how we might align the Shared Savings Program quality 
reporting requirements and scoring methodology more closely with the 
MIPS quality reporting and scoring methodology. We discussed utilizing 
the MIPS Quality performance category score to adjust shared savings 
and shared losses under the Shared Savings Program, as applicable. We 
also sought comment on a possible new approach to determining the 
threshold for minimum attainment. Under this potential policy, minimum 
attainment would continue to be defined as complete and accurate 
reporting for ACOs in their first performance year of their first 
agreement period, while a MIPS Quality performance category score at or 
above the 4th decile across all MIPS Quality performance category 
scores would be required for ACOs in all other performance years under 
the Shared Savings Program. ACOs with MIPS Quality performance category 
scores below the 4th decile of all MIPS Quality performance category 
scores would not meet the quality performance standard for the Shared 
Savings Program, and thus, would not be eligible to share in savings or 
would owe the maximum shared losses, if applicable. In addition, we 
sought comment on a potential policy under which ACOs with quality 
scores below the 4th decile of all MIPS Quality performance category 
scores would be subject to compliance actions and possible termination.
    We noted in the CY 2021 PFS proposed rule (85 FR 50230) that the 
majority of feedback received in response to our comment solicitation 
did not support this approach as it would hold ACOs to a higher 
standard to be eligible to share in savings, if earned. In addition, 
commenters that opposed aligning the Shared Savings Program quality 
score with the MIPS Quality performance category score, stated that 
significant restructuring of the Shared Savings Program quality 
performance requirements would introduce more confusion for ACOs that 
are also transitioning into new tracks under the December 2018 final 
rule. Commenters also expressed concern regarding the uncertainty 
associated with such an approach, as we had also proposed extensive 
revisions to MIPS as the program transitions to MIPS Value Pathways. 
Furthermore, commenters noted that ACOs are unique in that they are 
responsible for the total cost of care of their beneficiaries and 
should not be compared to clinicians in MIPS who are not participating 
in total cost of care programs.
    In the CY 2021 PFS proposed rule (85 FR 50230 and 50231), we 
acknowledged the commenters' concerns, but noted that section 
1899(b)(3)(C) of the Act not only gives us discretion to establish 
quality performance standards for the Shared Savings Program, but also 
indicates that we should seek to improve the quality of care furnished 
by ACOs over time by specifying higher standards, new measures, or both 
for purposes of assessing quality of care. The Shared Savings Program 
is now in its eighth performance year, and 85 percent of ACOs 
participating in the program are considered PY3 ACOs for purposes of 
quality reporting, with 65 percent of those ACOs participating in a 
second or subsequent agreement period. In light of the maturity of the 
program and consistent with section 1899(b)(3)(C) of the Act, we stated 
that we believe that it is appropriate to require a higher standard of 
care in order for ACOs to continue to share in any savings they 
achieve. In addition, holding ACOs to a higher standard is in line with 
CMS' goals of incentivizing

[[Page 84720]]

value-based care and driving the Medicare system to greater value and 
quality. However, we explained that after taking into consideration the 
stakeholder feedback, we had also considered ways to reduce reporting 
burden, offer more flexibility in the way quality data can be reported 
and submitted, and create a more meaningful measure set that would 
focus on population health measures and be more outcome-oriented, while 
also including patient experience of care metrics.
    We stated in the CY 2021 PFS proposed rule (85 FR 50231) that 
although the Alternative Payment Model Performance Pathway (APP) was 
designed for all MIPS APMs, it is also responsive to the concerns 
raised by commenters in their responses to our solicitation in the CY 
2020 PFS proposed rule, while still taking into consideration the 
maturity of the Shared Savings Program, ACOs' quality performance over 
time, and the intent of section 1899(b)(3)(C) of the Act. The APP 
contains a narrower measure set than has previously been used for 
Shared Savings Program quality measurement, 6 measures versus the 
current 23 scored measures, and is specifically intended for use in 
APMs and population health. The design of the APP aligns with 
stakeholder interests expressed through comments on our solicitation 
about aligning the Shared Savings Program with MIPS in the CY 2020 PFS 
proposed rule. These comments suggested adopting a smaller, more 
focused measure set in recognition of the fact that APM Entities are 
incentivized through the terms of the respective APMs to improve value. 
The measure set proposed for the APP aligns with the Meaningful 
Measures framework by identifying measures that address the highest 
priorities for quality measurement and improvement, while also reducing 
reporting burden, promoting alignment of measures and consolidation of 
reporting requirements across CMS programs moving payment toward value, 
and identifying consumers' key quality performance metrics. We noted 
that the measures proposed for inclusion in the APP measure set 
encompass the meaningful measure domains of patient voice, wellness and 
prevention, seamless communication, chronic disease management, and 
behavioral health. For these reasons, we stated in the CY 2021 PFS 
proposed rule that we believe that the proposed APP, along with the 
narrower measure set, which comprises it, would be appropriate to 
assess the quality performance of Shared Savings Program ACOs.
    The construction of the proposed APP for Shared Savings Program 
ACOs and the proposed measures within it were described in detail in 
section III.G.1.b.(1) of the CY 2021 PFS proposed rule (85 FR 50231 
through 50235). A detailed discussion of the proposal for use of the 
APP for MIPS APMs more generally can be found in section IV.A.3.b. of 
the CY 2021 PFS proposed rule (85 FR 50285 through 50288).
(1) APM Performance Pathway for Shared Savings Program ACOs
    In section III.G.1.b.(1) of the CY 2021 PFS proposed rule (85 FR 
50231 through 50235), we described the proposals related to the APM 
Performance Pathway for Shared Savings Program ACOs. In response to the 
stakeholder feedback and in order to improve alignment and integration 
with the Quality Payment Program policies and operations, align with 
CMS' Meaningful Measure Framework, increase participation in APMs and 
Advanced APMs by reducing reporting burden, and raise the quality 
performance standard under the Shared Savings Program, we proposed to 
revise the Shared Savings Program quality performance standard 
effective for performance year 2021 and subsequent performance years. 
We explained that the proposed revision would align the Shared Savings 
Program quality performance standard with the proposed APP under the 
Quality Payment Program as participants in the Shared Savings Program 
would be required to report quality for purposes of the Shared Savings 
Program via the APP, which was described in more detail in section 
IV.A.3.b. of the CY 2021 PFS proposed rule (85 FR 50285 through 50288).
    At a high level, we proposed that the APP would replace the current 
Shared Savings Program quality measure set to streamline reporting 
requirements for Shared Savings Program ACOs and would be a 
complementary path to the MIPS Value Pathways. The APP is designed to 
reduce reporting burden, create new scoring opportunities for 
participants in MIPS APMs, and encourage participation in APMs.
    Under this proposed new approach, ACOs would only need to report 
one set of quality metrics that would satisfy the reporting 
requirements under both MIPS and the Shared Savings Program. There 
would not be separate quality reporting requirements under the Shared 
Savings Program, as under the proposed new approach the quality 
measures reported for purposes of the APP would also be used to 
determine the quality performance of the ACO for purposes of the Shared 
Savings Program, which is used for purposes of calculating shared 
savings and also shared losses, where applicable. We stated that we 
believe this approach of streamlining the quality reporting 
requirements under the Shared Savings Program while maintaining 
alignment with the Quality Payment Program will help ACOs and their 
participating providers and suppliers dedicate their finite resources 
to engaging in efforts to improve quality and reduce costs for their 
assigned beneficiary population. In addition, we explained that using a 
single methodology to measure quality performance under both the Shared 
Savings Program and MIPS would allow ACOs to better focus on increasing 
the value of healthcare, improving care, and engaging patients. It 
would also reduce burden as ACOs would be able to track to a smaller 
set of measures under a unified scoring methodology.
    We received many public comments on the proposals to apply the APP 
to determine the quality performance of Shared Savings Program ACOs. 
The following is a summary of the comments we received and our 
responses.
    Comment: We received many comments on the proposal to apply the APP 
to determine quality performance of Shared Savings Program ACOs. 
Supportive commenters noted that this proposal would align reporting 
requirements for MIPS and the Shared Savings Program, shift the focus 
from process measures to clinical outcomes, move toward eliminating 
unnecessary and inappropriate measures, focus on appropriate measures 
for ACO accountability, and provide entities more flexibility for 
reporting and allow MIPS eligible clinicians the option of reporting 
quality data separately from the ACO for purposes of MIPS scoring. 
Further, one commenter noted that alignment between MIPS and quality 
reporting requirements for Advanced APMs would create a better 
glidepath for healthcare providers looking to transition away from fee-
for-service. Additionally, commenters noted that streamlined reporting 
requirements, a smaller set of measures, and a unified scoring 
methodology for the Shared Savings Program and MIPS would result in 
reduced burden for ACOs and allow ACOs to dedicate limited resources 
toward improving care for beneficiaries. One commenter noted that 
alignment of Shared Savings Program quality reporting requirements 
under the APP with reporting requirements under the MIPS program would 
minimize the

[[Page 84721]]

barrier for practices transitioning to an APM.
    However, a majority of commenters expressed concerns about the 
proposal. The most common concerns were the time, effort, and cost 
involved in transitioning to a new measure set, new reporting 
mechanisms, and all-payer reporting, with potentially unintended 
negative impacts on quality, particularly during a time when healthcare 
organizations are impacted by the PHE for COVID-19. Specific concerns 
included the time needed to identify and implement new data collection 
mechanisms, modify operational workflows and clinical strategies to 
align with the six APP quality measures, secure new technology 
capabilities, assess and respond to the impacts of the PHE for COVID-
19, understand the differences in measure specifications, train 
clinicians and office staff on a new reporting platform, and evaluate 
performance against the consolidated measure set to understand the 
impact this change will have on scoring standards. Comments included 
requests that implementation of the APP be delayed until 2022 or later; 
a voluntary transition period be offered to allow time for ACOs to 
adapt to the new requirements; a modified plan be implemented to allow 
ACOs to only report on a sample of patients while they prepare to 
implement automated population measurement; the first year following 
implementation of the APP be a pay-for-reporting year; exemptions to 
reporting requirements be offered; a bonus be offered to ACOs that are 
able to make the transition in 2021 without penalizing ACOs that need 
more time to prepare; and the timelines for implementing the APP and 
implementing the MIPS Value Pathways be aligned. One commenter 
requested that if the proposal is delayed until 2022 that CMS confirm 
the measure set that will be used starting in performance year 2022 in 
the CY 2021 PFS final rule so that ACOs have time to prepare. 
Commenters suggested that more stakeholder feedback should be collected 
before the proposed changes are finalized and that CMS should provide 
time for provider education, outreach, and support between finalizing a 
rule and implementing significant revisions to the quality reporting 
requirements.
    Some commenters supported sunsetting the CMS Web Interface as a way 
to meet the CMS objective of increasing the utilization of CEHRT and 
digital quality measures or interoperability initiatives; but, many 
commenters had concerns about sunsetting the CMS Web Interface. Several 
commenters requested that sunsetting the CMS Web Interface should 
either be a gradual transition or be delayed to allow organizations to 
prepare for the transition to reporting under the APP and ease 
financial constraints practices are currently facing due to the PHE for 
COVID-19.
    One commenter noted that even small changes to the program design 
could cause significant variance in performance for ACOs. The commenter 
recommended that CMS keep the current measure set, reporting mechanism, 
and scoring methods in place for performance 2021. Additionally, the 
commenter stated that healthcare providers should not be held 
accountable for performance against a benchmark that would not be set 
until the performance period closed and expressed concern that the PHE 
would continue to impact quality improvement efforts in 2021. The 
commenter recommended that CMS continue to monitor data submitted 
through the CMS Web Interface, evaluate the impact of the PHE for 
COVID-19 on quality performance, and revert all measures to pay-for-
reporting or provide ACOs with the option to choose historical 
performance scores.
    Other concerns raised by commenters included that the proposed APP 
does not align with the approach CMS uses to assess the quality of care 
furnished by other non-fee-for-service providers, such as Medicare 
Advantage organizations, even though the proposal would align quality 
scoring under the Shared Savings Program with MIPS. Two commenters 
noted that aligning requirements for Advanced APMs with MIPS program 
methodologies was a step backwards. One of these commenters stated that 
the guiding principle should be to ensure that there are strong 
incentives to participate in Advanced APMs relative to traditional 
Medicare fee-for-service, including being excluded from MIPS quality 
reporting processes, to increase the uptake of participation in 
Advanced APMs and decrease the need for MIPS over time. The other 
commenter stated that APMs should not have to align with MIPS, but 
rather MIPS reporting requirements should be structured to encourage 
clinicians to participate in APMs. Several commenters had concerns 
about changes to how ACO quality is reported, scored, and assessed and 
recommended that CMS obtain more stakeholder feedback before moving 
forward. One commenter expressed concern that the proposed APP does not 
support the Shared Savings Program's commitment to improved value, 
stating that the quality performance of ACOs should not be evaluated 
for purposes of the Shared Savings Program in the same manner as under 
other APMs or for individual MIPS clinicians because each APM has 
specific goals and objectives. Further, commenters noted that ACOs are 
distinct from single physician groups or hospital systems because ACOs 
are focused on managing population health and total cost of care for 
their aligned Medicare patient population, and therefore, should not be 
evaluated and assessed in the same manner as other types of healthcare 
providers. One commenter noted that the proposed APP will require 
significant investments while healthcare providers are still recovering 
from the PHE and this may disproportionately disadvantage smaller and 
rural ACOs and multi-practice independent physician ACOs operating many 
EHR systems.
    Response: We thank commenters for their detailed feedback on the 
proposal to apply the APP to Shared Savings Program ACOs beginning in 
performance year 2021. We appreciate the support for our proposal, but 
also understand the concerns raised by a number of commenters about the 
proposed implementation of the APP for Shared Savings Program ACOs 
starting in performance year 2021. The primary concern expressed by 
commenters centered around the timeline for ACOs to implement 
appropriate infrastructure changes in order to be able to report under 
the APP beginning in performance year 2021, particularly given the PHE 
for COVID-19. Commenters also raised concerns about the proposed 
removal of the CMS Web Interface as a collection type. In addition, 
commenters were concerned about the proposed APP measure set, including 
use of measures based on all payer data. In light of the significant 
concerns raised by the commenters about implementing the APP for Shared 
Savings Program ACOs beginning in performance year 2021, we are 
modifying our proposal to apply the APP to determine the quality 
performance of Shared Savings Program ACOs as described below.
    As discussed in section IV.A.3.c.1.c. of this final rule, we are 
extending the use of the CMS Web Interface as a collection type for the 
Quality Payment Program for CY 2021, and will sunset the CMS Web 
Interface starting with CY 2022. Accordingly, we are also modifying the 
quality measure set for the APP for Shared Savings Program ACOs to add 
the CMS Web Interface as an additional reporting option for performance 
year 2021, as discussed in this section and section IV.A.3.b. of this 
final rule. In addition, as discussed in

[[Page 84722]]

section III.G.1.c. of this final rule, we are modifying the proposed 
quality performance standard to include a gradual phase-in of the 
increase in the level of quality performance that would be required for 
ACOs to meet the quality performance standard under the APP for Shared 
Savings Program ACOs. We believe that these changes alleviate many of 
the concerns raised by commenters about the implementation of the APP 
for Shared Savings Program ACOs beginning in performance year 2021.
    Therefore, we are finalizing, with modifications, our proposed 
revisions to the quality reporting requirements under the Shared 
Savings Program effective for performance year 2021 and subsequent 
performance years. These revisions will align the Shared Savings 
Program quality reporting requirements with the requirements that will 
apply under the APP under the Quality Payment Program as Shared Savings 
Program ACOs will be required to report quality data for purposes of 
the Shared Savings Program via the APP. Under this new approach, ACOs 
will only need to report one set of quality metrics via the APP that 
will satisfy the quality reporting requirements under both the Shared 
Savings Program and the MIPS. As discussed in the CY 2021 PFS proposed 
rule (85 FR 50231), there will not be separate quality reporting 
requirements under the Shared Savings Program as the quality measures 
reported for purposes of the APP will be used to determine the quality 
performance of the ACO for purposes of calculating shared savings and 
also shared losses, where applicable. The final APP quality measure set 
is listed in Tables 40 and 46 in this final rule. The policies 
finalized for the APP are discussed in section IV.A.3.b. of this final 
rule. In order to meet the quality reporting requirements under the 
Shared Savings Program, ACOs must meet the requirements described below 
and summarized in Table 39.
     For performance year 2021, ACOs will be required to report 
quality data via the APP, and can choose to actively report either the 
10 measures under the CMS Web Interface or the 3 eCQM/MIPS CQM 
measures. In addition, ACOs will be required to field the CAHPS for 
MIPS survey, and CMS will calculate 2 measures using administrative 
claims data.
    As noted in Tables 40 and 46 in this final rule three of the CMS 
Web Interface measures (Statin Therapy for the Prevention and Treatment 
of Cardiovascular Disease (Quality ID# 438); Depression Remission at 
Twelve Months (Quality ID# 370), and Preventive Care and Screening: 
Screening for Depression and Follow-up Plan (Quality ID# 134)) do not 
have benchmarks, and therefore, will not be scored. However, these 
measures are required to be reported in order to complete the CMS Web 
Interface dataset. Based on the ACO's chosen reporting option, either 6 
or 10 measures will be included in the calculation of the ACO's quality 
performance score.
     For performance year 2022 and subsequent performance 
years, ACOs will be required to actively report quality data on the 3 
eCQM/MIPS CQM measures via the APP. In addition, ACOs will be required 
to field the CAHPS for MIPS survey, and CMS will calculate two measures 
using administrative claims data. All 6 measures will be included in 
the calculation of the ACO's quality performance score.

[[Page 84723]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.084

    The quality reporting requirements described above will provide 
ACOs with a one-year transition period during performance year 2021 
where they will have the option either to continue to report via the 
CMS Web Interface or to report on the 3 eCQM/CQM MIPS measures before 
being required to report on the 3 eCQM/MIPS CQM measures beginning in 
performance year 2022. As discussed in section III.G.1.c. of this final 
rule, we are also finalizing policies to phase-in the increase in the 
quality performance standard over 3 years. We believe that the phase-in 
policies, as summarized in Table 39, for applying the APP to Shared 
Savings Program ACOs address concerns raised by the commenters 
regarding the proposed timeline for implementing the APP and also help 
to mitigate the impact of the PHE for COVID-19 on ACOs. The phase-in 
policies provide ACOs with additional time to set up their systems and 
educate providers and office staff in order to report on the 3 eCQM/
MIPS CQM measures beginning in performance year 2022 and will also 
allow ACOs to become familiar with the new quality reporting 
requirements under the APP and gain experience reporting on the new 
measures before they are assessed under the higher quality performance 
standard beginning in performance year 2023. Commenters' concerns 
related to the APP quality measure set are addressed later in this 
section.
    In the CY 2021 PFS proposed rule, we explained that the APP is 
designed to reduce reporting burden by enabling ACOs to track to a 
smaller set of measures under a unified scoring methodology. The 
policies we are adopting in this final rule are consistent with our 
goal of reducing reporting burden for ACOs. Under our final policies, 
the total number of measures will be reduced from 23 to either 6 or 13 
measures (depending on the ACO's chosen reporting option) for 
performance year 2021 and to 6 measures beginning in performance year 
2022.
    For the commenter that expressed concern that providers should not 
be held accountable for performance against a benchmark that would not 
be set until the end of the performance period, we note that as 
discussed in section IV.A.3.d.1.b.ii. of this final rule, we are not 
finalizing the proposal to use performance period benchmarks and 
instead will continue to use historical benchmarks for quality measures 
for the CY 2021 MIPS performance period.
    We stated in the CY 2021 PFS proposed rule (85 FR 50231) that, 
under the APP proposed in section III.C.3.b., eligible clinicians in 
Shared Savings Program ACOs would continue to receive full credit for 
the improvement activities performance category in 2021 based on their 
performance of activities required under Sec.  425.112 of the Shared 
Savings Program regulations, as they do under current MIPS scoring 
policy. We also proposed that under the APP, the Promoting 
Interoperability performance category would be reported and scored by 
MIPS eligible clinicians and groups and calculated in the same manner 
described at Sec.  414.1375. Shared Savings Program ACOs are not 
currently assessed on the MIPS Cost performance category as they are 
already subject to cost and utilization performance

[[Page 84724]]

assessments as part of the Shared Savings Program, and we proposed that 
the cost performance category would continue to be weighted at zero 
percent under the APP. Under the proposed APP, the four performance 
categories would be weighted as follows: Quality: 50 percent; Promoting 
Interoperability: 30 percent; Improvement Activities: 20 percent; and 
Cost: 0 percent. These policies are being finalized as proposed in 
section IV.A.3.b.4. of this final rule.
    Under the APP, the quality performance score will be calculated for 
ACOs based on the same MIPS benchmarks that are used for other non-ACO 
group and individual reporters and reflect the method of data 
submission (for example, eCQM measures have benchmarks calculated using 
EHR data and CQM measures have benchmarks calculated using data for 
each specific non-EHR collection type). As discussed in section 
IV.A.3.d.1.b.ii of this final rule, we are not finalizing the proposal 
to use performance period benchmarks and instead will continue to use 
historical benchmarks for quality measures for the CY 2021 MIPS 
performance period. However, we note that, for the measures reported 
under the CMS Web Interface for performance year 2021, we will continue 
to use the Shared Savings Program benchmarks developed for the CMS Web 
Interface for performance year 2020. These Shared Savings Program 
benchmarks are based on data reported by ACOs, physicians, and groups 
through the CMS Web Interface, claims, and/or a registry from 2016, 
2017, and 2018. The use of the Shared Savings Program benchmarks for 
the CMS Web Interface measures for performance year 2021 will allow us 
to be consistent with the approach currently used for scoring CMS Web 
Interface measures in the Shared Savings Program. We note that the 
Shared Savings Program benchmarks will also be used for the CMS Web 
Interface measures reported by groups and virtual groups under MIPS.
    In the proposed CY 2021 PFS proposed rule (85 FR 50231 and 50232) 
we proposed that ACOs would be scored on the measures they report and 
will receive zero points for those measures they do not report. For 
example, if an ACO reported all three measures it is actively required 
to report but did not field a CAHPS for MIPS survey measure, the ACO 
would receive zero points for the CAHPS for MIPS survey measure, and 
that zero would be included in its MIPS Quality performance category 
score, along with its performance rates on the three measures it did 
actively report as well as the two claims-based measures included in 
the APP measure set. This proposed approach aligns with scoring under 
MIPS, rather than the current Shared Savings Program quality 
performance scoring methodology, which uses quality benchmarks 
established specifically for the Shared Savings Program and awards zero 
points for quality for ACOs that report some but not all of the 
required measures. We also noted that we believe this approach would be 
less punitive for ACOs than the current quality performance standard, 
under which ACOs that fail to completely report all quality measures 
receive a zero score for quality. We also noted that we believe that 
alignment with the MIPS scoring methodology would reduce the burden on 
ACOs of tracking to two different scoring methodologies. However, we 
proposed that if an ACO does not report any of the three APP measures 
it is required to actively report and does not field a CAHPS for MIPS 
survey the ACO would not meet the quality performance standard for 
purposes of the Shared Savings Program and would not be able to share 
in savings and would owe maximum shared losses, if applicable. We 
explained that if an ACO does not report any of the three measures it 
is required to actively report and does not field a CAHPS for MIPS 
survey, we did not believe that the remaining two claims-based measures 
in the APP core measure set would be sufficient to assess the quality 
of care provided by an ACO to its assigned beneficiaries and would 
likely not allow the ACO to achieve a MIPS Quality performance category 
score at or above the 40th percentile. Under our proposal, there would 
be no quality ``phase in'' for new ACOs or for newly introduced 
measures or for quality measures that undergo significant changes. All 
ACOs, regardless of performance year and agreement period, would be 
scored on all the measures in the APP for purposes of the Shared 
Savings Program quality performance standard.
    We did not receive any comments on the proposal that if an ACO does 
not report any of the three APP measures it is required to actively 
report and does not field a CAHPS for MIPS survey, the ACO would not 
meet the quality performance standard.
    Consistent with the quality reporting requirements finalized for 
Shared Savings Program ACOs under the APP, as discussed above, we are 
finalizing that:
     For performance year 2021: If an ACO does not report any 
of the ten CMS Web Interface measures or any of the three eCQM/MIPS CQM 
measures it is actively required to report and does not field a CAHPS 
for MIPS survey via the APP, the ACO would not meet the quality 
performance standard for purposes of the Shared Savings Program.
     For performance year 2022 and subsequent performance 
years: If an ACO does not report any of the three eCQM/MIPS CQM 
measures it is actively required to report and does not field a CAHPS 
for MIPS survey via the APP, the ACO would not meet the quality 
performance standard for purposes of the Shared Savings Program.
    Comment: We received several comments related to the proposal to 
remove the pay-for-reporting year for ACOs in the first year of their 
first agreement period. Commenters expressed concern that new ACOs may 
require an initial performance year in the Shared Savings Program to 
build operations before they will be prepared to meet pay-for-
performance standards. One commenter noted that new ACOs should have 1-
2 years to learn the quality measures and plan improvement processes. 
Additionally, commenters expressed that removing the pay-for-reporting 
option for new ACOs would deter participation in the Shared Savings 
Program and negatively impact ACOs that are comprised of smaller 
physician practices and do not have hospital system support.
    Response: We appreciate the commenters' concerns regarding the 
removal of the pay-for-reporting year for ACOs beginning an initial 
agreement period under the Shared Savings Program. The goal of the 
proposal was to align the Shared Savings Program quality performance 
standard with the APP under the Quality Payment Program, and there is 
no pay-for-reporting policy under the Quality Payment Program. However, 
in recognition of the concerns expressed by the commenters, we are 
modifying our original proposal and finalizing the following policy: 
Beginning January 1, 2022, for ACOs in the first performance year of 
their first agreement period under the Shared Savings Program, an ACO 
would meet the quality performance standard if it meets the MIPS data 
completeness and case minimum requirements on all three of the eCQM/
MIPS CQM measures and fields the CAHPS for MIPS survey via the APP. The 
scoring policy under MIPS would be the same as for other ACOs.
    We note that, as a result of CMS' decision to forgo an application 
cycle for a January 1, 2021 agreement start date in the Shared Savings 
Program, there will be no ACOs whose first

[[Page 84725]]

performance year of its first agreement period under the Shared Savings 
Program will begin on January 1, 2021. Therefore, this policy will be 
applicable for ACOs that are in the first performance year of their 
first agreement period in performance year 2022 or a subsequent 
performance year. We believe continuing this policy under the APP will 
provide new ACOs with additional time to set up their systems and 
educate providers and office staff, become familiar with the quality 
reporting requirements under the APP, and gain experience reporting on 
the measures under the APP before their performance is assessed in 
order to share in savings.
    Comment: We received several comments related to the proposal to 
remove the pay-for-reporting year for newly introduced quality measures 
and quality measures that have undergone significant changes. 
Commenters suggested that a pay-for-reporting transition year ensures 
that quality measures that are new or have undergone significant 
changes do not have unintended consequences and allows potential issues 
with measure specifications to be identified before ACOs are held 
accountable for measure performance. Additionally, commenters suggested 
that a pay-for-reporting transition year would allow ACOs to adjust 
workflows and operations to ensure that quality data for the new or 
significantly changed measure is appropriately captured.
    Response: We appreciate the commenters' concerns regarding the 
removal of the pay-for-reporting year under the Shared Savings Program 
for newly introduced quality measures and quality measures that undergo 
significant changes. We note that for each quality measure that an ACO 
submits that has significant changes, the total available measure 
achievement points are reduced by 10 points under the APP under current 
MIPS scoring policy (Sec.  414.1380(b)(1)(vii)(A)). We believe that 
adopting these policies for the Shared Savings Program is consistent 
with our goal to align the quality scoring methodology under the Shared 
Savings Program with MIPS. Therefore, we are finalizing our proposal to 
remove the pay-for-reporting year under the Shared Savings Program for 
newly introduced quality measures and quality measures that undergo 
significant changes.
    In the CY 2021 PFS proposed rule (85 FR 50232), we stated that for 
MIPS scoring purposes, an ACO that fails to report via the APP would 
receive a zero in the Quality performance category under MIPS. If an 
ACO fails to report via the APP on behalf of its ACO participants then 
the ACO participants could report outside the ACO, on behalf of the 
MIPS eligible clinicians who bill through the TIN of the ACO 
participant and receive a MIPS Quality performance category score 
calculated at the ACO participant level. If ACO participants report 
outside the ACO via the APP, they would be eligible to earn full credit 
for improvement activities based on ACO participation. If ACO 
participants choose to report outside the ACO via a different MIPS 
reporting option, then regular MIPS scoring rules would apply (that is, 
eligibility to earn full credit for improvement activities and zero 
cost category weight would not be applied). We proposed in the CY 2021 
PFS proposed rule (85 FR 50285) that MIPS eligible clinicians 
participating in ACOs also would have the option of reporting outside 
the APP, or within it at an individual or group level, for purposes of 
being scored under MIPS.
    Comment: One commenter supported the proposal to allow reporting at 
the clinician, group practice, or ACO level for purposes of MIPS 
scoring as it would allow clinicians more flexibility and allow 
clinicians to be recognized for the work they are doing both inside and 
outside the context of the ACO. Other commenters expressed concerns 
regarding a policy under which individual clinicians and group TINs 
would have the option to report outside of the ACO for the purposes of 
MIPS scoring. The commenters expressed concerns that this approach 
would cause unnecessary confusion and instability and could fracture 
the foundation of the ACO by negating the commitment to the ACO. 
Similarly, one provider expressed concern that individual reporting 
adds a layer of complexity that is not conducive to ACO shared 
learnings and best practice identification. Additionally, commenters 
were concerned that this approach would not allow for a fair assessment 
of quality improvement efforts by clinicians or group practices 
participating in ACOs because certain organizations could select 
measures for which they have the highest historical performance. One 
commenter was concerned that reporting separately could 
disproportionately impact rural and smaller providers. The commenter 
recommended that CMS instead maintain the APM Scoring Standard approach 
for all ACO clinicians.
    Another commenter had concerns that allowing TINs and/or NPIs to 
report data on their own, outside of the ACO, would cause even more 
confusion, citing previous concerns with the QPP help desk not 
understanding Medicare Shared Savings Program reporting requirements. 
Specifically, the commenter was concerned that ACO participant 
practices would think they do not need to report on the same measures 
that the ACO is required to report on under the Medicare Shared Savings 
Program.
    Response: Policies related to eligible clinicians and groups 
reporting outside of the APP are discussed in detail in section 
IV.A.3.c.5 of this final rule. We note that the policy discussion above 
relates to ACO participants reporting outside of the ACO via the APP 
when the ACO fails to report data via the APP on behalf of its 
participant TINs. Eligible clinicians participating in an ACO may 
report to MIPS independently at the individual or TIN level. If ACO 
participants report outside the ACO via the APP, they will be eligible 
to earn full credit for improvement activities based on ACO 
participation and to have the cost performance category reweighted. 
However, if ACO participants report to MIPS according to traditional 
MIPS rules, as a group or individual MIPS eligible clinician, MIPS 
scoring rules apply. These policies are discussed in further detail in 
section IV.A.3.b. of this final rule. Additionally, we refer readers to 
section IV.A.3.e. of this final rule for information concerning our 
final policy on the hierarchy that will apply when more than one final 
score is associated with a TIN/NPI. We also refer readers to the 
discussion earlier in this section where we are finalizing our proposal 
that if an ACO does not report any of the three APP measures it is 
required to actively report and does not field a CAHPS for MIPS survey, 
the ACO would not meet the quality performance standard.
    In the CY 2021 PFS proposed rule (85 FR 50232 and 50233), we 
proposed that for performance year 2021 and subsequent performance 
years, ACOs would be assessed on a smaller measure set under the APP 
for Shared Savings Program ACOs. The measures ACOs would be scored on 
would decrease from 23 measures to 6 measures and the number of 
measures on which ACOs would be required to actively report would be 
reduced from 10 to 3.
    ACOs would report under the APP on the following 3 measures:
     Quality ID#: 001: Diabetes: Hemoglobin A1c (HbA1c) Poor 
Control (>9%);
     Quality ID#: 134 Preventive Care and Screening: Screening 
for Depression and Follow-Up Plan; and
     Quality ID#: 236 Controlling High Blood Pressure.
    ACOs would report these measures via a submission method of their 
choice

[[Page 84726]]

that aligns with the MIPS data submission types for groups at Sec.  
414.1325(c) (direct, login and upload, or a third-party intermediary, 
described at Sec.  414.1400, submitting on behalf of the ACO). ACOs 
would receive a score of between 3 to 10 points for each measure that 
meets the data completeness and case minimum requirements, which would 
be determined by comparing measure performance to established 
benchmarks. In addition, ACOs would need to field a CAHPS for MIPS 
survey and would be measured on two claims-based measures: The 
Hospital-Wide, 30-day, All-Cause Unplanned Readmission (HWR) Rate for 
the Merit-Based Incentive Payment Program (MIPS) Eligible Clinician 
Groups; and the All-Cause Unplanned Admissions for Patients with 
Multiple Chronic Conditions (MCC). Please see Table 36 in the CY 2021 
PFS proposed rule (85 FR 50233) for full details on the measures 
proposed under the APP.
    The measures proposed for inclusion in the measure set for the APP 
would align with the Meaningful Measures framework by identifying the 
highest priorities for quality measurement and improvement with the 
goals of reducing burden, promoting alignment, moving payment toward 
value, and identifying key quality performance metrics for consumers. 
The proposed measures would also encompass the meaningful measure 
domains of patient voice, wellness and prevention, seamless 
communication, chronic disease management, and behavioral health. We 
explained that we believe that the measures included in the APP are 
appropriate to assess the quality performance of Shared Savings Program 
ACOs as they focus on the management of chronic health conditions that 
are high priority and have high prevalence among the population of 
Medicare beneficiaries assigned to ACOs. We also noted that we believe 
that the measure set chosen for inclusion within the APP would move the 
quality measure set used in the Shared Savings Program toward a more 
outcome based, primary care focused measure set. In addition to 
creating a pathway that would reduce reporting burden for ACOs and 
allow their participating MIPS eligible clinicians to meet requirements 
under MIPS through a smaller measure set, requiring ACOs to report 
through the APP would also eliminate differences in the way ACOs are 
scored under the Shared Savings Program, as compared to the way their 
MIPS eligible clinicians are scored under MIPS.
    We noted that under the current Shared Savings Program quality 
scoring methodology, the CAHPS for ACOs survey is counted as ten 
separate measures, while under the APP, the CAHPS for MIPS survey would 
be counted as one. We explained that we continue to value the patient 
voice and believe it should play a significant role in quality scoring. 
Using the CAHPS for MIPS survey would achieve that goal while further 
aligning the way in which the quality performance of ACOs and their 
MIPS eligible clinicians is scored under the Shared Savings Program and 
under MIPS, respectively. We noted that under the current Shared 
Savings quality scoring methodology, the 10 CAHPS for ACOs survey 
measures are scored as one domain, which makes up 25 percent of the 
Shared Savings Program quality score. In contrast, under the proposed 
approach, the CAHPS for MIPS survey would be counted as one measure out 
of the 6 measures that would be included in the calculation of the 
ACO's quality score under the APP. Both of these approaches have a 
similar weighting, which would maintain the relevance of patient voice. 
We also noted that we believed that the proposed approach under the APP 
of combining the CAHPS survey measures into a single measure for 
quality scoring purposes would allow Shared Savings Program ACOs to 
effectively target resources toward improving their assigned 
beneficiaries' experience of care in the areas for improvement on which 
they choose to focus, rather than having to track to ten separate 
survey measures, as is currently required by the CAHPS for ACOs used 
under the Shared Savings Program. We believed this approach would 
strike the right balance in reducing burden on ACOs and their 
participating providers and suppliers while preserving the patient's 
voice.
    Shared Savings Program ACOs are currently required to report on a 
set of ten measures via the CMS Web Interface. While these measures 
were appropriate for use in the program in the past because they are 
primary care focused, we explained that we now recognize that the 
majority of the measures have highly clustered performance. This means 
that they cannot meaningfully distinguish quality performance across 
groups or ACOs. We also noted that we recognize the value in the use of 
primary care-focused measures and in that developing the proposed 
measure set for use under the APP, we had sought to preserve the 
measures we believed most reflect high priority quality measurement 
areas while also placing more emphasis on outcome-based claims 
measures, which minimize reporting burden and reflect greater 
opportunity for improvement.
    We received many public comments on the proposed APP quality 
measure set as applied to Shared Savings Program quality performance 
scoring. The following is a summary of the comments we received and our 
responses. Please refer to section IV.A.3.b.(3)a. of this final rule 
for further discussion of comments and responses on the APP measure 
set.
    Comment: Many commenters were supportive of the overall goal of 
simplifying reporting and aligning quality measurement approaches 
across federal programs. Several commenters were supportive of the 
reduction in the number of measures to reduce burden for healthcare 
providers, including the reporting burden placed on rural primary care 
practices. One commenter supported the proposed measure set, stating 
that it was adequate to address the chronic conditions among Medicare 
beneficiaries. One commenter indicated that the proposed reduced 
measure set focused on clinical outcomes and patient experience and is 
less burdensome for healthcare providers. One commenter supported this 
proposal and specifically stated that requiring former users of the CMS 
Web Interface to report all payer data will result in more patients 
receiving the benefit of services captured in the quality metrics, such 
as depression screening and pneumococcal vaccination status, rather 
than practices focusing those wellness measures solely on Medicare 
patients.
    Response: We thank commenters for their positive feedback on the 
proposed APP quality measure set. The reduced measure set is intended 
to reduce reporting burden on ACOs and focus on quality measures that 
address patient outcomes and appreciate hearing that commenters also 
believe that the proposed measure set is consistent with those goals.
    Comment: Several commenters were concerned that the proposed 
measure set is not appropriate for healthcare providers, such as ACOs, 
that are responsible for the total cost of care for the populations 
they serve and will not allow for robust assessment of clinical 
quality. Some commenters noted that the reduction in measures would 
significantly increase the impact of each measure on an ACO's overall 
quality score, which could risk over-emphasizing certain metrics and 
underlying patient conditions, as well as create more disruption when 
the measure set is revised. Additionally, several commenters were 
concerned that reducing the quality measure set would de-emphasize 
quality and would

[[Page 84727]]

not allow for a representative assessment of ACOs' quality improvement 
efforts, making it more difficult for ACOs to distinguish themselves 
based on the care they provide. One commenter was concerned that the 
reduction in measures would limit the ability for consumers to evaluate 
and compare the quality of providers. Another commenter had concerns 
that reducing the number of ACO quality measures would make specialists 
less likely to participate in the Shared Savings Program. Another 
commenter stated that the proposed measures are not relevant to 
ophthalmology specialty practices and suggested that the same measure 
sets used in MIPS be permitted for reporting through the APP or a 
protocol be put in place to determine if the measures are relevant to 
the clinicians reporting under the APP.
    One commenter expressed concern that the narrower quality measure 
set would not appropriately protect patients because it would narrow 
the lens through which quality is assessed. Several commenters 
recommended that CMS work with stakeholders to refine the current set 
of measures to make it more appropriate for ACOs, which are responsible 
for total cost of care for the populations they serve. Another 
commenter stated that CMS should clarify if the outcome measures 
selected are representative of all of the different types of 
populations that ACOs treat and recommended that CMS take patient 
compliance and case mix into consideration when selecting measures 
because some patients may take longer to achieve health goals and ACOs 
may not have the same relative volume of patients with diagnoses such 
as diabetes and hypertension. One commenter suggested that CMS 
demonstrate that the proposed measures are of high significance to 
beneficiaries. Due to the impacts of the PHE for COVID-19, one 
commenter recommended that measures, such as breast cancer and 
colorectal cancer screening, be removed or treated as pay-for-reporting 
for performance year 2021.
    Some commenters also expressed concern that the limited measure set 
would allow little room for random variation in one measure because 
random variation in one measure will have a larger impact when there 
are fewer measures to absorb the impact. One commenter stated that the 
limited measure set puts ACOs at a disadvantage compared to entities 
that are able to report outside of the APP and who can choose from 
larger pool of measures. Commenters also expressed concern that the 
reduction in the number of measures was too drastic and may have 
unforeseeable impacts on quality scoring for ACOs. One commenter 
suggested a more gradual, phased reduction where measures would be 
removed in rounds based on level of priority so that the impact of 
reducing the size of the measure set could be evaluated before 
additional measures are removed. Commenters also suggested that CMS 
monitor the smaller measure set to ensure the measures are not overly 
sensitive to minor changes in performance, random variation, or risk 
adjustment methodologies.
    Other commenters suggested that CMS consider a broader measure set, 
and many commenters made recommendations for measures to be added to 
the measure set. One commenter suggested that a larger set of quality 
measures would be worth the additional burden because it would protect 
ACOs against errors in scoring, changes in risk adjustment methodology, 
and anomalies. Another commenter noted that while reducing the number 
of measures will reduce burden, ACOs also experience administrative 
burden due to year-to-year changes in the Shared Savings Program and 
the lack of alignment in measures between programs.
    Response: We appreciate the commenters' concerns and 
recommendations regarding the narrower set of quality metrics that we 
proposed for the APP and its appropriateness for assessing the quality 
of care furnished by ACOs and their ACO participants. The transition to 
the APP measure set is intended to reduce reporting burden and 
eliminate differences in the way ACOs are scored compared to their MIPS 
eligible clinicians, while also moving toward a more outcome-based, 
primary care focused measure set. Additionally, we selected the 
measures to be included in the measure set because they are broadly 
applicable for the primary care population and population health goals 
that are associated with the Shared Savings Program. These measures 
align with the Meaningful Measures framework while also being 
appropriate for assessing ACO quality performance as they focus on 
prevalent and high priority chronic health conditions. For example, 
hypertension and diabetes are chronic conditions that are applicable to 
both primary care practitioners and specialists.
    Comment: Several commenters expressed concern that two of the six 
proposed quality measures (Measure # 479 Hospital-Wide, 30-day, All-
Cause Unplanned Readmission (HWR) Rate for MIPS Eligible Clinician 
Groups and Measure # TBD Risk Standardized, All-Cause Unplanned 
Admissions for Multiple Chronic Conditions for ACOs) are focused on 
utilization even though the Shared Savings Program provides financial 
incentives for reducing avoidable hospital admissions and readmissions. 
Additionally, commenters stated that ACOs should be evaluated on 
quality measures that reflect core ACO competencies, such as care 
coordination activities and preventative health.
    Response: Under the Shared Savings Program, an ACO that lowers 
growth in Medicare Parts A and B expenditures such that performance 
year expenditures for the ACO's assigned beneficiary population are 
below the ACO's updated historical benchmark by an amount that meets or 
exceeds the applicable minimum savings rate, may be eligible to share 
in savings. We do not believe that the incentive for ACOs to lower 
growth in expenditures, in order to generate shared savings, conflicts 
with assessment of the quality of care furnished by an ACO that 
includes measures of utilization, such as Measure # 479 Hospital-Wide, 
30-day, All-Cause Unplanned Readmission (HWR) Rate for MIPS Eligible 
Clinician Groups and Measure # TBD Risk Standardized, All-Cause 
Unplanned Admissions for Multiple Chronic Conditions for ACOs. We note 
that section 1899(b)(3)(A) of the Act requires the Secretary to 
determine appropriate measures to assess the quality of care furnished 
by the ACO, such as measures of clinical processes and outcomes; 
patient, and, wherever practicable, caregiver experience of care; and 
utilization (such as rates of hospital admission for ambulatory 
sensitive conditions). Additionally, regarding the commenters' concerns 
about quality measures addressing core ACO competencies, we note that 
the APP measure set includes measures that address preventive health 
and care coordination. For example, the All-Cause Readmission (HWR) and 
All-Cause Unplanned Admissions for Multiple Chronic Condition measures 
fall into the Meaningful Measure domain of Promoting Effective 
Communication and Coordination of Care and the Preventive Care and 
Screening: Screening for Depression and Follow up plan falls into the 
Meaningful Measure domain of Promoting Effective Prevention & Treatment 
of Chronic Disease.
    Comment: Several commenters expressed concerns about data 
collection methods in light of the increasing use of telehealth visits, 
as well as the various measure types (such as eCQM/MIPS CQM measures, 
CAHPS

[[Page 84728]]

for MIPS survey measures, and claims-based measures) used in the APP 
measure set. Commenters recommended that the measures selected be 
viewed through the lens of the current PHE environment and that all 
quality measures allow data to be collected during telehealth visits 
because many ACO participants have been relying on telehealth visits to 
continue seeing their patients during the PHE.
    Response: We understand commenters' concerns related to the PHE for 
COVID-19. For the claims-based measures in the APP measure set, 
telehealth codes are not used to exclude claims from the measure 
calculation algorithm or the claims used to identify comorbidities as 
part of the risk adjustment model. Nine out of the ten CMS Web 
Interface measures, which are in the measure set for performance year 
2021, allow the requirements for inclusion in the numerator to be met 
during a telehealth encounter. Quality ID#: 438 is the only measure 
that does not allow the quality action required to meet numerator 
compliance, to occur during a telehealth encounter. Similar to the Web 
Interface measures, the three eCQM/MIPS CQM measures in the APP measure 
set allow the requirements for inclusion in the numerator to be met 
during a telehealth encounter.
    Comment: Commenters suggested that further consideration was needed 
to determine the appropriate composition of the quality measure set by 
measure type (that is, proportion of clinical, patient experience, and 
administrative claims measures) and the appropriate balance between 
clinical outcome measures and preventive care measures. One commenter 
recommended that, to the extent possible, CMS make use of 
administrative claims data, including CPT Category II codes, to 
determine measure performance with an opportunity for ACOs to provide 
supplementary data to reduce healthcare provider burden. One commenter 
supported the inclusion of eCQMs because eCQMs tie the use of 
technology to the Quality performance category by encouraging the 
proper use of EHRs and increase the reliability of data based upon not 
having human manipulation or intervention, but did not support the 
inclusion of administrative claims measures, citing concerns with 
reliability of the data and the cost to large practices.
    Response: In response to comments on the appropriate composition of 
the quality measure set by measure type (that is, proportion of 
clinical, patient experience, and administrative claims measures) and 
the appropriate balance between clinical outcome measures and 
preventive care measures, we note that the APP measure set is intended 
to assess a sample of the areas where ACOs should be focused on 
improving the quality of care; it is expected that ACOs should be 
working to improve quality in additional areas as well. We appreciate 
the commenters' concerns regarding the use of administrative claims 
measures. Administrative claims measures have historically been used 
successfully to measure ACO quality performance under the Shared 
Savings Program. CMS calculates the administrative claims measures for 
ACOs, which minimizes the burden associated with these measures.
    Comment: Commenters stated they would like to see more publicly 
available comparative data on ACO performance on the core quality 
measures under the Shared Savings Program, such as ACO-14, Influenza 
Immunization; ACO-19, Colorectal Cancer Screening; ACO-20, Breast 
Cancer Screening; and the previously used Pneumonia Vaccination 
measure. The commenters asserted that ACOs cannot be fairly assessed if 
they are only measured on the proposed APP measures because the 
measures do not reflect the true purpose of ACOs and the work they do 
in quality improvement.
    Response: Each year when CMS releases the Shared Savings Program 
Financial and Quality reconciliation results, Public Use files (PUFs) 
are posted that provide the public with comparative data on the quality 
results for a given performance year. We note that data on the measures 
referenced by the commenters are publicly available in these PUF files. 
We disagree with commenters that ACOs cannot be fairly assessed if they 
are only measured on the measures in the APP measure set. As discussed 
above, we believe that the measures in the APP measure set are broadly 
applicable for the primary care population and population health goals 
that are associated with the Shared Savings Program. These measures 
align with the Meaningful Measures framework while also being 
appropriate for assessing ACO quality performance as they focus on high 
prevalence, high cost, and high priority chronic health conditions.
    Comment: Several commenters expressed concern that half of an ACO's 
quality score would depend on the CAHPS measure and two administrative 
claims measures. One commenter asserted that these measures have 
potential for unpredictability because minor differences in CAHPS 
scores can cause significant variation in ACOs' overall quality scores 
and there can be variance in scores on administrative claims measures 
related to risk adjustment changes. These commenters also expressed 
concern that CMS does not publish detailed measure specifications for 
the CAHPS or administrative claims measures. One commenter was 
concerned that the readmission measure would have a greater impact on 
the overall quality score under our proposed changes to the quality 
measure set because the commenter believes that the readmission measure 
is volatile.
    Response: In regard to commenters' concern that the number of CAHPS 
measures is disproportionately high compared to clinical quality and 
outcomes measures, we note that under the new APP, the results of the 
CAHPS survey will account for a smaller proportion of ACOs' total 
quality score. Under the current scoring methodology, the CAHPS 
measures make up 1 domain or 25 percent of an ACO's quality score. 
Under the APP for Shared Savings Program ACOs that we are finalizing in 
this final rule, the results on the CAHPS measures will be combined to 
calculate a single composite score that will account for one sixth of 
the ACO's quality score or 16.7 percent or one tenth of the ACO's 
quality score or 10.0 percent, depending on which measure set the ACO 
reports on in 2021. Under both measure sets, patients' experience of 
care will meaningfully contribute to the overall quality score, while 
at the same time allowing other important measures of quality to also 
meaningfully contribute to the overall quality score.
    Comment: Some commenters expressed concern that quality measures in 
the APP quality measure set have narrow performance ranges. One 
commenter suggested an alternative approach to calculating the 
benchmarks for quality measures that includes creating expanded 
percentiles due to concern that the current percentiles result in too 
narrow of a performance range where variation could be due to a small 
number of events or beneficiaries.
    Response: We appreciate the commenter's recommendations regarding 
calculating benchmarks. We note that the seven CMS Web Interface 
measures with benchmarks for performance year 2020 are flat benchmarks 
that are used in accordance with Sec.  425.502(b)(2)(ii) for measures 
that have clustered high performance rates. For the measures reported 
under the CMS Web Interface for performance year 2021, we will continue 
to use the Shared Savings Program benchmarks developed for the CMS Web 
Interface for performance year 2020.

[[Page 84729]]

    We believe this practice addresses commenters' concerns about 
clustered performance having an adverse effect on ACOs' performance on 
the web interface measures. We refer readers to the MIPS benchmarking 
policy as defined at Sec.  414.1380(b)(1)(ii), topped out measure 
scoring as defined at Sec.  414.1380(b)(1)(iv), and flat percentage 
benchmark policy as defined at Sec.  414.1380(b)(1)(ii)(C).
    Comment: Several commenters suggested that CMS conduct further 
testing for risk adjustment of outcome measures, including social risk 
factors. These commenters requested CMS test the measures to ensure 
that minor changes to the risk adjustment methodology did not have 
significant impacts on the ACOs' quality scores. One commenter 
suggested that CMS enhance the risk adjustment of the outcome measures 
to address the high-risk patient populations of ACOs. Another commenter 
expressed concern that CMS should not include measures in the quality 
measure set used to assess ACO quality performance until they have been 
appropriately risk adjusted for sociodemographic factors, including 
socioeconomic status. The commenter explained that without appropriate 
risk adjustment for outcomes measures, such as the proposed readmission 
measure, the APP measure set could disproportionately impact the 
quality performance of ACOs that have an assigned beneficiary 
population served by ``essential hospitals''.
    Response: Both of the proposed claims-based measures are risk-
adjusted with beneficiary demographic characteristics and a wide range 
of clinical comorbidities to improve comparison of measure performance 
between organizations. These measures use a large number of 
Hierarchical Condition Category (HCC) comorbidity categories that 
account for many high-risk conditions among beneficiaries, which helps 
to adjust for differences in patient populations between ACOs. Risk 
adjusting in this manner is in accordance with best practices for risk 
adjustment to account for the higher level of risk for certain 
beneficiaries. We also note that the revised MCC measure has an 
additional risk adjustment not present in the original MCC measure that 
is in the current Shared Savings Program measure set. The revised 
measure adjusts for two area level social risk factors: (1) AHRQ socio-
economic status (SES) index; and (2) specialist density. The original 
MCC measure does not contain any social risk factors in the risk 
adjustment.
    We received several comments regarding the feasibility of using the 
alternative MIPS reporting options for purposes of quality reporting 
under the Shared Savings Program, which are summarized below.
    Comment: Several commenters requested clarification of whether ACOs 
would report quality data for all patients regardless of attribution or 
payer status. Additionally, commenters explained that ACOs often 
operate using multiple EHR systems and requested clarification of 
whether ACOs would report separately for each EHR system. Several 
commenters expressed concern that using the alternative MIPS reporting 
options would result in ACOs being evaluated on the quality of the care 
furnished to all of the patients they serve. These commenters were 
concerned that this data would not be a true reflection of an ACO's 
quality improvement efforts and objected that it would not be fair to 
measure ACO quality based on non-attributed patients. Commenters also 
expressed concern that ACOs may not have the legal ability to access 
data for patients that are not attributed to the ACO, which may skew 
any assessment of quality. Additionally, one commenter noted that the 
differences between community health center populations and private 
practice populations would be magnified by the requirement to report on 
all patients served and that unlike the administrative claims measures 
that use HCC risk adjustment, the three clinical quality measures do 
not have similar adjustments. The commenter recommended that ``CMS use 
the same eligibility category definitions used in cost calculations for 
peer groups that can be assumed to carry forward to the entire patient 
population.'' The commenter also recommended that CMS further consider 
whether reporting for all patients will improve or worsen disparities 
and urged CMS to seek to incentivize improvement of disparities between 
patients served by community health centers and private practices 
through clinical quality and claims based measurement and benchmarking. 
Another commenter noted that current measure specifications would 
result in patients being eligible for measure denominators regardless 
of provider specialty designation and recommended that CMS incorporate 
logic into the measures to require a qualifying visit with a primary 
care provider. This commenter also recommended that CMS modify the 
reporting requirements for the eCQM/MIPS CQM measures to exclude 
patients who are not assigned to the ACO for purposes of reporting 
under the Medicare Shared Savings Program. The commenter explained that 
if reporting on the measures is not limited to the ACO's assigned 
beneficiary population, ACOs that include an Academic Medical Center 
(AMC) could be particularly negatively impacted because AMCs often care 
for patients who have primary care providers in other states and 
patients that are seen for short term destination services.
    Some commenters expressed concern that vendors and developers would 
require additional lead time to update and test systems, configure 
tools and measurement algorithms to aggregate data at an ACO level, and 
handle the wave of new entities reporting using eCQMs/MIPS CQMs. 
Several commenters also noted that some ACOs would need to revise 
vendor participation agreements and contracts to allow them to access 
and report on data across all patients served by their ACO 
participants, which may cause further delays. Additionally, commenters 
also expressed concern that measure results may be unreliable due to 
vendors interpreting measure specifications differently.
    Although some commenters acknowledged that ACOs would be reporting 
fewer quality metrics under the proposed APP, these commenters believe 
the proposal would increase reporting burden because ACOs would be 
required to report on a larger pool of patients and to become familiar 
with new data collection and reporting mechanisms. The commenters 
recommended that if we were to finalize the proposed eCQM/MIPS CQM 
measures, ACOs should be required to report on a sample population or a 
maximum of 50 percent of ACO beneficiaries. Alternatively, one 
commenter suggested that instead of ACOs being responsible for 
aggregating data for the eCQM/MIPS CQM measures included in the APP to 
create an ACO-wide score, CMS should be responsible for aggregating 
data on behalf of the ACO. The commenter stated that this process would 
reduce burden on the ACOs. Other commenters suggested that ACOs should 
only be required to report eCQMs for assigned beneficiaries while ACOs 
are transitioning away from the CMS Web Interface reporting mechanism 
and that CMS should work with industry leaders to create QRDA III 
aggregate TIN level reporting for assigned beneficiaries so that each 
ACO Participant TIN could submit the QRDA III file via the QPP website 
and CMS would calculate performance scores for the ACO. Additionally, 
commenters suggested that some ACOs may not have the time or financial 
capacity to explore other data collection and reporting mechanism 
workflows, especially due

[[Page 84730]]

to constraints caused by the PHE for COVID-19. For example, commenters 
explained that some ACOs would need to pay fees to modify EHRs, obtain 
new EHR interfaces and aggregation tools, update performance 
dashboards, and potentially work with a registry, and that these costs 
could pose a significant hardship for smaller ACOs.
    Response: We acknowledge the concerns raised by the commenters 
about the change to reporting eCQMs/CQM MIPS measures, the need for 
time to transition to this new data collection format and collecting 
data on all-payer data and the time needed to set up new 
infrastructures for submitting this data to CMS. The CMS Quality 
Measurement Strategy is continuing to drive towards patient-centered, 
value-based care through the development, selection, and implementation 
of measurement that includes accelerating the move to digital measures, 
promoting the use of all payer data, increasing alignment of measures, 
and unleashing the voice of the patient through the use of patient 
reported outcomes. The APP measures include all-payer, patient-centric, 
and population-based outcome measures that are designed to promote the 
goals of the CMS Quality Measurement Strategy and align with the 
Meaningful Measures framework.
    While the three eCQM/MIPS CQM measures are based on all payer data, 
we believe they are appropriate for assessing the quality of care 
furnished by the ACO as required by section 1899(b)(3) of the Act. 
These measures focus on the management of chronic health conditions 
that are a high priority and have high prevalence among Medicare 
beneficiaries. To the extent that these conditions are also prevalent 
among other populations of patients that receive services from the 
eligible clinicians participating in an ACO, we believe it is relevant 
to consider the quality of care that is furnished by ACO participants 
across all of their patients as part of assessing the overall quality 
of care furnished by the ACO. We also note that measuring care delivery 
to all patients is appropriate because improving care processes and 
practices is expected to improve care for all patients (for example, 
improvements to an electronic health record would be expected to 
improve care for all patients, not just Medicare patients). 
Additionally, CMS would not want ACOs participating in the Shared 
Savings Program to improve care for Medicare beneficiaries by reducing 
care quality for non-Medicare beneficiaries. Thus looking at the 
overall quality of care furnished to all patients is consistent with 
the goal of improving care furnished by ACOs by ensuring that care 
delivery is improving across all patients, rather than encouraging ACOs 
to focus disproportionately on improving measure performance for 
Medicare beneficiaries.
    In addition, we believe the use of all-payer measures will provide 
an additional incentive for ACO participants to standardize care 
processes across all of their patient populations, which should improve 
the quality of care for all patients, including the ACO's assigned 
Medicare beneficiaries, while also making it easier to capture and 
report required data because ACOs would only need to capture and report 
one set of quality metrics to satisfy the reporting requirements under 
both MIPS and the Shared Savings Program.
    With regard to concerns about reporting the three eCQM/CQM 
measures, ACOs will need to determine which collection type, either 
eCQM specifications captured via an EHR or MIPS CQM specifications 
intended to be used by groups or ACOs submitting measures via qualified 
registry, they will use to collect and report quality measure data. The 
ACO will report data in the aggregate on behalf of its ACO participants 
using the relevant measure specifications and could submit data via the 
following MIPS submission types using either direct login, such as 
application program interface or API, or sign in and upload. For 
example, the ACO could, on behalf of its ACO participants combine the 
results from all the ACO participant TIN QRDA 3 files, by adding 
numerators, denominators, etc. and create an aggregate QRDA3 file (or 
other compliant file format) and submit as an ACO to CMS. ACOs could 
also contract with a third party intermediary (such as a registry) to 
submit data on behalf of the ACO. We acknowledge commenters' concerns 
about the time needed to set up new infrastructures to report all-payer 
data; therefore, we are finalizing a phase-in approach to the quality 
reporting requirements under the Shared Savings Program. For 
performance year 2021, ACOs can opt to report 10 measures via the CMS 
Web Interface or the three eCQM/CQM measures as part of the APP. If an 
ACO opts to report via the CMS Web Interface, the requirements for 
which patients must be included for purposes of quality reporting would 
remain unchanged, ACOs would report on the provided beneficiary sample.
    As discussed earlier in this section, in order to meet the quality 
reporting requirements under the Shared Savings Program and the MIPS, 
ACOs must meet the following requirements:
     For performance year 2021, ACOs will be required to report 
quality data via the APP, and an ACO can choose to actively report 
either the 10 measures under the CMS Web Interface or the 3 eCQM/MIPS 
CQM measures. In addition, ACOs will be required to field the CAHPS for 
MIPS survey, and CMS will calculate 2 measures using administrative 
claims data.
     For performance year 2022 and subsequent performance 
years, ACOs will be required to actively report quality data on the 3 
eCQM/MIPS CQM measures via the APP. In addition, ACOs will be required 
to field the CAHPS for MIPS survey, and CMS will calculate two measures 
using administrative claims data.
    As discussed in section III.G.1.c. of this final rule, we are also 
finalizing policies to phase-in the increase in the quality performance 
standard over 3 years. We believe that the phase-in policies for 
applying the APP to Shared Savings Program ACOs and increasing the 
quality performance standard address the concerns raised by the 
commenters regarding the proposed timeline for implementing APP and the 
challenges of reporting on the measures in the APP measure set. The 
quality reporting requirements described above will provide ACOs with a 
one-year transition period during performance year 2021 in which they 
will have the option either to continue to report via the CMS Web 
Interface or to report on the 3 eCQM/CQM MIPS measures before being 
required to report on the 3 eCQM/MIPS CQM measures beginning in 
performance year 2022. This transition period, coupled with the phase-
in of the new quality performance standard discussed earlier in this 
section, will provide ACOs with additional time to set up their systems 
and educate providers and office staff in order to be prepared report 
on the 3 eCQM/MIPS CQM measures beginning in performance year 2022 and 
will also allow ACOs to become familiar with the new quality reporting 
requirements under the APP and gain experience reporting on the new 
measures before they are assessed under the higher quality performance 
standard beginning in performance year 2023.
    We received comments on the individual measures in the proposed 
measure set, which are summarized below.
    Comment: We received several comments related to the proposal to 
include the CAHPS for MIPS measure in the APP for Shared Savings 
Program ACOs. One commenter noted support for the measures included in 
the CAHPS for MIPS. Several commenters

[[Page 84731]]

expressed concerns related to the CAHPS for MIPS measure. Specifically, 
the commenters noted that for this measure, small differences in 
quality can result in large quality score differences. The commenters 
stated that these differences are not meaningful and recommended that 
CMS work with stakeholders to improve the measure specifications before 
this measure is used as part of a limited quality measure set. 
Additionally, commenters were concerned that CMS has not detailed how 
the single composite CAHPS measure score will be calculated and were 
concerned with how the CAHPS measures are collected. Specifically, 
several commenters were concerned that the CAHPS measures use a small 
patient sample and rely on patients to recollect experiences that took 
place months before. One commenter had concerns about the small sample 
size for the CAHPS survey, citing previous experience with anomalies 
and unpredictable measure adjustments. Another commenter was concerned 
that the CAHPS sample size is the same for all ACOs regardless of ACO 
size; sampled patients do not represent the full population that ACOs 
serve; healthcare providers cannot provide supplemental information, 
such as more accurate contact information, in an effort to reach more 
patients; and surveys are only administered once annually with results 
received midway through the following performance year. Commenters 
recommended that CMS release additional information regarding how the 
CAHPS measure score will be calculated as soon as possible and 
recommended that CMS consider using a larger sample and modify the 
survey so that it is shorter and takes place closer in time to the care 
that beneficiaries are asked to assess.
    Another commenter expressed concern that survey fatigue among 
patients was leading to declining survey response rates. The commenter 
recommended that CMS allow providers to use surveys already in place 
rather than requiring administration of an additional CAHPS for MIPS 
survey. Another commenter expressed concern over the subjective nature 
of the survey leading to significant variation in scores over time. 
Another commenter noted that the methodology of the CAHPS for MIPS and 
CAHPS for ACO surveys differ, with the CAHPS for MIPS survey having 
minimum survey size requirements as a function of the Taxpayer 
Identification Number (TIN) and the CAHPS for ACOs survey having 
minimum survey size requirements as a function of the ACO. The 
commenter requested that CMS be explicit if it intends to make any 
changes in the survey methodology with this proposal because shifting 
the survey size requirement to be based on TINs rather than the ACO as 
a whole will result in substantial financial burden to ACOs.
    Response: We appreciate the commenters' concerns and 
recommendations regarding the CAHPS for MIPS measure. The CAHPS for 
MIPS survey uses the same survey instrument to assess the same patient 
experience domains as the CAHPS for ACO survey that is currently 
successfully used to measure ACO quality. The same shortened, 
streamlined version of the survey was implemented for both CAHPS for 
ACOs and CAHPS for MIPS in 2018, reflecting efforts by CMS to reduce 
the number of questions. We conducted analyses to assess the impact of 
aligning CAHPS scoring and benchmarking using 2019 CAHPS for ACOs and 
CAHPS for MIPS survey data. In 2019, the two programs used identical 
survey instruments. Analyses examined the impact of alignment on SSM 
scores, benchmarks, and quality points by comparing newly calculated 
SSM scores, benchmarks and quality points under the aligned approach to 
the official SSM scores, benchmarks, and quality points calculated 
under the original 2019 approach. The results of these analyses 
indicate that scoring ACOs using the MIPS methodology resulted in ACOs 
having a similar distribution of quality points as MIPS groups, which 
is wider than the distribution of quality points using the ACO scoring 
methodology. The wider score distribution is largely due to the 
differences across the two programs in the approach to benchmarking; 
CAHPS for ACOs uses flat percentage benchmarks for summary survey 
measures for which the 60th percentile of scores is greater than or 
equal to 80, or for which the 90th percentile of scores is greater than 
or equal to 95. CAHPS for MIPS does not use a flat percentage approach. 
While the shift away from flat percentage benchmarks may have the 
effect of creating larger differences in quality scores across Shared 
Savings Program ACOs, we believe that the scores will better reflect 
small differences in quality performance and will support the goal to 
improve the Shared Savings Program quality standard over time.
    Beneficiaries assigned to an ACO or MIPS group, who are eligible 
for the CAHPS for MIPS or CAHPS for ACOs survey, are randomly selected 
for inclusion in the sample. Each ACO or MIPS group sample is therefore 
representative of the ACO or group population. Sample size requirements 
for both CAHPS for MIPS and CAHPS for ACOs were established using the 
results of analyses that sought to establish measures that allowed for 
meaningful comparisons to be made across ACOs and MIPS groups. Samples 
are drawn at the ACO level for CAHPS for ACOs, and at the MIPS group 
TIN level for groups. Target samples for all participating ACOs, 
groups, and virtual groups is 860; for ACOs, groups, and virtual groups 
with 860 or more survey-eligible patients, a random sample of 860 
patients is drawn. In addition, groups and virtual groups with fewer 
than 860 survey-eligible patients are eligible to participate if they 
meet the following minimum sampling thresholds: Large groups or virtual 
groups with 100 or more eligible clinicians: 416 eligible patients; 
medium groups or virtual groups with 25-99 eligible clinicians: 255 
eligible patients; and small groups or virtual groups with 2-24 
eligible clinicians: 125 eligible patients. CMS will continue to draw 
the CAHPS survey samples for Shared Savings Program ACOs administering 
the CAHPS for MIPS survey at the Shared Savings Program ACO level, with 
a target sample size of 860 going forward.
    Both surveys ask respondents to provide responses about their 
experiences of primary care during the previous 6 months. This look 
back period is used across many CAHPS survey efforts and enables a 
beneficiary to reflect on multiple care experiences with the focal 
provider named on the survey. While response rates have declined over 
time, the CAHPS for MIPS and CAHPS for ACOs surveys still reliably 
capture important information about the quality of care from patients' 
perspective, which are not captured via other data sources such as 
administrative claims data. We refer readers to section IV.A.3.b.3.a. 
of this final rule for additional details on the CAHPS for MIPS 
measure. With the alignment of CAHPS for ACOs with CAHPS for MIPS, the 
benchmarking and scoring methodology used for CAHPS for MIPS will be 
used. A single set of benchmarks will be calculated using data from all 
applicable CAHPS for MIPS reporters. The CAHPS for MIPS survey is 
scored as one quality measure, which is a different scoring approach 
from the current SSP quality scoring methodology that scores the ten 
CAHPS for ACOs summary survey measures in one patient/caregiver 
experience quality domain. As described in the CY 2017 Quality Payment 
Program final rule, each summary survey measure (SSM)

[[Page 84732]]

will have an individual benchmark and each SSM will be scored 
individually and compared against the benchmark to establish the number 
of points earned. The CAHPS score will be the average number of points 
across SSMs (81 FR 77284).
    We received comments on the Hospital-Wide, 30-day, All-Cause 
Unplanned Readmission (HWR) Rate for MIPS Eligible Clinician Groups 
measure, which are summarized below.
    Comment: Several commenters expressed concerns related to the 
Hospital-Wide, 30-day, All-Cause Unplanned Readmission (HWR) Rate for 
MIPS Eligible Clinician Groups measure. One commenter did not support 
this measure. Another commenter recommended that CMS consider NCQA's 
Plan All-Cause Readmission (PCR) measure instead because health plans 
use the PCR measure more widely as it is an NCQA accreditation 
requirement and the PCR measure is more robust and broader than the HWR 
measure because it includes patients 18 and older, while the HWR 
measure only includes patients 65 and older. Another commenter was 
concerned that the measure was sensitive to risk adjustment and has a 
narrow range, which negatively impacts ``community health center 
ACOs''. Another commenter noted that readmissions are low volume and 
can be influenced by factors outside the control of healthcare 
providers. Additionally, the commenter explained that an unintended 
consequence can occur when an ACO's base number of admissions is low 
compared to other ACOs with high numbers of admissions because it 
increases the sensitivity of this measure. This commenter suggested 
that CMS consider the Ambulatory Sensitive Condition Acute Composite 
measure instead. Other commenters noted that for this measure, small 
differences in performance can result in large quality score 
differences. The commenters stated that these differences in 
performance are not meaningful and recommended that CMS work with 
stakeholders to improve the measure specifications before this measure 
is used as part of a limited quality measure set. One commenter noted 
concerns about unintended consequences due to the measure not 
adequately considering the competing risk of mortality. This commenter 
suggested using an alternative measure, such as risk-adjusted home 
time.
    Response: The proposed Hospital-Wide, 30-day, All-Cause Unplanned 
Readmission (HWR) Rate for MIPS Eligible Clinician Groups measure is a 
re-specified version of NQF #1789 (Hospital-Wide All-Cause Unplanned 
Readmission Measure), and an adapted version of NQF #1789 that is 
currently being used successfully to assess ACO quality performance 
(ACO-8: Risk-standardized, All Condition Readmission (ACR)). We note 
that the MIPS HWR is clinically aligned to the ACO ACR measure, with 
the same cohort inclusion and exclusion criteria, outcome, measurement 
period, and risk adjustment variables, but the attribution and risk-
standardized readmission rate calculation methodologies differ between 
the two measures. The ACO ACR measure attributes beneficiaries to ACOs 
prior to measurement, whereas the MIPS HWR measure is attributed to 
three clinician groups--primary inpatient provider, discharge 
clinician, and primary outpatient provider--based on measure 
specifications and care utilization data. In addition, the ACO ACR uses 
hierarchical logistic regression modeling to calculate risk adjustment 
while the MIPS HWR cannot use hierarchical logistic regression modeling 
because of attribution to multiple providers.
    We believe that this re-specified version of NQF #1789 will provide 
a meaningful assessment of ACO quality performance. We will use the 
MIPS HWR three clinician group attribution method to attribute episodes 
at the ACO level. However, we will monitor and evaluate the ACOs' 
performance on the MIPS HWR measure to ensure compatibility including 
evaluating attribution at the ACO level, as well as refinements to risk 
adjustment and risk stratification and may revisit the decision to 
include this measure in the APP measure set for Shared Savings Program 
ACOs in future rulemaking. Both the MIPS HWR and ACO ACR measures will 
undergo the NQF endorsement/re-endorsement process during 2021, and we 
welcome stakeholder feedback on these measures.
    We received comments on the three eCQM/CQM MIPS measures and the 
Risk Standardized, All-Cause Unplanned Admissions for Multiple Chronic 
Conditions for ACOs measure. These comments are summarized and 
responded to in section IV.A.3.B. of this final rule.
    Table 40 lists the measures included in the final APP measure set.

[[Page 84733]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.085

    In the CY 2021 PFS proposed rule (85 FR 50234), we noted that in 
addition to the measures included in the proposed APP measure set, 
based on recommendations from MedPAC in its 2015 Report to Congress: 
Medicare and the Health Care Delivery System,\56\ we were considering 
adding a ``Days at Home'' measure that is currently under development, 
to the APP core measure set in future years, once it has been through 
the MAP pre-rulemaking process. We explained that any future additions 
to the measure set, including to add a ``Days at Home'' measure would 
be proposed and finalized through notice and comment rulemaking.
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    \56\ http://medpac.gov/docs/default-source/reports/june-2015-report-to-the-congress-medicare-and-the-health-care-delivery-system.pdf.
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    While CMS is not proposing to incorporate a ``Days at Home'' 
measure at this time, we received several public comments and 
recommendations about this measure. We greatly appreciate the 
commenters' views on a ``Days at Home'' measure, and we will take this 
feedback into consideration as this measure is developed and considered 
during future rulemaking cycles.
    In addition, in the CY 2021 PFS proposed rule (85 FR 50234), we 
noted that we have received feedback from a few ACOs, including ACOs 
that have a significant number of beneficiaries in long-term care 
facilities or who are chronically ill or high-risk home bound

[[Page 84734]]

patients, that the measures ACOs are required to report are not always 
applicable to their patient population. Although we proposed to require 
ACOs to report via the APP, we also sought comment on an alternative 
approach that could be used in the event the three measures ACOs are 
required to actively report on are not applicable to their beneficiary 
population and there are more appropriate measure available under MIPS. 
Under this alternate approach, ACOs could opt out of the APP and report 
to MIPS as an APM entity. If the ACO decides to report as an APM entity 
to MIPS outside of the APP, CAHPS for MIPS would become optional; 
however, the ACO would be required to report PI and IA and would also 
be subject to cost under MIPS. In the event an ACO decides to report as 
an APM entity to MIPS outside the APP, we would use the ACO's MIPS 
Quality performance category score to determine if the ACO met the 
Shared Savings Program quality performance standard.
    We sought comment on this alternative reporting approach for ACOs 
in the event the three measures ACOs are required to actively report 
are not applicable to their beneficiary population.
    The following is a summary of the comments we received on this 
alternative approach and our response.
    Comment: One commenter supported this approach as it would allow 
more flexibility for clinicians to be recognized for the work they are 
doing inside and outside the context of an ACO. A few commenters stated 
that they believed all three eCQM/MIPS CQM measures were applicable to 
all ACOs and expressed concerns that allowing some ACOs to report under 
this alternative approach would make program evaluation challenging and 
would not allow for a fair assessment of quality across ACOs because 
certain organizations would have the opportunity to select measures for 
which they have the highest historical performance.
    Response: We appreciate the commenter's feedback on the alternate 
approach and CMS will consider the commenters' feedback as part of the 
development of any future policies in connection with this alternative 
approach.
c. Shared Savings Program Quality Performance Standard
    The quality performance standard is the minimum performance level 
ACOs must achieve in order to share in any savings earned, avoid 
maximum shared losses under certain payment tracks, and avoid quality-
related compliance actions. We proposed to increase the level of 
quality performance that would be required for all ACOs to meet the 
Shared Savings Program quality performance standard. As discussed in 
the CY 2021 PFS proposed rule (85 FR 50234), we explained that we 
believed the proposed changes would simplify the Shared Savings Program 
quality performance standard and were also consistent with the 
statutory requirement that we seek to improve the quality of care 
furnished by ACOs over time by specifying higher standards, new 
measures or both (section 1899(b)(3)(C) of the Act). We proposed to 
increase the quality performance standard for all ACOs to achievement 
of a quality performance score equivalent to the 40th percentile or 
above across all MIPS Quality performance category scores, excluding 
entities/providers eligible for facility-based scoring. We proposed to 
exclude entities/providers eligible for facility-based scoring from the 
overall MIPS quality score because facility-based scoring is determined 
using the Hospital Value Based Purchasing (HVBP) Total Performance 
Score (TPS), which includes quality and cost.
    Given that the statute requires that we seek to increase the 
quality performance standard over time, we explained our belief that 
changing the quality performance standard from the 30th percentile on 
one measure in each domain to a requirement that ACOs achieve a quality 
performance score equivalent to the 40th percentile or above across all 
MIPS Quality performance category scores, excluding entities/providers 
eligible for facility-based scoring, would be the next incremental step 
in increasing the quality performance standard. In the CY 2021 PFS 
proposed rule, we summarized the quality performance results for ACOs 
participating in the program in performance year 2018. Since the 
proposed rule was issued, we now have updated 2019 results. Under the 
current Shared Savings Program quality measurement methodology, 98.71 
percent or 534 ACOs participating in the program in 2019 met the 
quality performance standard of complete and accurate reporting for 
ACOs in the first year of their first agreement period or the 30th 
percentile on one measure in each domain, for ACOs in their second or 
subsequent years of participation in the program. Of these ACOs, 497 
were ACOs in second or subsequent years of participation in the program 
for which most quality measures were scored as pay-for-performance 
(P4P).
    As discussed in the CY 2021 PFS proposed rule (85 FR 50234), 
eligible clinicians participating in Shared Savings Program ACOs who 
obtain QP status would continue to be exempt from MIPS, and therefore, 
would not be subject to MIPS payment adjustments. ACOs participating in 
a track (or payment model within a track) that is an Advanced APM may 
elect to report on behalf of their eligible clinicians who do not meet 
the threshold to earn QP status but do meet the lower payment or 
patient count threshold to achieve Partial QP status, and these Partial 
QPs would be subject to a MIPS payment adjustment. Conversely, if an 
ACO does not elect to report for the Partial QPs, they would not 
receive a MIPS score or payment adjustment and would have no reporting 
responsibilities for MIPS. We also explained that utilizing the MIPS 
Quality performance category scoring methodology to assess the quality 
performance for purposes of the Shared Savings Program of ACOs 
participating in tracks (or payment models within a track) that qualify 
as an Advanced APM would not change whether the eligible clinicians 
participating in the ACO obtain QP status and are excluded from MIPS, 
nor would it change the eligible clinicians' eligibility to receive 
Advanced APM incentive payments.
    We received public comments on the proposal to revise the Shared 
Savings Program quality performance standard. The following is a 
summary of the comments we received and our responses.
    Comment: We received several comments in support of increasing the 
quality performance standard to the 40th percentile of MIPS Quality 
performance category scores, all noting that the proposal aligned with 
CMS' goal of improving quality and reducing cost. We also received many 
comments opposing the overall approach of changing the quality 
performance standard to the 40th percentile of all MIPS Quality 
Performance Category Scores. Several commenters noted the potential 
uncertainty that ACOs would experience because they would not have a 
clear indication ahead of the performance year of what standards need 
to be met to be eligible to receive shared savings. Commenters 
suggested that CMS set a threshold for the number of measures that must 
meet the 40th percentile benchmark of at least 50 percent of all 
measures. Other commenters suggested that the quality performance 
standard should remain at the current level to allow more time for ACOs 
to familiarize the new reporting requirements under the APP. One 
commenter suggested that the MIPS scoring methodology is flawed and 
introducing a change in the quality performance standard now would 
cause

[[Page 84735]]

instability in the Shared Savings Program. One commenter expressed 
concerns over ACOs' abilities to meet thresholds on certain measures. 
One commenter noted that moving the quality performance standard to the 
40th percentile would pose difficulties for organizations struggling 
with the readmission and unplanned admission for multiple chronic 
condition metrics. One commenter noted that the threshold change is 
drastic and also noted that with CAHPS data supplied only at the ACO 
level, not at the individual TIN level, it is hard to provide feedback 
to each participant TIN, and with ACOs trying to handle the current 
pandemic, it is difficult to influence performance in this area. In 
addition, several commenters expressed concerns over the potential 
impact of the pandemic and other natural disasters on quality 
performance and the uncertainty ACOs could face and suggested the 
implementation of a new quality performance standard should be delayed. 
Commenters expressed concern over the limited time to gain familiarity 
with the new requirements and difficulty meeting this new quality 
performance standard for certain measures. Several commenters expressed 
concerns regarding the shift from a domain-based scoring approach to 
the proposed approach of requiring an ACO to achieve an overall quality 
score equivalent to the 40th percentile of all MIPS quality performance 
category scores. One commenter expressed concerns that such a scoring 
approach would have major financial implications for the sustainability 
of the Shared Savings Program as financial implications for ACOs are 
much higher than MIPS participants.
    Response: We appreciate the commenters' feedback on our proposal to 
revise the Shared Savings Program quality performance standard. In 
light of the concerns raised by the commenters, we are finalizing a 
modified version of our original proposal to allow for a gradual phase-
in of the increase in the level of quality performance that would be 
required for all ACOs to meet the Shared Savings Program quality 
performance standard. Specifically, we are finalizing that an ACO would 
meet the quality performance standard if:
     For performance years 2021 and 2022, the ACO achieves a 
quality performance score that is equivalent to or higher than the 30th 
percentile across all MIPS Quality performance category scores; and
     For performance year 2023 and subsequent performance 
years, the ACO achieves a quality performance score that is equivalent 
to or higher than the 40th percentile across all MIPS Quality 
performance category scores.
    Achieving the applicable quality performance standard for a 
performance year will enable the ACO to share in the maximum amount of 
savings based on their Track, avoid maximum shared losses under certain 
payment tracks, and avoid quality-related compliance actions for that 
performance year.
    These policies are summarized in Table 39 in this final rule. The 
impact on shared savings payments as a result of these final policies 
is described in section VIII.H.7.a. of this final rule. We are also 
finalizing our proposal to exclude entities/providers eligible for 
facility-based scoring from the determination of the overall MIPS 
Quality performance category score because facility-based scoring is 
determined using the Hospital Value Based Purchasing (HVBP) Total 
Performance Score (TPS), which includes quality and cost.
    We believe that this phase-in of the quality performance standard, 
coupled with our decision to phase-in the reporting requirements under 
the APP for Shared Savings Program ACOs, as described in section 
III.G.1.b.(1). of this final rule, will alleviate many of the concerns 
raised by the commenters, especially those related to the PHE for 
COVID-19 and other natural disasters in 2020. We will monitor ACO 
performance under the new quality reporting requirements to determine 
the impact of this measured increase to the quality performance 
standard and may revisit this policy in future rulemaking if necessary 
to promote an attainable quality performance standard and degree of 
improvement. With respect to the concerns raised by commenters 
regarding the limited time to gain familiarity with the new 
requirements, the phase-in policies will give ACOs additional time to 
set up their systems to report all payer data on the three eCQM/MIPS 
CQM measures under the APP. The phase-in will also allow ACOs 
additional time to become familiar with the new quality reporting 
requirements and gain experience reporting on the new measures under 
the APP before they are assessed under the increased quality 
performance standard beginning in performance year 2023. We note that 
the quality performance standard that we are adopting for performance 
years 2021 and 2022 is analogous to the current quality performance 
standard, under which ACOs are required to achieve the 30th percentile 
on one measure in each domain. Therefore, we believe that this approach 
to phasing in the new, higher quality performance standard is 
consistent with the statutory requirement in section 1899(b)(3)(C) of 
the Act that we seek to increase the quality of care furnished by ACOs 
over time. We also note that ACOs will not be required to meet the 30th 
or 40th percentile (depending on the performance year) for all measures 
reported under the APP in order to meet the quality performance 
standard. If an ACO performs poorly on one measure under the APP, the 
ACO may still be able to meet the quality performance standard based on 
its performance across the remainder of the measures set. For 
commenters that expressed concern that ACOs would not have an 
indication prior to the start of the performance year of what standards 
would need to be met to be eligible to receive shared savings, we note 
that, as discussed in section IV.A.3.d.(1)b.ii. of this final rule, we 
are not finalizing the proposal to use performance period year 
benchmarks and instead will continue to use historical benchmarks for 
quality measures for the CY 2021 MIPS performance period.
    Comment: We received several comments related to how the quality 
performance standard would be assessed and applied. One commenter 
expressed uncertainty about whether CMS would assess the quality 
performance standard based on the aggregate score on all quality 
measures or require a 40th percentile score on each individual measure. 
Other commenters noted that they were uncertain if the quality 
performance standard was meant to apply across all domains in the 
aggregate, or across each individual domain at the 40th percentile.
    Response: Under the phase-in we are adopting in this final rule, an 
ACO's quality performance score must be equivalent to or higher than 
the 30th or 40th percentile (depending on the performance year) across 
all MIPS Quality performance category scores in order to meet the 
quality performance standard. ACOs will not be required to achieve a 
performance score that is equivalent to or higher than the 30th or the 
40th percentile (depending on the performance year) on each individual 
measure in order to meet the quality performance standard. We are also 
clarifying that each ACO's quality performance score will be calculated 
using the ACO's performance on the measures reported under the APP, any 
applicable MIPS bonus points, and quality improvement points. Please 
refer to section IV.A.3.b. of this final rule for information on 
scoring under the APP. Unlike the scoring methodology currently used in 
the Shared Savings Program, there are no quality domains

[[Page 84736]]

under the APP; rather, each measure will be weighted equally.
    In the CY 2021 PFS proposed rule (85 FR 50234 and 50235), we 
proposed to specify in a new section of the Shared Savings Program 
regulations at Sec.  425.510, policies governing the application of the 
APP to Shared Savings Program ACOs for performance years beginning on 
or after January 1, 2021. As proposed, this new section would include a 
general provision specifying that CMS establishes quality performance 
measures to assess the quality of care furnished by the ACO. If the ACO 
demonstrates to CMS that it has satisfied the quality performance 
requirements, and meets all other applicable requirements, the ACO is 
eligible to receive shared savings. We proposed that this general 
provision would also indicate that CMS seeks to improve the quality of 
care furnished by ACOs over time by specifying higher standards, new 
measures, or both. In the proposed new section, we also specified the 
requirement that ACOs must report quality data via the APP established 
under Sec.  414.1367 according to the method of submission established 
by CMS, and that CMS retains the right to audit and validate quality 
data reported by an ACO according to Sec.  414.1390.
    We did not receive any public comments on the proposed regulation 
at Sec.  425.510. We are finalizing Sec.  425.510 as proposed.
    We also proposed to specify in a new section of the Shared Savings 
Program regulations at Sec.  425.512 provisions for determining the ACO 
quality performance standard for performance years beginning on or 
after January 1, 2021. We proposed to specify that the quality 
performance standard is the overall standard the ACO must meet in order 
to be eligible to receive shared savings for a performance year, and 
that an ACO will not qualify to share in savings in any year it fails 
to meet the quality performance standard. Further, we proposed to 
specify that for all ACOs, CMS designates the quality performance 
standard as the ACO reporting quality data via the APP established 
under Sec.  414.1367, according to the method of submission established 
by CMS and achieving a quality performance score that is equivalent to 
or higher than the 40th percentile across all MIPS Quality performance 
category scores, excluding entities/providers eligible for facility-
based scoring. In addition, we proposed to specify that if an ACO does 
not report any of the three measures ACOs are actively required to 
report and does not field a CAHPS survey, the ACO would not meet the 
quality performance standard.
    We did not receive any public comments on the proposed regulation 
at Sec.  425.512. However, as a result of our decision to modify our 
original proposal to provide for a phase-in of the new quality 
reporting requirements under the APP for Shared Savings Program ACOs, 
as described in section III.G.1.b.1. of this final rule, and the 
increase in the quality performance standard, as described earlier in 
this section, we are finalizing the proposed regulations at Sec.  
425.512 with modifications, as described below.
    Revising Sec.  425.512(a)(3) to provide that:
     For performance years 2021 and 2022. CMS designates the 
quality performance standard for all ACOs, with the exception of ACOs 
in the first performance year of their first agreement period, as the 
ACO reporting quality data via the APP established under Sec.  
414.1367, according to the method of submission established by CMS and 
achieving a quality performance score that is equivalent to or higher 
than the 30th percentile across all MIPS Quality performance category 
scores, excluding entities/providers eligible for facility-based 
scoring.
     For performance year 2021. If an ACO does not report any 
of the ten CMS Web Interface measures or any of the three measures it 
is actively required to report and does not field a CAHPS for MIPS 
survey via the APP, the ACO will not meet the quality performance 
standard.
     For performance year 2022. If an ACO does not report any 
of the three measures it is actively required to report and does not 
field a CAHPS for MIPS survey via the APP the ACO will not meet the 
quality performance standard.
    Adding a new provision at Sec.  425.512(a)(4) to provide that for 
performance years 2023 and subsequent performances:
     CMS designates the quality performance standard for all 
ACOs, with the exception of ACOs in the first performance year of their 
first agreement period, as the ACO reporting quality data via the APP 
established under Sec.  414.1367, according to the method of submission 
established by CMS and achieving a quality performance score that is 
equivalent to or higher than the 40th percentile across all MIPS 
Quality performance category scores, excluding entities/providers 
eligible for facility-based scoring.
     If an ACO does not report any of the three measures it is 
actively required to report and does not field a CAHPS for MIPS survey 
via the APP the ACO will not meet the quality performance standard.
    We are also revising Sec.  425.512 to add a new language at Sec.  
425.512(a)(2) to provide that for performance year 2022 and subsequent 
performance years, for the first performance year of an ACO's first 
agreement period under the Shared Savings Program, if the ACO meets the 
data completeness requirement at Sec.  414.1340 and case minimum 
requirement at Sec.  414.1380 on the three measures it is actively 
required to report and fields a CAHPS for MIPS survey via the APP, the 
ACO will meet the quality performance standard. Finally, we are also 
revising the references to MIPS Quality performance category scores in 
Sec.  425.512(a)(3) and (4) to make clear that entities/providers 
eligible for facility-based scoring are excluded.
    In addition, we proposed to modify the existing Shared Savings 
Program regulation at Sec.  425.508, on incorporating quality reporting 
requirements related to the Quality Payment Program. We proposed to add 
a provision applicable to 2021 and subsequent performance years, which 
would specify that ACOs must submit quality data via the APP 
established under Sec.  414.1367 to satisfactorily report on behalf of 
the eligible clinicians who bill under the TIN of an ACO participant 
for purposes of the MIPS Quality performance category. We also proposed 
related technical and conforming modifications to Sec.  425.508.
    We did not receive any public comments on the proposed 
modifications, and related technical and conforming modifications to 
Sec.  425.508. We are finalizing all of the modifications to Sec.  
425.508 as proposed.
d. Use of ACO Quality Performance in Determining Shared Savings and 
Shared Losses
    In section III.G.1.d of the CY 2021 PFS proposed rule (85 FR 50235 
and 50236), we proposed modifications to the Shared Savings Program 
regulations on the use of the ACO quality performance in determining 
shared savings and shared losses. We explained that section 
1899(d)(1)(A) of the Act specifies an ACO is eligible to receive a 
shared savings payment for a portion of the savings generated for 
Medicare, provided that the ACO meets both the quality performance 
standards established by the Secretary and achieves the required level 
of savings against its historical benchmark. Section 1899(d)(2) of the 
Act provides the authority for the actual payments for shared savings 
under the Shared Savings Program. Specifically, if an ACO meets the 
quality performance standards established by the Secretary (according 
to section 1899(b)(3) of the

[[Page 84737]]

Act), and meets the savings requirements, a percent (as determined 
appropriate by the Secretary) of the difference between the estimated 
average per capita Medicare expenditures in the year, adjusted for 
beneficiary characteristics, and the benchmark for the ACO, may be paid 
to the ACO as shared savings and the remainder of the difference shall 
be retained by the Medicare program. The Secretary is required to 
establish limits on the total amount of shared savings paid to an ACO. 
We have also incorporated performance-based risk in the form of shared 
losses into certain financial models using the authority under section 
1899(i)(3) of the Act to use other payment models.
    The Shared Savings Program's one-sided shared savings only models, 
and two-sided shared savings and shared losses models are specified in 
subpart G of the Shared Savings Program regulations. For agreement 
periods beginning on July 1, 2019, and in subsequent years, eligible 
ACOs may participate under either: (1) The BASIC track, which includes 
a glide path consisting of five levels (Levels A through E) that allows 
eligible ACOs to begin under a one-sided model (Level A or Level B) and 
incrementally phases-in higher levels of risk and potential reward 
(Levels C, D, or E) (Sec.  425.605); or (2) the ENHANCED track, a two-
sided model with the highest level of risk and potential reward (Sec.  
425.610). Further, according to the May 8th COVID-19 IFC (85 FR 27574 
and 27575), ACOs that entered a first or second agreement period with a 
start date of January 1, 2018, whose participation agreements expire 
December 31, 2020, may elect to extend their agreement period for an 
optional fourth performance year, spanning January 1, 2021, to December 
31, 2021. This includes ACOs that entered agreement periods under Track 
1 (a one-sided model), Track 2 (a two-sided model), and Track 3 
(subsequently renamed the ENHANCED track). Further, this option to 
elect a 12-month extension of the agreement period also applies to ACOs 
participating in the Track 1+ Model whose participation agreements 
expire December 31, 2020.
    Under the Shared Savings Program regulations, for both one-sided 
models and two-sided models, CMS uses the ACO's quality performance to 
determine the ACO's eligibility to receive shared savings, and the rate 
at which ACOs share in these savings. We base the final shared savings 
rate on the ACO's quality performance. For ACOs meeting the quality 
performance standard, the final shared savings rate is equal to the 
product of the ACO's quality score and the maximum sharing rate. The 
maximum sharing rate is specific to the ACO's track/level of 
participation as follows: 50 percent for ACOs participating in Track 1; 
\57\ 60 percent for ACOs participating in Track 2; \58\ 40 percent for 
ACOs participating in Level A or Level B of the BASIC track; \59\ 50 
percent for ACOs participating in Levels C, D, or E of the BASIC track; 
\60\ and 75 percent for ACOs participating in the ENHANCED track.\61\ 
The upside of the Track 1+ Model is based on Shared Savings Program 
Track 1; therefore, a maximum sharing rate of 50 percent applies to 
Track 1+ Model ACOs.\62\
---------------------------------------------------------------------------

    \57\ Refer to Sec.  425.604(d).
    \58\ Refer to Sec.  425.606(d).
    \59\ Refer to Sec.  425.605(d)(1)(i)(A), (d)(1)(ii)(A).
    \60\ Refer to Sec.  425.605(d)(1)(iii)(A), (d)(1)(iv)(A), 
(d)(1)(v)(A).
    \61\ Refer to Sec.  425.610(d).
    \62\ Refer to the Track 1+ Model Participation Agreement, 
available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/track-1plus-model-par-agreement.pdf.
---------------------------------------------------------------------------

    Depending on the track, the ACO's quality performance may also be 
used to determine the amount of the ACO's shared losses, for ACOs under 
two-sided models. ACOs participating in the Track 1+ Model, and Level 
C, D, or E of the BASIC track are subject to a fixed shared loss rate 
(also referred to as the loss sharing rate) of 30 percent regardless of 
quality performance.\63\ Under Track 2 and the ENHANCED track, the 
shared loss rate is calculated as one minus the ACO's final shared 
savings rate based on quality performance, up to a maximum of 60 
percent or 75 percent, respectively, and the shared loss rate may not 
be less than 40 percent for both tracks.\64\ For ENHANCED track ACOs, 
this 40 percent minimum shared loss rate is expressly stated in the 
current regulations, whereas for Track 2 ACOs, it is the implicit 
minimum shared loss rate as calculated based on the inverse of the 
maximum final shared savings rate for the track. Track 2 and ENHANCED 
track ACOs that do not meet the quality performance standard for the 
performance year will be accountable for shared losses based on the 
highest shared loss rate for their track.
---------------------------------------------------------------------------

    \63\ Provisions specifying the shared loss rate for two-sided 
models of the BASIC track are specified in Sec.  
425.605(d)(1)(iii)(C), (d)(1)(iv)(C), (d)(1)(v)(C). The shared loss 
rate applicable to Track 1+ Model ACOs is specified in the Track 1+ 
Model Participation Agreement.
    \64\ Refer to Sec. Sec.  425.606(f), 425.610(f).
---------------------------------------------------------------------------

    In light of the proposed changes to the Shared Savings Program's 
quality performance standard, in the CY 2021 PFS proposed rule, we also 
proposed modifications to the regulations that specify the 
circumstances under which an ACO will qualify for a shared savings 
payment based on its quality performance and the determination of the 
rate at which the ACO will share in savings based on its quality 
performance.
    For all tracks, we proposed to specify, in revisions to the 
regulations, the requirements that must be met for an ACO to qualify 
for a shared savings payment for performance years beginning on or 
after January 1, 2021. We proposed that to qualify for shared savings, 
an ACO must meet the minimum savings rate requirements established for 
the track/level, meet the proposed quality performance standard 
described in section III.G.1.c. of the proposed rule, and otherwise 
maintain its eligibility to participate in the Shared Savings Program 
under part 425. We proposed to revise Sec. Sec.  425.604(c) (Track 1), 
425.605(c) (BASIC track), 425.606(c) (Track 2), and 425.610(c) 
(ENHANCED track) to reflect these requirements.
    We also proposed revisions to the provisions establishing the final 
sharing rate for all tracks. We proposed that for performance years 
beginning on or after January 1, 2021, if an ACO that is otherwise 
eligible to share in savings meets the proposed quality performance 
standard as described in section III.G.1.c. of the proposed rule, the 
ACO will share in savings at the maximum sharing rate according to the 
applicable financial model, up to the performance payment limit. We 
proposed that if the ACO fails to meet the proposed quality performance 
standard, the ACO would be ineligible to share in savings. We proposed 
to specify these policies in revisions to the provisions governing 
Track 1 (Sec.  425.604(d)), the BASIC track (Sec.  425.605(d)(1)(i)(A) 
(Level A), (d)(1)(ii)(A) (Level B), (d)(1)(iii)(A) (Level C), 
(d)(1)(iv)(A) (Level D), (d)(1)(v)(A) (Level E)), Track 2 (Sec.  
425.606(d)), and the ENHANCED track (Sec.  425.610(d)).
    We also proposed modifications to the methodology for determining 
shared losses under Track 2 and the ENHANCED track, for performance 
years beginning on or after January 1, 2021, to account for the 
proposed revisions to the quality performance standard. If the ACO 
meets the quality performance standard, we proposed to determine the 
shared loss rate as follows:
     Step 1: Calculate the quotient of the MIPS Quality 
performance category points earned divided by the total MIPS Quality 
performance category points available.
     Step 2: Calculate the product of the quotient described in 
step 1 and the

[[Page 84738]]

sharing rate for the relevant track, either 60 percent for Track 2 or 
75 percent for the ENHANCED track.
     Step 3: Calculate the shared loss rate as 1 minus the 
product determined in step 2. Consistent with the existing structure of 
the financial models: Under Track 2, the shared loss rate may not 
exceed 60 percent, and may not be less than 40 percent; under the 
ENHANCED track, the shared loss rate may not exceed 75 percent, and may 
not be less than 40 percent.
    Under the proposed approach, for an ACO that meets the quality 
performance standard we would take into consideration the ACO's quality 
score when determining the ACO's share of losses. An ACO with a higher 
quality score would owe a lower amount of losses compared to an ACO 
with an equivalent amount of losses but a lower quality score, so long 
as the ACO's quality score results in a shared loss rate within the 
range between the minimum shared loss rate (40 percent) and the maximum 
shared loss rate (60 percent under Track 2, or 75 percent under the 
ENHANCED track). To the extent the ACO's quality score results in a 
shared loss rate outside these limits, the shared loss rate is set to 
the minimum or maximum rate (as applicable). We also proposed to revise 
the regulation at Sec.  425.606(f) to expressly state both the minimum 
and maximum shared loss rates for Track 2.
    In addition, we also proposed that if the ACO fails to meet the 
quality performance standard, the shared loss rate would be 60 percent 
under Track 2 or 75 percent under the ENHANCED track. We explained that 
we believed this approach would maintain symmetry with the proposed 
approach to determining shared savings under Track 2 and the ENHANCED 
track based on quality performance. Thus, an ACO that fails to meet the 
quality performance standard would be ineligible to share in savings 
and would owe the maximum amount of shared losses.
    We proposed to specify these provisions for determining the shared 
loss rate under Track 2 and the ENHANCED track, for performance years 
beginning on or after January 1, 2021, through modifications to the 
regulations at Sec. Sec.  425.606(f) and 425.610(f). We also proposed 
technical and conforming changes to these provisions for clarity, and 
to specify that the current policy would continue to apply for purposes 
of determining the shared loss rate for Track 2 ACOs and ENHANCED track 
ACOs for performance years (or a performance period) beginning on or 
before January 1, 2020.
    We received public comments on the proposed use of ACO quality 
performance in determining shared savings and shared losses. The 
following is a summary of the comments we received and our responses.
    Comment: Some commenters expressed support for the proposed 
approach to determining the rate at which ACOs will share in savings 
based on quality performance, for performance years beginning on or 
after January 1, 2021. A few commenters expressed support for 
eliminating the sliding scale for determining shared savings based on 
quality performance, and allowing ACOs to earn savings at the maximum 
sharing rate according to the applicable financial model if the quality 
performance standard is met. One commenter expressed support for making 
an ACO ineligible to share in savings if it fails to meet the quality 
performance standard.
    Several commenters explained that they supported the proposed 
approach because it provides a larger reward to ACOs for meeting CMS' 
increased quality performance standard. One commenter explained the 
proposed approach would simplify financial calculations.
    Some commenters opposed the proposed approach to determining 
whether an ACO shares in savings at the maximum rate, or not at all, 
based on whether or not the ACO meets the proposed revised quality 
performance standard. Commenters suggested instead that CMS use a 
scoring approach that is more similar to the current domain-based 
scoring approach rather than an all-or-nothing approach as proposed. In 
particular, some commenters preferred an approach that differentiates 
higher quality performers and rewards quality improvement over time 
with a higher savings percentage.
    Some commenters urged CMS to better reward high quality performers, 
as is done in the Medicare Advantage program by providing bonuses or 
higher shared savings rates to high quality performers or those that 
notably improve quality scores over time.
    Some commenters suggested that the proposed approach would make it 
more challenging for ACOs to share in savings, and that may discourage 
program participation by ACOs. One commenter explained that the change 
from a quality multiplier on payment, to all-or-nothing savings, adds 
another significant dimension of risk to the program for ACOs that 
depend on shared savings to operate. A few commenters expressed concern 
that the proposed approach may limit participation by ACOs that depend 
on shared savings to support their participation in the Shared Savings 
Program, such as to cover ongoing operational costs and infrastructure 
costs. One commenter suggested that this dynamic could ultimately 
discourage participation by physician-led ACOs or lead to consolidation 
of physician-led ACOs with larger entities to manage the ACO, 
ultimately stifling innovation.
    Several commenters expressed concern about an approach that makes 
the ACO's ability to share in savings an all-or-nothing proposition, 
particularly as CMS also proposed to increase the quality performance 
standard for ACOs. One commenter expressed concerns about the proposed 
approach, suggesting it places the entirety of an ACO's shared savings 
payment at risk if one measure is missed. This commenter explained that 
an all-or-nothing approach to determining an ACO's eligibility to share 
in savings, in combination with higher standards and volatile measures, 
would negatively impact their decision about continuing their 
participation in the Shared Savings Program, including whether to enter 
into a new participation agreement under the Shared Savings Program or 
take on increased downside risk, and their overall investment in the 
program.
    One commenter supported raising the quality performance standard 
and allowing ACOs that meet that standard to receive full shared 
savings, provided that this change accompanies a smaller program 
measure set and the standard is assessed as an average of the measures. 
The commenter noted that it would not support a 40th percentile 
standard applied to each measure given its concerns about several of 
the measures.
    Response: We agree with the comments suggesting that the proposed 
approach will simplify program calculations going forward. Under the 
proposed approach, an ACO is eligible to share in the maximum amount of 
savings if it meets the quality performance standard, and is ineligible 
to share in savings if it fails to meet the quality performance 
standard, thereby removing the variation in sharing rates based on the 
ACO's quality performance score.
    We believe a number of factors mitigate commenters' concerns about 
the determination of shared savings based on the revised quality 
performance standard for the Shared Savings Program. As discussed 
elsewhere in section III.G.1 of this final rule, in response to 
commenters' concerns about the transition to the APP

[[Page 84739]]

for Shared Savings Program ACOs, we are finalizing our proposal with 
certain modifications, including to allow for continued use of the Web 
Interface as a reporting mechanism for PY 2021, and to allow for a more 
gradual phase-in of the quality performance standard. We believe this 
phase-in will give ACOs additional time to prepare to transition to the 
APP, and thereby to prepare to meet the new quality reporting 
requirements and quality performance standard, and in turn to meet the 
requirements for sharing in savings. Further, under the APP (as 
described in section III.G.1.c of this final rule), we will determine 
whether the ACO has met the quality performance standard based on the 
ACO's quality performance score as compared to the relevant percentile 
across all MIPS Quality performance category scores, excluding 
entities/providers eligible for facility-based scoring, that comprises 
the quality performance standard for the applicable performance year. 
Therefore, an ACO that performs poorly on one or several measures under 
the APP may still have the opportunity to share in savings at the 
maximum sharing rate, if it meets the quality performance standard 
based on its performance across the remainder of the measure set.
    Additionally, we note that while our final policy will require ACOs 
to meet a higher quality performance standard starting in PY 2023, ACOs 
that achieve the quality performance standard maximize their upside 
potential. In contrast, under the existing approach, which is designed 
to differentiate between higher and lower quality performers, it is 
rare for ACOs to achieve the maximum sharing rate based on quality 
performance under the program's pay for performance standards that 
phase-in after the ACO's first performance year in the Shared Savings 
Program. Under the existing approach, in an ACO's first performance 
year in the program, the ACO will receive a quality score of 100 
percent, and therefore the maximum sharing rate based on quality 
performance, if it completely and accurately reports all quality 
measures. For subsequent performance years, under a pay for performance 
standard, we multiply an ACO's quality score (as a percentage) by the 
maximum sharing rate for the track in which the ACO participates to 
determine the ACO's final sharing rate based on quality performance. 
Thus, ACOs are effectively limited from maximizing their upside 
potential since their quality scores are typically below 100 percent. 
We believe that allowing ACOs to maximize their upside potential year 
after year, as provided under the policies we are finalizing in this 
rule, could further facilitate ACOs' participation in the Shared 
Savings Program and their investments in accountable care activities to 
meet the program's goals.
    We appreciate commenters' concerns that this revised methodology 
for measuring quality performance and rewarding ACOs with savings based 
on their quality performance could have the effect of limiting 
participation by certain types of ACOs. However, we believe commenters' 
concerns are mitigated by the aforementioned factors, including the 
gradual phase-in of the quality performance standard and the potential 
for ACOs to more consistently share savings at the highest sharing 
rates under the revised approach. We anticipate monitoring to determine 
if the revised quality performance standard and the approach of 
determining an ACO's eligibility to share in savings at the maximum 
sharing rate based on their ability to meet the quality performance 
standard, disproportionately disadvantage certain ACOs based on 
composition and experience in the Shared Savings Program, among other 
factors, and will consider whether any adjustments may be warranted. 
Any changes to the policies we are adopting in this final rule would be 
made through notice and comment rulemaking.
    In response to commenters' preference that CMS retain an approach 
that continues to reward quality improvement over time, we note that 
under the APP, the MIPS quality improvement scoring methodology, as 
specified under Sec.  414.1370(g)(1)(iv), will be used in determining 
an ACO's quality performance score. Under this approach, we will 
consider the improvement in an ACO's quality performance category 
achievement percent score from the previous performance period in the 
determination of whether the ACO has met the quality performance 
standard, and therefore whether the ACO is eligible for sharing savings 
at the maximum sharing rate. In comparison, the Shared Savings 
Program's current quality improvement reward as specified in Sec.  
425.502(e)(4) rewards ACOs that demonstrate quality improvement with a 
higher quality score, and therefore a potentially greater share of 
savings, but the amount of shared savings still would not exceed the 
maximum sharing rate. Accordingly, given that quality improvement will 
be factored into determining an ACO's quality performance score under 
the APP and ACOs that meet the quality performance standard will be 
eligible to share in savings at the maximum sharing rate for their 
track, we do not believe it is necessary to provide any additional 
adjustment to shared savings for ACOs that demonstrate improved quality 
performance over time.
    Further, at this time, we decline commenters' suggestions that we 
adopt an approach for rewarding higher quality performance, and quality 
improvement, similar to the approach specified under Medicare 
Advantage. We note that the focus of the proposed changes was on 
aligning the Shared Savings Program's quality performance standard with 
the APP under the Quality Payment Program (as previously described 
elsewhere in section III.G.1 of this final rule). Further, we believe 
the approach we are finalizing will be effective in rewarding ACOs that 
perform well on quality measures and improve quality performance over 
time. As we have previously described, ACOs that meet the revised 
quality performance standard, which phases-in a higher performance 
standard over time, are eligible to share in savings at the maximum 
sharing rate, and we will factor quality improvement into determining 
an ACO's quality performance score under the APP.
    After considering the comments and the modifications that we are 
making to phase-in the new quality reporting requirements and quality 
performance standard under the APP, we are finalizing as proposed our 
approach to determining an ACO's eligibility for shared savings based 
on quality performance, for performance years beginning on or after 
January 1, 2021.
    Comment: The few commenters that discussed the proposed approach to 
determining shared losses based on quality performance were generally 
supportive of the proposed approach. In particular, commenters 
expressed support for the proposed approach under which an ACO's shared 
losses are based on its quality performance such that an ACO with a 
higher quality score would owe lower shared losses. One commenter 
supported the proposed modifications to the shared loss calculations 
for Track 2 and the ENHANCED track, which would still allow an ACO's 
quality score to be taken into consideration as long as the loss rate 
stays within the minimum and maximum range, because they would simplify 
financial calculations.
    Response: We are finalizing as proposed the modifications to the 
methodology for determining shared losses under Track 2 and the 
ENHANCED track for performance years beginning on or after January 1, 
2021, to

[[Page 84740]]

account for the revisions to the quality performance standard discussed 
elsewhere in this section III.G.1 of this final rule.
    We did not receive comments on the revisions we proposed to make to 
the regulations to specify the requirements that must be met for an ACO 
to qualify for a shared savings payment for performance years beginning 
on or after January 1, 2021. We are finalizing as proposed the 
revisions to Sec. Sec.  425.604(c) (Track 1), 425.605(c) (BASIC track), 
425.606(c) (Track 2), and 425.610(c) (ENHANCED track) to reflect these 
requirements. Specifically, to qualify for shared savings, an ACO must 
meet the minimum savings rate requirements established for the track/
level, meet the quality performance standard established under the new 
provision at Sec.  425.512 as described in section III.G.1.c. of this 
final rule, and otherwise maintain its eligibility to participate in 
the Shared Savings Program under part 425.
    After considering the public comments we received, we are 
finalizing as proposed revisions to the provisions establishing the 
final sharing rate for all tracks. For performance years beginning on 
or after January 1, 2021, if an ACO that is otherwise eligible to share 
in savings meets the quality performance standard established under 
Sec.  425.512, the ACO will share in savings at the maximum sharing 
rate according to the applicable financial model, up to the performance 
payment limit. If the ACO fails to meet the quality performance 
standard, the ACO will be ineligible to share in savings. These final 
policies are specified in revisions to the provisions governing Track 1 
(Sec.  425.604(d)), the BASIC track (Sec.  425.605(d)(1)(i)(A) (Level 
A), (d)(1)(ii)(A) (Level B), (d)(1)(iii)(A) (Level C), (d)(1)(iv)(A) 
(Level D), (d)(1)(v)(A) (Level E)), Track 2 (Sec.  425.606(d)), and the 
ENHANCED track (Sec.  425.610(d)).
    After considering the public comments we received, we are also 
finalizing our proposals for determining the shared loss rate under 
Track 2 and the ENHANCED track, for performance years beginning on or 
after January 1, 2021, through modifications to the regulations at 
Sec. Sec.  425.606(f) and 425.610(f). Specifically, we will determine 
the shared loss rate as follows:
     Step 1: Calculate the quotient of the MIPS Quality 
performance category points earned divided by the total MIPS Quality 
performance category points available.
     Step 2: Calculate the product of the quotient described in 
step 1 and the sharing rate for the relevant track, either 60 percent 
for Track 2 or 75 percent for the ENHANCED track.
     Step 3: Calculate the shared loss rate as 1 minus the 
product determined in step 2. Consistent with the existing structure of 
the financial models: Under Track 2, the shared loss rate may not 
exceed 60 percent, and may not be less than 40 percent; under the 
ENHANCED track, the shared loss rate may not exceed 75 percent, and may 
not be less than 40 percent. If the ACO fails to meet the quality 
performance standard, the shared loss rate will be 60 percent under 
Track 2 or 75 percent under the ENHANCED track.
    We received no comments on our proposed technical and conforming 
changes to Sec. Sec.  425.606(f) and 425.610(f), for clarity. We are 
finalizing these changes as proposed in order to specify the policy 
that would apply for purposes of determining the shared loss rate for 
Track 2 ACOs and ENHANCED track ACOs for performance years (or a 
performance period) beginning on or before January 1, 2020. We are also 
finalizing our proposed revision to Sec.  425.606(f) to expressly state 
both the minimum and maximum shared loss rates for Track 2.
e. Compliance With the Quality Performance Standard
(1) Background
    As discussed in more detail in section III.G.1.c. of the CY 2021 
PFS proposed rule (85 FR 50234), the quality performance standard is 
the minimum performance level ACOs must achieve in order to share in 
any savings earned, avoid maximum shared losses under certain payment 
tracks, and avoid quality-related compliance actions. Section 
1899(d)(4) of the Act authorizes the Secretary to terminate an 
agreement with an ACO that does not meet the established quality 
performance standards. Through earlier rulemaking we established an 
approach to enforce ACO compliance with the quality performance 
standards, as specified in the Shared Savings Program regulations at 
Sec.  425.316 (see 76 FR 67951, 80 FR 32818 and 32819, 81 FR 80492 
through 80494).
    To identify ACOs that do not meet the established quality 
performance standards, we review the ACO's quality data submission. 
Under our current policies, as specified in Sec.  425.316(c), if an ACO 
does not meet quality performance standards or fails to report on one 
or more quality measures, in addition to actions set forth at 
Sec. Sec.  425.216 and 425.218, we will take the following actions:
     The ACO may be given a warning for the first time it fails 
to meet the minimum attainment level on at least 70 percent of the 
measures, as determined under Sec.  425.502, in one or more domains and 
may be subject to a corrective action plan (CAP). CMS may forgo the 
issuance of the warning letter depending on the nature and severity of 
the noncompliance and instead subject the ACO to actions set forth at 
Sec.  425.216 or immediately terminate the ACO's participation 
agreement under Sec.  425.218.
     The ACO's compliance with the quality performance 
standards will be re-evaluated the following year. If the ACO continues 
to fail to meet the quality performance standards in the following 
year, the agreement will be terminated.
     An ACO will not qualify to share in savings in any year it 
fails to report accurately, completely, and timely on the quality 
performance measures.
    Further, according to Sec.  425.224(b), in evaluating the 
eligibility of a renewing ACO or re-entering ACO to enter a new 
participation agreement with CMS for participation in the Shared 
Savings Program, we consider the ACO's history of noncompliance with 
the program's quality performance standard. For evaluating ACOs that 
entered into a participation agreement for a 3-year period, we consider 
whether the ACO failed to meet the quality performance standard during 
1 of the first 2 performance years of the previous agreement period. 
For evaluating ACOs that entered into a participation agreement for a 
period longer than 3 years, we consider whether the ACO failed to meet 
the quality performance standard for 2 consecutive performance years 
and was terminated as specified in Sec.  425.316(c)(2), or whether the 
ACO failed to meet the quality performance standard for 2 or more 
performance years of the previous agreement period, regardless of 
whether the years were consecutive.
    The terms ``renewing ACO'' and ``re-entering ACO'' are defined in 
the regulations at Sec.  425.20. We define renewing ACO to mean an ACO 
that continues its participation in the program for a consecutive 
agreement period, without a break in participation, because it is 
either: (1) An ACO whose participation agreement expired and that 
immediately enters a new agreement period to continue its participation 
in the program; or (2) an ACO that terminated its current participation 
agreement under Sec.  425.220 and immediately enters a new agreement 
period to continue its participation in the program. We define

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re-entering ACO to mean an ACO that does not meet the definition of a 
renewing ACO and meets either of the following conditions: (1) Is the 
same legal entity as an ACO that previously participated in the program 
and is applying to participate in the program after a break in 
participation, because the ACO's participation agreement expired 
without having been renewed, or the ACO's participation agreement was 
terminated under Sec.  425.218 or Sec.  425.220; or (2) is a new legal 
entity that has never participated in the Shared Savings Program and is 
applying to participate in the program and more than 50 percent of its 
ACO participants were included on the ACO participant list under Sec.  
425.118, of the same ACO in any of the 5 most recent performance years 
prior to the agreement start date.
(2) Revisions
    In the CY 2021 PFS proposed rule (85 FR 50237), we explained that 
we had revisited the provisions of Sec.  425.316(c) on monitoring 
compliance with quality reporting and performance requirements in light 
of our proposed modifications to the quality performance standard. We 
proposed to modify the introductory text at Sec.  425.316(c) to state 
that we will review an ACO's submission of quality measurement data to 
identify ACOs that are not meeting the applicable quality performance 
standard under Sec.  425.500 or Sec.  425.512. As proposed, we would 
retain the discretion to request additional documentation from an ACO, 
ACO participants, or ACO providers/suppliers. Further, we noted our 
belief that in conjunction with the proposed changes to the quality 
performance standard, it would be appropriate to strengthen our 
policies for compliance with the quality performance standard by 
broadening the conditions under which CMS may terminate an ACO's 
participation agreement when the ACO demonstrates a pattern of failure 
to meet the quality performance standard.
    As currently structured, the regulation at Sec.  425.316 does not 
specify what actions CMS will take when an ACO fails to meet the 
quality performance standard for multiple, nonconsecutive performance 
years, or 2 consecutive performance years that span 2 agreement periods 
(that is, the last performance year of an agreement period and the 
first performance year of the subsequent agreement period). 
Accordingly, we proposed a new approach that CMS would follow to 
monitor for and address an ACO's continued noncompliance with the 
applicable quality performance standard for performance years beginning 
on or after January 1, 2021. Noncompliance with the quality performance 
standard during earlier performance years would continue to be subject 
to the rules set forth at Sec.  425.316(c)(1) through (3), which we 
proposed would be consolidated at Sec.  425.316(c)(1). For performance 
years beginning on or after January 1, 2021, we proposed that when CMS 
determines an ACO fails to meet the quality performance standard (as 
described in section III.G.1.c. of the proposed rule), CMS may take the 
actions prior to termination set forth at Sec.  425.216, and may 
terminate the ACO's participation agreement according to Sec.  425.218. 
In addition to the actions set forth at Sec. Sec.  425.216 and 425.218, 
we proposed to adopt a specific approach that CMS would follow to 
monitor for and address an ACO's continued noncompliance with the 
quality performance standard.
    We proposed that ACOs exhibiting a pattern of failure to meet the 
quality performance standard would be terminated from the program. 
Specifically, we proposed to terminate an ACO's participation agreement 
when the ACO fails to meet the quality performance standard for 2 
consecutive performance years within an agreement period or fails to 
meet the quality performance standard for any 3 performance years 
within an agreement period, regardless of whether the years are in 
consecutive order. We also proposed that we would terminate the 
participation agreement of a renewing ACO or a re-entering ACO if the 
ACO fails to meet the quality performance standard for 2 consecutive 
performance years across 2 agreement periods, specifically the last 
performance year of the ACO's previous agreement period and the first 
performance year of the ACO's new agreement period. In addition, we 
proposed that we would terminate the participation agreement of a 
renewing ACO or a re-entering ACO if the ACO fails to meet the quality 
performance standard for the last performance year of the ACO's 
previous agreement period and this occurrence was either the second 
consecutive performance year of failed quality performance or the third 
nonconsecutive performance year of failed quality performance during 
the previous agreement period. We proposed to amend Sec.  425.316(c)(2) 
to reflect this new approach.
    We explained that the proposal to terminate an ACO if it fails to 
meet the quality performance standard for 2 consecutive performance 
years within an agreement period would be consistent with the current 
approach. However, we also proposed to terminate an ACO's participation 
agreement if the ACO fails to meet the quality performance standard for 
any 3 performance years within an agreement period, regardless of 
whether these years are in consecutive order. In the December 2018 
final rule (83 FR 67831), we extended participation agreements from 3-
years to 5-years. ACOs participating under a 5-year agreement period 
may show a pattern of failure to meet the quality performance standard 
in performance years that are not consecutive. Therefore, we noted that 
we believe it is important to continue to monitor ACOs throughout their 
5-year agreement period and if an ACO fails to meet the quality 
performance standard for 3 nonconsecutive performance years we proposed 
to terminate their participation agreement.
    Additionally, we noted that we were concerned that a renewing ACO's 
quality performance results for the last performance year of the 
current agreement period would not be available for us to consider in 
reviewing the ACO's application to renew its agreement, as currently 
provided in Sec.  425.224(b)(1)(ii)(A). We noted that we had a similar 
concern with respect to some re-entering ACOs (particularly, an ACO 
that notifies CMS of its decision to terminate its participation 
agreement and subsequently submits an application to re-enter the 
program for the next start date following the effective date of its 
termination). To prevent these ACOs from remaining in the program, 
despite a pattern of noncompliance with the quality performance 
standard, we proposed that if we determine that the last performance 
year of the ACO's previous agreement period was either the second 
consecutive performance year of failed quality performance or the third 
nonconsecutive performance year of failed quality performance during 
the prior agreement period, CMS would terminate the ACO's new 
participation agreement. For example, if an ACO failed to meet the 
quality performance standard in the first, third and fifth performance 
years of a 5-year agreement period, or failed to meet the quality 
performance standard in the fourth and fifth performance years of a 5-
year agreement period, results for the fifth performance year would not 
be available until after the ACO has renewed and entered a new 
agreement period. We explained that, in both examples, we would 
anticipate determining during the first performance year of the ACO's 
new agreement period that the ACO had failed to meet the quality 
performance standard for the last performance year of

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its previous agreement period. Therefore, under the proposal, CMS would 
terminate the ACO's new participation agreement during the first 
performance year of that agreement period.
    Furthermore, we expressed concern that an ACO could have a pattern 
of failing to meet the quality performance standard for consecutive 
years spanning 2 agreement periods. Therefore, if a renewing or re-
entering ACO fails to meet the quality performance standard for 2 
consecutive performance years across 2 agreement periods (the last 
performance year of the ACO's previous agreement period and the first 
performance year of the ACO's new agreement period), we proposed to 
terminate the ACO's participation agreement. We noted that we 
anticipated that quality performance results for the ACO's first 
performance year of its new agreement period would be available during 
the second performance year of the ACO's new agreement period. 
Therefore, CMS would terminate the ACO's new participation agreement 
during the second performance year of the new agreement period.
    We recognized there would be additional complexity in the 
application of these policies to a new ACO that is identified as a re-
entering ACO because of its ACO participants' prior participation in 
another Shared Savings Program ACO. Under the proposed approach, we 
would apply to the re-entering ACO the other ACO's quality performance 
for previous years (prior to the start of the re-entering ACO's 
agreement period) and would terminate the re-entering ACO if the other 
ACO is determined to have failed to meet the quality performance 
standard in 2 consecutive performance years within an agreement period, 
or if the other ACO is determined to have failed to meet the quality 
performance standard for 3 performance years (in nonconsecutive order) 
within an agreement period. We acknowledged that under the proposed 
approach, this could occur in circumstances when the other ACO's most 
recent performance year of failed quality performance is determined 
after the start of the new, re-entering ACO's agreement period. 
Further, under the proposed approach, we would also consider whether 
the other ACO failed to meet the quality performance standard in the 
most recent performance year prior to the start of the new, re-entering 
ACO's agreement period, and whether the new, re-entering ACO also fails 
to meet the quality performance standard for its first performance 
year. Under our proposal, because these 2 performance years of failed 
quality performance would be consecutive, we would terminate the 
participation of the new, re-entering ACO.
    We noted that because a significant percentage of the ACO 
participants in the new, re-entering ACO were previously participating 
in this other ACO, we believed it would be appropriate to hold the new, 
re-entering ACO accountable for the quality performance of the other 
ACO. According to the definition of re-entering ACO, more than 50 
percent of the entity's ACO participants must have participated 
together in the same ACO within a 5-performance year lookback period. 
As a result, over half of the new, re-entering ACO's ACO participants 
can be considered to have contributed to the failed quality performance 
of this other ACO. We explained that if we were to disregard the recent 
failed quality performance of this other ACO, these ACO participants 
would be allowed to continue participation in the Shared Savings 
Program as part of the new, re-entering ACO, and potentially take 
advantage of program flexibilities, despite a pattern of noncompliance 
with the quality performance standard.
    We proposed to implement these policies starting with performance 
year 2021 and subsequent years. We acknowledged that an ACO currently 
participating under a performance agreement spanning 5-years could fail 
the quality performance standard for a performance year starting in 
2019 under Sec.  425.502. The same ACO could then again fail the 
quality performance standard under the proposed new provision at Sec.  
425.512 in performance years 2021 and 2023. In this scenario, the ACO 
would have failed the quality performance standards for 3 
nonconsecutive years under the same agreement period, but the ACO would 
not be terminated in this scenario because the proposed policies would 
apply starting with performance year 2021. However, we noted that if 
the ACO decides to apply as a renewing or re-entering ACO, we would 
review its history of noncompliance with the requirements of the Shared 
Savings Program as provided under Sec.  425.224(b)(1) when determining 
whether to approve its application.
    We also explained that under the current regulation at Sec.  
425.316(c)(3), an ACO will not qualify to share in savings in any year 
in which it fails to report accurately, completely, and timely on the 
quality performance measures. Consistent with the proposed revisions to 
the quality performance standard under the Shared Savings Program 
discussed in section III.G.1.c. of the proposed rule, we proposed to 
specify in the proposed new provision at Sec.  425.512 that, for 
performance years beginning on or after January 1, 2021, an ACO will 
not qualify to share in savings in any year it fails to meet the 
quality performance standard.
    We noted that the termination of an ACO's participation agreement 
for failure to meet the quality performance standard under the proposed 
approach described in the proposed rule, would also make the ACO 
subject to the payment consequences of early termination as specified 
in Sec.  425.221(b). Under Sec.  425.221(b)(1)(ii), if the 
participation agreement is terminated at any time by CMS under Sec.  
425.218, the ACO is not eligible to receive shared savings for the 
performance year during which the termination becomes effective. Under 
Sec.  425.221(b)(2)(ii)(B), an ACO participating under a two-sided 
model whose participation agreement is terminated by CMS under Sec.  
425.218 is liable for a pro-rated share of any shared losses determined 
for the performance year during which the termination becomes 
effective. These policies would apply whenever an ACO is terminated for 
non-compliance with the quality performance standard in accordance with 
Sec.  425.316(c).
    We proposed to revise Sec.  425.316(c) to incorporate the proposed 
approach for monitoring ACO compliance with the quality performance 
standard for performance years beginning on or after January 1, 2021. 
We also proposed to make other technical and conforming changes to the 
regulations at Sec.  425.316(c). In particular, we proposed to amend 
the existing provisions for monitoring ACO compliance with the quality 
performance standards to specify that those provisions are applicable 
to performance years (or a performance period) beginning on or before 
January 1, 2020.
    We noted that we also continue to believe in the importance of 
considering an ACO's history of noncompliance with the quality 
performance standard in evaluating the eligibility of a renewing ACO or 
a re-entering ACO to enter a new agreement period under the Shared 
Savings Program. In light of our proposed changes to Sec.  425.316(c), 
we proposed to make conforming changes to Sec.  425.224(b)(1)(ii)(A), 
which authorizes CMS to approve or deny a renewing ACO's or re-entering 
ACO's application to participate in the Shared Savings Program based on 
an evaluation of the ACO's history of non-compliance with the quality 
performance standard. Specifically, we proposed to revise Sec.  
425.224(b)(1)(ii)(A) to state that as part

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of its evaluation of a renewing or re-entering ACO's history of 
noncompliance with the requirements of the Shared Savings Program, we 
will evaluate whether the ACO demonstrated a pattern of failure to meet 
the quality performance standards or met any of the criteria for 
termination under Sec.  425.316(c)(1)(ii) or (c)(2)(ii).
    We received public comments on the proposals concerning monitoring 
compliance with the quality performance standard. The following is a 
summary of the comments we received and our responses.
    Comment: We received a few comments supporting our proposals to 
modify our policies for monitoring ACOs for compliance with the quality 
performance standard. Two commenters suggested we modify the proposed 
approach to provide that an ACO's participation agreement will be 
terminated after 3 consecutive years of failing to meet the quality 
performance standard. One commenter noted this approach would align 
with policies used in Medicare Advantage where plans' contracts may be 
terminated after three consecutive years of failing to achieve an 
overall quality rating of at least 3 stars. One of the commenters 
further suggested we terminate an ACO's participation agreement for 
failure to meet the quality performance standard after 4 non-
consecutive years of failing to meet the quality performance standard.
    Response: We appreciate the additional suggestions for modifying 
our approach for monitoring and enforcing compliance with the quality 
performance standard. Since the beginning of the Shared Savings 
Program, we have terminated 3 ACOs for failure to report quality for 
two consecutive years. We decline to modify the proposed changes to our 
policies for monitoring compliance with the quality performance 
standard to provide for termination only after 3 consecutive years or 4 
non-consecutive years of noncompliance. We believe the policies as 
proposed, under which an ACO will be terminated following 2 consecutive 
years or 3 non-consecutive years of non-compliance, provide ACOs enough 
time to implement processes and procedures that will allow them to meet 
the quality performance standard. If an ACO repeatedly fails to meet 
the quality performance standard the ACO should not continue 
participating in the Shared Savings Program. The Shared Savings Program 
seeks to both improve quality performance and reward high quality, 
while reducing the growth in Medicare spending. We believe these 
requirements for enforcing compliance with the quality performance 
standard help to hold ACOs accountable for the quality of the care they 
furnish to their beneficiaries and further encourage ACOs to 
demonstrate consistently that they are providing high quality of care 
to their beneficiary populations year over year.
    Comment: We received a few comments opposing our proposed policies 
for terminating an ACO's participation agreement for a pattern of 
failure to meet the quality performance standard. One commenter 
suggested we develop a compliance standard that includes educating ACOs 
and issuing corrective action plans. The commenter suggested that we 
should terminate an ACO's participation agreement only if the ACO's 
failure to meet the quality performance standard was due to ``gross 
negligence.''
    Response: We appreciate the commenter's suggestions; however, we 
note that we already incorporate education and outreach activities and 
compliance activities into our management and operations of the Shared 
Savings Program. We encourage and support ACOs in sharing their best 
practices and lessons learned from their experiences participating in 
the Shared Savings Program. We have hosted in-person learning 
collaboratives where ACOs can meet one another and listen to case study 
presentations about their experiences. We have also hosted webinars 
where ACOs present case studies on providing value-based care, 
including sharing lessons learned and best practices in quality 
reporting. Recordings of these webinars and supporting materials remain 
available for ACOs participating in the Shared Savings Program to 
access. Additionally, as proposed, if the ACO fails to meet the quality 
performance standard, CMS may take one or more of the actions prior to 
termination specified in Sec.  425.216, which may include requesting a 
corrective action plan from the ACO. Lastly, we disagree with the 
commenter's suggestion that CMS should not terminate an ACO's 
participation agreement unless the ACO's failure to meet the quality 
performance standard was due to ``gross negligence.'' 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. The gross 
negligence standard advocated by the commenter would set far too high a 
bar for enforcement of the quality performance requirements and thereby 
do little to encourage improvement in quality of care over time. We 
believe it is important for ACOs to meet the quality performance 
standard and that ACOs that repeatedly fail to meet the quality 
performance standard should not be able to continue their participation 
in the program.
    We did not receive comments concerning our proposal to make 
conforming changes to Sec.  425.224(b)(1)(ii)(A). After considering the 
comments received, we are finalizing our proposed policies without 
modifications. We are revising Sec.  425.316(c) to modify our approach 
for monitoring ACO compliance with the quality performance standard for 
performance years beginning on or after January 1, 2021. We are also 
making technical and conforming changes to amend the existing 
provisions on monitoring ACO compliance with the quality performance 
standards to specify that those provisions are applicable to 
performance years (or a performance period) beginning on or before 
January 1, 2020. Lastly, we are making conforming changes to Sec.  
425.224(b)(1)(ii)(A) to provide that as part of evaluating a renewing 
or re-entering ACO's application to participate in the Shared Savings 
Program, CMS will consider whether the ACO has demonstrated a pattern 
of failure to meet the quality performance standards or met any of the 
criteria for termination under Sec.  425.316(c)(1)(ii) or (c)(2)(ii).
f. Updating the Process Used To Validate ACO Quality Data Reporting
    In the CY 2017 PFS final rule, we finalized modifications to the 
quality measures validation audit process. These modifications changed 
the overall audit process from a 3-phased medical record review to an 
audit conducted in a single phase. Under our current process, if 
selected for an audit, an ACO must provide beneficiary medical records 
data to substantiate the quality data reported by the ACO. As part of 
the audit, CMS calculates an overall audit match rate, which is derived 
by dividing the total number of audited records that match the 
information reported in the CMS Web Interface by the total number of 
the medical records audited. For example: (1) If the ACO has an audit 
match rate of 90 percent or above it will pass the audit; (2) if the 
ACO has an audit match rate of less than 90 percent, but greater than 
80 percent, the ACO may be required to submit a CAP under Sec.  425.216 
for CMS approval; (3) if the ACO has an audit match rate of less than 
80 percent, absent unusual circumstances, we will adjust the ACO's

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overall quality score proportional to the ACO's audit match rate, which 
may have implications for the ACO's financial reconciliation.
    We stated in the CY 2021 PFS proposed rule (85 FR 50239) that under 
our proposal to align the quality reporting requirements under the 
Shared Savings Program with quality reporting under the APP, we 
believed it would be appropriate to also align with the MIPS Data 
Validation and Audit (DVA) process (Sec.  414.1390). Rather than 
continuing to validate ACO quality data reporting under the Shared 
Savings Program, we noted that we believed it would be more appropriate 
for MIPS to validate the data submitted by ACOs for the three measures 
in the APP, as ACOs will be able to select the submission method for 
these measures and the MIPS DVA is based on submission method. We also 
noted that we believed streamlining the approach to data validation and 
audit would minimize administrative burden associated with the audit 
for ACOs as they would only need to track to one validation process, 
and for ACOs in a track (or payment model within a track) that does not 
meet the definition of an Advanced APM, the results of the audit would 
be applicable for purposes of both the Shared Savings Program and MIPS.
    We proposed to address the audit and validation of data used to 
determine the ACO's quality performance in a new provision we proposed 
to add to the Shared Savings Program regulations at Sec.  425.510(c). 
Specifically, we proposed that CMS would retain the right to audit and 
validate the quality data reported by an ACO under Sec.  425.510(b) 
according to Sec.  414.1390.
    We received public comments on the proposed updates to the process 
used to validate ACO quality data reporting. The following is a summary 
of the comments we received and our response.
    Comment: We received comments that supported our proposal. One 
commenter indicated that the proposed approach would allow for the 
continued oversight of quality performance, while reducing 
administrative burden on ACOs as they ensure audit readiness.
    Response: We are finalizing the updates to the process used to 
validate ACO quality data reporting and the conforming changes to Sec.  
425.510(c) as proposed. Specifically, we are finalizing that CMS 
retains the right to audit and validate quality data reported by an ACO 
via the APP according to the MIPS DVA process for performance years 
beginning on or after January 1, 2021. We believe that this updated 
process will reduce administrative burden on ACOs by allowing them to 
track only one validation process that will be applicable for both the 
Shared Savings Program and MIPS. We note that in section III.G.1.e. of 
this final rule, we are finalizing our proposals related to ACOs' 
compliance with the quality performance standard, including the 
proposed approach to terminating ACOs that exhibit a pattern of failure 
to meet the quality performance standard.
g. Changes to the Extreme and Uncontrollable Circumstances Policy for 
Performance Year 2021 and Subsequent Performance Years
    As discussed in section III.G.1.c. of the CY 2021 PFS proposed 
rule, we proposed to make changes to the quality performance standard 
for the Shared Savings Program for the performance year beginning on 
January 1, 2021, and subsequent performance years. We explained that we 
continue to believe it is appropriate to adjust the quality performance 
scores for ACOs affected by extreme and uncontrollable circumstances. 
Therefore, we proposed to update the extreme and uncontrollable 
circumstances policy under the Shared Savings Program consistent with 
the proposal to align the quality reporting requirements for the Shared 
Savings Program with the proposed APP. Specifically, for performance 
year (PY) 2021 and subsequent performance years, we proposed to set the 
minimum quality performance score for an ACO affected by an extreme and 
uncontrollable circumstance during the performance year, including the 
applicable quality data reporting period for the performance year, to 
equal the 40th percentile MIPS Quality performance category score. If 
the ACO is able to report quality data and meet the MIPS data 
completeness and case minimum requirements, we would use the higher of 
the ACO's MIPS Quality performance category score or the 40th 
percentile MIPS Quality performance category score. If an ACO is unable 
to report quality data and meet the MIPS Quality data completeness and 
case minimum requirements due to an extreme and uncontrollable 
circumstance, we would apply the 40th percentile MIPS Quality 
performance category score. We noted that we believed this approach 
would be appropriate as it aligns with the proposed threshold for 
meeting the quality performance standard allowing impacted ACOs to 
share in savings at their maximum sharing rate. We acknowledged that 
using the 40th percentile may not offer the same level of protection 
for ACOs incurring losses that would receive the higher of their ACO 
quality score or the mean ACO score under the current policy. However, 
we noted that for ACOs in Track 2 and the ENHANCED track, under which 
shared losses are determined based in part on an ACO's quality 
performance, ACOs are also afforded relief from shared losses through 
the application of the extreme and uncontrollable circumstances policy 
under which shared losses are reduced based on the percentage of the 
year and percentage of assigned beneficiaries impacted by an extreme 
and uncontrollable circumstance.
    In the CY 2021 PFS proposed rule (85 FR 50240), we explained that 
under the proposed revisions to the quality reporting requirements, we 
would no longer generate a CMS Web Interface quality reporting sample 
for ACOs because ACOs would no longer be reporting measures via the Web 
Interface; therefore, we proposed to determine the percentage of the 
ACO's performance year assigned beneficiary population that was 
affected by an extreme and uncontrollable circumstances based on the 
quarter four list of assigned beneficiaries, rather than the list of 
assigned beneficiaries used to generate the Web Interface quality 
reporting sample, which is currently used. We explained that using the 
quarter four list of assigned beneficiaries would be an appropriate 
alternative because the file is generated after the end of the fourth 
quarter and would offer a more complete representation of the 
population of assigned beneficiaries that reside in an area that is 
impacted by an extreme and uncontrollable circumstance during the 
performance year. Accordingly, we solicited comment on our proposed 
revisions to the extreme and uncontrollable circumstances policy for 
performance year 2021 and subsequent performance years.
    We proposed to specify our proposed policies for addressing the 
effect of extreme and uncontrollable circumstances on ACO quality 
performance for performance year 2021 and subsequent performance years 
in the proposed new provision at Sec.  425.512. In addition, we 
proposed to include policies that parallel the existing policies, as 
specified in Sec.  425.502(f), for determining when an extreme and 
uncontrollable circumstance has occurred and identifying affected ACOs. 
In particular, we proposed to include a provision, similar to the 
current provision at Sec.  425.502(f)(1), to establish our policies for 
determining whether an ACO has been affected by an extreme and 
uncontrollable circumstance. We also

[[Page 84745]]

proposed to include a provision, similar to the provision at Sec.  
425.502(f)(2), to establish the policies that would apply for 
calculating an affected ACO's quality performance score. Similar to the 
existing provision at Sec.  425.502(f)(3), we proposed to specify that 
we would apply determinations made under the Quality Payment Program 
with respect to whether an extreme and uncontrollable circumstance has 
occurred, and the affected areas. Consistent with the existing policy 
under Sec.  425.502(f)(4), this new provision would also specify that 
we have sole discretion to determine the time period during which an 
extreme and uncontrollable circumstance occurred, the percentage of the 
ACO's assigned beneficiaries residing in the affected areas, and the 
location of the ACO legal entity.
    We received public comments on the proposed changes to the extreme 
and uncontrollable circumstances policy for PY 2021 and subsequent 
performance years. The following is a summary of the comments we 
received and our response.
    Comment: Several commenters supported our proposal to set the 
minimum quality performance score for an ACO affected by an extreme and 
uncontrollable circumstance during the performance year, including the 
applicable quality data reporting period for the performance year, to 
equal the 40th percentile MIPS Quality performance category score in 
performance year 2021. Two commenters did not support the proposed 
changes to the extreme and uncontrollable policy for performance year 
2021. One commenter explained that ACO participants tend to have higher 
MIPS Quality performance category scores than non-ACO participants; 
therefore, setting the minimum quality performance score for an ACO 
affected by an extreme and uncontrollable circumstance to equal the 
40th percentile MIPS Quality performance would be lower than what the 
ACO may have earned. The other commenter stated that our proposal would 
effectively lower the protections for impacted ACOs and comes at a 
particularly tumultuous time due to the PHE for COVID-19. The commenter 
noted that they would support a similar policy if CMS maintained a 
baseline level of protection, such as the affected ACO's mean quality 
performance score, because this would maintain current levels of 
protection, which is particularly critical in the midst of the PHE for 
COVID-19, while also incentivizing ACOs to report data to improve their 
quality scores.
    Several commenters encouraged CMS to apply the alternative extreme 
and uncontrollable circumstances policy discussed in the CY 2021 PFS 
proposed rule for performance year 2020 to performance year 2021. These 
commenters cited their concerns that the effects of the PHE for COVID-
19 would extend into 2021 and urged CMS to extend this alternative 
policy to performance year 2021.
    Other commenters urged us to refrain from making further changes to 
the extreme and uncontrollable circumstances policy for other 
performance years at this time, given that all ACOs are currently 
subject to the existing policy due to the PHE for COVID-19. These 
commenters explained that numerous changes to the extreme and 
uncontrollable circumstances policy were made in performance years 2019 
and 2020, including additional modifications due to the PHE for COVID-
19, and therefore CMS should refrain from making further changes to the 
policy at this time. Commenters noted that abrupt changes in policy, 
like changing the reporting requirements during the PHE for COVID-19, 
have been difficult for healthcare providers to adjust to and that 
these policy changes should take place only after the end of the PHE 
for COVID-19, once the totality of information and learnings can be 
assessed. The commenters suggested that we allow more time to examine 
the impacts of the PHE for COVID-19 and gather further stakeholder 
input before proceeding with any changes to the policy for performance 
year 2021 and subsequent years.
    Response: We acknowledge that we have made multiple changes to the 
extreme and uncontrollable circumstances policy over the past few years 
in order to provide relief to ACOs impacted by extreme and 
uncontrollable circumstances. We also agree with the commenter that 
ACOs typically have higher MIPS Quality performance category scores 
than non-ACO MIPS participants, based on their performance on the 
measures reported via the CMS Web Interface and the CAHPS for ACOs; 
however, given that the APP measure set is smaller and includes a 
combination of eCQMs/CQM MIPS measures, CAHPS for MIPS and 2 claims-
based measures, we have no comparisons to determine how ACOs will 
perform in relation to non-ACO groups under the APP. Accordingly, we 
believe setting the minimum quality performance score for an ACO 
affected by an extreme and uncontrollable circumstance during the 
performance year to equal the MIPS Quality performance category score 
that will satisfy the quality performance standard is appropriate and 
aligns with the policies regarding for the quality performance standard 
as discussed in section III.G.1.b.(1) of this final rule.
    We note that as discussed in section III.G.1.c. of this final rule, 
we are finalizing a gradual phase-in of the increase in the level of 
quality performance standard that would be required for all ACOs to 
meet the Shared Savings Program quality performance standard to allow 
time for ACOs to gain experience. For performance years 2021 and 2022, 
the threshold for the quality performance standard will be set at a 
quality performance score equivalent to or above the 30th percentile 
across all MIPS Quality performance category scores, excluding 
entities/providers eligible for facility-based scoring, and for 
performance year 2023 and subsequent performance years, the threshold 
for the quality performance standard will be set at a quality score 
equivalent to or above the 40th percentile across all MIPS Quality 
performance category scores, excluding entities/providers eligible for 
facility-based scoring. This gradual phase-in is designed to allow ACOs 
to gain experience under the new standard. We agree that the extreme 
and uncontrollable circumstances policy should offer an appropriate 
level of protection for ACOs that are impacted by an extreme and 
uncontrollable circumstance while still incentivizing quality 
reporting. We believe that aligning the extreme and uncontrollable 
circumstances policy with the gradual phase in of the quality 
performance standard will offer protection for ACOs, while still 
incentivizing reporting. Moreover, this policy enables ACOs impacted by 
an extreme and uncontrollable circumstance to share in savings at their 
maximum sharing rate. We acknowledge that this policy change will 
potentially affect ACOs in Track 2 and the ENHANCED track, for whom 
shared losses are determined based in part on an ACO's quality 
performance. These ACOs, however, will have relief from shared losses 
through the application of the extreme and uncontrollable circumstances 
policy under which shared losses are reduced based on the percentage of 
the year and percentage of assigned beneficiaries impacted by an 
extreme and uncontrollable circumstance.
    Although several commenters encouraged CMS to apply the alternative 
extreme and uncontrollable circumstances policy we sought comment on in 
the CY 2021 PFS

[[Page 84746]]

proposed rule for performance year 2020 to performance year 2021, we do 
not believe applying the same policy we sought comment on for 
performance year 2020, as described in section III.I.2 of this final 
rule would be appropriate for performance year 2021. We do not believe 
assigning the higher of an ACO's 2019 or 2021 quality score to 
determine an ACO's quality performance score for performance year 2021 
would be an effective way to mitigate the concerns related to the PHE 
for COVID-19 because there would be a mismatch in the datasets and the 
scoring methodologies between the 2 years. One score would be based on 
a one to 100 scale while the other would be based on a percentile 
range. As a result, the scores for the 2 years would not be comparable 
across years. However, in this final rule, we are lowering the 
threshold for the quality performance standard to the 30th percentile 
from the initially proposed 40th percentile for performance years 2021 
and 2022, and we believe this change will help to alleviate and 
mitigate the impact of COVID-19.
    We received no comments on our proposal to determine the percentage 
of the ACO's performance year assigned beneficiary population that was 
affected by an extreme and uncontrollable circumstances based on the 
quarter four list of assigned beneficiaries.
    For these reasons, we are finalizing our proposed changes to the 
extreme and uncontrollable circumstances policy for performance year 
2021 and subsequent performance years with modifications and conforming 
changes as follows:
    For PY 2021 and PY 2022, consistent with the modifications to the 
quality performance standard described in section III.G.1.b.(1). of 
this final rule, the minimum quality performance score for an ACO 
affected by an extreme and uncontrollable circumstance during the 
performance year, including the applicable quality data reporting 
period for the performance year, will be set equal to the 30th 
percentile MIPS Quality performance category score as determined under 
Sec.  425.512(a)(3). If the ACO is able to report quality data and 
meets the MIPS data completeness and case minimum requirements, we will 
use the higher of the ACO's quality performance score or the 30th 
percentile MIPS Quality performance category score. If an ACO is unable 
to report quality data and meet the MIPS Quality data completeness and 
case minimum requirements due to an extreme and uncontrollable 
circumstance, we will apply the 30th percentile MIPS Quality 
performance category score.
    For PY 2023, we will set the minimum quality performance score for 
an ACO affected by an extreme and uncontrollable circumstance during 
the performance year, including the applicable quality data reporting 
period for the performance year, to equal the 40th percentile MIPS 
Quality performance category score as determined under Sec.  
425.512(a)(4). If the ACO is able to report quality data and meets the 
MIPS data completeness and case minimum requirements, we will use the 
higher of the ACO's quality performance score or the 40th percentile 
MIPS Quality performance category score. If an ACO is unable to report 
quality data and meet the MIPS Quality data completeness and case 
minimum requirements due to an extreme and uncontrollable circumstance, 
we will apply the 40th percentile MIPS Quality performance category 
score.
    For additional information, we refer readers to Table 39, in 
section III.G.1.b.(1) above, which shows the Shared Savings Program 
quality performance standard for PY 2021, PY 2022, and PY 2023.
    We are finalizing our proposal to determine the percentage of the 
ACO's performance year assigned beneficiary population that was 
affected by an extreme and uncontrollable circumstances based on the 
quarter four list of assigned beneficiaries as proposed. We are also 
finalizing our proposal to specify the policies for addressing the 
effect of extreme and uncontrollable circumstances on ACO quality 
performance for performance year 2021 and subsequent performance years 
with the modifications and conforming changes described previously, in 
the new provision at Sec.  425.512(b).
    In the CY 2021 PFS proposed rule (85 FR 50240 and 50241), we also 
solicited comment on a potential alternative extreme and uncontrollable 
circumstances policy for PY 2022 and subsequent years that would 
continue to incentivize reporting but also acknowledge the challenges 
presented by extreme and uncontrollable circumstances. We explained 
that we were considering creating an extreme and uncontrollable 
circumstances methodology that would adjust the amount of shared 
savings determined for affected ACOs that complete quality reporting 
but do not meet the quality performance standard or that are unable to 
complete quality reporting. This methodology would be similar to the 
methodology currently used to adjust for extreme and uncontrollable 
circumstances when calculating the amount of shared losses for impacted 
ACOs. Under this alternative approach, instead of determining that ACOs 
are affected by an extreme and uncontrollable circumstances if 20 
percent of their beneficiaries or their legal entity are located in an 
area impacted by an extreme and uncontrollable circumstance and 
determining shared savings using the higher of the ACO's own quality 
score and the mean ACO quality score, we would determine shared savings 
for an affected ACO by multiplying the maximum possible shared savings 
the ACO would be eligible to receive based on its financial performance 
and track (or payment model within a track) by the percentage of the 
total months in the performance year affected by an extreme and 
uncontrollable circumstance, and the percentage of the ACO's assigned 
beneficiaries who reside in an area affected by an extreme and 
uncontrollable circumstance.
    If an ACO impacted by an extreme and uncontrollable circumstance 
does not report quality or reports quality, but does not meet the 
quality performance standard of a quality performance score equivalent 
to a MIPS Quality performance category score at or above the 40th 
percentile and owes shared losses, we noted that the existing extreme 
and uncontrollable circumstances methodology that applies when 
calculating the amount of shared losses would help to mitigate those 
losses.
    We received public comments on this potential alternative extreme 
and uncontrollable circumstances policy for PY 2022 and subsequent 
years. The following is a summary of the comments we received and our 
responses.
    Comment: We received two comments in support of the potential 
alternative extreme and uncontrollable circumstances policy for 
performance year 2022 and subsequent years. One commenter noted that 
the proposed methodology to adjust the amount of shared savings 
determined for affected ACOs that complete quality reporting but do not 
meet the quality performance standard or that are unable to complete 
quality reporting would provide affected ACOs with flexibility in 
reporting. The commenter emphasized that this would help ACOs continue 
participating in the Shared Savings Program.
    Several other commenters stated that they did not support CMS 
making additional changes to the extreme and uncontrollable 
circumstances policy at this time. These commenters urged CMS to 
refrain from making any significant changes to the extreme and 
uncontrollable policy at this time and to continue to assess the impact 
of the PHE

[[Page 84747]]

for COVID-19 before making any further changes to the established 
policy.
    Response: As we plan for future updates and changes to the extreme 
and uncontrollable circumstances policy for performance year 2022 and 
subsequent years, we will consider this feedback in the development of 
our proposals.
h. Technical Changes To Incorporate References To Revised Quality 
Performance Standard
    In section III.G.1.h of the CY 2021 PFS proposed rule (85 FR 
50241), we proposed to make certain technical, conforming changes to 
provisions of the Shared Savings Program regulations to reflect the 
proposal to add new sections of the regulations at Sec.  425.510 on the 
application of the APP to Shared Savings Program ACOs for performance 
years beginning on or after January 1, 2021, and Sec.  425.512 on 
determining the ACO quality performance standard for performance years 
beginning on or after January 1, 2021. We did not receive comments 
directly addressing our proposed technical changes to incorporate 
references to the proposed new regulations. In this section, we specify 
the technical changes we are finalizing either as proposed, or with 
additional revisions to account for the modifications we are making to 
phase in the new quality performance standard for performance years 
beginning on or after January 1, 2021, as discussed elsewhere in 
section III.G.1 of this final rule.
     Under subpart A, which specifies general provisions 
governing the Shared Savings Program:
    ++ In Sec.  425.100(b), the general description of ACOs that are 
eligible to receive payments for shared savings under the program, we 
are finalizing our proposed revisions for clarity and to add a 
reference to Sec.  425.512. In the description of the quality 
performance standard that must be met for the ACO to be receive payment 
for shared savings, we are finalizing our proposal to specify that the 
quality performance standards established under Sec.  425.500 are 
applicable for performance years (or a performance period) beginning on 
or before January 1, 2020, and that the quality performance standard 
under Sec.  425.512 is applicable for performance years beginning on or 
after January 1, 2021.
    ++ In Sec.  425.112(b)(2)(i), the provision specifying the ACO must 
have processes to promote patient engagement including to address 
compliance with patient experience of care survey requirements, we are 
finalizing our proposal to add a reference to Sec.  425.510.
     Under subpart C, which governs application procedures and 
the participation agreement, we are finalizing our proposed addition of 
a reference to Sec.  425.510 in the provision at Sec.  425.200(d) 
specifying that ACOs must submit measures in the form and manner 
required by CMS.
     Under subpart D, which specifies program requirements and 
beneficiary protections, we are finalizing our proposed addition of a 
reference to Sec.  425.510 in Sec.  425.302(a)(1) specifying 
requirements for data submission and certification.
     Under subpart G, which specifies the program's financial 
models for determining shared savings and shared losses (as 
applicable), we proposed to revise the description of program 
requirements that phase-in over multiple agreement periods in Sec.  
425.600(f)(4). We are finalizing our proposal to revise this provision 
with modifications to account for the phase-in of the revised quality 
performance standard that we describe in section III.G.1.b and section 
III.G.1.c of this final rule with modifications. Specifically, we are 
revising this provision to account for the approach we are finalizing 
under Sec.  425.512(a), which differentiates the quality performance 
standard applicable to ACOs in the first performance year of their 
first agreement period from the standard that is applicable to ACOs in 
subsequent years. This aspect of the phase-in of the quality 
performance standard applies to ACOs entering their first agreement 
period in the Shared Savings Program beginning on January 1, 2022, and 
in subsequent years, consistent with CMS' decision to forgo an 
application cycle for a January 1, 2021 agreement start date in the 
Shared Savings Program. Therefore, we are finalizing revisions to Sec.  
425.600(f)(4)(i) to add a reference to the quality performance standard 
as described in Sec.  425.512(a), which will be applicable for the 
performance year starting on January 1, 2021, and subsequent 
performance years.
     Under subpart I, which governs the reconsideration review 
process, we are finalizing our proposed addition of references to Sec.  
425.510, Sec.  425.512, or both to Sec.  425.800(a)(1), (2), and (6).
2. Revisions to the Definition of Primary Care Services Used in Shared 
Savings Program Beneficiary Assignment
a. Healthcare Common Procedure Coding System (HCPCS) and Current 
Procedural Terminology (CPT) Codes Used in Assignment
(1) Background
    Section 1899(c)(1) of the Act, as amended by the 21st Century Cures 
Act and the Bipartisan Budget Act of 2018, provides that for 
performance years beginning on or after January 1, 2019, the Secretary 
shall assign beneficiaries to an ACO based on their utilization of 
primary care services provided by a physician who is an ACO 
professional and all services furnished by Rural Health Clinics (RHCs) 
and Federally Qualified Health Centers (FQHCs). However, the statute 
does not specify which kinds of services may be considered primary care 
services for purposes of beneficiary assignment.
    In the November 2011 final rule (76 FR 67853), we established the 
initial list of services, identified by CPT and HCPCS codes, that we 
considered to be primary care services. In that final rule, we 
indicated that we intended to monitor CPT and HCPCS codes and would 
consider making changes to the definition of primary care services to 
add or delete codes used to identify primary care services, if there 
were sufficient evidence that revisions were warranted. We have updated 
the list of primary care service codes in subsequent rulemaking to 
reflect additions or modifications to the codes that have been 
recognized for payment under the Medicare PFS and to incorporate other 
changes to the definition of primary care services for purposes of the 
Shared Savings Program.
    In the June 2015 final rule (80 FR 32746 through 32748), we 
expanded the definition of primary care services to include two 
transitional care management (TCM) codes (CPT codes 99495 and 99496), 
and one chronic care management (CCM) code (CPT 99490). As discussed in 
the final rule, the TCM codes were established to pay a patient's 
physician or practitioner to coordinate the patient's care in the 30 
days following a hospital or SNF stay. Including these codes in the 
definition of primary care services reflects our belief that the work 
of community physicians and practitioners in managing a patient's care 
following discharge from a hospital or nursing facility (NF) to ensure 
better continuity of care for these patients and help

[[Page 84748]]

reduce avoidable readmissions is a key aspect of primary care.
    In the CY 2016 PFS final rule (80 FR 71270 through 71273), we 
revised the definition of primary care services to exclude services 
billed under CPT codes 99304 through 99318, containing the place of 
service 31 modifier specifying that the service was furnished in a SNF. 
We also revised the definition of primary care services to include 
claims submitted by Electing Teaching Amendment (ETA) hospitals.
    In the CY 2018 PFS final rule, we revised the definition of primary 
care services to include three additional CCM service codes, 99487, 
99489, and G0506, and four behavioral health integration (BHI) service 
codes, G0502, G0503, G0504 and G0507 (82 FR 53212 and 53213). We 
further revised the definition of primary care services in the November 
2018 final rule. In the November 2018 final rule, we added new codes to 
the definition of primary care services (CPT codes 99497, 99498, 96160, 
96161, 99354, and 99355, and HCPCS codes G0444, G0442, and G0443), and 
revised how we determine whether services identified by CPT codes 99304 
through 99318 were furnished in a SNF (83 FR 59964 through 59968).
    For performance years beginning on January 1, 2019, and subsequent 
performance years, we defined primary care services in Sec.  
425.400(c)(1)(iv) for purposes of assigning beneficiaries to ACOs under 
Sec.  425.402 as the set of services identified by the following HCPCS/
CPT codes:
    CPT codes:
    (1) 99201 through 99215 (codes for office or other outpatient visit 
for the E/M of a patient).
    (2) 99304 through 99318 (codes for professional services furnished 
in a NF; services identified by these codes furnished in a SNF are 
excluded).
    (3) 99319 through 99340 (codes for patient domiciliary, rest home, 
or custodial care visit).
    (4) 99341 through 99350 (codes for E/M services furnished in a 
patients' home for claims identified by place of service modifier 12).
    (5) 99487, 99489 and 99490 (codes for chronic care management).
    (6) 99495 and 99496 (codes for transitional care management 
services).
    (7) 99497 and 99498 (codes for advance care planning).
    (8) 96160 and 96161 (codes for administration of health risk 
assessment).
    (9) 99354 and 99355 (add-on codes, for prolonged E/M or 
psychotherapy services beyond the typical service time of the primary 
procedure; when the base code is also a primary care service code).
    (10) 99484, 99492, 99493 and 99494 (codes for behavioral health 
integration services).
    HCPCS codes:
    (1) G0402 (the code for the Welcome to Medicare visit).
    (2) G0438 and G0439 (codes for the annual wellness visits).
    (3) G0463 (for services furnished in ETA hospitals).
    (4) G0506 (code for chronic care management).
    (5) G0444 (codes for annual depression screening service).
    (6) G0442 (code for alcohol misuse screening service).
    (7) G0443 (code for alcohol misuse counseling service).
    In the May 8th COVID-19 IFC (85 FR 27582 through 27586), we revised 
the regulations to add Sec.  425.400(c)(2), specifying the definition 
of primary care services for purposes of beneficiary assignment for the 
performance year starting on January 1, 2020, and for any subsequent 
performance year that starts during the PHE for COVID-19 defined in 
Sec.  400.200, to include the foregoing codes specified in Sec.  
425.400(c)(1)(iv), as well as specified codes for remote evaluations, 
virtual check-ins, e-visits, and telephone E/M services. In section 
III.G.5.e of this final rule, we discuss the final policies regarding 
the definition of primary care services during the PHE for COVID-19.
(2) Revisions
    Based on feedback from ACOs and our further review of the HCPCS and 
CPT codes currently recognized for payment under the PFS, we discussed 
in the CY 2021 PFS proposed rule (85 FR 50242 through 50248) our belief 
that it would be appropriate to amend the definition of primary care 
services used in the Shared Savings Program assignment methodology to 
include certain additional codes and make other technical changes to 
the definition of primary care services, for use in determining 
beneficiary assignment for the performance year starting on January 1, 
2021, and subsequent performance years.
    We proposed to revise the definition of primary care services in 
the Shared Savings Program regulations to include the following 
additions: (1) Online digital E/M CPT codes 99421, 99422, and 99423; 
(2) assessment of and care planning for patients with cognitive 
impairment CPT code 99483; (3) chronic care management code CPT code 
99491; (4) non-complex chronic care management HCPCS code G2058 and its 
proposed replacement CPT code, if finalized through the CY 2021 PFS 
rulemaking; (5) principal care management HCPCS codes G2064 and G2065; 
and (6) psychiatric collaborative care model HCPCS code GCOL1, if 
finalized through the CY 2021 PFS rulemaking.
    The following provides additional information about the CPT and 
HCPCS codes that we proposed to add to the definition of primary care 
services used in assignment:
     Online Digital Evaluation and Management Services (CPT 
codes 99421, 99422, and 99423): In the CY 2020 PFS final rule (84 FR 
62797), we finalized payment for new online digital assessment 
services, also referred to as ``E-Visits,'' beginning in CY 2020 for 
practitioners billing under the PFS. These services are non-face-to-
face, patient-initiated communications using online patient portals. 
These digital assessment services are for established patients who 
require a clinical decision that otherwise typically would have been 
provided in the office. Practitioners who may independently bill 
Medicare for E/M services (for instance, physicians and NPs) can bill 
the following codes:
    ++ 99421 (Online digital evaluation and management service, for an 
established patient, for up to 7 days, cumulative time during the 7 
days; 5-10 minutes.)
    ++ 99422 (Online digital evaluation and management service, for an 
established patient, for up to 7 days cumulative time during the 7 
days; 11-20 minutes.)
    ++ 99423 (Online digital evaluation and management service, for an 
established patient, for up to 7 days, cumulative time during the 7 
days; 21 or more minutes.)
    In the May 8th COVID-19 IFC (85 FR 27583), we stated that we 
believe it is appropriate to include these CPT and HCPCS codes in the 
definition of primary care services used for assignment for PY 2020 and 
any subsequent performance year that starts during the PHE for COVID-19 
because the services represented by these codes are being used in place 
of similar E/M services, the codes for which are already included in 
the list of codes used for assignment. We also explained our belief 
that it is important to include these services in our assignment 
methodology because we determine assignment to ACOs based upon where 
beneficiaries receive the plurality of their primary care services or 
whether they have designated an ACO professional as their primary 
clinician, responsible for their overall care, and hold ACOs 
accountable for the resulting

[[Page 84749]]

assigned beneficiary population. Subsequent to the publication of the 
May 8th COVID-19 IFC, we have determined, based on the justification 
above, that these codes should be included in the definition of primary 
care services under Sec.  425.400(c) permanently for purposes of 
determining beneficiary assignment for the performance year starting on 
January 1, 2021, and subsequent performance years, and should not be 
linked to the duration of the PHE for COVID-19.
     Assessment of and care planning for patients with 
cognitive impairment (CPT code 99483): In the CY 2017 PFS final rule 
(81 FR 80252-54), we finalized a G-code that would provide separate 
payment to recognize the work of a physician (or other appropriate 
billing practitioner) in assessing and creating a care plan for 
beneficiaries with cognitive impairment, such as from Alzheimer's 
disease or dementia, at any stage of impairment, G0505 (Cognition and 
functional assessment using standardized instruments with development 
of recorded care plan for the patient with cognitive impairment, 
history obtained from patient and/or caregiver, in office or other 
outpatient setting or home or domiciliary or rest home). In the CY 2018 
PFS final rule (82 FR 53077), we deleted the interim HCPCS code G0505 
and replaced it with 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 caregiver).
    CPT code 99483 includes the same elements included in the Level 5 
E/M service CPT code 99215, such as, a comprehensive history, 
comprehensive exam, and high complexity medical decision-making. CPT 
code 99215 is included in the definition of primary care services used 
for assignment. Accordingly, we noted in the proposed rule that we 
believe it would be appropriate to also include CPT code 99483 in the 
definition of primary care services used for assignment under Sec.  
425.400(c) for the performance year starting on January 1, 2021, and 
subsequent performance years.
     Chronic Care Management (CPT code 99491): In the CY 2019 
PFS final rule (83 FR 59577), we finalized CPT code 99491 (Chronic care 
management services, provided personally by a physician or other 
qualified healthcare 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). This code requires two or more chronic conditions that 
place the patient at significant risk of death, acute exacerbation/
decompensation, or functional decline, and that a comprehensive care 
plan has been established, implemented, revised or monitored by the 
billing practitioner for such patient. In earlier rulemaking, we 
finalized the inclusion of CCM CPT codes 99487, 99489, and 99490 (codes 
for chronic care management) in the definition of primary care services 
for the Shared Savings Program. Refer to the June 2015 final rule (80 
FR 32746 through 32748), and CY 2018 PFS final rule (82 FR 53212 
through 53213). ``Non-complex'' CCM services (CPT codes 99490 and 
99491), and ``complex'' CCM services (CPT codes 99487 and 99489) share 
a common set of service elements, including the following: (1) 
Initiating visit, (2) structured recording of patient information using 
certified electronic health record technology (EHR), (3) 24/7 access to 
physicians or other qualified health care professionals or clinical 
staff and continuity of care, (4) comprehensive care management 
including systematic assessment of the patient's medical, functional, 
and psychosocial needs, (5) comprehensive care plan including a 
comprehensive care plan for all health issues with particular focus on 
the chronic conditions being managed, and (6) management of care 
transitions. They differ in the amount of clinical staff service time 
provided, the involvement and work of the billing practitioner, and the 
extent of care planning performed.\65\ CPT code 99491 includes only 
time that is spent personally by the billing practitioner. Clinical 
staff time is not counted towards the required time threshold for 
reporting this code, whereas CPT codes 99487, 99489, and 99490 include 
time spent directly by the billing practitioner and by other clinical 
staff that counts toward the threshold clinical staff time required to 
be spent during a given month. Accordingly, CPT code 99491 cannot be 
reported for a beneficiary by a billing practitioner in the same month 
as CCM codes 99487, 99489, or 99490. Therefore, we noted in the 
proposed rule that we believe it would be appropriate to propose to 
include CCM CPT code 99491 in the definition of primary care services 
under Sec.  425.400(c) for the performance year starting on January 1, 
2021, and subsequent performance years, in order to capture these CCM 
services when attributing beneficiaries to an ACO.
---------------------------------------------------------------------------

    \65\ Refer to CMS Medicare Learning Network, MLN Booklet 
``Chronic Care Management Services'' (ICN MLN909188, July 2019); 
available at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/ChronicCareManagement.pdf.
---------------------------------------------------------------------------

     Non-Complex CCM (HCPCS code G2058 and its proposed 
replacement CPT code): In the CY 2020 PFS final rule (84 FR 62690), we 
finalized the creation of HCPCS code G2058 (Chronic care management 
services, each additional 20 minutes of clinical staff time directed by 
a physician or other qualified health care professional, per calendar 
month (List separately in addition to code for primary procedure). (Do 
not report G2058 for care management services of less than 20 minutes 
additional to the first 20 minutes of chronic care management services 
during a calendar month). (Use G2058 in conjunction with 99490). (Do 
not report 99490, G2058 in the same calendar month as 99487, 99489, 
99491)) for additional time spent beyond the initial 20 minutes 
included in the current coding for CCM services. As described in the CY 
2021 PFS proposed rule, we proposed the

[[Page 84750]]

adoption of the permanent CPT code to replace HCPCS code G2058. As 
described in previous rulemaking, practitioners who choose to use G2058 
can report the initial 20 minutes of non-complex CCM under CPT code 
99490 and receive increased payment for their work under HCPCS code 
G2058 (84 FR 62690). Since CPT code 99490 is currently included in the 
Shared Savings Program's definition of primary care services under 
Sec.  425.400(c)(1)(iv), we proposed to add G2058 to the definition, 
effective for performance years starting on or after January 1, 2021, 
because the services furnished during the additional time billed under 
HCPCS code G2058, would be expected to be substantially similar to the 
services furnished under CPT code 99490, and thus should also be 
considered for purposes of assignment under Sec.  425.400 for the 
performance year starting on January 1, 2021, and subsequent 
performance years. In the CY 2021 PFS proposed rule, we stated that, if 
the proposal to adopt the permanent CPT code to replace HCPCS code 
G2058 is finalized, we would instead include that CPT code in the 
definition of primary care services used for purposes of assignment 
under Sec.  425.400(c) for the performance year starting on January 1, 
2021, and subsequent performance years. Elsewhere in this rule, we 
discuss the finalization of 99439 (Chronic care management services, 
each additional 20 minutes of clinical staff time directed by a 
physician or other qualified health care professional, per calendar 
month) as the permanent CPT code to replace G2058.
     Principal Care Management (HCPCS codes G2064 and G2065): 
The CY 2020 PFS final rule (84 FR 62692 through 62697) introduced two 
new HCPCS codes (G2064 and G2065) for Principal Care Management (PCM) 
services. G2064 (Comprehensive care management services for a single 
high-risk disease, e.g., principal care management, at least 30 minutes 
of physician or other qualified health care professional time per 
calendar month with the following elements: One complex chronic 
condition lasting at least 3 months, which is the focus of the care 
plan, the condition is of sufficient severity to place patient at risk 
of hospitalization or have been the cause of a recent hospitalization, 
the condition requires development or revision of disease-specific care 
plan, the condition requires frequent adjustments in the medication 
regimen, and/or the management of the condition is unusually complex 
due to comorbidities), for use by physicians and NPPs, and G2065 
(Comprehensive care management for a single high-risk disease services, 
e.g. principal care management, at least 30 minutes of clinical staff 
time directed by a physician or other qualified health care 
professional, per calendar month with the following elements: One 
complex chronic condition lasting at least 3 months, which is the focus 
of the care plan, the condition is of sufficient severity to place 
patient at risk of hospitalization or have been cause of a recent 
hospitalization, the condition requires development or revision of 
disease-specific care plan, the condition requires frequent adjustments 
in the medication regimen, and/or the management of the condition is 
unusually complex due to comorbidities), for use by clinical staff.
    As discussed in the proposed rule, we expect that most services 
billed under these codes will be billed by specialists who are focused 
on managing patients with a single complex chronic condition requiring 
substantial care management. HCPCS code G2064 would be reported when, 
during the calendar month, at least 30 minutes of physician or other 
qualified health care professional time is spent on comprehensive care 
management for a single high-risk disease or complex chronic condition. 
HCPCS code G2065 would be reported when, during the calendar month, at 
least 30 minutes of clinical staff time is spent on comprehensive 
management for a single high-risk disease or complex chronic condition. 
Comprehensive care management codes require patients to have two or 
more chronic conditions and are primarily billed by practitioners who 
are managing a patient's total care over a month, including primary 
care practitioners and some specialists, such as cardiologists or 
nephrologists. By contrast, PCM services involve care management 
services for one serious chronic condition, typically expected to last 
between 3 months and a year, or until the death of the patient, that 
may have led to a recent hospitalization, and/or places the patient at 
significant risk of death, acute exacerbation/decompensation, or 
functional decline. Specifically, we stated in the CY 2020 PFS final 
rule (84 FR 62693 through 62697) that we agree that the relativity 
between CCM CPT codes 99490 and 99491 should be preserved in PCM HCPCS 
codes G2064 and G2065 and crosswalked the RVUs for G2064 and G2065 to 
99491 and 99490, respectively. Due to the similarity between the 
description of the PCM and CCM services, both of which involve non-
face-to-face care management services, we finalized that the full CCM 
scope of service requirements apply to PCM, including documenting the 
patient's verbal consent in the medical record. CCM services billed 
under code 99490 are currently included in the Shared Savings Program's 
definition of primary care services under Sec.  425.400(c)(1)(iv), and 
as discussed previously, we proposed to include CCM services billed 
under code 99491 for performance years starting on or after January 1, 
2021; therefore, for the foregoing reasons, we also proposed to add 
G2064 and G2065 to the definition of primary care services for the 
performance year starting on January 1, 2021, and subsequent 
performance years.
     Psychiatric collaborative care model HCPCS code GCOL1: In 
the CY 2017 PFS final rule (81 FR 80230-36), we established G-codes 
used to bill for monthly services furnished using the Psychiatric 
Collaborative Care Model (CoCM), an evidence-based approach to 
behavioral health integration that enhances ``usual'' primary care by 
adding care management support and regular psychiatric inter-specialty 
consultation. These G-codes were replaced by CPT codes 99484, 99492, 
99493, and 99494, which we established for payment under the PFS in the 
CY 2018 PFS final rule (82 FR 53077 and 53078).
    As discussed in the proposed rule, we proposed to add a new HCPCS 
code GCOL1 (Initial or subsequent psychiatric collaborative care 
management, first 30 minutes in a month of behavioral health care 
manager activities, in consultation with a psychiatric consultant, and 
directed by the treating physician or other qualified health care 
professional) in response to stakeholders who have requested additional 
coding to capture shorter increments of time spent, for example, when a 
patient is seen for services, but is then hospitalized or referred for 
specialized care, and the number of minutes required to bill for 
services using the current coding is not met. Specifically, we proposed 
to establish a G-code to describe 30 minutes of behavioral health care 
manager time. This code would describe one-half of the time described 
by the existing code that describes subsequent months of CoCM services, 
CPT code 99493 (Subsequent psychiatric collaborative care management, 
first 60 minutes in a subsequent month of behavioral health care 
manager activities, in consultation with a psychiatric consultant, and 
directed by the treating physician or other qualified

[[Page 84751]]

health care professional, with the following required elements:
     Tracking patient follow-up and progress using the 
registry, with appropriate documentation; participation in weekly 
caseload consultation with the psychiatric consultant;
     Ongoing collaboration with and coordination of the 
patient's mental health care with the treating physician or other 
qualified health care professional and any other treating mental health 
providers;
     Additional review of progress and recommendations for 
changes in treatment, as indicated, including medications, based on 
recommendations provided by the psychiatric consultant;
     Provision of brief interventions using evidence-based 
techniques such as behavioral activation, motivational interviewing, 
and other focused treatment strategies;
     Monitoring of patient outcomes using validated rating 
scales; and
     Relapse prevention planning with patients as 
they achieve remission of symptoms and/or other treatment goals and are 
prepared for discharge from active treatment).
    Because CPT code 99493 is currently included in the Shared Savings 
Program's definition of primary care services under Sec.  
425.400(c)(iv), we believe it is appropriate to add GCOL1 to the 
definition since the services furnished under the proposed new code 
would be expected to be substantially similar to the services furnished 
under CPT code 99493. Accordingly, contingent upon its finalization, we 
proposed to add HCPCS code GCOL1 to the definition of primary care 
services for purposes of assignment under Sec.  425.400 for the 
performance year starting on January 1, 2021, and subsequent 
performance years. HCPCS code GCOL1 is being finalized as HCPCS code 
G2214 (Initial or subsequent psychiatric collaborative care management, 
first 30 minutes in a month of behavioral health care manager 
activities, in consultation with a psychiatric consultant, and directed 
by the treating physician or other qualified health care professional), 
as discussed elsewhere in this final rule.
    In the May 8th COVID-19 IFC (85 FR 27583), we revised the 
definition of primary care services used in the Shared Savings Program 
assignment methodology for the performance year starting on January 1, 
2020, and for any subsequent performance year that starts during the 
PHE for COVID-19, as defined in Sec.  400.200, to include the following 
additions: (1) HCPCS code G2010 (remote evaluation of patient video/
images); (2) HCPCS code G2012 (virtual check-in); and (3) CPT codes 
99441, 99442, and 99443 (telephone evaluation and management services).
    We considered adding HCPCS codes G2010 (Remote evaluation of 
recorded video and/or images submitted by an established patient (e.g., 
store and forward), including interpretation with follow-up with the 
patient within 24 business hours, not originating from a related E/M 
service provided within the previous 7 days nor leading to an E/M 
service or procedure within the next 24 hours or soonest available 
appointment) and G2012 (Brief communication technology-based service, 
e.g. virtual check-in, by a physician or other qualified health care 
professional who can report E/M 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 the definition of primary care services for purposes of 
assignment under Sec.  425.400 for the performance year starting on 
January 1, 2021, and subsequent performance years; however, while we 
recognized the importance of the flexibility these HCPCS codes provide 
during the PHE for COVID-19, we explained in the proposed rule that we 
do not believe they should be added to definition of primary care 
services for purposes of assignment under Sec.  425.400 on a permanent 
basis. In the context of the PHE for COVID-19, when brief 
communications with practitioners and other non-face-to-face services 
could mitigate the need for an in-person visit that could represent an 
exposure risk for vulnerable patients, healthcare providers, and 
individuals in the community, we concluded that it was appropriate to 
include HCPCS codes G2010 and G2012 in the definition of primary care 
services used in assignment. However, outside the context of the PHE 
for COVID-19, we expect that these monitoring/check-in services for 
established patients will no longer replace primary care services 
because these separately billable brief communication-technology based 
services describe a check-in directly with the billing practitioner to 
assess whether an office visit is needed. When the PHE for COVID-19 
ends, these services would likely be replaced by an in-person primary 
care visit on which assignment would be based.
    We sought comment on this issue and on the alternative approach of 
permanently including HCPCS codes G2010 and G2012 in the definition of 
primary care services used in assignment. We noted that we would 
consider the comments received in developing the policies for the final 
rule.
    We noted that we did not consider including CPT codes 99441, 99442, 
and 99443 in the definition of primary care services at Sec.  
425.400(c) on a permanent basis. Telephone E/M services CPT codes 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.); 99442 (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; 11-20 
minutes of medical discussion.); and 99443 (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; 21-30 minutes of medical discussion.) are non-
covered services when not provided during the PHE for COVID-19, as 
defined in Sec.  400.200, and so could not be included in the 
definition of primary care services for purposes of assignment outside 
the context of the PHE.
    We also proposed to modify the definition of primary care services 
for purposes of assignment in the Shared Savings Program regulations to 
exclude advance care planning CPT code 99497 and the add-on code 99498 
when billed in an inpatient care setting, for use in determining 
beneficiary assignment for the performance year starting on January 1, 
2021, and subsequent performance years. In the November 2018 final rule 
(83 FR 59964 through 59968), we finalized the inclusion of CPT code 
99497 and the add-on code 99498 in the definition of primary care 
services. We did not propose any exceptions to place of service or 
provider type because there

[[Page 84752]]

are no facility setting limitations or provider specialty limitations 
on these codes.\66\ In the CY 2021 PFS proposed rule (85 FR 50245), we 
explained that since adding these codes to the definition of primary 
care services we have received feedback from an ACO that, by not 
restricting place of service when using advance care planning codes in 
assignment, our methodology may inappropriately assign beneficiaries. 
Specifically, we described our concern that the inclusion of these CPT 
codes when the services are provided in an inpatient care setting may 
result in beneficiaries being assigned based on inpatient care rather 
than based on primary care by their regular healthcare providers. Based 
on an initial analysis using calendar year 2019 claims data, we 
observed the following frequencies for occurrence of place of service 
code 21, which identifies the place of service as an inpatient 
hospital, with CPT codes 99497 and 99498 in Part B claims: Over 13 
percent of approximately 1.6 million Part B claims for CPT code 99497 
had place of service code 21; over 48 percent of approximately 43,000 
Part B claims for CPT code 99498 had place of service code 21. We 
explained that operationally we would exclude advanced care planning 
services claims billed under CPT codes 99497 and 99498 from use in the 
assignment methodology when there is an inpatient facility claim in our 
claims files with dates of service that overlap with the date of 
service for the professional service billed under CPT code 99497 or 
add-on code 99498. A similar operational approach is currently used to 
exclude certain codes for professional services furnished in a SNF 
pursuant to Sec.  425.400(c)(1)(iv)(A)(2), as described in the proposed 
rule.
---------------------------------------------------------------------------

    \66\ Refer to CMS, Medicare Learning Network, ``Advance Care 
Planning'' (ICN MLN909289, August 2019); available at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/AdvanceCarePlanning.pdf.
---------------------------------------------------------------------------

    We also sought comment on an alternative method for determining 
operationally whether advance care planning services are provided in an 
inpatient care setting. Specifically, we sought comment on whether to 
exclude advance care planning services identified by CPT code 99497 or 
add-on code 99498, or both, reported on claims with place of service 
code 21, which identifies the place of service as an inpatient 
hospital.\67\ We explained that based on initial analysis, we had 
determined that this alternative approach would capture slightly fewer 
claims for advance care planning, compared to the proposed approach. We 
noted that we would consider any comments received on this alternative 
approach in developing our policies for the final rule.
---------------------------------------------------------------------------

    \67\ See for example, CMS.gov, Place of Service Code Set 
(updated October 2019); available at https://www.cms.gov/Medicare/Coding/place-of-service-codes/Place_of_Service_Code_Set.
---------------------------------------------------------------------------

    We proposed to specify a revised definition of primary care 
services in a new provision of the Shared Savings Program regulations 
at Sec.  425.400(c)(1)(v) to include the list of HCPCS and CPT codes 
specified in Sec.  425.400(c)(1)(iv) with the proposed additional CPT 
and HCPCS codes, and reflecting the proposal to exclude advance care 
planning codes when provided in an inpatient setting in the new 
provision at Sec.  425.400(c)(1)(v)(A)(12). We also proposed that the 
new provision in Sec.  425.400(c)(1)(v) would reflect technical 
modifications to the previously finalized descriptions of the CPT and 
HCPCS codes for consistency and clarity, including grammatical updates 
and ordering the codes sequentially. We proposed the new provision at 
Sec.  425.400(c)(1)(v) would be applicable for use in determining 
beneficiary assignment for the performance year starting on January 1, 
2021, and subsequent performance years. Further, we proposed technical 
modifications to the introductory text in Sec.  425.400(c)(1)(iv) to 
specify the applicability of this provision for determining beneficiary 
assignment for performance years (or a performance period) during 2019 
and performance year 2020.
    We sought comment on the proposed changes to the definition of 
primary care services used for assigning beneficiaries to Shared 
Savings Program ACOs for the performance year starting on January 1, 
2021, and subsequent performance years. We also sought comments on any 
other existing HCPCS or CPT codes, and new HCPCS or CPT codes proposed 
in the CY 2021 PFS proposed rule, that we should consider adding to the 
definition of primary care services for purposes of assignment in 
future rulemaking.
    We noted that, under Sec.  425.212, an ACO is subject to all 
regulatory changes that become effective during the agreement period, 
with the exception of the following program areas, unless otherwise 
required by statute: (1) Eligibility requirements concerning the 
structure and governance of ACOs; and (2) calculation of sharing rate. 
As we have explained in earlier rulemaking, consistent with our 
authority under section 1899(d)(1)(B)(ii) of the Act to adjust the 
benchmark for beneficiary characteristics and other factors as the 
Secretary determines appropriate, CMS adjusts an ACO's historical 
benchmark to account for any regulatory changes affecting assignment 
during the agreement period (80 FR 32730 through 32732). Accordingly, 
we stated in the proposed rule that, if we finalized any of the 
proposed changes to the definition of primary care services discussed 
in section III.G.2. of the CY 2021 PFS proposed rule for purposes of 
beneficiary assignment applicable for the performance year starting on 
January 1, 2021, and subsequent performance years, we would adjust 
ACOs' historical benchmarks to account for these changes. Although it 
has been our historical practice to make these adjustments, the 
regulations establishing our benchmarking methodology do not explicitly 
describe these adjustments. Accordingly as discussed in the CY 2021 PFS 
proposed rule, we proposed conforming revisions to the regulations in 
Sec. Sec.  425.601(a)(9), 425.602(a)(8), and 425.603(c)(8), to specify 
that CMS will adjust the ACO's historical benchmark to reflect any 
changes to the beneficiary assignment methodology specified in part 
425, subpart E during an ACO's agreement period including revisions to 
the definition of primary care services in Sec.  425.400(c). Further, 
in light of the proposed changes, we proposed to make certain other 
technical changes to Sec. Sec.  425.601, 425.602, and 425.603 for 
clarity and internal consistency.
    We received public comments on the proposed revisions to HCPCS and 
CPT codes used for purposes of assignment in the Shared Savings Program 
regulations. The following is a summary of the comments we received and 
our responses.
    Comment: Most commenters were generally supportive of our proposals 
regarding the expansion of the definition of primary care services for 
purposes of assignment in the Shared Savings Program regulations. Many 
comments indicated that the PHE for COVID-19 has led healthcare 
providers to expand their provision of services via telehealth, which 
has allowed beneficiaries to access to many services that otherwise 
might have been foregone due to the PHE. Furthermore, some commenters 
suggested that increased delivery of services via telehealth is likely 
to continue after the PHE, as healthcare providers and patients are 
increasingly accustomed to this service delivery modality and have 
found it to be a convenient and appropriate means for delivery of 
certain healthcare services. A few commenters noted it is vital that 
ACOs are held responsible for the correct cohort of patients, and these

[[Page 84753]]

changes to the definition of primary care services would help to `move 
the needle' in that direction. One commenter stated that it has 
increased its provision of telehealth services exponentially due to the 
PHE and expects that the volume of these types of visits will remain 
elevated even after the PHE ends. This commenter stated its belief that 
these changes will be necessary to accurately reflect the Medicare 
patient population's health care utilization patterns going forward.
    While most commenters supported the addition of Principal Care 
Management (PCM) codes G2064 and G2065 to the list of primary care 
services, a few commenters did not support adding the PCM codes. These 
commenters noted that these codes will primarily be used by specialists 
and while the scope and description of services for CCM and PCM may be 
similar, it does not necessarily follow that both services should be 
considered primary care services.
    Response: We appreciate the commenters' support for our proposal to 
revise the definition of primary care services used for assignment 
under the Shared Savings Program regulations to include the following 
additions: (1) Online digital E/M CPT codes 99421, 99422, and 99423; 
(2) assessment of and care planning for patients with cognitive 
impairment CPT code 99483; (3) chronic care management code CPT code 
99491; (4) non-complex chronic care management HCPCS code G2058 and its 
replacement CPT code 99439; (5) principal care management services 
HCPCS codes G2064 and G2065; and (6) psychiatric collaborative care 
model HCPCS code GCOL1, which is being finalized as HCPCS code G2214, 
as discussed elsewhere in this final rule. We agree that expanding the 
definition of primary care services used for beneficiary assignment 
will allow for more accurate assignment. While we appreciate the 
concerns raised by commenters regarding the addition of PCM codes G2064 
and G2065, due to the similarity between the description of the PCM and 
CCM services, we continue to believe that these codes are a valuable 
addition to the definition of primary care services used for 
beneficiary assignment, because the full CCM scope of service 
requirements apply to PCM, and the CCM services are included in the 
Shared Savings Program's current definition of primary care services 
under Sec.  425.400(c)(1)(iv). Additionally, consistent with our 
current methodology, if services billed under these codes are provided 
by specialists not used in the Shared Savings Program beneficiary 
assignment methodology, then they will not be included in beneficiary 
assignment. Therefore, we are finalizing our proposal to incorporate 
the aforementioned codes into the definition of primary care services 
that will be used in determining beneficiary assignment for the 
performance year starting on January 1, 2021, and subsequent 
performance years. We are also finalizing our proposal to specify the 
updated definition of primary care services in a new provision of the 
regulations at Sec.  425.400(c)(1)(v).
    Comment: Several commenters supported the permanent addition of the 
remote evaluation of patient video/images (G2010) and virtual check-in 
(G2012) HCPCS codes to the Shared Savings Program definition of primary 
care services used for assignment, beginning with performance year 
2021. These commenters indicated that virtual check-ins and remote 
evaluation of patient video/images are communications-based technology 
services that have proven their value across the disease spectrum and 
care continuum and should continue to be included in the definition of 
primary care services used for assignment after the PHE ends.
    Response: We appreciate the comments in support of the permanent 
addition of the remote evaluation of patient video/images (G2010) and 
virtual check-in (G2012) HCPCS codes to the Shared Savings Program 
definition of primary care services used for assignment, beginning with 
performance year 2021. In the CY 2021 PFS proposed rule (85 FR 50245), 
we stated that, outside the context of the PHE for COVID-19, we did not 
expect these monitoring/check-in services for established patients to 
replace primary care services. This was because these separately 
billable brief communication-technology based services describe a 
check-in directly with the billing practitioner to assess whether an 
office visit is needed; and we believed that when the PHE for COVID-19 
ends, these services would likely be replaced by an in-person primary 
care visit on which assignment would be based. However, based on 
comments received anticipating that healthcare providers will continue 
to provide the services identified by G2010 and G2012 and that there 
will continue to be an uptake of services identified by these codes in 
lieu of an in-person primary care visit by the beneficiary even 
following the end of the PHE for COVID-19, we are persuaded that 
including G2010 and G2012 in the Shared Savings Program definition of 
primary care services used for assignment, beginning with performance 
year 2021, would result in more accurate assignment of beneficiaries 
based on where they receive the plurality of their primary care 
services. We are therefore adding HCPCS codes G2010 and G2012 to the 
definition of primary care services for purposes of beneficiary 
assignment in the Shared Savings Program for the performance year 
starting on January 1, 2021, and subsequent performance years, as 
specified in the regulations at Sec.  425.400(c)(1)(v).
    Comment: Several commenters supported our proposal to exclude 
advance care planning CPT code 99497 and the add-on code 99498 when 
billed in an inpatient care setting. These commenters appreciated the 
concern that codes billed in an inpatient setting in the beneficiary 
assignment methodology may result in beneficiaries being assigned to an 
ACO based on inpatient care, rather than on primary care. However, one 
commenter was concerned that removing these services from the 
definition of primary care services used for assignment may 
inadvertently discourage healthcare provider from furnishing these 
services in inpatient settings. This commenter stated that evidence 
shows that usage of these billing codes is low, even though most 
Americans do not have advance directives. Therefore, the commenter 
suggested that advance care planning should be promoted, not in any way 
discouraged. Commenters also appreciated CMS' desire to ensure that 
beneficiaries are attributed to the ACOs from whom they receive their 
primary care services.
    Response: We appreciate the support from commenters regarding our 
proposal to exclude advance care planning CPT code 99497 and the add-on 
code 99498 when billed in an inpatient care setting, for purposes of 
determining beneficiary assignment for the performance year starting on 
January 1, 2021, and subsequent performance years. Although we do not 
want to discourage the provision of advance care planning services or 
the appropriate use of the associated advance care planning codes, we 
do not believe that these services, when provided in an inpatient 
setting represent primary care services that should be used in 
assignment. In particular, we continue to have concerns that including 
these codes when billed in an inpatient setting may result in 
beneficiaries being assigned to an ACO based on inpatient care, rather 
than on primary care. By this, we mean that a beneficiary could be 
assigned to the ACO with which the physician providing inpatient care 
is associated,

[[Page 84754]]

which may be different from the ACO in which the physician from which 
the beneficiary typically receives primary care services in the 
community is participating, which could be disruptive to the 
beneficiary's overall care management. Therefore, we are finalizing our 
proposal to specify in Sec.  425.400(c)(1)(v)(A)(12) that advance care 
planning services identified by CPT code 99497 and add-on code 99498 
are excluded when furnished in an inpatient setting.
    We did not receive comments regarding our proposal to exclude 
advanced care planning services claims billed under CPT codes 99497 and 
99498 from use in the assignment methodology when there is an inpatient 
facility claim in our claims files with dates of service that overlap 
with the date of service for the professional service billed under CPT 
code 99497 or add-on code 99498. We also did not receive comments 
regarding the potential alternative method for determining whether 
advance care planning services are provided in an inpatient care 
setting. Specifically, we sought comment on whether to exclude advance 
care planning services identified by CPT code 99497 or add-on code 
99498, or both, reported on claims with place of service code 21, which 
identifies the place of service as an inpatient hospital. Accordingly, 
we are finalizing as proposed the operational approach of excluding 
advanced care planning services claims billed under CPT codes 99497 and 
99498 from use in the assignment methodology when there is an inpatient 
facility claim in our claims files with dates of service that overlap 
with the date of service for the professional service billed under CPT 
code 99497 or add-on code 99498. This operational approach is similar 
to the operational approach currently used to exclude certain codes for 
professional services furnished in a SNF under Sec.  
425.400(c)(1)(iv)(A)(2) and, as we discussed in the CY 2021 PFS 
proposed rule (85 FR 50246) captures slightly more claims than the 
alternative proposed approach We believe this more inclusive approach 
is appropriate in order to ensure that beneficiaries are assigned based 
on primary care services, not inpatient care services.
    Comment: We received a couple of comments suggesting that CMS add 
the Primary Care Add-on HCPCS Code GPC1X, which is being finalized as 
HCPCS code G2211, as discussed elsewhere in this final rule, and the 
new Prolonged Services Add-on CPT Code 99417 (when the base code is 
also a primary care service code) to the list of primary care services 
used for assignment.
    Response: We appreciate the feedback from commenters on our comment 
solicitation regarding any existing HCPCS or CPT codes and new HCPCS or 
CPT codes proposed in the CY 2021 PFS proposed rule that we should 
consider adding to the definition of primary care services for purposes 
of assignment in future rulemaking. HCPCS G2211 (Visit complexity 
inherent to evaluation and management associated with medical care 
services that serve as the continuing focal point for all needed health 
care services and/or with medical care services that are part of 
ongoing care related to a patient's single, serious, or complex 
condition. (Add-on code, list separately in addition to office/
outpatient evaluation and management visit, new or established)) and 
prolonged visit add-on CPT code 99417 (Prolonged office or other 
outpatient evaluation and management service(s) (beyond the total time 
of the primary procedure which has been selected using total time), 
requiring total time with or without direct patient contact beyond the 
usual service, on the date of the primary service; each additional 15 
minutes (List separately in addition to CPT codes 99205, 99215 for 
office or other outpatient evaluation and management services)) are 
used to report prolonged care provided to beneficiaries as an add-on to 
an E/M service. Under Medicare FFS payment policy, G2211 may be used in 
combination with certain E/M codes for new or established patients, 
including CPT codes 99201 through 99215, which are included within the 
definition of primary care services used for beneficiary assignment as 
specified under Sec.  425.400(c).
    Because we did not discuss adding add-on HCPCS Code G2211 and the 
prolonged services add-on CPT Code 99417, formerly CPT code 99XXX, to 
the list of primary care services used for assignment in the CY 2021 
PFS proposed rule, we cannot finalize the inclusion of these codes in 
the definition of primary care services used for beneficiary assignment 
as specified under Sec.  425.400(c), for the performance year beginning 
January 1, 2021, and subsequent performance years. We agree with 
commenters that G2211 and 99417 seem to fit within the definition of 
primary care services used for beneficiary assignment as specified 
under Sec.  425.400(c). We will continue to evaluate and may consider 
the addition of these codes in future rulemaking.
    In summary, after considering comments we received, we are 
finalizing the proposed definition of primary care services for use in 
determining beneficiary assignment for the performance year starting on 
January 1, 2021, and subsequent performance years, with a modification 
to include G2010 and G2012 in the definition of primary care services 
used in assignment. We are finalizing this definition in a new 
provision of the regulations at Sec.  425.400(c)(1)(v), which includes 
the HCPCS and CPT codes specified in Sec.  425.400(c)(1)(iv), as well 
as the following additional codes, and limitations on the use of 
certain codes:
     Online digital E/M CPT codes 99421, 99422, and 99423;
     Assessment of and care planning for patients with 
cognitive impairment CPT code 99483;
     Chronic care management code CPT code 99491;
     Exclusion of advance care planning CPT code 99497 and the 
add-on code 99498 when billed in an inpatient care setting;
     Remote evaluation of patient video/images HCPCS codes 
G2010;
     Virtual check-in HCPCS code G2012;
     Non-complex chronic care management HCPCS code G2058 and 
its replacement CPT code 99439 as finalized elsewhere in this final 
rule;
     Principal care management HCPCS codes G2064 and G2065; and
     Psychiatric collaborative care model HCPCS code GCOL1, 
which is being finalized as HCPCS code G2214, as discussed elsewhere in 
this final rule.
    We did not receive comments specifically addressing our proposals 
for technical modifications, which we are finalizing without 
modification. Specifically, we are finalizing as proposed the technical 
modifications to the introductory text in Sec.  425.400(c)(1)(iv) to 
specify the applicability of this provision for determining beneficiary 
assignment for performance years (or a performance period) during 2019 
and performance year 2020. We are also finalizing the proposal to 
include technical modifications to the previously finalized 
descriptions of the CPT and HCPCS codes for consistency and clarity, 
including grammatical updates and ordering the codes sequentially, in 
the new provision at Sec.  425.400(c)(1)(v).
    We did not receive comments on our proposed conforming revisions to 
the regulations at Sec. Sec.  425.601(a)(9), 425.602(a)(8), and 
425.603(c)(8), to specify that CMS will adjust the ACO's historical 
benchmark to reflect any changes to the beneficiary assignment 
methodology specified in part 425, subpart E during an ACO's agreement 
period including revisions to the

[[Page 84755]]

definition of primary care services in Sec.  425.400(c). Further, we 
did not receive comments on our proposed technical changes to 
Sec. Sec.  425.601, 425.602, and 425.603 for clarity and internal 
consistency. We are finalizing these proposals without modification.
b. Exclusion From Assignment of Certain Services Reported by FQHCs or 
RHCs When Furnished in Skilled Nursing Facilities (SNFs)
(1) Background
    As we described in section III.G.2.a.(1) of the proposed rule, 
under the Shared Savings Program, we define primary care services in 
Sec.  425.400(c)(1) and (2) for purposes of assigning beneficiaries to 
ACOs under Sec.  425.402 as the set of services identified by the 
specified HCPCS and CPT codes. In the November 2018 final rule (83 FR 
59965 through 59968), we finalized a policy, specified in the 
regulation at Sec.  425.400(c)(1)(iv)(A)(2) and effective for 
performance years starting on January 1, 2019, and subsequent 
performance years, to exclude services billed under CPT codes 99304 
through 99318 when such services are furnished in a SNF. As described 
in the earlier rulemaking, CPT codes 99304 through 99318 are used for 
reporting E/M services furnished by physicians and other practitioners 
in a SNF or NF (83 FR 59964).
    In the November 2018 final rule, we explained our operational 
approach to excluding CPT codes 99304 through 99318 from use in the 
assignment methodology when such services are furnished in a SNF. We 
explained that we would exclude professional services claims billed 
under CPT codes 99304 through 99318 from use in the assignment 
methodology when there is a SNF facility claim in our claims files with 
dates of service that overlap with the date of service for the 
professional service (83 FR 59967). This exclusion methodology replaced 
the prior approach, established through earlier rulemaking (80 FR 71271 
and 71272), which excluded from the definition of primary care services 
claims billed under CPT codes 99304 through 99318 when the claim 
included the place of service code 31 modifier, specifying that the 
service was furnished in a SNF.
    In earlier rulemaking (see for example, 83 FR 59964 and 59965), we 
have explained our belief that excluding from assignment certain 
services rendered to beneficiaries during a SNF stay is appropriate 
because it helps to ensure that beneficiaries who receive care in a SNF 
are assigned to ACOs based on care received from primary care 
professionals in the community (including nursing facilities), who are 
typically responsible for providing care to meet the primary care needs 
of these beneficiaries. We previously explained that SNF patients are 
shorter stay patients who are generally receiving continued acute 
medical care and rehabilitative services. Although their care may be 
coordinated during their time in the SNF, they are then transitioned 
back into the community to the primary care professionals who are 
typically responsible for providing care to meet their primary care 
needs.
    Section 1899(c)(1) of the Act, as amended by the 21st Century Cures 
Act and the Bipartisan Budget Act of 2018, requires the Secretary to 
assign beneficiaries to ACOs participating in the Shared Savings 
Program based not only on their utilization of primary care services 
furnished by ACO professionals who are physicians but also on their 
utilization of services furnished by FQHCs and RHCs, effective for 
performance years beginning on or after January 1, 2019. The statute 
provides the Secretary with broad discretion to determine how to 
incorporate services provided by FQHCs and RHCs into the Shared Savings 
Program beneficiary assignment methodology.
    In earlier rulemaking, we established and modified special 
assignment conditions for FQHCs and RHCs (see for example, 82 FR 53210 
through 53212). According to Sec.  425.404(b), for performance years 
starting on January 1, 2019, and subsequent performance years, under 
the assignment methodology in Sec.  425.402, CMS treats a service 
reported on an FQHC or RHC claim as a primary care service performed by 
a primary care physician. Therefore, according to the Shared Savings 
Program's step-wise claims-based assignment methodology, as specified 
in Sec.  425.402(b), all services furnished by an FQHC or RHC to a 
beneficiary eligible for assignment to an ACO are considered in the 
first step of the assignment methodology. As specified in Sec.  
425.402(b)(3), under this first step, a beneficiary eligible for 
assignment is assigned to an ACO if the allowed charges for primary 
care services furnished to the beneficiary by primary care physicians 
who are ACO professionals and non-physician ACO professionals in the 
ACO are greater than the allowed charges for primary care services 
furnished by primary care physicians, nurse practitioners, physician 
assistants, and clinical nurse specialists who are ACO professionals in 
any other ACO, or not affiliated with any ACO and identified by a 
Medicare-enrolled billing TIN.
    Currently, the exclusion from beneficiary assignment of 
professional services claims with CPT codes 99304 through 99318, when 
there is an overlapping SNF stay, does not apply to services billed 
through FQHCs/RHCs. Because FQHC/RHC claims are submitted to CMS using 
institutional claim forms, we currently do not exclude these FQHC/RHC 
claims from assignment when a service billed under CPT codes 99304 
through 99318 is provided concurrently with a SNF stay, as when claims 
for services billed under these codes are submitted by physicians and 
other practitioners. Rather, consistent with the requirement in Sec.  
425.404(b), we consider all FQHC/RHC claims for purposes of beneficiary 
assignment.
(2) Revisions
    As discussed in the CY 2021 PFS proposed rule (85 FR 50247), an ACO 
has raised concerns that our methodology for excluding primary care 
services billed under CPT codes 99304 through 99318 from use in 
beneficiary assignment when provided during a beneficiary's stay in a 
SNF does not apply to these services when billed by FQHCs. The ACO 
described a circumstance where ACO professionals, billing through ACO 
participant FQHCs, submitted claims using CPT codes 99304 through 99318 
for services provided to patients in SNFs. Specifically, the ACO 
participant FQHCs' physicians provided services billed under these 
codes to beneficiaries in community SNFs. Following discharge from the 
SNF, these beneficiaries returned to receiving care from their regular 
primary care physicians (outside the ACO). However, because the SNF 
exclusion for services billed under CPT codes 99304 through 99318 does 
not apply to services furnished by FQHCs/RHCs, these beneficiaries were 
assigned to the ACO in which the FQHC was an ACO participant based on 
the services rendered in the SNF. We believe this result is contrary to 
the original intention of our policy of excluding claims billed under 
CPT codes 99304 through 99318 for professional services furnished 
during a SNF stay from consideration in the assignment methodology, as 
described in the background for this section.
    Section 1899(c)(1) of the Act provides discretion for the Secretary 
to determine the appropriate method to utilize services provided by 
FQHCs and RHCs in conducting assignment for performance years beginning 
on or after January 1, 2019. As discussed in the proposed rule, we 
believe it is important

[[Page 84756]]

to exclude claims for FQHC and RHC services that include CPT codes 
99304 through 99318 from use in assignment when there is a SNF facility 
claim in our claims files with a date of service that overlaps with the 
date of FQHC or RHC services. Consistent with the previously 
established exclusion for claims billed under these codes when the 
services are provided to beneficiaries with an overlapping SNF stay, we 
believe it is important to exclude the same services from use in 
assignment when they are furnished by physicians and NPPs billing 
through an FQHC or RHC to beneficiaries in a SNF. As we explained in 
the CY 2021 PFS proposed rule, this approach would better recognize 
that beneficiaries who receive care from physicians and NPPs billing 
through an FQHC or RHC during a SNF stay are expected to return to 
receiving primary care from the health care professionals typically 
responsible for meeting their primary care needs when they transition 
back into the community.
    Therefore, we proposed to revise the existing exclusion for 
professional services billed under CPT codes 99304 through 99318 that 
are furnished in a SNF to include services reported on an FQHC or RHC 
claim that includes CPT codes 99304 through 99318, when those services 
are furnished in a SNF. Operationally, the exclusion would occur when 
the following conditions are met:
    (1) Either a professional service is billed under CPT codes 99304 
through 99318, or an FQHC/RHC submits a claim including a qualifier CPT 
code 99304 through 99318; and
    (2) A SNF facility claim is in our claims files with dates of 
service that overlap with the date of service for the professional 
service or FQHC/RHC service.
    As discussed in section III.G.2.a.(2) of the proposed rule, we 
proposed to incorporate the revised definition of primary care services 
in a new provision of the Shared Savings Program regulations at Sec.  
425.400(c)(1)(v), applicable for use in determining beneficiary 
assignment for the performance year starting on January 1, 2021, and 
subsequent performance years. As part of this revised definition, we 
proposed to incorporate the proposed revisions to the exclusion for CPT 
codes 99304 through 99318 when services are furnished in a SNF at Sec.  
425.400(c)(1)(v)(A)(3) to extend the exclusion to services identified 
by these codes reported on an FQHC or RHC claim when furnished in a 
SNF. We proposed that this revision would also be applicable to 
determining assignment for the performance year starting on January 1, 
2021, and subsequent performance years.
    As we explained in section III.G.2.a.(2) of the proposed rule, we 
adjust the ACO's historical benchmark for changes in the program's 
assignment methodology occurring during the ACO's agreement period. We 
stated in the proposed rule that, if we finalized the proposed 
exclusion from beneficiary assignment of services reported by FQHCs or 
RHCs on claims that include CPT codes 99304 through 99318, when 
furnished in a SNF, we would adjust ACOs' historical benchmarks to 
account for these changes.
    Further, we noted that we believe the existing process is 
appropriately excluding from assignment professional services billed 
under CPT codes 99304 through 99318 when these services are provided to 
beneficiaries receiving SNF services in swing beds in Critical Access 
Hospitals (CAHs) or Electing Teaching Amendment (ETA) hospitals. Based 
on our operational experience:
     We exclude professional services billed under CPT codes 
99304 through 99318 when such services are furnished for care of a 
beneficiary in a CAH swing bed; however, relatively few claims are 
identified for exclusion on this basis.
     We do not believe that ETA hospitals are billing for 
services furnished to beneficiaries in a SNF or swing bed setting by 
physicians and other practitioners that have reassigned their billing 
rights to ETA hospitals.
    However, we solicited comment on whether additional exceptions are 
needed to ensure that all claims for services that include CPT codes 
99304 through 99318 are excluded from assignment when those services 
are furnished to a beneficiary receiving SNF care, including when these 
professional services are billed by a Method II CAH or ETA hospital.
    We received public comments on the proposed revisions to exclude 
from assignment certain services reported by FQHCs or RHCs when 
furnished in SNFs. We received no comments regarding additional 
exceptions that may be needed to ensure that all claims for services 
that include CPT codes 99304 through 99318 are excluded from assignment 
when those services are furnished to a beneficiary receiving SNF care, 
including when these professional services are billed by a Method II 
CAH or ETA hospital.
    The following is a summary of the comments we received and our 
responses.
    Comment: Commenters were overwhelmingly supportive of CMS' proposal 
to exclude professional services furnished by FQHCs or RHCs when 
delivered in a SNF, for purposes of assignment. Several commenters 
stated that this policy would ensure parity between FQHC practitioners, 
including physicians, and practitioners who practice in other settings, 
with respect to this issue. One commenter stated that, because FQHCs do 
not use place of service codes or other indicators that would 
demonstrate that a claim is eligible for exclusion, their claims are 
always considered primary care claims under current policy, even when 
the services are furnished in a SNF. These claims are then used for ACO 
beneficiary attribution, to the disadvantage of ACOs that include FQHCs 
as participants. Commenters noted that the proposed change, while 
technical in nature, would result in more accurate beneficiary 
assignment lists for ACOs.
    Response: We agree with commenters that this policy will allow for 
more accurate assignment of beneficiaries. Accordingly, we are 
finalizing our proposal to revise the existing exclusion for 
professional services billed under CPT codes 99304 through 99318 that 
are furnished in a SNF to include services reported on an FQHC or RHC 
claim that includes CPT codes 99304 through 99318, when those services 
are furnished in a SNF. By finalizing this policy, we will have a more 
consistent and accurate assignment approach. We are finalizing the 
definition of primary care services for use in beneficiary assignment 
for performance years starting on January 1, 2021, and subsequent 
performance years in the regulations at Sec.  425.400(c)(1)(v), which 
includes the codes for professional services furnished in a nursing 
facility (CPT codes 99304 through 99318) at Sec.  
425.400(c)(1)(v)(A)(3). The provision at Sec.  425.400(c)(1)(v)(A)(3) 
specifies that professional services or services reported on an FQHC or 
RHC claim identified by these codes are excluded from the definition of 
primary care services when furnished in a SNF.
3. Reducing the Amount of Repayment Mechanisms for Eligible ACOs
a. Background
    An ACO that will participate in a two-sided model must demonstrate 
that it has established an adequate repayment mechanism to provide CMS 
assurance of its ability to repay shared losses for which the ACO may 
be liable upon reconciliation for each performance year. The 
requirements for an ACO to establish and maintain an adequate repayment 
mechanism are described in Sec.  425.204(f), and we have provided 
additional program guidance on

[[Page 84757]]

repayment mechanism arrangements.\68\ We established the repayment 
mechanism requirements through earlier rulemaking,\69\ and recently 
modified the repayment mechanism requirements in the December 2018 
final rule (83 FR 67928 through 67938).
---------------------------------------------------------------------------

    \68\ Medicare Shared Savings Program, Repayment Mechanism 
Arrangements, Guidance Document, available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/Repayment-Mechanism-Guidance.pdf (herein Repayment 
Mechanism Arrangements Guidance).
    \69\ See 76 FR 67937 through 67940 (establishing the requirement 
for Track 2 ACOs). See 80 FR 32781 through 32785 (adopting the same 
general requirements for Track 3 ACOs with respect to the repayment 
mechanism and discussing modifications to reduce burden of the 
repayment requirements on ACOs).
---------------------------------------------------------------------------

    According to Sec.  425.204(f)(4)(iv), in the case of an ACO that 
has submitted a request to renew its participation agreement and wishes 
to use its existing repayment mechanism to establish its ability to 
repay any shared losses incurred for performance years in the new 
agreement period, the amount of the repayment mechanism must be equal 
to the greater of the following: (1) The amount calculated by CMS in 
accordance with Sec.  425.204(f)(4)(ii) at the time of renewal 
application; or (2) the repayment mechanism amount that the ACO was 
required to maintain during the last performance year of the 
participation agreement it seeks to renew. This approach ensures that a 
renewing ACO would remain capable of repaying losses incurred under its 
old agreement period (83 FR 67931). Based on our operational experience 
with implementing these policies, of 55 renewing two-sided model ACOs 
for a July 1, 2019, or January 1, 2020 start date, 43 ACOs (or 78.2 
percent) elected to continue use of their existing repayment mechanism, 
and 22 (or 51.2 percent) of these ACOs had a higher existing repayment 
mechanism amount compared to the amount calculated for the new 
agreement period (determined at the time of renewal application).
    Alternatively, to meet the requirements of Sec.  425.204(f), a 
renewing ACO could establish a new repayment mechanism arrangement to 
support its participation in its new agreement period, in addition to 
maintaining its existing repayment mechanism. This option allows an ACO 
to establish a repayment mechanism to support its new agreement period 
at a potentially different amount (determined according to Sec.  
425.204(f)(4)(ii)) than the amount of the existing arrangement. 
However, under this approach there is a period of time during which the 
ACO must maintain multiple repayment mechanisms. The ACO must maintain 
the repayment mechanism established to support the ACO's previous 
agreement period until the term of the repayment mechanism arrangement 
expires, or conditions arise to allow for termination of the repayment 
mechanism according to Sec.  425.204(f)(6)(iv) (see 83 FR 67933 through 
67936). Once the repayment mechanism for the previous agreement period 
is closed, the ACO would be required to maintain only the repayment 
mechanism arrangement applicable to its current agreement period. An 
ACO could use this option to establish a repayment mechanism at a 
relatively lower amount (if applicable) for its current agreement 
period, while maintaining and eventually closing-out a repayment 
mechanism at a relatively higher amount needed for its previous 
agreement period.
    As specified under Sec.  425.204(f)(4)(iii), for agreement periods 
beginning on or after July 1, 2019, CMS recalculates the ACO's 
repayment mechanism amount before the second and each subsequent 
performance year in the agreement period based on the certified ACO 
participant list for the relevant performance year. We require an 
increase in the repayment mechanism amount if the recalculated 
repayment mechanism amount exceeds the existing repayment mechanism 
amount by at least 50 percent or $1,000,000, whichever is the lesser 
value. Under Sec.  425.204(f)(4)(iii), an ACO cannot decrease the 
amount of its repayment mechanism during its agreement period as a 
result of changes in its composition.
    In implementing the revised repayment mechanism rules, we have 
discovered some unintended consequences. Specifically, under Sec.  
425.204(f)(4), a renewing ACO that chooses to retain its higher 
repayment mechanism for a new agreement period might never be able to 
reduce its repayment mechanism even after the ACO has paid any shared 
losses incurred for performance years in the previous agreement period. 
Moreover, the ACO would have to maintain the higher repayment mechanism 
amount in future agreement periods unless the ACO opts to establish a 
new repayment mechanism. We did not intend this result.
    More generally, based on our operational experience, many ACOs 
fully repay shared losses without use of their repayment mechanism 
arrangement. For example, of the eleven ACOs that owed shared losses 
for performance year 2018, CMS used the repayment mechanism for one ACO 
to support recoupment. Considering this experience, which suggests 
there may be low risk to the Shared Savings Program by allowing lower 
repayment mechanism amounts, and the potential reduction in burden on 
ACOs by lower repayment mechanism amounts, we revisited in the CY 2021 
PFS proposed rule the policies requiring renewing ACOs to retain higher 
repayment mechanism amounts when these amounts may no longer be needed 
to support their continued participation.
b. Revisions
    In the CY 2021 PFS proposed rule (85 FR 50248 through 50251), we 
proposed to establish two policies that would allow certain ACOs to 
benefit from a lower repayment mechanism amount than would otherwise be 
required under the current regulations. Under the first proposed 
policy, a renewing ACO that uses an existing repayment mechanism to 
establish its ability to repay any shared losses incurred for 
performance years in its new agreement period may reduce its existing 
repayment mechanism amount if the repayment mechanism amount calculated 
for the new agreement period is less than the amount of the existing 
repayment mechanism. The second proposed policy would permit certain 
ACOs whose agreement periods began July 1, 2019 or January 1, 2020 to 
elect to reduce the amount of their repayment mechanisms.
    Under Sec.  425.204(f)(4)(iv), a renewing ACO that wishes to use 
its existing repayment mechanism to establish its ability to repay any 
shared losses incurred for performance years in the new agreement 
period must maintain its existing repayment mechanism amount if it is 
higher than the repayment mechanism amount calculated for the new 
agreement period in accordance with Sec.  425.204(f)(4)(ii). We 
proposed to discontinue this policy by revising the regulations to 
specify that we will determine the repayment mechanism amount for such 
a renewing ACO only according to the methodology currently specified in 
Sec.  425.204(f)(4)(ii). Under the proposed approach, a renewing ACO 
that wishes to use its existing repayment mechanism to establish its 
ability to repay any shared losses incurred for performance years in 
the new agreement period would be required to have a repayment 
mechanism amount equal to the lesser of the following: (1) 1 percent of 
the total per capita Medicare Parts A and B FFS expenditures for the 
ACO's assigned beneficiaries, based on expenditures for the most recent 
calendar year for which 12 months of data are available; or (2) 2 
percent of the total Medicare Parts A and B FFS

[[Page 84758]]

revenue of its ACO participants, based on revenue for the most recent 
calendar year for which 12 months of data are available.
    As specified in the May 8th COVID-19 IFC (85 FR 27574 and 27575), 
we are forgoing the application cycle for the January 1, 2021 start 
date. Therefore, the proposed policy for determining the repayment 
mechanism amount for renewing ACOs would apply with the application 
cycle for an agreement period starting on January 1, 2022, and in 
subsequent years.
    As discussed in the CY 2021 PFS proposed rule (85 FR 50249), a 
renewing ACO could still choose to establish a new repayment mechanism 
arrangement for the amount calculated at the time of the renewal 
application to support its participation in its new agreement period 
and maintain its existing repayment mechanism at the previously 
required amount. Once the conditions arise for termination of the 
repayment mechanism arrangement supporting the ACO's previous agreement 
period, according to Sec.  425.204(f)(6)(iv), only the arrangement 
supporting the ACO's current agreement period would remain.
    In the CY 2021 PFS proposed rule (85 FR 50249), we explained our 
belief that the proposed approach would reduce burden by allowing 
renewing ACOs that wish to continue use of their existing repayment 
mechanism to decrease their repayment mechanism amount if a higher 
amount is not needed to support their new agreement period. As 
discussed in the CY 2021 PFS proposed rule, the proposal would prevent 
a higher repayment mechanism amount from following the ACO from one 
agreement period to the next, as is the case with the current approach. 
Further, an ACO would no longer need to establish another repayment 
mechanism for the ACO's new agreement period to ultimately get relief 
from the higher amount of its existing repayment mechanism arrangement, 
which the ACO would need to maintain until the conditions arise 
allowing for termination.
    As discussed in the CY 2021 PFS proposed rule, we recognize that 
the proposal would reduce the amount available to support repayment of 
shared losses. The typical timing of issuance to ACOs of financial 
reconciliation, which includes performance results and written 
notification from CMS of the amount of shared losses owed (if any), is 
in the summer following the conclusion of the performance year. 
Renewing ACOs permitted to reduce the amount of their existing 
repayment mechanism may be notified of shared losses owed for their 
most recent prior performance year during the application review period 
and would be in the process of paying shared losses within 90 days of 
written notification from CMS of the amount owed (according to 
Sec. Sec.  425.605(e)(3), 425.606(h)(3), 425.610(h)(3)). Further, at 
the time of renewal application, the ACO would be completing the last 
performance year of its existing agreement period, and financial 
reconciliation results for this performance year would likely be 
available during the summer of the ACO's first performance year of its 
new agreement period.
    However, as discussed in the CY 2021 PFS proposed rule, we believe 
this risk to CMS noted above is mitigated for a number of reasons. The 
Shared Savings Program's existing policies require ACOs to pay shared 
losses, in full, within 90 days of written notification from CMS of the 
amount owed (according to Sec. Sec.  425.605(e)(3), 425.606(h)(3), 
425.610(h)(3)). ACOs have an interest in fully paying the amount of 
shared losses owed within the 90-day payment window to remain in 
compliance with the Shared Savings Program's requirements and avoid 
compliance actions including involuntary termination from the program. 
CMS may terminate an ACO's participation agreement for reasons 
including, but not limited to, non-compliance with requirements in part 
425 (Sec.  425.218(b)(1)), such as failure to repay shared losses owed 
according to the program's regulations and may take pre-termination 
actions as described in Sec.  425.216. Under Sec.  
425.221(b)(2)(ii)(B), an ACO under a two-sided model whose 
participation agreement is terminated by CMS under Sec.  425.218 is 
liable for a pro-rated share of any shared losses determined for the 
performance year during which the termination becomes effective. ACOs 
must also repay shared losses owed to avoid accruing interest on any 
amount that remains unpaid after the 90-day payment window, and 
referral of an unpaid debt to the Department of Treasury for 
collection. Based on our operational experience, nearly all ACOs fully 
repay shared losses without use of their repayment mechanism 
arrangement.
    Nevertheless, in the CY 2021 PFS proposed rule we considered 
finalizing a policy that would require a renewing ACO to maintain its 
existing, higher repayment mechanism amount until the ACO has fully 
repaid the amount of shared losses determined to be owed for the most 
recent performance year for which financial reconciliation results are 
available. Under this approach, for instance, Sec.  425.204(f)(4)(iv) 
would remain unchanged, and we would amend Sec.  425.204(f)(4)(iii) to 
add a provision permitting a renewing ACO to reduce the amount of its 
repayment mechanism.
    As discussed in the CY 2021 PFS proposed rule, the Shared Savings 
Program regulations do not address the opportunity for a re-entering 
ACO, defined according to Sec.  425.20, to use a repayment mechanism 
arrangement established to support its participation in an earlier 
agreement period to also support its participation in a new agreement 
period. As defined at Sec.  425.20, a ``re-entering ACO'' may or may 
not be the same legal entity that previously participated in the Shared 
Savings Program. Specifically, a ``re-entering ACO'' is defined to 
include the following: (1) An ACO that is the same legal entity as an 
ACO that previously participated in the program and is applying to 
participate in the program after a break in participation due to early 
termination of its participation agreement or the expiration and non-
renewal of its participation agreement; and (2) a new legal entity that 
has never participated in the Shared Savings Program, provided that 
more than 50 percent of its ACO participants were included on the ACO 
participant list of the same ACO in any of the 5 most recent 
performance years prior to the agreement start date for the new legal 
entity.
    In the CY 2021 PFS proposed rule, we stated that we were 
considering finalizing provisions specifying the conditions under which 
a re-entering ACO may use an existing repayment mechanism arrangement 
to support its participation in a subsequent agreement period in the 
Shared Savings Program. Specifically, because a repayment mechanism is 
valid only with respect to amounts owed by the legal entity to whom or 
on whose behalf it was issued, we stated that we were considering 
specifying in the final rule that a re-entering ACO may use its 
existing repayment mechanism only if it is the same legal entity as the 
ACO that previously participated in the program. We stated that this 
option for continued use of an existing repayment mechanism would not 
be feasible for (and therefore would not be applicable to) a re-
entering ACO that is not the same legal entity as the ACO that 
previously participated in the program and is identified on the 
repayment mechanism documentation (that is, the proposed policy would 
not apply to an ACO identified as a re-entering ACO because more than 
50 percent of its ACO participants were included on the ACO participant 
list for a single ACO in

[[Page 84759]]

any of the 5 most recent performance years prior to the agreement start 
date).
    We also proposed to establish a second policy that would allow 
certain ACOs a one-time opportunity to decrease the amount of their 
repayment mechanisms. Under this proposal, an ACO that renewed its 
agreement period beginning on July 1, 2019, or January 1, 2020, may 
elect to decrease the amount of its repayment mechanism if (1) upon 
renewal, it elected to use an existing repayment mechanism to establish 
its ability to repay any shared losses incurred in its new agreement 
period and the amount of that repayment mechanism was greater than the 
repayment mechanism amount estimated for the ACO's new agreement 
period; and (2) the recalculated repayment mechanism amount for 
performance year 2021 is less than the existing repayment mechanism 
amount. We noted that the proposal would not be finalized if we 
finalized our alternate proposal described above to modify Sec.  
425.204(f)(4)(iii) to permit a renewing ACO to reduce the amount of its 
repayment mechanism after the ACO fully repaid the amount of shared 
losses determined to be owed for the final performance year of its 
prior agreement period. We explained that the purpose of this second 
proposal is to let any ACO that renewed for an agreement period 
beginning on July 1, 2019, or beginning on January 1, 2020, to decrease 
its repayment mechanism amount before it seeks to renew its current 
agreement under the first proposed policy, which if finalized, would 
otherwise be the earliest opportunity for the ACO to reduce its 
repayment mechanism amount.
    To determine if an ACO that renewed for an agreement period 
beginning on July 1, 2019, or beginning on January 1, 2020, is eligible 
for the one-time opportunity to lower its repayment mechanism amount, 
we proposed to compare the recalculated amount of the ACO's repayment 
mechanism based on its certified ACO participant list for performance 
year 2021, calculated according to Sec.  425.204(f)(4)(iii), to the 
ACO's existing repayment mechanism amount. If the recalculated 
repayment mechanism amount for performance year 2021 is less than the 
existing repayment mechanism amount, the ACO would be eligible to 
decrease the amount of its repayment mechanism to the recalculated 
amount. Under this approach, we would permit a decrease in the 
repayment mechanism amount even for relatively small differences in 
dollar amounts. However, an ACO may wish to maintain the existing 
amount of its repayment mechanism arrangement, particularly if the cost 
to the ACO of amending the arrangement outweighs the potential benefit 
of a nominal decrease in the amount of the repayment mechanism.
    We proposed that CMS would notify the ACO in writing that the ACO 
may elect to decrease the amount of its repayment mechanism. We 
explained that if we finalized our proposal to allow a one-time 
opportunity for a repayment mechanism decrease by eligible ACOs that 
renewed for an agreement period beginning on July 1, 2019, or beginning 
on January 1, 2020, we would notify an ACO that it may elect to reduce 
its repayment mechanism amount after the start of performance year 
2021. We also proposed that an ACO must submit such election, together 
with revised repayment mechanism documentation, in a form and manner 
and by a deadline specified by CMS. CMS would review the revised 
repayment mechanism documentation and may reject the election if the 
repayment mechanism documentation does not comply with the requirements 
of Sec.  425.204(f).
    Regarding the timeframe for an ACO to elect to decrease the amount 
of its repayment mechanism, we indicated that we might require an ACO 
to submit its election, together with revised repayment mechanism 
documentation, within 30 days from the date of the written notice from 
CMS, particularly if prompt election is needed to ensure compliance 
with other program requirements. For instance, CMS may notify the ACO 
that it may elect to decrease the amount of its repayment mechanism 
after using the ACO's existing repayment mechanism to support repayment 
of shared losses. In this case, prompt notification by the ACO of its 
election to decrease the amount of its repayment mechanism may be 
necessary if the ACO seeks to replenish the amount of its repayment 
mechanism to the permitted lower amount within the 90-day replenishment 
period according to Sec.  425.204(f)(5). However, we recognized that 
there may be circumstances that necessitate a longer timeframe.
    We proposed to amend Sec.  425.204(f)(4)(iv) by removing the 
introductory text and specifying in paragraph (f)(4)(iv)(A) the revised 
methodology for determining the repayment mechanism amount for renewing 
ACOs that seek to use their existing repayment mechanism to support 
their continued participation in their new agreement period. We 
proposed to revise Sec.  425.204(f)(4)(iv)(B) to establish the policy 
and relevant procedure for allowing eligible ACOs with July 1, 2019, or 
January 1, 2020 start dates to elect to lower the amount of their 
repayment mechanism arrangements.
    We proposed to amend Sec.  425.204(f)(5), which requires an ACO to 
replenish the amount of funds available through the repayment mechanism 
within 90 days of use of the arrangement to repay any portion of shared 
losses. Specifically, we proposed to specify that the resulting amount 
available through the repayment mechanism after replenishment must be 
at least the amount specified by CMS in accordance with Sec.  
425.204(f)(4). For example, these revisions would allow an eligible 
ACO, that renewed its agreement period beginning on July 1, 2019, or 
January 1, 2020, to replenish the repayment mechanism to the lower 
amount determined by CMS, according to the proposed approach described 
in the CY 2021 PFS proposed rule. As proposed, the revision may also be 
relevant to a renewing ACO that is seeking to use its existing 
repayment mechanism to support its participation in its new agreement 
period. Specifically, if the renewing ACO's existing repayment 
mechanism is used to support payment of shared losses, based on 
financial reconciliation results available at the time of renewal 
application, CMS may permit the renewing ACO to replenish the amount of 
its existing repayment mechanism to the lower amount determined to be 
applicable for the ACO's new agreement period.
    We also proposed technical changes to Sec.  425.204(f)(3)(iv) for 
clarity. This provision specifies that an ACO that has submitted a 
request to renew its participation agreement must submit as part of the 
renewal request documentation demonstrating the adequacy of the 
repayment mechanism that could be used to repay any shared losses 
incurred for performance years in the next agreement period, and 
describes the conditions under which an ACO may use its current 
repayment mechanism to apply to the new agreement period. For clarity, 
we proposed to specify under this provision that the duration of the 
existing repayment mechanism must be revised to comply with Sec.  
425.204(f)(6)(ii), and the amount of the repayment mechanism must 
comply with Sec.  425.204(f)(4).
    Further, we proposed that an ACO must demonstrate the adequacy of 
its repayment mechanism prior to any change in the terms and type of 
the repayment mechanism. Based on our operational experience, ACOs 
periodically request to close-out their

[[Page 84760]]

existing repayment mechanisms and establish new repayment mechanisms to 
support their continued participation under a two-sided model. We have 
typically permitted these requests, under the following circumstances: 
We first ensure the ACO's new repayment mechanism meets the program's 
requirements and is fully executed; and then we permit cancellation of 
the repayment mechanism arrangement(s) being replaced. Further, when 
reviewing requested modifications to repayment mechanism documentation 
it is our practice to ensure that all the terms of the repayment 
mechanism are compliant with the program's policies. Therefore, we 
proposed to revise the regulations in Sec.  425.204(f)(3)(i) through 
(iii) to further specify that an ACO must demonstrate the adequacy of 
its repayment mechanism prior to any change in the terms and type of 
the repayment mechanism.
    We received public comments on the proposals for reducing the 
amount of repayment mechanisms for eligible ACOs. The following is a 
summary of the comments we received and our responses.
    Comment: Many commenters addressing the program's repayment 
mechanism policies expressed their support for CMS' proposal to 
eliminate the requirement that renewing ACOs that wish to continue use 
of their existing repayment mechanism maintain the higher repayment 
mechanism amount in their subsequent agreement period, when a lower 
amount is calculated at the time of renewal application.
    One commenter commended CMS for addressing the unintended 
consequences of ACOs having to maintain a higher-than-required 
repayment mechanism as they transition to new agreement periods.
    One commenter acknowledged CMS' consideration of an alternative 
that would require renewing ACOs to maintain existing, higher repayment 
mechanism amounts until they have fully repaid any shared losses owed 
for the most recent performance year. This commenter stated its belief 
that other enforcement mechanisms, such as possible pre-termination 
actions and accruing interest for not repaying shared losses, are 
sufficient to warrant timely repayment of shared losses.
    Response: We are finalizing the proposed changes to determining the 
amount for repayment mechanisms for renewing ACOs that elect to 
continue use of their existing repayment mechanism to support their 
continued participation in a new agreement period, to permit the amount 
of these arrangements to be reduced.
    Under this final policy, specified in revisions to Sec.  
425.204(f)(4)(iv)(A), a renewing ACO that wishes to use its existing 
repayment mechanism to establish its ability to repay any shared losses 
incurred for performance years in the new agreement period will be 
required to have a repayment mechanism amount equal to the lesser of 
the following, as currently specified in Sec.  425.204(f)(4)(ii): (1) 1 
Percent of the total per capita Medicare Parts A and B FFS expenditures 
for the ACO's assigned beneficiaries, based on expenditures for the 
most recent calendar year for which 12 months of data are available; or 
(2) 2 percent of the total Medicare Parts A and B FFS revenue of its 
ACO participants, based on revenue for the most recent calendar year 
for which 12 months of data are available. As we described in the CY 
2021 PFS proposed rule, and restated in this section of this final 
rule, these modifications apply to the application cycle for an 
agreement period starting on January 1, 2022, and in subsequent years.
    We are not adopting the alternative we described in the CY 2021 PFS 
proposed rule, under which we would require a renewing ACO to maintain 
its existing, higher repayment mechanism amount until the ACO has fully 
repaid the amount of shared losses determined to be owed for the most 
recent performance year for which financial reconciliation results are 
available. Although the policy changes we are finalizing for 
determining the amount for repayment mechanisms for renewing ACOs may 
reduce the amount available to CMS to support repayment of shared 
losses in some cases, we believe the potential burden reduction for 
ACOs outweighs the risk to CMS. We continue to believe the risk to CMS 
of reduced repayment amounts for supporting repayment of shared losses 
is mitigated because the effect of other policies is to encourage 
compliance with the requirement that ACOs timely repay shared losses in 
full. As described in the proposed rule and reiterated in this section 
of the this final rule, ACOs have an interest in fully paying the 
amount of shared losses owed within the 90-day payment window 
(according to Sec. Sec.  425.605(e)(3), 425.606(h)(3), 425.610(h)(3)); 
timely payment in full allows the ACO to remain in compliance with the 
Shared Savings Program's requirements and to avoid compliance actions, 
including involuntary termination from the program and related payment 
consequences of early termination. Also, timely payment in full of 
shared losses allows an ACO to avoid accruing interest charges on any 
unpaid shared losses and referral of an unpaid debt to the Department 
of Treasury for collection.
    Comment: One commenter generally supported the approach that CMS 
sought comment on for allowing a re-entering ACO identified as the same 
legal entity as an ACO that previously participated in the program to 
use that ACO's existing repayment mechanism to support its 
participation in a new agreement period.
    Response: We appreciate the commenter's support for this 
consideration. We are finalizing this approach by amending Sec.  
425.204(f)(4)(iv)(A) to specify that the requirements regarding use of 
an existing repayment mechanism arrangement to support the ACO's 
participation in a new agreement period in the Shared Savings Program 
will apply to both a renewing ACO, and a re-entering ACO that is the 
same legal entity that previously participated in the Shared Savings 
Program (either an ACO whose participation agreement expired without 
having been renewed, or an ACO whose participation agreement was 
terminated under Sec.  425.218 or Sec.  425.220). Specifically, if a 
renewing ACO or re-entering ACO that is the same legal entity as an ACO 
that previously participated in the program wishes to use its existing 
repayment mechanism to establish its ability to repay any shared losses 
incurred for performance years in the new agreement period, the amount 
of the repayment mechanism must be equal to at least the amount 
calculated by CMS in accordance with Sec.  425.204(f)(4)(ii), which is 
the lesser of the following: (1) 1 percent of the total per capita 
Medicare Parts A and B FFS expenditures for the ACO's assigned 
beneficiaries, based on expenditures for the most recent calendar year 
for which 12 months of data are available; or (2) 2 percent of the 
total Medicare Parts A and B FFS revenue of its ACO participants, based 
on revenue for the most recent calendar year for which 12 months of 
data are available.
    Section 425.204(f)(3)(iv), as amended by this final rule, describes 
repayment mechanism documentation requirements, and specifies the 
condition under which a renewing ACO may use its existing repayment 
mechanism to support its continued participation under a new agreement 
period. To apply similar requirements to eligible, re-entering ACOs, we 
are revising the regulations to add a new paragraph (f)(3)(v) to Sec.  
425.204 to specify that an ACO that has submitted

[[Page 84761]]

an application to the program after a break in participation must 
submit as part of its application, documentation demonstrating the 
adequacy of the repayment mechanism that could be used to repay any 
shared losses incurred for performance years in the next agreement 
period. The repayment mechanism applicable to the new agreement period 
may be the same repayment mechanism currently used by the re-entering 
ACO, provided that the ACO is the same legal entity as an ACO that 
previously participated in the program, and the ACO submits 
documentation establishing that the duration of the existing repayment 
mechanism has been revised to comply with Sec.  425.204(f)(6)(ii) and 
the amount of the repayment mechanism complies with Sec.  
425.204(f)(4).
    We are revising Sec.  425.204(f)(6)(ii), which specifies the 
required duration for repayment mechanisms for a renewing ACO that 
wishes to use its existing repayment mechanism to establish its ability 
to repay any shared losses incurred for performance years in the new 
agreement period. Specifically, we are revising paragraph (ii) to make 
it applicable to re-entering ACOs that are the same legal entity as an 
ACO that previously participated in the program. With these 
modifications, the provision specifies that a renewing ACO, or a re-
entering ACO that is the same legal entity as an ACO that previously 
participated in the program, that wishes to use its existing repayment 
mechanism to establish its ability to repay any shared losses incurred 
for performance years in the new agreement period, must amend its 
existing repayment mechanism to meet either Sec.  425.204(f)(6)(ii)(A) 
or (B). Respectively, these provisions specify the following:
     The duration of the existing repayment mechanism is 
extended by an amount of time that covers the duration of the new 
agreement period plus 12 months following the conclusion of the new 
agreement period.
     The duration of the existing repayment mechanism is 
extended, if necessary, to cover a term of at least the first two 
performance years of the new agreement period and provides for 
automatic, annual 12-month extensions of the repayment mechanism such 
that the repayment mechanism will eventually remain in effect for the 
duration of the new agreement period plus 12 months following the 
conclusion of the new agreement period.
    Comment: Commenters expressed support for CMS' proposed approach 
that provides a one-time opportunity for eligible ACOs that renewed 
their agreement periods beginning on July 1, 2019 or January 1, 2020, 
and elected to continue use of their existing repayment mechanism at a 
higher amount, to decrease their repayment mechanism amount if the 
recalculated amount for performance year 2021 is less than the existing 
amount.
    Some commenters expressed support for an approach that would allow 
any ACO the option to decrease its repayment mechanism amount if the 
recalculated amount for the performance year is less than the current 
repayment mechanism amount and requested that CMS finalize this policy.
    Response: We are finalizing the proposed policy at Sec.  
425.204(f)(4)(iv)(B), which grants a one-time opportunity for an ACO 
that renewed its agreement period beginning on July 1, 2019, or January 
1, 2020, to elect to decrease the amount of its repayment mechanism if 
(1) upon renewal, it elected to use an existing repayment mechanism to 
establish its ability to repay any shared losses incurred in its new 
agreement period and the amount of that repayment mechanism was greater 
than the repayment mechanism amount estimated for the ACO's new 
agreement period; and (2) the recalculated repayment mechanism amount 
for performance year 2021 is less than the existing repayment mechanism 
amount.
    At this time, we decline commenters' suggestions to establish a 
policy to allow for annual repayment mechanism decreases by all two-
sided model ACOs, if the recalculated amount for the performance year 
is lower than their existing repayment mechanism amount. This 
alternative goes beyond the scope of the modifications we proposed to 
the program's repayment mechanism requirements. However, we will 
consider commenters' suggestions and we may revisit this issue in 
future notice and comment rulemaking.
    Comment: One commenter addressing the proposed one-time opportunity 
for eligible renewing ACOs with a July 1, 2019 and January 1, 2020 
start date, to elect to decrease their repayment mechanism amount, 
urged CMS to consider allowing these ACOs longer than 30 days to submit 
elections to reduce their repayment mechanism amounts, particularly 
given the circumstances of COVID-19. However, the commenter did not 
provide additional details on an alternative timeframe for this 
election.
    Response: We proposed that such elections must be submitted ``by a 
deadline specified by CMS'' and noted that the deadline might be 30 
days from the date of CMS' written notification to the ACO, of its one-
time opportunity to decrease its repayment mechanism amount. We 
appreciate the commenter's concern that an ACO may need more than 30 
days to submit its election and the revised repayment mechanism 
documentation. We are not finalizing a 30-day deadline in regulation 
text, although such a deadline may ultimately be necessary depending on 
the circumstances. We continue to believe it is important for ACOs to 
promptly elect the option for a repayment mechanism decrease, 
particularly when prompt election is needed to ensure compliance with 
other program requirements. Consistent with our existing approach to 
supporting ACOs in meeting repayment mechanism requirements, we 
anticipate working closing with ACOs to ensure the documentation they 
provide is sufficient.
    We are finalizing the proposed policy by revising Sec.  
425.204(f)(4)(iv)(B) to specify that CMS will notify an eligible ACO in 
writing if the ACO may elect to decrease the amount of its repayment 
mechanism. We are also finalizing as proposed the policy that the ACO 
must submit such election, together with revised repayment mechanism 
documentation, in a form and manner and by a deadline specified by CMS. 
CMS will review the revised repayment mechanism documentation and may 
reject the election if the repayment mechanism documentation does not 
comply with the requirements of Sec.  425.204(f).
    Comment: Some commenters explained that securing a repayment 
mechanism is a regulatory burden, which is time consuming and costly 
for ACOs. While some commenters expressed their appreciation for CMS' 
efforts to minimize burdens associated with the repayment mechanism 
through the changes proposed with the CY 2021 PFS proposed rule, they 
also urged CMS to take additional steps to minimize burdens on ACOs 
associated with repayment mechanism requirements.
    Some commenters explained that many ACOs cite the burden and cost 
of securing a repayment mechanism as reasons not to move to a 
performance-based risk model. Commenters urged CMS to remove the 
repayment mechanism requirement when an ACO can prove that it has an 
investor or financial backer with a demonstrated high credit rating, 
instead of requiring the ACO to incur the costs of obtaining a 
repayment mechanism, and thereby direct the ACO's resources away from 
its core mission of improving patient

[[Page 84762]]

care. As suggested by the commenters, financial backers could include 
outside investors, insurers or hospitals or health systems that are 
aligned with the ACO and committed to providing financial support, 
which would be available should losses occur. These commenters noted 
that this assurance would protect the Medicare Trust Funds in the event 
the ACO has losses while avoiding the financial inefficiency and 
regulatory burden of involving outside financial institutions.
    These commenters also noted that this alternative approach would 
also eliminate the need to have a 24-month ``tail period''. Although 
not specifically stated, we believe commenters are referring to a 
requirement that ACOs maintain their repayment mechanism for a period 
of time following the conclusion of the ACO's agreement period. 
Commenters explained that the additional burden of a 24-month tail 
period heightens concerns, and increases financial requirements for 
ACOs. Should CMS maintain requirements for a repayment mechanism, 
commenters requested that CMS minimize this regulatory and financial 
burden by removing the requirement for tail period coverage. Commenters 
indicated this was especially important considering longer agreement 
periods.
    Response: We note that commenters' alternative suggestions, for 
removing or significantly revising the repayment mechanism 
requirements, go beyond the scope of the proposals to revise the 
repayment mechanism requirements discussed in the CY 2021 PFS proposed 
rule. We decline the commenters' suggestions, including to establish 
alternative pathways for ACOs to demonstrate their ability to repay 
shared losses or to shorten the duration for which a repayment 
mechanism must be available.
    We are concerned that commenters' references to a 24-month ``tail 
period'' requirement suggest a misunderstanding of the existing 
requirements for the duration of a repayment mechanism. Although in 
recent rulemaking (83 FR 67933 through 67937) we proposed requiring 
repayment mechanisms to be in effect for the duration of the ACO's 
participation in a two-sided model plus 24 months after the conclusion 
of the agreement period, we ultimately finalized an approach (taking 
into consideration public comments on our proposals) that requires the 
repayment mechanism to be available for 12 months following the 
conclusion of the ACO's agreement period. In brief, as specified under 
Sec.  425.204(f)(6), the repayment mechanism must be in effect for the 
duration of the ACO's participation under a two-sided model plus 12 
months following the conclusion of the agreement period, and this can 
be demonstrated by either of the following: (1) The repayment mechanism 
covers the entire duration of the ACO's participation under a two-sided 
model plus 12 months following the conclusion of the agreement period; 
or (2) the repayment mechanism covers a term of at least the first 2 
performance years in which the ACO is participating under a two-sided 
model and provides for automatic, annual 12-month extensions of the 
repayment mechanism such that the repayment mechanism will eventually 
remain in effect for the duration of the agreement period plus 12 
months following the conclusion of the agreement period.
    As we have explained in previous rulemaking (see for example, 83 FR 
67933, and 80 FR 32783), this tail period must be sufficient to permit 
CMS to calculate the amount of any shared losses that may be owed by 
the ACO and to collect this amount from the ACO. This is necessary, in 
part, because financial reconciliation results are not available until 
the summer following the conclusion of the performance year, and ACOs 
have 90 days to make payment in full once they are notified of shared 
losses based on financial reconciliation (see Sec. Sec.  425.605(e), 
425.606(h), and 425.610(h)). Therefore, we continue to believe that a 
requirement that an ACO's repayment mechanism be available for 12 
months following the conclusion of its agreement period is critical to 
ensuring the availability of the repayment mechanism to support 
collection of shared losses that may be owed for the final performance 
year of the agreement period. As we explained in previous rulemaking, 
in allowing for a shorter tail period of 12-months, we believed the 
importance of reducing burden on ACOs outweighed the possible risk to 
the Trust Funds (83 FR 67934). We would also note that the program's 
policies under Sec.  425.204(f)(6)(iv) specify the conditions upon 
which we permit early termination of a repayment mechanism and release 
of the arrangement's remaining funds to the ACO. This allows us to 
terminate repayment mechanism arrangements that are no longer needed to 
support ACOs' participation in the Shared Savings Program, which may 
free up capital for ACOs.
    We appreciate the continued engagement of ACOs and other program 
stakeholders in suggesting policy alternatives to reducing the burdens 
of the repayment mechanism requirements on ACOs. We will consider 
commenters' suggestions, and we may revisit this issue in future notice 
and comment rulemaking.
    As a result of the comments received, we are amending Sec.  
425.204(f)(4)(iv) to specify in paragraph (f)(4)(iv)(A) that a renewing 
ACO or a re-entering ACO that is the same legal entity as an ACO that 
previously participated in the program may use its existing repayment 
mechanism to establish its ability to repay any shared losses incurred 
for performance years in the new agreements period. That provision also 
sets forth the revised methodology for determining the repayment 
mechanism amount for such ACOs. These modifications apply to the 
application cycle for an agreement period starting on January 1, 2022, 
and in subsequent years. We are also adding provisions in Sec.  
425.204(f)(4)(iv)(B) establishing policies and procedures that allow 
certain ACOs that renewed for an agreement period beginning on July 1, 
2019, or January 1, 2020, to elect to decrease the amount of their 
existing repayment mechanisms.
    We are adding new paragraph (f)(3)(v) to Sec.  425.204 to allow a 
re-entering ACO to use its existing repayment mechanism to establish 
its ability to repay any shared losses incurred for performance years 
in the new agreement period, provided that the ACO is the same legal 
entity as an ACO that previously participated in the Shared Savings 
Program and the ACO submits documentation establishing that the 
duration of the existing repayment mechanism has been revised to comply 
with Sec.  425.204(f)(6)(ii) and the amount of the repayment mechanism 
complies with Sec.  425.204(f)(4). We are also revising Sec.  
425.204(f)(6)(ii) (describing the required duration of the repayment 
mechanism) to make it applicable to a renewing ACO or a re-entering ACO 
that is the same legal entity as an ACO that previously participated in 
the program, that wishes to use its existing repayment mechanism to 
support its participation in its new agreement period.
    Additionally, we received no public comments on the following 
proposals, which we are finalizing as proposed:
    We are amending Sec.  425.204(f)(5) (regarding the replenishment of 
funds available through the repayment mechanism) to specify that the 
resulting amount available through the repayment mechanism after 
replenishment must be at least the amount specified by CMS in 
accordance with Sec.  425.204(f)(4).
    We are finalizing as proposed certain technical changes to Sec.  
425.204(f)(3)(iv). This provision specifies that an ACO that has 
submitted a request to renew its

[[Page 84763]]

participation agreement must submit as part of the renewal request 
documentation demonstrating the adequacy of the repayment mechanism 
that could be used to repay any shared losses incurred for performance 
years in the next agreement period, and describes the conditions under 
which an ACO may use its current repayment mechanism to apply to the 
new agreement period. For clarity, we are finalizing our proposed 
modification to specify under this provision that the duration of the 
existing repayment mechanism must be revised to comply with Sec.  
425.204(f)(6)(ii), and the amount of the repayment mechanism must 
comply with Sec.  425.204(f)(4).
    Lastly, we are finalizing the proposal to revise Sec.  
425.204(f)(3)(i) through (iii) to further specify that an ACO must 
demonstrate the adequacy of its repayment mechanism prior to any change 
in the terms and type of the repayment mechanism.
4. Applicability of Policies to Track 1+ Model ACOs
    In the CY 2021 PFS proposed rule (85 FR 50251 and 50252), we 
provided a comprehensive discussion of the applicability of the 
proposed policies specified in section III.G and section III.I of the 
proposed rule to Track 1+ Model ACOs. We explained which of the 
proposed policies would become applicable to Track 1+ Model ACOs either 
through revisions to existing Shared Savings Program regulations that 
currently apply to Track 1+ Model ACOs or through the addition of new 
provisions that would apply to Track 1+ ACOs in the same way that they 
apply to ACOs in Track 1. However, we also explained the circumstances 
under which certain changes in policies would become applicable through 
an amendment to the ACO's Track 1+ Model Participation Agreement.
    We received no public comments directly addressing the 
applicability of the policies proposed in the CY 2021 PFS proposed rule 
to Track 1+ Model ACOs. However, a few commenters expressed their 
support for applying the voluntary 1-year extension, for ACOs whose 
agreement periods would otherwise expire on December 31, 2020, to Track 
1+ Model ACOs. Although this policy was established in the May 8th 
COVID-19 IFC (85 FR 27574 and 27575, see also 85 FR 27586 and 27587), 
we explained in the CY 2021 PFS proposed rule (85 FR 50251) that Track 
1+ Model ACOs, among other ACOs whose agreement periods would otherwise 
expire on December 31, 2020, were eligible to voluntarily elect a 1-
year extension of their agreement period for a fourth performance year 
from January 1, 2021, to December 31, 2021.
    However, we believe it would be helpful to summarize how the 
policies we are finalizing in sections III.G and III.I of this final 
rule apply to Track 1+ Model ACOs. Unless specified otherwise, the 
changes to the program's regulations finalized in this final rule that 
are applicable to Shared Savings Program ACOs within a current 
agreement period will apply to ACOs in the Track 1+ Model in the same 
way that they apply to ACOs in Track 1, so long as the applicable 
regulation has not been waived under the Track 1+ Model. Similarly, to 
the extent that certain requirements of the regulations that apply to 
ACOs under Track 2 or the ENHANCED track have been incorporated for 
ACOs in the Track 1+ Model under the terms of the Track 1+ Model 
Participation Agreement, any changes to those regulations that are 
finalized in this final rule will also apply to ACOs in the Track 1+ 
Model in the same way that they apply to ACOs in Track 2 or the 
ENHANCED track. For example, the following final policies will apply to 
Track 1+ Model ACOs:
     The application of the APP to determine the quality 
performance of Shared Savings Program ACOs (section III.G.1.c. of this 
final rule).
     The revisions to the Shared Savings Program quality 
performance standard. Specifically, under the modified approach we are 
finalizing, the quality performance standard for Track 1+ Model ACOs 
will be set at a quality score that is equivalent to or higher than the 
30th percentile across all MIPS Quality performance category scores, 
for performance year 2021 (section III.G.1.c. of this final rule).
     The modifications to the regulations under Sec.  
425.604(c) specifying the circumstances under which a Track 1 ACO will 
qualify to receive a shared savings payment (section III.G.1.d. of this 
final rule).
     The modifications to the regulations under Sec.  
425.604(d) governing the determination of the final sharing rate for 
Track 1 ACOs (section III.G.1.d. of this final rule).
     The modifications to Sec.  425.316 to allow CMS to 
identify ACOs that are not meeting the revised quality performance 
standard finalized this final rule, and to require these ACOs to take 
actions to address their poor quality performance or face termination 
of their Shared Savings Program participation agreement (section 
III.G.1.e. of this final rule).
     The modifications to the policies governing the audit and 
validation of data used to determine the ACO's quality performance. 
Specifically, under the new provision of the regulations at Sec.  
425.510(c), CMS retains the right to audit and validate the quality 
data reported by an ACO according to Sec.  414.1390 (section III.G.1.f. 
of this final rule).
     The new provision of the regulations at Sec.  425.512(b) 
to address the effect of extreme and uncontrollable circumstances on 
ACOs' quality performance for performance year 2021 and subsequent 
performance years (section III.G.1.g. of this final rule).
     The revisions to the definition of primary care services 
used in beneficiary assignment. The revised definition is applicable to 
Track 1+ Model ACOs for the performance year starting on January 1, 
2021, and we will adjust the Track 1+ ACO's historical benchmark to 
reflect these policies (section III.G.2 of this final rule).
     The changes to the CAHPS for ACOs reporting requirements 
for performance year 2020 (section III.I.1 of this final rule).
5. Medicare Shared Savings Program Provisions From the May 8th COVID-19 
IFC
    In the May 8th COVID-19 IFC, we noted that, as of January 1, 2020, 
there were 517 Medicare Shared Savings Program (Shared Savings Program) 
Accountable Care Organizations (ACOs) serving approximately 11.2 
million Medicare FFS beneficiaries across the country: 37 percent of 
ACOs (192 of 517) were participating under two-sided shared savings and 
shared losses models; and 160 ACOs had agreements ending December 31, 
2020, and would be required to renew under the BASIC track or ENHANCED 
track to continue in the Shared Savings Program, including 20 ACOs 
participating in the Medicare ACO Track 1+ Model (Track 1+ Model).
    In the May 8th COVID-19 IFC, we expressed our belief that the 
COVID-19 pandemic, and the resulting PHE as defined in Sec.  400.200, 
have created a lack of predictability for many ACOs regarding the 
impact of expenditure and utilization changes on historical benchmarks 
and performance year expenditures, and for those under performance-
based risk, the potential liability for shared losses, as well as 
disrupting population health activities, as clinicians, care 
coordinators and financial and other resources are diverted to address 
immediate acute care needs. We explained that ACOs and other program 
stakeholders have advocated for CMS to modify Shared Savings Program 
policies to address the

[[Page 84764]]

impact of the COVID-19 pandemic including to:
     Adjust the methodology for determining shared savings and 
shared losses, such as by: Reducing or eliminating liability for ACOs 
under performance-based risk for shared losses for PY 2020; not sharing 
savings or losses with ACOs for PY 2020; or adjusting program 
calculations to address the impact of COVID-19 on benchmark and PY 
expenditures, particularly for calendar year 2020.
     Eliminate or extend the deadline for ACOs to voluntarily 
terminate from the program without being financially reconciled for PY 
2020, which under Sec.  425.221(b)(2)(ii)(A) is June 30, 2020, with 
notification 30 days prior (no later than June 1).
     Maintain or ``freeze'' ACOs in their current participation 
options so that ACOs otherwise required to renew their participation 
for a new agreement period starting on January 1, 2021, to continue 
their participation in the Shared Savings Program, are not burdened 
with meeting application deadlines, and forgo the requirement that ACOs 
participating in the BASIC track's glide path advance to the next level 
for PY 2021.
     Account for changes in billing and care patterns in 
determining beneficiary assignment.
    In the May 8th COVID-19 IFC (85 FR 27574), we explained that ACOs 
and other program stakeholders had indicated that there was an urgent 
need to address these concerns because ACOs needed to make 
participation decisions for PY 2020 and PY 2021 and may choose to 
terminate their participation in the Shared Savings Program on or 
before June 30th, rather than face the potential of pro-rated losses 
for PY 2020 if the PHE for COVID-19 does not extend for the entire year 
or the program's policies do not adequately mitigate liability for 
shared losses.
    We expressed our belief that it is vital to the stability of the 
Shared Savings Program to encourage continued participation by ACOs by 
adjusting program policies as necessary to address the impact of the 
COVID-19 pandemic, including by offering certain flexibilities in 
program participation options to currently participating ACOs and 
addressing potential distortions in expenditures resulting from the 
pandemic to ensure that ACOs are treated equitably regardless of the 
degree to which their assigned beneficiary populations are affected by 
the pandemic. We explained that the changes we were making in the May 
8th COVID-19 IFC would help to ensure a more equitable comparison 
between ACOs' expenditures for PY 2020 and ACOs' updated historical 
benchmarks and that ACOs are not rewarded or penalized for having 
higher/lower COVID-19 spread in their patient populations which, in 
turn, would help to protect ACOs from owing excessive shared losses and 
the Medicare Trust Funds from paying out windfall shared savings. As 
described in the May 8th COVID-19 IFC (85 FR 27573 through 27587), we 
modified Shared Savings Program policies to: (1) Allow ACOs whose 
current agreement periods expire on December 31, 2020, the option to 
extend their existing agreement period by one year, and allow ACOs in 
the BASIC track's glide path the option to elect to maintain their 
current level of participation for PY 2021; (2) clarify the 
applicability of the program's extreme and uncontrollable circumstances 
policy to mitigate shared losses for the period of the PHE for COVID-
19; (3) adjust program calculations to mitigate the impact of COVID-19 
on ACOs; and (4) expand the definition of primary care services for 
purposes of determining beneficiary assignment to include telehealth 
codes for virtual check-ins, e-visits, and telephonic communication. We 
also addressed how these adjustments to program policies would apply to 
ACOs participating in the Track 1+ Model.
    In response to the May 8th COVID-19 IFC, CMS received 57 timely 
pieces of correspondence addressing Shared Savings Program policies. We 
thank commenters for their thoughtful consideration of the 
modifications to and clarifications of Shared Savings Program policies 
included in the May 8th COVID-19 IFC. Within section III.G.5. of this 
final rule, we summarize and respond to public comments, and discuss 
our final policies after taking into consideration the public comments 
we received on the May 8th COVID-19 IFC. Some commenters' suggestions 
for modifications to Shared Savings Program policies went beyond the 
scope of the policies addressed in the May 8th COVID-19 IFC, and will 
not be addressed in this section of this final rule.
    Comment: Generally, some commenters expressed their appreciation 
for CMS' call for a renewed national commitment to value-based 
care.\70\ These commenters generally underscored the importance of 
value-based healthcare as a stabilizing force during the COVID-19 
pandemic. A few commenters explained that alternative payment models 
like the Shared Savings Program have enabled healthcare providers and 
ACOs to more effectively adapt to the challenges of delivering care 
during the PHE compared to their counterparts that are more reliant on 
reimbursement under traditional FFS. Another commenter described value-
based healthcare initiatives, of which the Shared Savings Program is 
Medicare's flagship program, as proving to be ``a port in the storm 
during COVID-19'' offering both infrastructure and expertise 
unavailable in traditional FFS and predictable revenue during 
unpredictable times. One commenter explained that ACOs represent a 
viable path for a further step away from volume-focused medicine and 
its problematic incentives.
---------------------------------------------------------------------------

    \70\ Although not specifically described in the May 8th COVID-19 
IFC, CMS' commitment to value-based care has been announced in 
recent publications. See for example, Verma S. New CMS Payment Model 
Flexibilities for COVID-19. Health Affairs. June 3, 2020. Available 
at https://www.healthaffairs.org/do/10.1377/hblog20200602.80889/full/. See also, CMS Press Release, ``Trump Administration Issues 
Call to Action Based on New Data Detailing COVID-19 Impacts on 
Medicare Beneficiaries'' (June 22, 2020), available at https://www.cms.gov/newsroom/press-releases/trump-administration-issues-call-action-based-new-data-detailing-covid-19-impacts-medicare.
---------------------------------------------------------------------------

    Some commenters specifically described ACOs' efforts to meet the 
Shared Savings Program's goals and provide for the health and safety of 
their patients during the COVID-19 pandemic, as in any other 
performance year. Some commenters described ACOs' agility in responding 
to disruptions in their routine monitoring of and care for patients, 
for example by rapidly deploying, or implementing, strategies to 
respond to the COVID-19 pandemic, including coordinating with local 
healthcare providers, expanding telehealth services, and diverting care 
coordinators to help manage patient outcomes. One commenter described 
ACOs' efforts to ``double down on existing risk targeting and care 
coordination efforts'' which helped support vulnerable patients to 
shelter safely in their homes with needed medications, food and other 
essentials. As another commenter described, many program participants 
have transitioned care to virtual platforms and/or provided care on 
porches or in parking lots or other outdoor settings as appropriate. 
This commenter explained that program participants are also working to 
establish long-term plans for triaging and treating patients with 
chronic conditions who are currently not seeking care because of the 
COVID-19 pandemic.
    Some commenters detailed the challenges ACOs face in implementing 
their business operations within the pandemic. As described by one

[[Page 84765]]

commenter, ACOs are procuring the personal protective equipment (PPE) 
needed to treat patients in person, applying for loans, keeping track 
of new guidance and policy changes, and making financial decisions 
related to their business. As another illustration, some commenters 
explained that while their commitment to value-based care was 
unwavering, the financial strains and uncertainty of the COVID-19 
pandemic presents a difficult choice for ACOs' future.
    Response: As we described in a recent publication,\71\ we recognize 
beneficiaries and healthcare providers have been facing unprecedented 
challenges due the COVID-19 pandemic. The pandemic has underscored the 
need for a resilient healthcare system where reimbursement is not tied 
to the volume of services provided, but rather to value-based 
incentives to keep patients healthy. The Shared Savings Program is one 
of the country's largest initiatives on value-based care, equipping 
healthcare providers with the flexibility to innovate and focus on 
health outcomes that can help them respond to the pandemic. We 
appreciate ACOs' continued commitment to meeting the goals of the 
Shared Savings Program while facing challenges in caring for Medicare 
FFS beneficiaries and operating their organizations during the COVID-19 
pandemic.
---------------------------------------------------------------------------

    \71\ Verma S. 2019 Medicare Shared Savings Program ACO 
Performance: Lower Costs And Promising Results Under `Pathways To 
Success.' Health Affairs. September 14, 2020. Available at https://www.healthaffairs.org/do/10.1377/hblog20200914.598838/full/.
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a. Application Cycle for January 1, 2021 Start Date and Extension of 
Agreement Periods Expiring on December 31, 2020
    As we explained in the May 8th COVID-19 IFC (85 FR 27574), a 
renewing ACO is defined as an ACO that continues its participation in 
the program for a consecutive agreement period, without a break in 
participation, because it is an ACO whose participation agreement 
expired and that immediately enters a new agreement period to continue 
its participation in the program, or an ACO that terminated its current 
participation agreement under Sec.  425.220 and immediately enters a 
new agreement period to continue its participation in the program (see 
Sec.  425.20). Section 425.224 specifies application procedures for a 
renewing ACO applying to enter a new participation agreement with CMS 
for participation in the Shared Savings Program. In the May 8th COVID-
19 IFC, we explained that we were seeking to reduce operational burden 
for ACOs and their healthcare providers while they respond to the 
serious health threats posed by the spread of the COVID-19. We 
described that we had received feedback from ACO stakeholders 
requesting that CMS delay the Shared Savings Program application cycle 
for a January 1, 2021 start date (occurring in CY 2020), since they had 
reassigned staff and care coordinators to respond to the current 
pandemic. Stakeholders expressed concern about focusing resources on 
applying to the Shared Savings Program rather than on patient care 
during the PHE for COVID-19. Additionally, stakeholders expressed 
uncertainty over their continued participation in the Shared Savings 
Program in 2021 given the lack of predictability of the impact of 
COVID-19 on the expenditures used to establish an ACO's historical 
benchmark.
    In response to stakeholder feedback, in the May 8th COVID-19 IFC 
(85 FR 27574), we announced we were forgoing the application cycle for 
a January 1, 2021 start date (herein referred to as the 2021 
application cycle). We explained our belief that it is appropriate to 
forgo the 2021 application cycle as the PHE for COVID-19 continues 
because this would allow ACOs and their ACO providers/suppliers 
currently participating in the Shared Savings Program to continue 
focusing on treating patients during the pandemic. We explained there 
were 160 Medicare Shared Savings Program ACO participation agreements 
that would end on December 31, 2020, including 20 ACOs participating in 
the Track 1+ Model. These ACOs would have been required to apply to 
renew their participation agreement to continue participating in the 
Shared Savings Program effective January 1, 2021. To reduce burden and 
allow these ACOs to continue participating in the program without a 
2021 application cycle, we allowed ACOs that entered a first or second 
agreement period with a start date of January 1, 2018, the opportunity 
to elect to extend their agreement period for an optional fourth 
performance year. The fourth performance year would span 12 months from 
January 1, 2021, to December 31, 2021. This election to extend the 
agreement period would be voluntary and an ACO could choose not to make 
this election, and therefore, conclude its participation in the program 
with the expiration of its current agreement period on December 31, 
2020. Under this approach, eligible ACOs would be able to remain under 
their existing historical benchmark for an additional year, which would 
increase stability and predictability given the potential impact of the 
pandemic on beneficiary expenditures under FFS Medicare and help 
provide greater certainty for ACOs making determinations regarding 
their future participation in the Shared Savings Program.
    Additionally, we explained that by forgoing the 2021 application 
cycle for new applicants, CY 2020 will not serve as benchmark year 3 
for a cohort of ACOs that would otherwise be January 1, 2021 starters 
(85 FR 27574 and 27575). An ACO's historical benchmark is determined 
based on the 3 most recent years prior to the start of its agreement 
period. For ACOs in a first agreement period, benchmark year 3 is given 
the highest weight of the 3 benchmark years and, because we expected CY 
2020 to be an anomalous year, we explained our belief that it could be 
disadvantageous to include CY 2020 expenditures as the third benchmark 
year for this cohort of ACOs. Cancelling the 2021 application cycle 
would provide us with additional time to consider and develop 
approaches to further mitigate the role of 2020 as a benchmark year 
given the unusual expenditure and utilization trends likely to result 
from the pandemic.
    As established in the May 8th COVID-19 IFC (85 FR 27575), the ACO's 
voluntary election to extend its agreement period must be made in the 
form and manner and by a deadline established by CMS, and an ACO 
executive who has the authority to legally bind the ACO must certify 
the election. We noted that this optional 12-month agreement period 
extension was a one-time exception for all ACOs with agreements 
expiring on December 31, 2020; it would not be available to other ACOs 
or to future program entrants. Eligible ACOs were able to notify CMS of 
their decision to elect to extend their agreement starting June 18, 
2020 and ending September 22, 2020.
    We explained that under the existing provision at Sec.  425.210(a), 
the ACO must provide a copy of its participation agreement with CMS to 
all ACO participants, ACO providers/suppliers, and other individuals 
and entities involved in ACO governance. In the case of an ACO that 
elects to extend its agreement period pursuant to the May 8th COVID-19 
IFC, we indicated that we would consider the ACO to be in compliance 
with Sec.  425.210(a) if it notifies these parties that it will 
continue to participate in the program for an additional year. Further, 
under Sec.  425.210(b), all contracts or arrangements between or among 
the

[[Page 84766]]

ACO, ACO participants, ACO providers/suppliers, and other individuals 
or entities performing functions or services related to ACO activities 
must require compliance with the requirements and conditions of the 
program's regulations, including, but not limited to, those specified 
in the participation agreement with CMS (see also Sec.  425.116(a)(3) 
(as to agreements with ACO participants) and (b)(3) (as to agreements 
with ACO providers/suppliers)). Thus, as we explained in the May 8th 
COVID-19 IFC (85 FR 27575), an ACO that elects to extend its 
participation agreement pursuant to the policy established by the IFC 
must require its ACO participants, ACO providers/suppliers, and other 
individuals or entities performing functions or services related to ACO 
activities during PY 2021 to comply with the program's requirements 
through December 31, 2021. We noted that to remain in compliance with 
Sec.  425.116, an ACO may need to extend the duration of its agreements 
with ACO participants and ACO providers/suppliers.
    We revised Sec.  425.200(b)(3)(ii) to allow ACOs that entered a 
first or second agreement period with a start date of January 1, 2018, 
to elect to extend their agreement period for an optional fourth 
performance year (85 FR 27575). We explained that while we were 
forgoing the application cycle for ACOs to apply to enter an agreement 
period beginning on January 1, 2021, eligible, currently participating 
ACOs would be able to apply for a SNF 3-day rule waiver (Sec.  
425.612(a)(1)(i)), apply to establish a beneficiary incentive program 
(Sec.  425.304(c)(2)), modify ACO participant (Sec.  425.118(b)) and/or 
SNF affiliate lists (Sec.  425.612(a)(1)(i)(B)), and elect to change 
their assignment methodology (Sec.  425.226(a)(1)) for PY 2021 (85 FR 
27575). Also, an ACO participating under the BASIC track's glide path 
could still elect to transition to a higher level of risk and potential 
reward within the BASIC track's glide path other than the level of risk 
and potential reward that the ACO would be automatically transitioned 
to for PY 2021, absent the ACO's election to maintain its current 
participation level for one year as described in section II.L.2. of the 
May 8th COVID-19 IFC (85 FR 27575 and 27576). For example, an ACO 
participating in BASIC track Level B in PY 2020 could still elect to 
transition to BASIC track level D or E in PY 2021.
    We received public comments on the approach we established in the 
May 8th COVID-19 IFC under which ACOs whose participation agreements 
were scheduled to expire on December 31, 2020, could elect to extend 
their agreement period for an optional fourth performance year. The 
following is a summary of the comments we received and our responses.
    Comment: Several commenters supported CMS' decision to allow ACOs 
that entered a first or second agreement period with a start date of 
January 1, 2018, the opportunity to extend their agreement period for 
an optional fourth performance year, spanning 12 months, from January 
1, 2021, to December 31, 2021.
    Response: We appreciate commenters' support for providing eligible 
ACOs the opportunity to extend their agreement period for an optional 
fourth performance year. Eligible ACOs had until September 22, 2020, to 
notify us of their election to extend their participation agreement. Of 
the Shared Savings Program ACOs with an agreement set to expire on 
December 31, 2020, 89 percent have elected to extend their agreement 
period for an additional performance year.
    Comment: Most commenters urged CMS to reconsider its decision to 
forgo the Shared Savings Program 2021 application cycle, and a few 
commenters noted that the decision to cancel the application cycle 
would impede participation in Alternative Payment Models (APMs) during 
2021. Several organizations commented on CMS' commitment to reducing 
administrative burdens on applicants, given the strain on resources as 
a result of the PHE for COVID-19, expressing appreciation for the added 
flexibility, but strongly believed that the decision whether it is too 
burdensome to apply to enter a new agreement period should be left up 
to the ACO. A number of commenters suggested that CMS reverse its 
decision to forgo a 2021 application cycle, and allow (for example) 
agreement period start dates of either April 1, 2021, or July 1, 2021. 
In urging CMS to allow for an agreement period start date in 2021, one 
commenter suggested an alternative approach to identifying the 
benchmark years, which included using 2017, 2018, and 2019 as benchmark 
years, and thereby avoiding the use of 2020 as a benchmark year.
    A few commenters requested that CMS consider making opportunities 
available for Track 1 ACOs whose agreement periods expire on December 
31, 2020, to elect to transition to a two-sided model for performance 
year 2021, or to enter a new agreement period under a two-sided model 
beginning on January 1, 2021, such as by allowing these ACOs to enter 
the ENHANCED track or the BASIC track's glide path.
    Response: While we appreciate commenters' support for an agreement 
period start date in 2021, we decline at this time to establish such an 
option. At the time of this final rule, we do not believe that we have 
enough time to develop policies for a mid-year start date in 2021, 
because the program's rules and regulations are generally based on the 
calendar year from January 1 through December 31, and significant 
modifications would be needed to accommodate a start date other than 
January 1 during 2021. Such regulatory changes would require notice and 
comment rulemaking, and we would then require time to implement an 
application process. We would also need to allow ACOs enough time to 
review the regulation and apply for the program; allow for CMS' review 
of applications, including vetting of ACO participants through program 
integrity and law enforcement screening; allow for both parties to sign 
participation agreements; and allow time for CMS to deliver assignment 
list reports prior to the start date of the agreement period. Further, 
there would be complexities with establishing a mid-year start date in 
2021, which would require additional analysis and policy development, 
followed by further consideration of those policies by prospective 
applicants and existing ACOs. These complexities, as described in 
previous rulemaking (see, for example, 83 FR 67944 through 67967), 
include policies for determining the ACO's assigned population, 
determining shared savings and shared losses, and quality reporting for 
a short performance year, among other factors. A further consideration 
would be the use of 2020 as benchmark year 3 in establishing historical 
benchmarks for agreement periods starting in 2021. While we appreciate 
the commenter's suggestion that we use alternative benchmark years in 
order to avoid using 2020 as a benchmark year, we decline at this time 
to make any additional modifications to the Shared Savings Program's 
benchmarking methodology. As discussed in section III.G.5.d.(2) of this 
final rule, we anticipate continuing to monitor and evaluate the impact 
of the PHE for COVID-19 on Medicare FFS expenditures and Shared Savings 
Program payment calculations, to help inform potential future policy 
modifications to the Shared Savings Program. We believe it is premature 
to undertake such policy modifications at the time of this final rule.
    We appreciate commenters' support for APM participation through 
participation in a Shared Savings Program ACO. We note that existing

[[Page 84767]]

ACOs had the opportunity to make ACO participant list modifications 
that will be effective for performance year 2021, which we believe 
provided an opportunity for additional TINs, and thereby the providers 
and suppliers that have assigned their billing rights to these TINs, to 
begin participating in the Shared Savings Program, or for existing ACO 
participant TINs to participate under a different Shared Savings 
Program ACO.
    We decline at this time to adopt the commenters' suggestions to 
allow ACOs that elect the 1-year extension of their participation 
agreement to also elect a different track of participation for 
performance year 2021 or to allow these ACOs to enter a new agreement 
period under a two-sided model, beginning on January 1, 2021, such as 
allowing Track 1 ACOs to elect to transition to performance-based risk 
on the BASIC track's glide path or to enter the ENHANCED track. The 
approach we established in the May 8th COVID-19 IFC contemplates an 
extension of the ACO's existing agreement period, not entry into a new 
agreement period, which would include (for instance) rebasing the ACO's 
historical benchmark. Such an approach would also raise the same 
concerns as allowing ACOs to enter the Shared Savings Program for a 
start date in 2021, in particular around the use of 2020 as a benchmark 
year. Similarly, the approach adopted in the May 8th COVID-19 IFC does 
not contemplate that ACOs would be permitted to elect to participate 
under a different track during the optional fourth performance year 
under their current participation agreement. We encourage ACOs 
interested in transitioning to performance-based risk, or entering 
higher levels of risk and potential reward, to apply to do so at the 
next opportunity, which will be the application cycle for an agreement 
period beginning on January 1, 2022.
    After considering the comments received, we are finalizing without 
modification the revisions to the provision at Sec.  425.200(b)(3)(ii) 
to allow ACOs that entered a first or second agreement period with a 
start date of January 1, 2018, to elect to extend their agreement 
period for an optional fourth performance year.
b. Allow BASIC Track ACOs To Elect To Maintain Their Participation 
Level for One Year
    We finalized a redesign of Shared Savings Program's participation 
options in the final rule entitled ``Medicare Program; Medicare Shared 
Savings Program; Accountable Care Organizations--Pathways to Success 
and Extreme and Uncontrollable Circumstances Policies for Performance 
Year 2017'', which appeared in the Federal Register on December 31, 
2018 (83 FR 67816). We finalized the BASIC track, added as a new 
provision at Sec.  425.605, which includes an option for eligible ACOs 
to begin participation under a one-sided model and incrementally phase-
in risk (calculated based on ACO participant revenue and capped at a 
percentage of the ACO's updated benchmark) and potential reward over 
the course of a single agreement period, an approach referred to as the 
glide path (83 FR 67841). The glide path includes five levels: A one-
sided model available only for the first 2 consecutive performance 
years of a 5-year agreement period, each year of which is identified as 
a separate level (Levels A and B); and three levels of progressively 
higher risk and potential reward in performance years 3 through 5 of 
the agreement period (Levels C, D, and E). ACOs are automatically 
advanced along the progression of risk/reward levels at the start of 
each participation year, over the course of a 5-year agreement period, 
unless the ACO elects to advance more quickly, until ACOs reach the 
BASIC track's maximum level of risk/reward (Level E) (83 FR 67844). For 
ACOs that entered the BASIC track's glide path for an agreement period 
beginning on July 1, 2019, the progression through the levels of risk 
and potential reward spans 6 performance years, including the ACO's 
first performance year from July 1, 2019, through December 31, 2019; 
these ACOs were not automatically advanced to the next risk/reward 
level at the start of PY 2020 (Sec.  425.200(b)(4)(ii), (c)(3); Sec.  
425.600(a)(4)(i)(B)(2)(i)).
    As explained in the May 8th COVID-19 IFC (85 FR 27575 and 27576), 
stakeholders have expressed concerns that due to the unpredictable 
impact of COVID-19 during PY 2020, and the uncertainty as to their 
ability to secure a repayment mechanism for PY 2021, ACOs are uncertain 
they will continue participating in the program if they are 
automatically transitioned to downside risk or a higher level of 
downside risk in PY 2021. Specifically, stakeholders requested we 
``freeze,'' or forgo the automatic advancement of BASIC track ACOs and 
allow them to remain at their current level of participation for PY 
2021. Additionally, per Sec.  425.204(f)(3)(iii), an ACO entering an 
agreement period in Level A or Level B of the BASIC track must 
demonstrate the adequacy of its repayment mechanism prior to the start 
of any performance year in which it either elects to participate in, or 
is automatically transitioned to a two-sided model of the BASIC track, 
including Level C, Level D, or Level E. We noted our concern whether 
some ACOs, particularly those that would automatically transition to 
Level C of the BASIC track, would be able to establish a repayment 
mechanism prior to the start of PY 2021 because the source of capital 
to cover potential losses may be uncertain for some ACOs given the 
resource intensity of responding to the pandemic. We noted that 136 
ACOs participating under Level B of the BASIC track were scheduled to 
automatically advance to Level C on January 1, 2021. As discussed in 
the May 8th COVID-19 IFC (85 FR 27576), some stakeholders indicated 
that they may be unable to secure a letter of credit, while other 
stakeholders indicated that their discretionary funds were fully 
committed to responding to the PHE for COVID-19.
    We also expressed concern that some of the care coordination 
processes ACOs have been developing may be interrupted by the pandemic. 
For example, ACOs may have reallocated funding and staff resources to 
respond to the PHE for COVID-19, thereby temporarily disrupting their 
ability to implement redesigned care processes that would support their 
transition to risk. We agreed with stakeholders that most ACOs did not 
know the impact that COVID-19 would have on their expenditures or 
beneficiary population and the potential for losses under risk 
arrangements. Therefore, we permitted ACOs participating in the BASIC 
track's glide path to elect to maintain their current level of 
participation under the BASIC track for PY 2021. During the summer of 
2020, applicable ACOs were able to elect to remain in the same level of 
the BASIC track's glide path that the ACO entered for PY 2020. For PY 
2022, an ACO that elected this advancement deferral option will be 
automatically advanced to the level of the BASIC track's glide path in 
which it would have participated during PY 2022 if it had advanced 
automatically to the next level for PY 2021 (unless the ACO elects to 
advance more quickly before the start of PY 2022). For example, if an 
ACO participating in the BASIC track, Level B, in PY 2020 elected to 
maintain its current level of participation for PY 2021, it will 
participate under Level B for PY 2021 and then will automatically 
advance to Level D for PY 2022, since the ACO would have moved 
automatically to Level C for PY 2021 under current program rules, 
absent this

[[Page 84768]]

change. The ACO could also elect to advance more quickly by opting to 
move to Level E instead of Level D for PY 2022, in which case the ACO 
would participate under Level E for the remainder of its agreement 
period.
    In the May 8th COVID-19 IFC, we redesignated Sec.  
425.600(a)(4)(i)(B)(2)(iii) as Sec.  425.600(a)(4)(i)(B)(2)(iv) and 
added a new Sec.  425.600(a)(4)(i)(B)(2)(iii) to allow ACOs currently 
participating in the BASIC track's glide path to elect to maintain 
their current participation level for PY 2021.
    We received public comments on the advancement deferral option we 
established in the May 8th COVID-19 IFC. The following is a summary of 
the comments we received and our responses.
    Comment: Many commenters expressed support for CMS' decision to 
permit ACOs participating in the BASIC track's glide path the option to 
voluntarily elect to maintain their current participation level under 
the BASIC track for PY 2021.
    Response: We appreciate commenters' support for allowing ACOs 
participating in the BASIC track the opportunity to elect to remain in 
the same level of the BASIC track's glide path for PY 2021 as they 
entered for PY 2020.
    Comment: Several commenters urged CMS to reconsider its decision to 
move ACOs to the level of risk they would have been in for 2022, absent 
the freeze. Commenters noted that skipping a level would be challenging 
under normal circumstances. However, under the extenuating 
circumstances of the PHE for COVID-19, they believed this requirement 
would not allow them the opportunity to focus on recovering financially 
and would take attention away from providing the best patient care, 
serving only to drive ACOs from the Shared Savings Program. Some 
commenters suggested that CMS allow ACOs to freeze their current risk 
level as proposed, but then resume the glide path in performance year 
2022 at the risk level they would have been automatically advanced to 
for performance year 2021, absent their election to freeze their 
participation level for that performance year.
    Response: Of the BASIC track ACOs that participated in PY 2020, 77 
percent of these ACOs began the agreement period that includes that 
performance year as renewing or re-entering ACOs, as defined at Sec.  
425.20. These ACOs all have prior experience participating in the 
Shared Savings Program; some of these ACOs have continuously 
participated in the program since 2012. We believe that entering an 
agreement period under the BASIC track's glide path suggests that these 
ACOs should already have been taking steps to prepare to enter 
performance-based risk and to progress to higher levels of risk and 
potential reward in order to continue their participation in the Shared 
Savings Program. We believe that by enabling these ACOs to gain 
additional experience in meeting the Shared Savings Program's goals 
within the context of the PHE for COVID-19 by allowing them to maintain 
their current participation level for performance year 2021, these ACOs 
will be further prepared to progress to higher levels of risk and 
potential reward within the BASIC track's glide path in PY 2022. 
Additionally, we note that some ACOs are currently ready to take on 
increasing levels of performance-based risk, as 9 percent of the ACOs 
participating in the BASIC track's glide path in PY 2020 have elected 
to advance along the glide path more quickly than required. Therefore, 
at this time, we decline commenters' suggestions to further slow ACOs' 
progression along the BASIC track's glide path by allowing ACOs that 
have elected to maintain their position on the glide path for PY 2021 
to resume their progression at the level they would have entered for PY 
2021, absent the freeze.
    Comment: Many commenters suggested that CMS allow additional 
participation options under which ACOs would be protected from shared 
losses (such as options to allow ACOs to select no downside risk), with 
some commenters suggesting that these alternatives include reduced 
(lower) shared savings rates. For example, commenters suggested that we 
allow ACOs to elect the level of risk/reward currently available under 
the one-sided models of the BASIC track, under which ACOs take on no 
downside risk and share in savings at a rate of up to 40 percent, based 
on quality performance. While some commenters suggested making this 
alternative available for PY 2020, other commenters' suggestions for 
such an option seemed to be more open-ended, without specifying which 
cohorts of ACOs should be eligible or for how long this option should 
continue to be available. A number of commenters conveyed their belief 
that, absent this protection, and given the uncertainty around the end 
date of the PHE for COVID-19, ACOs may choose to leave the program 
rather than be at risk for shared losses under a two-sided model. One 
commenter explained that, at a minimum, CMS should allow ACOs to opt 
for lower shared savings rates in exchange for reduced downside risk, 
given that, due to the PHE for COVID-19, circumstances have drastically 
changed since ACOs performed their original cost-benefit calculations 
and signed their participation agreements. Another commenter explained 
that many clinicians are concerned about their ability to assume 
financial risk during this unprecedented time. Allowing ACOs the option 
to be protected from shared losses, along with existing policies in the 
Shared Savings Program to address extreme and uncontrollable 
circumstances, would support participants as they weigh continued 
participation in the program. Finally, some commenters conveyed their 
belief that it is very important to protect ACOs that are harmed by the 
PHE for COVID-19 from shared losses, and that it is also critical to 
allow eligible ACOs to still earn shared savings for PY 2020. These 
commenters explained that ACOs make significant investments to enhance 
quality, address chronic disease, and improve patient care, and shared 
savings are instrumental to continuing those initiatives.
    Response: At this time, we do not believe it is necessary to 
provide alternative participation options for future performance years, 
and note that any new participation options would need to be 
established through additional notice and comment rulemaking. We 
believe a combination of policies will encourage continued 
participation by ACOs under the Shared Savings Program's existing 
financial models, in particular: The program's extreme and 
uncontrollable circumstances policies for mitigating shared losses, 
which will reduce ACOs' liability for losses for months covered by the 
PHE for COVID-19, including any applicable months within performance 
year 2021 (refer to section III.G.5.c of this final rule); the 
adjustment to program calculations for episodes of care for treatment 
of COVID-19, triggered by inpatient services (as discussed in section 
III.G.5.d.(2) of this final rule); and the policies to address the 
effect of extreme and uncontrollable circumstances on ACO quality 
performance (as discussed in section III.G.1.g and section III.I of 
this final rule).
    At the time of this final rule, the PHE for COVID-19 has been 
renewed with an effective date of October 23, 2020, and, unless 
terminated early, will remain in effect for 90 days from the effective 
date. Under the Shared Savings Program's extreme and uncontrollable 
circumstances policies for mitigating shared losses (described in 
section III.G.5.c of this final rule), shared losses will be mitigated 
for all ACOs

[[Page 84769]]

participating in a performance-based risk track, including: Track 2, 
the ENHANCED track, Levels C, D and E of the BASIC track, and the Track 
1+ Model, for the duration of the PHE for COVID-19 as specified in 
Sec.  400.200, which started in January 2020. If the PHE covers the 
full year (January through December 2020) any shared losses an ACO 
incurs for performance year 2020 would be reduced completely, and the 
ACO would not owe any shared losses. Under the Shared Savings Program's 
existing policies, ACOs will continue to be eligible to share in 
savings if they meet the criteria for doing so, as specified in the 
regulations at Sec. Sec.  425.604(c), 425.605(c), 425.606(c), 
425.610(c). As described in section III.G.5.d. of this final rule, we 
will adjust certain Shared Savings Program calculations, including the 
determination of benchmark and performance year expenditures, to remove 
payment amounts for episodes of care for treatment of COVID-19, 
triggered by an inpatient service. These adjustments will help protect 
CMS and ACOs against distortions in expenditures resulting from the 
COVID-19 pandemic that could affect shared savings and shared losses 
calculations. We believe these policies mitigate commenters' concerns 
about the availability of shared savings and the risk of shared losses 
under the existing participation options.
    After considering the comments received, we are finalizing without 
modification the redesignation of Sec.  425.600(a)(4)(i)(B)(2)(iii) as 
Sec.  425.600(a)(4)(i)(B)(2)(iv) and the addition of a new Sec.  
425.600(a)(4)(i)(B)(2)(iii) to allow ACOs currently participating in 
the BASIC track's glide path to elect to maintain their current 
participation level for PY 2021.
c. Applicability of Extreme and Uncontrollable Circumstances Policies 
to the PHE for COVID-19
    In the May 8th COVID-19 IFC (85 FR 27576 and 27577), we clarified, 
for purposes of the Shared Savings Program, that the months affected by 
an extreme and uncontrollable circumstance would begin with January 
2020, consistent with the PHE for COVID-19 determined to exist 
nationwide as of January 27, 2020, by the Secretary on January 31, 
2020, and continue through the end of the PHE, as defined in Sec.  
400.200, which includes any subsequent renewals.
    We explained in the May 8th COVID-19 IFC (85 FR 27577) that 
catastrophic events outside the ACO's control could also increase the 
difficulty of coordinating care for patient populations, and due to the 
unpredictability of changes in utilization and cost of services 
furnished to beneficiaries, may have a significant impact on 
expenditures for the applicable performance year and the ACO's 
benchmark in the subsequent agreement period. We explained these 
factors could jeopardize the ACO's ability to succeed in the Shared 
Savings Program, and ACOs, especially those in performance-based risk 
tracks, may reconsider whether they are able to continue their 
participation in the program.
    Therefore, as explained in the May 8th COVID-19 IFC (85 FR 27577), 
we believed it was important to make clear that, under the existing 
extreme and uncontrollable circumstances policies for the Shared 
Savings Program, the timeframe for the extreme and uncontrollable 
circumstance of the COVID-19 pandemic for purposes of mitigating shared 
losses will extend for the duration of the PHE for COVID-19 as 
specified in Sec.  400.200, which begins in January 2020. We explained 
that if the PHE for COVID-19 extends through all of CY 2020, all shared 
losses for PY 2020 will be mitigated for all ACOs participating in a 
performance-based risk track: Including Track 2, the ENHANCED track, 
Levels C, D and E of the BASIC track, and the Track 1+ Model. At the 
time of the May 8th COVID-19 IFC, the PHE for COVID-19 had covered 4 
months (January through April 2020) meaning any shared losses an ACO 
incurred for PY 2020 would be reduced by at least one-third. We 
explained that if the PHE for COVID-19 extends for a large portion, if 
not all of the year, the existing extreme and uncontrollable 
circumstances policy under the Shared Savings Program would mitigate a 
significant portion of, if not all, shared losses an ACO may owe for PY 
2020. For example, if the PHE for COVID-19 were to cover 6 months 
(January through June 2020) any shared losses an ACO incurs for PY 2020 
would be reduced by one-half; if the PHE for COVID-19 were to cover 9 
months (January through September 2020) any shared losses an ACO incurs 
for PY 2020 would be reduced by three-fourths; and if the PHE for 
COVID-19 were to cover the full year (January through December 2020) 
any shared losses an ACO incurs for PY 2020 would be reduced 
completely, and the ACO would not owe any shared losses.
    We received public comments on our clarification of the 
applicability of the extreme and uncontrollable circumstances policies 
to the COVID-19 pandemic for purposes of mitigating shared losses under 
the Shared Savings Program. The following is a summary of the comments 
we received and our responses.
    Comment: Commenters discussing this topic generally welcomed the 
clarification that the PHE for COVID-19 constituted an extreme and 
uncontrollable circumstance for purposes of mitigating shared losses, 
beginning in January 2020. While one commenter expressed support for 
the approach specified in the May 8th COVID-19 IFC, under which the 
extreme and uncontrollable circumstances policy would mitigate shared 
losses based on the duration of the PHE, many other commenters 
addressing this issue tended to express concern that mitigation of 
shared losses would cease with the end of the PHE. In particular, 
commenters expressed concern about the extent to which this approach 
would mitigate shared losses in light of the uncertainty over the 
length of the PHE (at the time of the comment period, which closed on 
July 7, 2020, the PHE was known to extend through July 25, 2020) and 
the potential for ``early termination'' of the PHE. Several commenters 
suggested that CMS extend the extreme and uncontrollable circumstances 
policy for mitigating shared losses for the duration of PY 2020. 
Several commenters suggested that CMS extend the policy to any 
performance year that starts during the PHE. One commenter questioned 
how CMS would adjust the methodology to account for variability in 
impact if the Secretary were to amend the PHE from a nationwide 
declaration to a regional one. More generally, one commenter explained 
the Shared Savings Program extreme and uncontrollable circumstances 
policy had previously been used to address natural phenomena (such as 
hurricanes or wildfires), which may be short-lived, and noted the 
COVID-19 global pandemic is different due to the uncertainty over when 
it may end.
    One commenter, in expressing support for the approach to mitigating 
shared losses under the extreme and uncontrollable circumstances policy 
described in the May 8th COVID-19 IFC, also expressed their support for 
the continued ability of ACOs to share in savings generated from their 
diligent investments in the health and safety of their patient 
populations during the COVID-19 crisis. This echoed some other 
commenters' suggestions, underscoring the importance of shared savings 
payments in helping to address the financial strains placed on ACOs by 
COVID-19.

[[Page 84770]]

    Response: We appreciate the commenters' support for the 
clarification regarding the duration of the PHE for COVID-19 and the 
applicability of the extreme and uncontrollable circumstances policy to 
mitigate shared losses for PY 2020.
    In December 2017, we issued an interim final rule with comment 
period entitled ``Medicare Program: Medicare Shared Savings Program: 
Extreme and Uncontrollable Circumstances Policies for Performance Year 
2017'' (hereinafter referred to as the ``December 2017 IFC''), which 
appeared in the December 26, 2017 Federal Register (82 FR 60912 through 
60919). In the December 2017 IFC (82 FR 60914), we aligned the extreme 
and uncontrollable circumstances policies under the Shared Savings 
Program with the policy established under the Quality Payment Program. 
Specifically, the Shared Savings Program extreme and uncontrollable 
circumstances policies apply when we determine that an event qualifies 
as an automatic triggering event under the Quality Payment Program. We 
use the determination of an extreme and uncontrollable circumstance 
under the Quality Payment Program, including the identification of 
affected geographic areas and applicable time periods, for purposes of 
determining the applicability of the extreme and uncontrollable 
circumstances policies with respect to both financial performance and 
quality reporting under the Shared Savings Program. We extended the 
extreme and uncontrollable circumstances policies finalized for PY 
2017, including the alignment with the Quality Payment Program, to PY 
2018 and subsequent years in the CY 2019 PFS final rule (83 FR 59969 
through 59973). The Medicare Shared Savings Program and Quality Payment 
Program interact closely. All of the tracks of the Shared Savings 
Program are considered MIPS APMs, and Track 2, the ENHANCED track, and 
Level E of the BASIC track are also designated Advanced APMs. The two 
programs have several overlapping goals, including achieving better 
health for individuals, better population health, and lowering growth 
in expenditures. Because of these interactions and overlaps, we 
continue to believe that it is appropriate to use the same time periods 
and geographic areas as the Quality Payment Program when implementing 
the Shared Savings Program extreme and uncontrollable circumstances 
policies. We further clarify that if the PHE for COVID-19 transitions 
from a national PHE to a regional PHE, the Shared Savings Program will 
continue to apply the extreme and uncontrollable circumstances policy 
in the impacted geographic areas. At the time of this final rule, the 
PHE for COVID-19 has been renewed for another 90 days, with an 
effective date of October 23, 2020. Unless the PHE for COVID-19 is 
terminated early, all shared losses for performance year 2020 would be 
mitigated.
d. Adjustments to Shared Savings Program Calculations To Address the 
COVID-19 Pandemic
(1) Background
    Section 1899(d)(1)(B)(ii) of the Act addresses how ACO benchmarks 
are to be established and updated under the Shared Savings Program. 
This provision specifies that the Secretary shall estimate a benchmark 
for each agreement period for each ACO using the most recent available 
3 years of per beneficiary expenditures for Parts A and B services for 
Medicare FFS beneficiaries assigned to the ACO. Such benchmark shall be 
adjusted for beneficiary characteristics and such other factors as the 
Secretary determines appropriate, and updated by the projected absolute 
amount of growth in national per capita expenditures for Parts A and B 
services. Section 1899(d)(1)(B)(i) of the Act specifies that, in each 
year of the agreement period, an ACO is eligible to receive payment for 
shared savings only if the estimated average per capita Medicare 
expenditures under the ACO for Medicare FFS beneficiaries for Parts A 
and B services, adjusted for beneficiary characteristics, is at least 
the percent specified by the Secretary below the applicable benchmark 
under section 1899(d)(1)(B)(ii) of the Act.
    Section 1899(i)(3) of the Act grants the Secretary the authority to 
use other payment models if the Secretary determines that doing so 
would improve the quality and efficiency of items and services 
furnished under Title XVIII and the alternative methodology would 
result in program expenditures equal to or lower than those that would 
result under the statutory payment model. The authority under section 
1899(i)(3) of the Act to use other payment models includes authority to 
adopt alternatives to the benchmarking methodology set forth in section 
1899(d)(1)(B)(ii) of the Act, and alternatives to the methodology for 
determining expenditures for each performance year as set forth in 
section 1899(d)(1)(B)(i) of the Act. As discussed in earlier 
rulemaking, we have used our authority under section 1899(i)(3) of the 
Act to adopt alternative policies to the provisions of section 
1899(d)(1)(B) of the Act for updating the historical benchmark,\72\ and 
calculating performance year expenditures.\73\ We have also used our 
authority under section 1899(i)(3) of the Act to establish the Shared 
Savings Program's two-sided payment models,\74\ and to mitigate shared 
losses owed by ACOs affected by extreme and uncontrollable 
circumstances during PY 2017 and subsequent performance years.\75\
---------------------------------------------------------------------------

    \72\ Such as using only assignable beneficiaries instead of all 
Medicare FFS beneficiaries in calculating the benchmark update based 
on national FFS expenditures (81 FR 37986 through 37989), 
calculating the benchmark update using factors based on regional FFS 
expenditures (81 FR 37977 through 37981), and calculating the 
benchmark update using a blend of national and regional expenditure 
growth rates (83 FR 68027 through 68030).
    \73\ Such as excluding indirect medical education and 
disproportionate share hospital payments from ACO performance year 
expenditures (76 FR 67921 through 67922), and determining shared 
savings and shared losses for the 6-month performance years (or 
performance period) in 2019 using expenditures for the entire CY 
2019 and then pro-rating these amounts to reflect the shorter 
performance year or performance period (83 FR 59949 through 59951, 
83 FR 67950 through 67956).
    \74\ See earlier rulemaking establishing two-sided models: Track 
2 (76 FR 67904 through 67909), Track 3 (subsequently renamed the 
ENHANCED track) (80 FR 32771 through 32772), and the BASIC track (83 
FR 67834 through 67841).
    \75\ See earlier rulemaking establishing policies for mitigating 
shared losses owed by ACOs affected by extreme and uncontrollable 
circumstances (82 FR 60916 through 60917, 83 FR 59974 through 
59977).
---------------------------------------------------------------------------

    Under the Shared Savings Program, providers and suppliers continue 
to bill for services furnished to Medicare beneficiaries and receive 
FFS payments under traditional Medicare. CMS uses payment amounts for 
Parts A and B FFS claims for a variety of Shared Savings Program 
operations, which include: Calculations under the benchmarking 
methodology; determining an ACO's eligibility for shared savings and 
liability for shared losses for each performance year under the 
program's financial models as specified in the regulations in subpart 
G; determining an ACO's eligibility for certain participation options 
as set forth in Sec.  425.600(d); and calculating the amount of the 
repayment mechanism required for ACOs participating in a two-sided 
model according to Sec.  425.204(f)(4). These operations typically 
require the determination of expenditures for Parts A and B services 
under the original Medicare FFS program for a specified population of 
Medicare FFS beneficiaries or the Medicare Parts A and B FFS revenue of 
ACO participants. We note that the Medicare FFS beneficiary population 
for which expenditures are determined may

[[Page 84771]]

differ depending on the specific program operation being performed and 
may reflect expenditures for the ACO's assigned beneficiaries, 
assignable beneficiaries as defined in Sec.  425.20, or all Medicare 
FFS beneficiaries. The applicable Medicare FFS beneficiary population 
is specified in the regulations governing each program operation.
(2) Removing Payment Amounts for Episodes of Care for Treatment of 
COVID-19 From Shared Savings Program Expenditure and Revenue 
Calculations
    Section 3710 of the CARES Act amended section 1886(d)(4)(C) of the 
Act to specify that for discharges occurring during the emergency 
period described in section 1135(g)(1)(B) of the Act, in the case of a 
discharge of an individual diagnosed with COVID-19, the Secretary shall 
increase the weighting factor that would otherwise apply to the 
diagnosis-related group (DRG) to which the discharge is assigned by 20 
percent. Further, the Secretary shall identify a discharge of such an 
individual through the use of diagnosis codes, condition codes, or 
other such means as may be necessary. In this section of this final 
rule, we refer to this increase in the weighting factor for DRGs as the 
``DRG adjustment.''
    In the May 8th COVID-19 IFC (85 FR 27578), we explained our 
expectation that the localized nature of infections (for example, rapid 
outbreaks in individual nursing facilities (NFs)) and the unanticipated 
increase in expenditures, along with the increased flexibilities that 
have been implemented to allow healthcare providers to identify and 
treat COVID-19 patients would affect the level of Medicare Parts A and 
B expenditures during 2020, both for the Medicare FFS beneficiaries 
assigned to ACOs and for the other populations of Medicare FFS 
beneficiaries whose expenditures are considered in performing 
calculations under the Shared Savings Program. The localized nature of 
outbreaks and the increased utilization of acute care occurring in PY 
2020 and the associated higher costs are not reflected in ACOs' 
historical benchmarks, which are determined under Sec.  425.601(b), 
Sec.  425.602(b), or Sec.  425.603(d), as applicable, based on Parts A 
and B expenditures for the beneficiaries who would have been assigned 
to that ACO during the three benchmark years. For some ACOs, the higher 
costs associated with COVID-19 may not be fully accounted for (or in 
other cases may be over-represented) by the retrospective application 
of the update factor to the benchmark at the time of financial 
reconciliation. In addition, the prospective CMS-HCC risk scores, which 
are used to adjust the historical benchmark each performance year for 
changes in severity and case mix (refer to Sec. Sec.  425.601(a)(10), 
425.602(a)(9), and 425.603(c)(10); and Sec. Sec.  425.604(a)(1), 
425.605(a)(1), 425.606(a)(1), and 425.610(a)(1), (2)), would not be 
expected to meaningfully adjust for such variability because they are 
prospective, and therefore, use diagnoses from 2019 to predict costs in 
2020.
    Furthermore, including the increased expenditures related to 
treatment of COVID-19 in calculations of ACO benchmarks for which CY 
2020 is a benchmark year could lead to higher than anticipated future 
historical benchmarks unnecessarily advantaging some ACOs once the 
prevalence of COVID-19 in the population begins to decrease, and the 
corresponding reduction in expenditures is reflected in performance 
year expenditures. In contrast, we explained our belief that the 
methodology used to update benchmarks would appropriately reflect any 
reduction in expenditures due to a cumulative yearlong decline in 
elective services and the deferral of other services as a result of 
regionally-uniform responses by beneficiaries and providers/suppliers 
to directives issued at federal, state, and local levels. Therefore, 
the retrospective application of the historical benchmark update (which 
for PY 2020 is either an update factor based on national growth rates, 
regional growth rates, or a blend of national and regional growth 
rates, depending on the start date of the ACO's agreement period) would 
be expected to reasonably account for lower utilization of services by 
non-COVID-19 patients and prevent windfall shared savings payments to 
ACOs for PY 2020.
    In the May 8th COVID-19 IFC (85 FR 27579), we explained that 
including payment amounts for treatment of acute care for COVID-19 in 
calculations for which calendar year 2020 is used as a reference year 
could also distort repayment mechanism estimates and the identification 
of high and low revenue ACOs and influence ACO participation options. 
For example, ACOs could potentially be misclassified as either high 
revenue or low revenue, due to changes in expenditures arising from the 
COVID-19 pandemic, and either moved more quickly to higher levels of 
risk and reward if they are identified as high revenue ACOs or allowed 
additional time under a one-sided model (if eligible) or in relatively 
lower levels of performance-based risk if they are identified as low 
revenue ACOs.
    We explained our belief, at the time of the May 8th COVID-19 IFC, 
that ACOs currently participating in a performance-based risk track 
urgently needed to understand how we would address any distortions in 
expenditures resulting from the COVID-19 pandemic. Under the Shared 
Savings Program's regulations at Sec.  425.221(b)(2)(ii)(A), an ACO 
under a two-sided model that voluntarily terminates its participation 
agreement with an effective date of termination after June 30th of the 
applicable performance year is liable for a pro-rated share of any 
shared losses determined for that performance year. Under Sec.  
425.220(a) of the regulations, ACOs are required to provide CMS at 
least 30 days' advance notice of their decision to voluntarily 
terminate from the program. As a result, ACOs participating under a 
two-sided model would need to provide notice to CMS no later than June 
1, 2020, to avoid liability for a pro-rated share of any shared losses 
that may be determined for PY 2020. We explained that ACOs and other 
program stakeholders had expressed concern that ACOs would need to make 
participation decisions in advance of this June 1, 2020 deadline, and 
might choose to terminate their participation in the Shared Savings 
Program on or before June 30th, rather than risk owing pro-rated shared 
losses for PY 2020. We noted that the Shared Savings Program's extreme 
and uncontrollable circumstances policy would mitigate shared losses 
for these ACOs. However, given the uncertainty surrounding the duration 
of the PHE for COVID-19, at the time of the May 8th COVID-19 IFC, 
specifically, whether the PHE would cover the entire CY 2020, and 
absent information regarding the steps that CMS intended to take to 
address the high costs associated with COVID-19 patients, we 
acknowledged that many risk-based ACOs might elect to leave the program 
by June 30, 2020, to avoid the risk of owing shared losses.
    We explained our belief that it was necessary to revise the 
policies governing Shared Savings Program financial calculations, as 
well as certain other program operations, to mitigate the impact of 
unanticipated increases in expenditures related to the treatment of 
COVID-19. Given that ACOs in two-sided models had very limited time 
(less than 2 months at the time of development of the May 8th COVID-19 
IFC) to decide whether to continue their participation in the program 
or voluntarily terminate without being liable for shared losses, we 
identified an urgent need to establish policies to

[[Page 84772]]

address the impact of COVID-19 on Shared Savings Program financial 
calculations. More generally, we explained that ACOs engage in care 
coordination and population-based activities for Medicare FFS 
beneficiaries, as they work towards achieving the Shared Savings 
Program's goals of lowering growth in Medicare FFS expenditures and 
improving the quality of care furnished to Medicare beneficiaries. We 
noted the urgency in taking steps to avoid adversely impacting ACOs, 
many of which rapidly adapted to the circumstances of the PHE for 
COVID-19 in order to continue to coordinate care and deliver value-
based care to Medicare FFS beneficiaries and meet program goals. We 
expressed our concern that, in the absence of policies that adjust 
certain program calculations to remove payment amounts for episodes of 
care for treatment of COVID-19, ACOs might elect to leave the Shared 
Savings Program, setting back progress made in transitioning the 
healthcare system from volume-based to value-based payment. Therefore, 
as described in the May 8th COVID-19 IFC, we found good cause to waive 
prior notice and comment rulemaking to establish policies to mitigate 
the impact of the COVID-19 pandemic on Shared Savings Program financial 
calculations.
    We revised our policies under the Shared Savings Program to exclude 
from Shared Savings Program calculations all Parts A and B FFS payment 
amounts for an episode of care for treatment of COVID-19, triggered by 
an inpatient service during the PHE for COVID-19, and as specified on 
Parts A and B claims with dates of service during the episode. We 
relied on our authority under section 1899(d)(1)(B)(ii) of the Act to 
adjust benchmark expenditures for other factors in order to remove 
COVID-19-related expenditures from the determination of benchmark 
expenditures. We also exercised our authority under section 1899(i)(3) 
of the Act to apply this adjustment to certain other program 
calculations, including the determination of performance year 
expenditures.
    We explained that an approach that makes the triggering event for 
this adjustment the beneficiary's receipt of inpatient care for COVID-
19, would identify the most acutely ill patients and, as a result, 
those patients with the highest-costs associated with acute care 
treatment. In contrast, we explained our belief that treatment for 
COVID-19 that does not result in an inpatient admission does not raise 
the same level of concern in terms of generating unexpected performance 
year expenditures that are not appropriately reflected in the benchmark 
calculations. As William Bleser and colleagues described,\76\ citing a 
recent actuarial estimate of COVID-19 costs,\77\ outpatient care was 
approximately 10 percent of the cost of hospital care, indicating that 
hospital costs are the dominant source of overall costs for treatment 
of COVID-19. We believed these findings supported an approach that 
bases the exclusion of expenditures on the triggering event of an 
inpatient admission for treatment of COVID-19. Furthermore, we 
explained that some outpatient care would occur close-in-time to an 
eventual inpatient admission and following discharge. Under the 
approach we established, where an episode of care includes the month of 
admission and the month following discharge, outpatient care occurring 
within the timeframe for an episode of care would also be excluded from 
financial calculations.
---------------------------------------------------------------------------

    \76\ Bleser WK, et al. Maintaining Progress Toward Accountable 
Care And Payment Reform During A Pandemic, Part 1: Utilization And 
Financial Impact. Health Affairs. April 14, 2020. Available at 
https://www.healthaffairs.org/do/10.1377/hblog20200410.281882/full/.
    \77\ COVERED California. The Potential National Health Cost 
Impacts to Consumers, Employers and Insurers Due to the Coronavirus 
(COVID-19). Policy/Actuarial Brief (March 22, 2020). Available at 
https://hbex.coveredca.com/data-research/library/COVID-19-NationalCost-Impacts03-21-20.pdf.
---------------------------------------------------------------------------

    Accordingly, under the approach we adopted in the May 8th COVID-19 
IFC, we indicated we would identify an episode of care triggered by an 
inpatient service for treatment of COVID-19, based on either: (1) 
Discharges for inpatient services eligible for the 20 percent DRG 
adjustment under section 1886(d)(4)(C) of the Act; or (2) discharges 
for acute care inpatient services for treatment of COVID-19 from 
facilities that are not paid under the IPPS, such as CAHs, when the 
date of admission occurs within the PHE for COVID-19 as defined in 
Sec.  400.200.
    For example, we indicated that we would identify discharges of an 
individual diagnosed with COVID-19 using the following ICD-10-CM codes:
     B97.29 (Other coronavirus as the cause of diseases 
classified elsewhere) for discharges occurring on or after January 27, 
2020, and on or before March 31, 2020.
     U07.1 (COVID-19) for discharges occurring on or after 
April 1, 2020, through the duration of the PHE for COVID-19, as defined 
in Sec.  400.200.\78\
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    \78\ See for example, MLN Matters, ``New Waivers for Inpatient 
Prospective Payment System (IPPS) Hospitals, Long-Term Care 
Hospitals (LTCHs), and Inpatient Rehabilitation Facilities (IRFs) 
due to Provisions of the CARES Act'' (April 15, 2020), available at 
https://www.cms.gov/files/document/se20015.pdf.
---------------------------------------------------------------------------

    We explained that episodes of care for treatment of COVID-19 may be 
triggered by an inpatient admission for acute care either at an acute 
care hospital or other healthcare facility, which may include temporary 
expansion sites, Medicare-enrolled ASCs providing hospital services to 
help address the urgent need to increase hospital capacity to treat 
COVID-19 patients, CAHs, and potentially other types of providers.\79\
---------------------------------------------------------------------------

    \79\ See CMS fact sheet, ``Hospitals: CMS Flexibilities to Fight 
COVID-19'', dated March 30, 2020, available at https://www.cms.gov/files/document/covid-hospitals.pdf, describing flexibilities CMS 
specified for hospitals for the provision of inpatient care to fight 
COVID-19.
---------------------------------------------------------------------------

    We defined the episode of care as starting in the month in which 
the inpatient stay begins as identified by the admission date, all 
months during the inpatient stay, and the month following the end of 
the inpatient stay as indicated by the discharge date. We explained 
that this approach to measuring the length of the episode of care in 
units of months aligns with the Shared Savings Program's methodology 
for calculating benchmark year and performance year expenditures by 
performing separate calculations for each of four Medicare enrollment 
types (ESRD, disabled, aged/dual eligible for Medicare and Medicaid, 
and aged/non-dual eligible for Medicare and Medicaid). As described in 
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 appeared in 
the June 10, 2016 Federal Register (81 FR 37950), we account for 
circumstances where a beneficiary is enrolled in a Medicare enrollment 
type for only a fraction of a year (see 81 FR 37981). Specifically, we 
determine the number of months that an assigned beneficiary is enrolled 
in each specific Medicare enrollment type and divide by 12. Summing 
these fractions across all assigned beneficiaries in each Medicare 
enrollment type results in total person years for the beneficiaries 
assigned to the ACO. Benchmark and performance year expenditures for 
each enrollment type are calculated on a per capita basis. The 
numerator of the per capita expenditure calculation for a particular 
enrollment type reflects the total Parts A and B expenditures incurred 
by all assigned beneficiaries in that enrollment type during the year, 
with adjustments made to exclude indirect medical education and 
disproportionate share hospital payments, to include individually 
beneficiary identifiable

[[Page 84773]]

final payments made under a demonstration, pilot or time limited 
program, and to truncate beneficiary expenditures to minimize variation 
from catastrophically large claims. The denominator reflects total 
person years for the enrollment type.
    In addition to excluding Parts A and B payment amounts with dates 
of service in the months associated with an episode of care for 
treatment of COVID-19, we explained that we would also exclude the 
affected months from total person years used in per capita expenditure 
calculations. For example, if a beneficiary had an episode of care for 
COVID-19 that lasted for 2 months, but was otherwise enrolled as an 
aged/non-dual eligible beneficiary for the full calendar PY, we would 
exclude their Parts A and B expenditures for those 2 months and compute 
their fraction of the year enrolled in the aged/non-dual eligible 
population as 10/12. Adjusting both expenditures and person years 
ensures that both the numerator and denominator used to calculate per 
capita expenditures are based on the same number of months of 
beneficiary experience and allow ACOs to be treated equitably 
regardless of the degree to which their assigned beneficiary population 
is affected by the pandemic.
    We expressed our belief that this approach would provide for a more 
equitable comparison between an ACO's performance year expenditures and 
its historical benchmark and help to ensure that ACOs are not rewarded 
or penalized for having higher/lower COVID-19 spread in their assigned 
beneficiary populations which, in turn, would help to protect CMS 
against paying out windfall shared savings and ACOs in two-sided models 
from owing excessive shared losses. Further, we described our belief 
that the retrospective application of the historical benchmark update, 
which is calculated based on factors that reflect actual expenditure 
and utilization changes nationally and regionally, other than 
expenditures for episodes of care for treatment of COVID-19, would also 
help to mitigate the potential for windfall savings due to potentially 
lower utilization of services not related to treatment for COVID-19.
    In the May 8th COVID-19 IFC, we established an adjustment to the 
following Shared Savings Program calculations to exclude all Parts A 
and B FFS payment amounts for a beneficiary's episode of care for 
treatment of COVID-19:
     Calculation of Medicare Parts A and B FFS expenditures for 
an ACO's assigned beneficiaries for all purposes, including the 
following: Establishing, adjusting, updating, and resetting the ACO's 
historical benchmark and determining performance year expenditures.
     Calculation of FFS expenditures for assignable 
beneficiaries as used in determining county-level FFS expenditures and 
national Medicare FFS expenditures, including the following 
calculations:
    ++ Determining average county FFS expenditures based on 
expenditures for the assignable population of beneficiaries in each 
county in the ACO's regional service area according to Sec. Sec.  
425.601(c) and 425.603(e) for purposes of calculating the ACO's 
regional FFS expenditures. For example, for ACOs in agreement periods 
beginning on July 1, 2019, and in subsequent years, we will use county 
FFS expenditures from which we exclude all Parts A and B FFS payment 
amounts for a beneficiary's episode of care for treatment of COVID-19 
in determining the regional component of the blended national and 
regional growth rates used to (1) Trend forward benchmark year 1 and 
benchmark year 2 expenditures to benchmark year 3 according to Sec.  
425.601(a)(5)(iii), and (2) to update the benchmark according to Sec.  
425.601(b)(3). Further, we will use county expenditures from which we 
exclude all Parts A and B FFS payment amounts for a beneficiary's 
episode of care for treatment of COVID-19 to update the ACO's rebased 
historical benchmark, according to Sec.  425.603(d) for ACOs in a 
second agreement period beginning on or before January 1, 2019, based 
on regional growth rates in Medicare FFS expenditures.
    ++ Determining the 99th percentile of national Medicare FFS 
expenditures for assignable beneficiaries for purposes of the 
following: (1) Truncating assigned beneficiary expenditures used in 
calculating benchmark expenditures (Sec. Sec.  425.601(a)(4), 
425.602(a)(4), 425.603(c)(4)), and performance year expenditures 
(Sec. Sec.  425.604(a)(4), 425.605(a)(3), 425.606(a)(4), 
425.610(a)(4)); and (2) truncating expenditures for assignable 
beneficiaries in each county for purposes of determining county FFS 
expenditures according to Sec. Sec.  425.601(c)(3) and 425.603(e)(3).
    ++ Determining 5 percent of national per capita expenditures for 
Parts A and B services under the original Medicare FFS program for 
assignable beneficiaries for purposes of capping the regional 
adjustment to the ACO's historical benchmark according to Sec.  
425.601(a)(8)(ii)(C).
    ++ Determining the flat dollar equivalent of the projected absolute 
amount of growth in national per capita expenditures for Parts A and B 
services under the original Medicare FFS program for assignable 
beneficiaries, for purposes of updating the ACO's historical benchmark 
according to Sec.  425.602(b)(2).
    ++ Determining national growth rates that are used as part of the 
blended growth rates used to trend forward benchmark year 1 and 
benchmark year 2 expenditures to benchmark year 3 according to Sec.  
425.601(a)(5)(ii) and as part of the blended growth rates used to 
update the benchmark according to Sec.  425.601(b)(2).
     Calculation of Medicare Parts A and B FFS revenue of ACO 
participants for purposes of calculating the ACO's loss recoupment 
limit under the BASIC track as specified in Sec.  425.605(d).
     Calculation of total Medicare Parts A and B FFS revenue of 
ACO participants and total Medicare Parts A and B FFS expenditures for 
the ACO's assigned beneficiaries for purposes of identifying whether an 
ACO is a high revenue ACO or low revenue ACO, as defined under Sec.  
425.20, and determining an ACO's eligibility for participation options 
according to Sec.  425.600(d).
     Calculation or recalculation of the amount of the ACO's 
repayment mechanism arrangement according to Sec.  425.204(f)(4).
    We noted that there are certain payments related to the PHE for 
COVID-19 that fall outside of Medicare FFS Parts A and B claims, and by 
virtue of this fact, these payments would not be utilized under the 
Shared Savings Program methodology for determining beneficiary 
expenditures. For example, we would not account for recoupment of 
accelerated or advance payments,\80\ which occurs outside of the FFS 
claims processing system. This is because the underlying Parts A and B 
claims used in Shared Savings Program expenditure calculations would 
continue to reflect the amount the providers/suppliers are eligible to 
be paid, although that payment may be subject to offset for repayment 
of accelerated or advance payments. Further, Shared Savings Program 
expenditure calculations also would not need to account for lump sum 
payments made to hospitals and other healthcare providers through the

[[Page 84774]]

CARES Act Provider Relief Fund,\81\ that occur outside of Parts A and B 
claims. We explained that we would continue to capture Medicare FFS 
Parts A and B payments to providers/suppliers, including hospitals and 
other healthcare providers receiving these funds, in Shared Savings 
Program calculations.
---------------------------------------------------------------------------

    \80\ See CMS, ``Fact Sheet: Expansion of the Accelerated and 
Advance Payments Program for Providers and Suppliers During COVID-19 
Emergency,'' available at https://www.cms.gov/files/document/accelerated-and-advanced-payments-fact-sheet.pdf.
    \81\ See HHS website, CARES Act Provider Relief Fund, at https://www.hhs.gov/provider-relief/index.html.
---------------------------------------------------------------------------

    We explained that it was necessary to use our authority under 
section 1899(i)(3) of the Act to remove payment amounts for episodes of 
care for treatment of COVID-19 from the following calculations: (1) 
Performance year expenditures; (2) updates to the historical benchmark; 
and (3) ACO participants' Medicare FFS revenue used to determine the 
loss sharing limit in the two-sided models of the BASIC track. To use 
our authority under section 1899(i)(3) of the Act to adopt an 
alternative payment methodology to remove payment amounts for episodes 
of care for treatment of COVID-19 from these calculations, we had to 
determine that the alternative payment methodology would improve the 
quality and efficiency of items and services furnished to Medicare 
beneficiaries, without resulting in additional program expenditures. We 
explained our belief that these adjustments, which remove payment 
amounts for episodes of care for treatment of COVID-19 from the 
specified Shared Savings Program calculations, would capture and remove 
from program calculations expenditures that are outside of an ACO's 
control, but that could significantly affect the ACO's performance 
under the program. In particular, we believed that failing to remove 
this spending would likely create highly variable savings and loss 
results for individual ACOs that happen to have over-representation or 
under-representation of COVID-19 hospitalizations in their assigned 
beneficiary populations.
    Based on our assessment of the impacts of this policy for purposes 
of the May 8th COVID-19 IFC (85 FR 27615 and 27616), we did 
not believe excluding payment amounts for episodes of care for 
treatment of COVID-19 from the specified calculations would result in 
an increase in spending beyond the expenditures that would otherwise 
occur under the statutory payment methodology in section 1899(d) of the 
Act. Further, we believed these adjustments to our payment calculations 
to remove expenditures associated with treatment of COVID-19, in 
combination with the optional 1-year extension for ACOs whose current 
agreement periods expire on December 31, 2020 (as discussed in section 
II.L.1. of the May 8th COVID-19 IFC, 85 FR 27574 and 27575), and the 
option for ACOs in the BASIC track's glide path to elect to maintain 
their current level of risk and reward for PY 2021 (as discussed in 
section II.L.2. of the May 8 CthOVID-19 IFC, 85 FR 27575 and 
27576) would provide greater certainty for currently participating 
ACOs. As a result, we expected that these policies would support ACOs' 
continued participation in the Shared Savings Program in the face of 
significant uncertainty arising from the disruptions due to the COVID-
19 pandemic and the resulting PHE. We believed that, in turn, these 
organizations would continue working towards meeting the Shared Savings 
Program's goals of lowering growth in Medicare FFS expenditures and 
improving the quality of care furnished to Medicare beneficiaries.
    Based on these considerations, and our assessment of the impacts of 
these adjustments in the May 8th COVID-19 IFC (85 FR 27615 
and 27616), we believed adjusting certain Shared Savings Program 
calculations to remove payment amounts for episodes of care for 
treatment of COVID-19 from the calculation of performance year 
expenditures, updates to the historical benchmark, and ACO 
participants' Medicare FFS revenue used to determine the loss sharing 
limit in the two-sided models of the BASIC track, would meet the 
requirements for use of our authority under section 1899(i)(3) of the 
Act.
    In the May 8th COVID-19 IFC, we also acknowledged that some trends 
and longer lasting effects of the COVID-19 pandemic were challenging to 
anticipate at the time of development of the IFC, and we would continue 
to evaluate the ongoing impact of the COVID-19 pandemic to determine 
whether additional rulemaking would be necessary to further adjust 
Shared Savings Program policies. For example, we noted that it was 
unclear whether the COVID-19 pandemic may have longer-term effects into 
2021, such as through rebounding elective procedure costs in 2021 
following potentially sustained reductions in 2020 or to what extent 
the reduction in these procedures may persist. Further, we anticipated 
learning more about the potential longer-term implications of the 
COVID-19 pandemic on Medicare beneficiaries' health and the healthcare 
system.
    We added a new provision at Sec.  425.611 to describe the 
adjustments CMS makes to Shared Savings Program calculations to address 
the impact of the COVID-19 pandemic.
    We received comments on the approach to adjusting program 
calculations to mitigate the financial impact of the COVID-19 pandemic 
on ACOs that we established in the May 8th COVID-19 IFC. The following 
is a summary of the comments we received and our responses.
    Comment: Many commenters that commented on the adjustments to 
Shared Savings Program calculations generally supported removal of 
Parts A and B FFS payment amounts for a beneficiary's episode of care 
for treatment COVID-19 from those calculations. Some commenters 
specified their support in particular for application of this 
adjustment to the determination of benchmark expenditures, truncation 
factors, and performance year expenditures. Some commenters specified 
their support for adjustments to remove Parts A and B FFS payment 
amounts associated with episodes of care for treatment of COVID-19 from 
revenue calculations used for purposes of determining loss recoupment 
limits, as well as identifying whether an ACO is a high revenue ACO or 
low revenue ACO, and determining the ACO's eligibility for certain 
participation options. One commenter also stated its support for 
adjustment of repayment mechanism amount calculations, or 
recalculations of these amounts, to remove episodes of care for 
treatment of COVID-19.
    A few commenters agreed that these adjustments would lead to more 
equitable comparisons between ACOs' performance year expenditures and 
their benchmarks, and assist in ensuring ACOs are not rewarded or 
penalized for being more or less impacted by COVID-19. One commenter 
stated that these adjustments would address potential distortions in 
the determination of shared savings and shared losses for the months 
impacted by COVID-19. One commenter, addressing the adjustment to 
remove payment amounts for episodes of care from benchmark 
expenditures, indicated that the approach adopted in the May 8th COVID-
19 IFC addressed uncertainty related to COVID-19. One commenter 
explained that this adjustment will help to protect ACOs from 
circumstances out of their control at a time of immense financial risk 
and will provide them with important protections that will allow them 
to continue participating in the Shared Savings Program.
    Response: We appreciate the support of commenters for the approach 
we established in the May 8th COVID-19 IFC to adjust certain Shared 
Savings

[[Page 84775]]

Program calculations to exclude all Parts A and B FFS payment amounts 
for a beneficiary's episode of care for treatment of COVID-19, as 
described previously in this section of this final rule and specified 
in Sec.  425.611.
    Comment: A few commenters stated that the existing benchmarking 
methodology, and in particular the retrospective application of the 
benchmark update that reflects Medicare cost trends in the ACO's 
regional service area, was resilient to the impacts of COVID-19, 
suggesting that CMS' concern over windfall shared savings may be 
overstated. Some commenters indicated that the effects of the 
adjustment of benchmark and performance year expenditures for episodes 
of care are uncertain and could be either beneficial or disadvantageous 
to ACOs when they are compared to the national or regional expenditure 
trends that factor into their benchmarks.
    One commenter explained that for ACOs in markets hard hit by COVID-
19, the benchmark update will reflect those additional costs, and ACOs 
will be judged by whether they reduced costs relative to other 
healthcare providers that are subject to the same market conditions. 
Another commenter, describing concerns about the Shared Savings 
Program's blended national and regional growth rates used to trend and 
update the benchmark, explained that relying too heavily on a national 
trend (for ACOs whose assigned beneficiaries represent a large share of 
the assignable beneficiaries in their regional service area) is 
especially problematic during a pandemic with regional variation as it 
ignores important local market dynamics that differ across the country. 
This commenter explained that ACOs in COVID-19 hot spots will likely 
have higher costs than the overall nation. Therefore, according to this 
commenter, using the national trend as part of the benchmarking 
methodology would be detrimental and unfair to these ACOs as it is not 
reflective of the pandemic's effect on costs in their region.
    Several commenters indicated that if COVID-19 causes Medicare costs 
to drop in a market, the benchmark update will reflect those lower 
costs, and ACOs in those markets would have to lower costs even more to 
generate shared savings. One commenter expressed concern over whether 
the retrospective application of the benchmark update would reasonably 
account for lower utilization of services by non-COVID-19 patients. 
Some commenters viewed this dynamic as potentially unfair for ACOs 
engaged in efforts to reduce inappropriate utilization or over 
utilization compared to existing high spending ACOs.
    A few commenters urged CMS to undertake further analysis of the 
impact of COVID-19 on ACO benchmarks. For example, commenters urged CMS 
to evaluate whether the factors based on regional FFS expenditures in 
program calculations sufficiently account for irregular distribution of 
COVID-19 impacts across different regions and even within regions, wide 
variation in expenses, divergent practice patterns, and the 
unprecedented change in beneficiary behavior.
    Response: We continue to believe the adjustments to Shared Savings 
Program calculations for episodes of care for treatment of COVID-19 are 
an important and necessary safeguard to help to protect ACOs from owing 
excessive shared losses, and the Medicare Trust Funds from paying out 
windfall shared savings.
    We believe one significant function of the adjustment for episodes 
of care for treatment of COVID-19 is to protect ACOs from higher-cost 
COVID-19 expenditures that may be variable and therefore hard to 
predict. At the time of this final rule, based on initial analysis of 
data through Q2 of 2020 used in developing Shared Savings Program 
reports, most ACOs appear to have experienced a relatively small impact 
from the adjustments that remove episodes of care for treatment of 
COVID-19 from performance year expenditures. We observed a 1 percent or 
less median difference between adjusted and non-adjusted Q2 2020 
expenditure values for ACOs relative to non-adjusted Q1 2020 
expenditure values. We also observed, for example, that ACOs with 
higher impacts as a result of removing episodes of care for treatment 
of COVID-19 also tended to have higher proportions of older 
beneficiaries and beneficiaries who are dually eligible for Medicare 
and Medicaid, which is consistent with observations about COVID-19 
trends in the Medicare population.\82\
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    \82\ These observations appear consistent with other recent 
observations about COVID-19 trends in the Medicare population. See 
for example, CMS Press Release, ``Trump Administration Issues Call 
to Action Based on New Data Detailing COVID-19 Impacts on Medicare 
Beneficiaries'' (June 22, 2020), available at https://www.cms.gov/newsroom/press-releases/trump-administration-issues-call-action-based-new-data-detailing-covid-19-impacts-medicare (Describing a 
snapshot of data on the Medicare population, for the period between 
January 1 and May 16, 2020. Observations included the following: 
Older Americans and those with chronic health conditions are at the 
highest risk for COVID-19; and dual eligible beneficiaries had the 
second highest rates of hospitalization among the Medicare 
population).
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    Currently, ACOs participating in the Shared Savings Program are 
subject to several different benchmarking methodologies that vary in 
the degree to which trends in national or regional FFS expenditures are 
used in calculating the annual update to the ACO's historical 
benchmark, which is applied retrospectively following the conclusion of 
the performance year. Depending on the ACO's agreement period start 
date, an ACO's benchmark will be updated for performance year 2020 
according to one of the following approaches (as applicable): Blended 
national and regional expenditure growth rates (Sec.  425.601(b)); 
growth rates in risk-adjusted FFS expenditures among assignable 
beneficiaries in the ACO's regional service area (Sec.  425.603(d)); or 
the absolute amount of projected growth in national per capita 
expenditures for Parts A and B services under the original Medicare FFS 
program, for assignable beneficiaries (Sec.  425.602(b)).
    As we have described in earlier rulemaking (see for example, 76 FR 
67925 through 67927, 81 FR 38004, and 83 FR 68026), benchmark updates 
could have mixed effects on ACOs, depending on changes in utilization 
and expenditure patterns within the assignable beneficiary population 
used to calculate these factors in the performance year compared to 
benchmark year 3. We agree with commenters that significant changes in 
expenditures and utilization within the Medicare FFS population during 
a performance year, including as a result of COVID-19, have the 
potential to result in variances in the benchmark update.
    Early analysis indicates that the adjustment to remove episodes of 
care for treatment of COVID-19 may mitigate commenters' concerns that 
ACOs may be disadvantaged by the benchmark update methodology under the 
circumstances of the pandemic. When modeling the impact of removing 
episodes of care for treatment of COVID-19 from trend factors for ACOs 
with the highest rates of COVID-19 diagnoses, these ACOs' regional 
trends appear lower than national trends, suggesting that ACOs in ``hot 
spots'' appear to benefit from the blend. Additionally, after removing 
episodes of care for treatment of COVID-19, the distribution of ACO 
expenditure trends and regional expenditure trends between Q1 and Q2 
2020 are fairly similar. This suggests ACOs and their regions are 
likely experiencing the same localized effects as a result of the 
pandemic and that use of regional factors in updating ACOs' benchmarks 
should help to protect against windfall

[[Page 84776]]

savings without unduly disadvantaging ACOs.
    However, at the time of this final rule, we believe it is still too 
soon to identify the full extent of the impact of COVID-19 on regional 
and national FFS expenditures. We anticipate better understanding these 
impacts as we analyze data for the remaining quarters of 2020 and the 
performance year 2020 results (determined after the conclusion of the 
performance year). We agree with the comments indicating the importance 
of ongoing evaluation of factors used in program calculations. We 
anticipate continuing to monitor the program's calculations, and in 
particular, the factors used to trend and update the benchmark, to 
understand the impact of any anomalies in Medicare FFS expenditures 
resulting from the costs of treating COVID-19, as well as changes in 
healthcare utilization by Medicare FFS beneficiaries resulting from the 
COVID-19 pandemic.
    More generally, as described in the recently released results for 
performance years (or the performance period) in 2019, we are still 
gaining experience with the benchmarking methodology established in the 
Shared Savings Program December 2018 final rule (83 FR 68005 through 
68030) and specified in Sec.  425.601, which includes the use of 
blended national and regional trend and update factors. However, we 
believe the 2019 Shared Savings Program results are a promising 
indicator that this benchmarking methodology provides appropriate 
incentives for Shared Savings Program ACOs.\83\
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    \83\ Verma S. 2019 Medicare Shared Savings Program ACO 
Performance: Lower Costs And Promising Results Under `Pathways To 
Success.' Health Affairs. September 14, 2020. Available at https://www.healthaffairs.org/do/10.1377/hblog20200914.598838/full/.
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    Comment: One commenter sought clarification of the retrospective 
application of the historical benchmark update discussed in the May 8th 
COVID-19 IFC.
    Response: The Shared Savings Program's benchmarking methodology is 
specified in regulations in part 425, subpart G (titled Shared Savings 
and Losses), and in particular within Sec. Sec.  425.601, 425.602, 
425.603, and 425.611. For detailed information on how CMS calculates 
the financial benchmark that is used to assess annual financial 
performance, we also refer readers to the Shared Savings and Losses and 
Assignment Methodology Specifications, available on the Shared Savings 
Program ``Program Guidance & Specifications'' web page, available at 
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/program-guidance-and-specifications.
    At the time of financial reconciliation for each performance year, 
which follows the conclusion of the performance year, CMS calculates 
and applies an update to the ACO's historical benchmark to reflect the 
rate of growth in expenditures since benchmark year 3. The methodology 
for calculating the update to the benchmark is determined based on the 
ACO's agreement period start date as specified in the regulations at 
Sec. Sec.  425.601(b), 425.603(d), and 425.602(b), as applicable.
    The update to the benchmark is calculated and applied 
retrospectively after the conclusion of the performance year. CMS 
provides each ACO with the calculated updated benchmark amount in the 
financial reconciliation report for the performance year. ACOs 
reconciled for participation in performance year 2020 will receive a 
financial reconciliation report in the summer of 2021, which will 
include the ACO's updated historical benchmark, for which the update 
will have been determined after removing expenditures for episodes of 
care for treatment of COVID-19 as specified in Sec.  425.611.
    Comment: One commenter expressed its belief that removing spending 
for COVID-19 is unlikely to produce a reasonable estimate of what 
spending would have been without COVID-19. The commenter stated that 
this approach may, for example, underestimate the services patients 
with certain chronic conditions (who are disproportionately affected by 
COVID-19) would have used had they not been admitted for inpatient 
hospital services for COVID-19. The commenter indicated that the 
approach for adjusting expenditures for episodes of care for treatment 
of COVID-19 might increase the possibility that CMS will be rewarding 
ACOs for random variation rather than reductions in spending resulting 
from ACOs' care management. The commenter indicated there is 
uncertainty about how the adjustment to performance year expenditures 
to remove episodes of care for treatment of COVID-19 would affect the 
ACO when those expenditures are compared against the updated benchmark 
that reflects a regional and/or national trend.
    Response: As discussed in the May 8th COVID-19 IFC, we adjust 
beneficiary person years to exclude months associated with episodes of 
care. The ACO's performance year expenditures, adjusted for episodes of 
care for treatment of COVID-19, will be weighted by person years 
calculated by Medicare enrollment type (ESRD, disabled, aged/dual 
eligible for Medicare and Medicaid, and aged/non-dual eligible for 
Medicare and Medicaid) that are also adjusted to exclude months 
associated with an episode of care for treatment of COVID-19. To the 
extent that beneficiaries being hospitalized for treatment of COVID-19 
tend to have chronic conditions, the removal of these beneficiaries' 
months of experience from expenditure calculations could shift more 
weight to expenditures among healthier beneficiaries. However, as 
described elsewhere in this section of this final rule, we will also 
exclude from program calculations beneficiaries' CMS-HCC risk scores 
from months associated with episodes of care for treatment of COVID-19, 
which would also cause weighted average risk scores to be similarly 
weighted towards healthier beneficiaries. We believe that this balanced 
approach to expenditures and risk scores may mitigate to some degree 
the commenter's concern about the potential for underrepresentation of 
beneficiaries' acuity in relation to adjusted expenditures within 
program calculations leading to windfall savings for ACOs.
    Comment: A few commenters pointed to the program's existing 
policies to limit shared savings, specifically the shared savings rates 
(under which ACOs may share in a percentage of savings based on quality 
performance) and the cap on the amount of shared savings that will be 
paid to an ACO under each track (or payment level within a track), as 
built in protection against ACOs' receiving windfall shared savings.
    Response: We agree with commenters that the sharing rates based on 
quality performance and the performance payment limits provide some 
built in protections against windfall shared savings. However, we 
believe that absent the adjustment for episodes of care for treatment 
of COVID-19, the Shared Savings Program financial calculations would 
not fully address the unique expenditure experience resulting from the 
PHE for COVID-19 and leave ACOs and CMS vulnerable to these variations 
in Medicare FFS expenditures.
    Comment: A few commenters expressed concerns about the mid-year 
change to the methodology for determining the updated benchmark for 
performance year 2020 to remove Parts A and B FFS payment amounts for 
episodes of care for treatment of COVID-19, when the ACO agreed to 
participate based on the policy that existed prior to the May 8th 
COVID-19 IFC.

[[Page 84777]]

    Response: Under Sec.  425.212, an ACO is subject to all regulatory 
changes that become effective during the agreement period, with the 
exception of the following program areas, unless otherwise required by 
statute: (1) Eligibility requirements concerning the structure and 
governance of ACOs; and (2) calculation of sharing rate. Typically, we 
would undertake notice and comment rulemaking to propose modifications 
to provisions of the program's financial methodology, including to the 
benchmarking methodology, and subsequently issue a final rule, 
reflecting any policies that we finalize taking into consideration 
public comments received on the proposals, prior to the start of any 
performance year during which such policies would apply. In 
establishing the adjustment for episodes of care for treatment of 
COVID-19 in the May 8th COVID-19 IFC, we explained the urgent need for 
Shared Savings Program ACOs to understand how we would address any 
distortions in expenditures resulting from the COVID-19 pandemic (85 FR 
27579). We found good cause to waive notice and comment procedures for 
the regulatory changes made to the Shared Savings Program in the May 
8th COVID-19 IFC (85 FR 27607 and 27608). In addition, section 
1871(e)(1)(A)(ii) of the Act permits the Secretary to issue a rule for 
the Medicare program with retroactive effect if the failure to do so 
would be contrary to the public interest. In the May 8th COVID-19 IFC 
(85 FR 27609), we explained that we believed it would be contrary to 
the public interest not to implement certain Medicare provisions in the 
IFC as soon as we were authorized to do so under the authority of 
section 1871(e)(1)(A)(ii) of the Act, that is retroactively to either 
the start of the national emergency or the PHE for the COVID-19 
pandemic, as applicable. In the case of the adjustment to remove 
expenditures associated with episodes of care for the treatment of 
COVID-19, we determined that it would be contrary to the public 
interest not to implement this adjustment retroactively to the start of 
the PHE for COVID-19 in January 2020 to ensure that all costs 
associated with episodes of care for treatment of COVID-19 could be 
removed from financial calculations for performance year 2020.
    Comment: Some commenters expressed uncertainty around whether the 
full extent of the impact of COVID-19 on ACOs' benchmark and 
performance year expenditures, and revenue, will be accounted for in 
the adjustment to program calculations for episodes of care for 
treatment of COVID-19 triggered by an inpatient service for a patient 
that has a COVID-19 diagnosis.
    Commenters' uncertainty over the adequacy of the adjustment for 
episodes of care for treatment of COVID-19 often stemmed from the many 
unknown factors surrounding COVID-19 and the COVID-19 pandemic. For 
instance, the length and severity of the COVID-19 pandemic and its 
geographic distribution; the end date of the PHE for COVID-19; long 
term effects of the virus on patients' health; whether patients may 
experience worse health outcomes because of postponed or foregone care 
resulting from widespread delay or cancellation of elective or non-
urgent procedures and/or preventive well visits or patients' avoidance 
of care, and in particular the potential for these circumstances to 
exacerbate chronic conditions; and the unknown impact of the COVID-19 
pandemic on utilization and expenses, including the reduction in 
elective surgeries that impact revenue, and the potential for increased 
costs that result from ``catch up'' utilization and expenses for 
elective services and procedures, as well as the potential for 
unaccounted for variations in utilization in program calculations.
    Some commenters suggested that alternative modifications were 
necessary in light of their concerns that CMS' approach for adjusting 
program calculations to remove episodes of care for treatment of COVID-
19 triggered by an inpatient service may not be sufficient to address 
the impact of COVID-19 or the COVID-19 pandemic on ACOs. Commenters 
offered a variety of alternative approaches, including the following 
suggestions.
    One commenter suggested that CMS disregard ACO financial and 
quality performance in 2020 to the extent possible, and instead 
implement an alternative incentive system for ACOs for COVID-19 
specific activities, such as by compensating ACOs to focus on COVID-19 
surveillance, data collection, and care management activities 
(particularly for beneficiaries with high risk chronic diseases). This 
commenter suggested that by disregarding 2020 performance, ACOs and 
their ACO participants would be allowed to respond to COVID-19 without 
considering the traditional cost and savings incentives of the Shared 
Savings Program.
    Some commenters suggested modifications to how CMS determines 
benchmark or performance year expenditures. For example, one commenter 
suggested the benchmark may need to be increased to offset increased 
utilization. Another commenter suggested that CMS cap actual 
performance year 2020 expenditures at an estimate of expected 
expenditures based on the Shared Savings Program and other benchmark-
based population models, similar to the approach used by the 
Comprehensive Care for Joint Replacement (CJR) model in response to the 
PHE for COVID-19.
    Some commenters suggested that CMS modify the program's payment 
models for purposes of determining shared savings and shared losses for 
performance year 2020, such as to: Increase the minimum loss rate 
corridor to further protect ACOs under two-sided models from shared 
losses; eliminate shared losses altogether but maintain shared savings; 
eliminate both shared losses and shared savings; reduce shared losses 
and reduce shared savings; or eliminate shared losses and reduce shared 
savings. For example, one commenter suggested that CMS avoid imposition 
of downside risk for 2020, and cap shared savings at 2 percent of 
benchmark for ACOs that are eligible to share in savings, and provide 
bonus payments to ACOs that are not eligible to share in savings but 
that are still participating in the Shared Savings Program in 
performance year 2021, such as bonus payment of 0.5 percent of 
benchmark. These suggestions reflected commenters' differing 
perspectives. While some commenters believed it was an appropriate 
trade-off to reduce or eliminate shared savings in combination with 
reducing or eliminating downside risk, some commenters strongly 
supported an approach that continued ACOs' ability to fully share in 
savings generated under the program's existing payment models while 
protecting ACOs from losses.
    Some commenters more generally encouraged CMS to continue to work 
with ACOs and other program stakeholders, commit to ongoing monitoring 
or evaluation of the Shared Savings Program, and make adjustments as 
needed, such as to the participation options, financial methodology, 
including the benchmarking methodology, beneficiary assignment 
methodology, and quality measurement methodology.
    Response: For the reasons discussed in the May 8th COVID-19 IFC and 
in this final rule, we believe the adjustment to Shared Savings Program 
calculations for episodes of care for treatment of COVID-19, which we 
are finalizing in this final rule, address the impact of COVID-19. We 
plan to continue to monitor for and consider the impact of the COVID-19 
pandemic on ACOs and their ACO participants, and

[[Page 84778]]

we would address any additional modifications to Shared Savings Program 
policies in future notice and comment rulemaking. Therefore, we decline 
at this time to adopt commenters' suggestions for alternative payment 
models, alternative approaches to determining benchmark and performance 
year expenditures, and other modifications to the program's financial 
calculations. We note that elsewhere in this final rule, we address 
comments received in response to the May 8th COVID-19 IFC related to 
changes to the beneficiary assignment methodology (refer to section 
III.G.5.e of this final rule), and the quality performance requirements 
for performance year 2020 (refer to section III.I. of this final rule).
    Comment: One commenter suggested that CMS consider applying the 
adjustment for episodes of care for treatment of COVID-19 on a case-by-
case basis, for ACOs in areas with higher COVID-19 prevalence, rather 
than program-wide.
    Response: We decline to revise the approach adopted in the May 8th 
COVID-19 IFC to apply the adjustment for episodes of care for treatment 
of COVID-19 on a case-by-case basis. Given that ACOs' assigned 
beneficiary populations are often dispersed across different regions, 
we believe it would be difficult to fairly and accurately apply the 
policies on an individual ACO basis when (as commenters point out) the 
impacts of COVID-19 are variable from region to region. We also believe 
that a program-wide approach is more reflective of the PHE for COVID-
19, which is nationwide. Further, a program-wide approach allows for 
greater certainty, transparency, and less complexity, than an approach 
applied on a case-by-case basis when there are more than 500 ACOs 
actively participating in the program as of January 1, 2020.\84\
---------------------------------------------------------------------------

    \84\ CMS, ``Shared Savings Program Fast Facts--As of January 1, 
2020'', available at https://www.cms.gov/files/document/2020-shared-savings-program-fast-facts.pdf.
---------------------------------------------------------------------------

    Comment: A few commenters expressed their support for an approach 
that identifies episodes of care triggered by inpatient care for 
treatment of COVID-19. One commenter stated their belief that CMS 
struck the right balance of capturing the most variable COVID-19 costs 
in a well-defined episode.
    One commenter explained that the effects of COVID-19 on patients 
vary greatly, providing as an example that patients who were previously 
healthy can require lengthy hospitalizations, intubation and mechanical 
ventilation, and a host of other costly interventions. Consequently, 
according to this commenter, ACOs and their providers cannot be 
reasonably expected to manage costs for these patients during an 
inpatient episode of care. This commenter welcomed the decision by CMS 
to exclude from Shared Savings Program financial calculations all Parts 
A and B FFS payment amounts for an episode of care for treatment of 
COVID-19, triggered by an inpatient service.
    Response: We appreciate commenters' support for the approach we 
adopted in the May 8th COVID-19 IFC, under which an episode of care for 
treatment of COVID-19 is triggered by an inpatient service.
    Comment: A few commenters suggested that there was a lack of 
clarity around when an episode of care will be triggered by acute care 
inpatient services for treatment of COVID-19 from facilities not paid 
under the IPPS, including SNFs. Several commenters asked that CMS 
clarify that such services will trigger an episode of care when the 
date of admission occurs within the PHE for COVID-19.
    Response: In the May 8th COVID-19 IFC, we adopted an approach to 
identifying inpatient services for the treatment of COVID-19 provided 
by non-IPPS providers at Sec.  425.611(b)(1)(ii), which applies when 
the date of admission occurs within the PHE as defined in Sec.  
400.200. Since the issuance of the May 8th COVID-19 IFC, we have 
determined that this approach to identifying inpatient services for the 
treatment of COVID-19 provided by non-IPPS providers creates an 
unintended inconsistency with the approach in Sec.  425.611(b)(1)(i) to 
identifying inpatient services for the treatment of COVID-19 furnished 
by IPPS providers eligible for the 20 percent DRG adjustment under 
section 1886(d)(4)(C) of the Act, which is based on discharges within 
the PHE for COVID-19. If the approaches are not synchronized, we may 
(for example) identify fewer inpatient services provided by non-IPPS 
providers occurring near the start of the PHE for COVID-19, since the 
admission date for these services would have needed to occur within the 
PHE, as opposed to the discharge date occurring with the PHE. Further, 
we may capture more inpatient services furnished by non-IPPS providers 
at the end of the PHE for COVID-19 because the admission occurs during 
the PHE, but the discharge does not. This discrepancy could cause a 
distortion in the effects of the adjustment within program 
calculations, depending on the type of facility that provides the 
inpatient service that is the trigger for the episode of care for 
treatment of COVID-19.
    To ensure greater consistency in the description of the policies 
used to identify inpatient services provided by IPPS and non-IPPS 
providers that trigger an episode of care for treatment of COVID-19, we 
are making a revision to the regulation at Sec.  425.611(b)(1)(ii) that 
establishes the criteria for identifying an episode of care triggered 
by inpatient services furnished by a non-IPPS provider. We are revising 
the provision to specify that CMS identifies episodes of care for 
treatment of COVID-19 based on discharges for acute care inpatient 
services for treatment of COVID-19 from facilities that are not paid 
under the inpatient prospective payment system, such as CAHs, when the 
date of discharge occurs within the Public Health Emergency as defined 
in Sec.  400.200. Furthermore, because the purpose of this revision is 
to avoid distorting the effects of the adjustment for episodes of care 
for the treatment of COVID-19 within program calculations, we believe 
it is in the public interest to use our authority under section 
1871(e)(1)(A)(ii) of the Act to apply this change retroactively to the 
start of the PHE for COVID-19 on January 27, 2020. We note that this is 
consistent with the applicability date for the original provision, 
which was also retroactive to the start of the PHE in January 2020, and 
will help to ensure that adjustments under Sec.  425.611 are made 
consistently regardless of the type of provider that furnished the 
inpatient services for COVID-19.
    Further, we anticipate identifying inpatient claims that trigger an 
episode of care for treatment of COVID-19 using all of the following 
criteria, regardless of whether the claim is submitted by an IPPS or 
non-IPPS provider. Claims that do not meet these criteria will not 
trigger an episode of care for treatment of COVID-19.
     Inpatient claims identified by claim type 60.
     Facility type as identified by the character in the third 
position of the CMS Certification Number (CCN) equal to ``T'' 
(Rehabilitation Unit) or ``R'' (CAH Rehabilitation Unit), or by the 
last four digits of the CCN in any of the following ranges: 0001-0879, 
Short-term (General or Specialty) Hospital; 0880-0899, Hospital that 
participated in an Office of Research and Development demonstration 
project; 1300-1399, CAH; 2000-2299, Long-term Care Hospital; 3025-3099, 
Inpatient Rehabilitation Facility; 3300-3399, Children's Hospital.
     Admission date and discharge date both populated.

[[Page 84779]]

     Discharge date between January 27, 2020, and March 31, 
2020 (inclusive), and diagnosis code equal to B97.29, or discharge date 
between April 1, 2020, and expiration date of the PHE for COVID-19 
specified in Sec.  400.200 (if known, inclusive) and diagnosis code 
equal to U07.1. (The applicable diagnosis code may be present in any 
diagnosis code field based on established coding guidelines.)
    We note that the aforementioned criteria were used in identifying 
episodes of care for treatment of COVID-19 in Q2 and Q3 2020 program 
reports provided to ACOs. Prior to preparing the Q4 2020 program 
reports we plan to incorporate an additional criterion that will ensure 
that expenditures related to treatment of COVID-19 are not excluded 
from program calculations when the IPPS provider is not eligible to 
receive the 20 percent DRG adjustment, for example because the provider 
has specified a billing note NTE02 ``No Pos Test'' on the electronic 
claim 837I, or a remark ``No Pos Test'' on a paper claim. This note or 
remark on the claim indicates that the beneficiary did not have a 
positive laboratory test result for COVID-19 documented in the 
beneficiary's medical record. This is for consistency with CMS' new 
requirement that there must be a positive laboratory test result for 
COVID-19 documented in the beneficiary's medical record in order for an 
IPPS provider to receive the 20 percent DRG adjustment. This 
requirement was developed to address potential Medicare program 
integrity risks, and became effective with admissions occurring on or 
after September 1, 2020.\85\
---------------------------------------------------------------------------

    \85\ For more information, see CMS, MLN Matters, ``New Waivers 
for Inpatient Prospective Payment Systems (IPPS) Hospitals, Long-
Term Care Hospitals (LTCHs), and Inpatient Rehabilitation Facilities 
(IRFs) due to Provisions of the Cares Act'' (revised September 11, 
2020), available at https://www.cms.gov/files/document/se20015.pdf.
---------------------------------------------------------------------------

    Comment: One commenter urged CMS to clarify that an inpatient 
COVID-19 stay (with proper ICD-10-CM codes and within the PHE for 
COVID-19) in a SNF, which the commenter indicated was an ``other type 
of provider'' as described in the May 8th COVID-19 IFC, will be 
considered a triggering inpatient admission for an episode of care for 
treatment of COVID-19. This commenter explained that many ACO 
beneficiaries that reside in long-term care facilities have been 
transferred from a long-term care bed to a dedicated Medicare-covered 
bed within the same facility when they were diagnosed with COVID-19, 
due to the waiver of the 3-day hospital stay in connection with the PHE 
for COVID-19, as well as hospital capacity issues. These beneficiaries 
received Part A SNF services in the facility while they remained at 
that level of care. The commenter further explained that while many of 
these beneficiaries were never admitted to an acute inpatient hospital 
for their COVID-19 treatment, they still incurred inpatient COVID-19 
related Part A and B costs. This commenter explained that exclusion of 
these beneficiaries' costs for treatment of COVID-19 from Shared 
Savings Program calculations is needed to ensure ACOs with long-term 
care Medicare beneficiaries are not unfairly penalized for treating 
patients at the inpatient SNF level of care during the pandemic.
    Response: Under Sec.  425.611(b)(1)(ii), as modified by this final 
rule, a discharge for acute care inpatient services for treatment of 
COVID-19 from facilities that are not paid under the IPPS, which would 
include a SNF, will trigger an episode of care when the date of 
discharge occurs within the PHE as defined in Sec.  400.200. Elsewhere 
in this section of this final rule, we have detailed the criteria we 
will use for identifying claims for inpatient services that trigger an 
episode of care, which include: Claim type 60, facility type identified 
based on certain CCNs, admission date and discharge date both 
populated, and discharge date within the PHE for COVID-19 with a 
diagnosis code equal to either B97.29 or U07.1 (for an inclusive range 
of dates). A claim for inpatient services provided in a SNF that meets 
these criteria would be identified as the trigger for an episode of 
care for treatment of COVID-19.
    We discussed the related issue of services furnished by SNFs under 
arrangements with an acute care hospital in an FAQ.\86\ Under 
flexibilities adopted in response to the COVID-19 pandemic, a SNF (for 
example) can work with hospitals under arrangement to be able to 
provide inpatient acute care to Medicare beneficiaries and these 
admissions would trigger an excluded COVID-19 episode of care.\87\ If a 
SNF is working under arrangement with a hospital to provide inpatient 
acute care, we would expect these services to be billed by the hospital 
which would be one of the CCN types we use to identify an inpatient 
claim that triggers an episode of care, as described elsewhere in this 
section of this final rule. However, if the beneficiary's SNF admission 
is for post-acute services, this alone would not trigger an episode of 
care for treatment of COVID-19. It is important to note that if post-
acute care, such as SNF care, follows a beneficiary's discharge from a 
facility or unit where they were receiving inpatient services for 
treatment of COVID-19, payment amounts for post-acute care in the month 
of and the month following the discharge date (along with all other 
Parts A and B services) will also be excluded. As specified in Sec.  
425.611(b)(2), CMS defines an episode of care for the treatment of 
COVID-19 as starting in the month in which the inpatient stay begins, 
as identified by the admission date, all months during the inpatient 
stay, and the month following the end of the inpatient stay as 
indicated by the discharge date.
---------------------------------------------------------------------------

    \86\ CMS, ``COVID-19 Frequently Asked Questions (FAQs) on 
Medicare Fee-For-Service (FFS) Billing'', available at https://www.cms.gov/files/document/03092020-covid-19-faqs-508.pdf. Refer to 
section U ``Medicare Shared Savings Program--Accountable Care 
Organizations (ACO)'' question 29.
    \87\ Refer to CMS, ``Medicare 1135 Waivers & Two Interim Final 
Rules Enabling Health System Expansion'', available at https://www.cms.gov/files/document/covid-19-regulations-waivers-enable-health-system-expansion.pdf.
---------------------------------------------------------------------------

    Comment: When the comment period for the May 8th COVID-19 IFC 
closed on July 7, 2020, the PHE for COVID-19 extended until July 25, 
2020.\88\ Some commenters suggested CMS use inpatient services provided 
after the end of the PHE for COVID-19 to identify episodes of care for 
treatment of COVID-19. Some commenters suggested that CMS extend the 
identification of episodes of care for treatment of COVID-19 through 
the remainder of 2020. One commenter believed this extension was 
necessary to provide more certainty to ACOs in the event that the PHE 
is not extended beyond July 25, 2020, expressing concern that there 
could be a ``second wave'' of infections and a non-continuous PHE 
scenario. Some commenters suggested that CMS reevaluate whether 
additional revisions may be necessary to allow the policy to extend 
into 2021. These commenters explained that these approaches were needed 
to further protect two-sided model ACOs against financial losses, or 
more generally to ensure the future success of Shared Savings Program 
ACOs.
---------------------------------------------------------------------------

    \88\ Renewal of determination that a public health emergency 
existed, with an effective date of April 26, 2020, for the duration 
of the emergency or 90 days, unless extended by the Secretary. Refer 
to U.S. Department of Health & Human Services, Public Health 
Emergency web page, ``April 21, 2020: Renewal of the Determination 
that a Public Health Emergency Exists as the Result of the Continued 
Consequences of Coronavirus Disease 2019 (COVID-19) (formerly called 
2019 Novel Coronavirus (2019-nCoV))'', available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/covid19-21apr2020.aspx.
---------------------------------------------------------------------------

    A few commenters suggested CMS remove any end-point to the 
adjustment. One commenter explained that limiting

[[Page 84780]]

the adjustment to discharges within the PHE established an artificial 
cutoff point, which the commenter believed was unnecessary because the 
adjustment was already limited to a select group of ICD-10-CM diagnosis 
codes that were inherently tied to the treatment of COVID-19. Another 
commenter pointed to unknowns about the recovery time of infected 
individuals, suggesting it may take years to recover. This commenter 
further indicated that lifting the time limitation on the applicability 
of the adjustment would help ensure that ACOs are not penalized for 
having higher COVID-19 spread in their assigned beneficiary 
populations.
    Response: At the time of this final rule, the PHE for COVID-19 has 
been renewed with an effective date of October 23, 2020, and, unless 
terminated early, will remain in effect for 90 days after the effective 
date. Under this extension, we would continue to identify episodes of 
care for treatment of COVID-19 until at least late-January 2021. Some 
commenters' suggestions, such as to extend the approach to identifying 
episodes of care to inpatient services for treatment of COVID-19 for 
the duration of the performance year 2020, or into 2021, are therefore 
addressed by the latest renewal of the PHE for COVID-19.
    At this time, we decline to adopt the commenters' suggestions to 
use inpatient services with a discharge date after the end of the PHE 
for COVID-19 (as defined under Sec.  400.200) to identify an episode of 
care for treatment of COVID-19 for purposes of adjusting Shared Savings 
Program calculations. Under the statutory requirements established in 
section 3710 of the CARES Act, with the conclusion of the PHE, IPPS 
providers will no longer receive the 20 percent DRG adjustment, which 
is one factor that the existing adjustment was designed to address.
    We recognize that COVID-19 may continue to exist in communities 
even after the conclusion of the PHE for COVID-19 and that, as a 
result, some Medicare FFS beneficiaries will likely continue to require 
higher-cost care, including inpatient care, for the treatment of COVID-
19. We believe a number of existing aspects of the Shared Savings 
Program payment methodology will help to mitigate the impact of these 
higher costs on ACOs, in the absence of the adjustment for episodes of 
care for treatment of COVID-19 following the conclusion of the PHE for 
COVID-19. For instance, as discussed elsewhere in this section of this 
final rule, the program's existing methodology for updating historical 
benchmarks, reflecting regional and/or national FFS expenditure trends, 
will help to ensure that an ACO's benchmark remains comparable with the 
performance year expenditures, which may include higher costs of care 
for patients with COVID-19. Further, the program's methodology for 
truncating assigned beneficiary expenditures, used in calculating 
benchmark expenditures (Sec. Sec.  425.601(a)(4), 425.602(a)(4), 
425.603(c)(4)) and performance year expenditures (Sec. Sec.  
425.604(a)(4), 425.605(a)(3), 425.606(a)(4), 425.610(a)(4)), at the 
99th percentile of national Medicare FFS expenditures for assignable 
beneficiaries, will continue to help minimize variation from 
catastrophically large claims.
    We also note that the adjustments for episodes of care for the 
treatment of COVID-19, as applied for the duration of the PHE for 
COVID-19, will continue to be reflected in program calculations for the 
affected time period. In particular, 2020 serves as a performance year 
for currently participating ACOs, and will be a benchmark year for 
future program entrants with 2022 and 2023 start dates. In light of the 
shift to 5-year agreement periods, adjustments made to expenditures 
during benchmark year 2020 will continue to be reflected in benchmark 
calculations until the end of performance year 2027 (the final 
performance year for 2023 starters), under the program's existing 
policies.
    However, we anticipate monitoring the program's calculations for 
the impact of any anomalies in Medicare FFS expenditures resulting from 
the costs of treating COVID-19, as well as changes in healthcare 
utilization by Medicare FFS beneficiaries resulting from the COVID-19 
pandemic. We may revisit the need to extend or modify the adjustment to 
program calculations in future notice and comment rulemaking.
    Comment: One commenter suggested that we exclude short term, CAH 
swing-bed costs from Shared Savings Program financial calculations 
during the PHE for COVID-19. This commenter explained that swing-beds 
in CAHs can be safer for patients in hard-hit COVID-19 areas needing 
post-acute care than SNFs, but they are paid at approximately 3 times 
the rate.
    Response: CAH swing-bed services, for skilled nursing care, have a 
``Z'' in third position of the CCN. Elsewhere in this section of this 
final rule, we detail the criteria we use for identifying claims for 
inpatient services that trigger an episode of care for treatment of 
COVID-19, which include: Claim type 60, facility type identified based 
on certain CCNs, admission date and discharge date both populated, and 
discharge date within the PHE for COVID-19 with a diagnosis code equal 
to either B97.29 or U07.1 (for an inclusive range of dates). According 
to these criteria, we would not identify a CAH swing-bed service billed 
by a CCN with ``Z'' in the third position of the CCN, as a trigger for 
an episode of care for treatment of COVID-19.
    However, a claim for inpatient services provided by a CAH may meet 
the criteria to be identified as the trigger for an episode of care for 
treatment of COVID-19. For example, if an inpatient service is provided 
by a CAH, and billed under a CCN identified by ``R'' (CAH 
Rehabilitation Unit) in the third position of the CCN or with the last 
four digits of the CCN in the range of 1300-1399 (CAH), this inpatient 
service would be the basis for an episode of care, if the other 
previously described criteria are also met. Further, CAH swing-bed 
services that fall within an episode of care for treatment of COVID-19, 
triggered by an inpatient admission identified according to the 
criteria in Sec.  425.611, would also be excluded.
    We decline to more broadly exclude all CAH swing-bed costs from the 
determination of ACO expenditures, which goes beyond the scope of the 
adjustment for episodes of care for treatment of COVID-19 that we 
adopted in the May 8th COVID-19 IFC. We believe the existing higher 
payments for care furnished in swing-beds in CAHs are presently 
reflected in ACOs' benchmark expenditures. Further adjustments to 
performance year expenditures to remove all such swing-bed costs would 
likely exclude expenditures associated with swing bed services that 
would have been rendered even in the absence of the PHE for COVID-19, 
creating asymmetry between benchmark and performance year calculations.
    Comment: Some commenters suggested that CMS exclude as part of the 
adjustment for episodes of care for treatment of COVID-19, costs for 
outpatient services associated with a COVID-19 diagnosis regardless of 
whether the patient has an inpatient hospital admission. A few 
commenters explained that the long-term effects of COVID-19 are 
unknown, and patients may need ongoing care as they recover, and this 
care may not be provided in the inpatient setting. A few commenters 
explained that there is an increased cost of care for COVID-19 patients 
treated solely on an outpatient basis, including increased utilization 
of high-tech imaging and follow-up care. Pointing to the description in 
the May 8th COVID-19 IFC in which CMS explained that outpatient care 
was approximately 10

[[Page 84781]]

percent of the cost of hospital care for COVID-19, one commenter noted 
the costs of outpatient care for beneficiaries who do not have an 
inpatient admission for treatment of COVID-19 represents potentially 
sizeable COVID-19-related costs that would not be captured by episodes 
of care triggered by the receipt of inpatient services for the 
treatment of COVID-19, particularly for non-hospital-based ACOs.
    One commenter, concerned about the impact of increased outpatient 
care costs of COVID-19 on ACO expenditures, suggested that CMS exclude 
all COVID-19 related payment amounts from performance year expenditures 
when these expenses are not reflected in the ACO's benchmark.
    Further, a few commenters suggested that CMS monitor the long-term 
costs of outpatient care for recovered COVID-19 patients, to fully 
assess the total cost of care implications of the disease. One 
commenter suggested CMS do so before including these costs in Shared 
Savings Program benchmark calculations. Another commenter noted it 
would not expect COVID-19 related outpatient costs to vary 
significantly within a region, but encouraged CMS to monitor COVID-19 
costs outside an episode of care for treatment of COVID-19 as defined 
in the May 8th COVID-19 IFC.
    Response: As one commenter asserted, we would not expect COVID-19 
related outpatient costs to vary significantly within a region. Data 
from quarterly reports appears to support this; as noted elsewhere 
within this section of this final rule, the distribution of ACO 
expenditure trends and regional expenditure trends between Q1 and Q2 
2020 after removing episodes of care for treatment of COVID-19 are 
fairly similar. As a result, we believe the program's existing 
methodology for updating historical benchmarks, which incorporates 
regional and/or national FFS expenditures trends, should adequately 
adjust an ACO's benchmark to be more comparable with performance year 
expenditures by reflecting the changes in outpatient utilization as a 
result of COVID-19 and the COVID-19 pandemic. For related reasons, we 
do not believe that changes in outpatient utilization will unfairly 
impact physician-led ACOs as these changes should also be reflected in 
the adjusted expenditure trends used to update these ACOs' benchmarks.
    We also expect outpatient care for COVID-19 to taper off as a 
beneficiary's symptoms resolve. As a result, if we were to remove 
expenditures arising during months of outpatient care for individuals 
with a diagnosis for COVID-19 that are not already captured by the 
definition of episode of care for treatment of COVID-19 in Sec.  
425.611(b), we could risk removing too many months of care for assigned 
beneficiaries from program calculations, which in turn could cause 
benchmarks to become less accurate and disrupt ACOs' shared savings 
potential.
    We decline at this time to modify our approach to exclude all costs 
for outpatient care for treatment of COVID-19 or, more generally, all 
costs for treatment of COVID-19. As we have explained elsewhere in this 
section of this final rule, we believe it is too soon to identify the 
full extent of the impact of COVID-19 on FFS expenditures. We 
anticipate monitoring the program's calculations for the impact of any 
anomalies in Medicare FFS expenditures resulting from the costs of 
treating COVID-19, as well as changes in healthcare utilization by 
Medicare FFS beneficiaries resulting from the COVID-19 pandemic. We may 
revisit these considerations in future notice and comment rulemaking 
for the Shared Savings Program.
    Comment: A few commenters urged CMS to clarify that an episode of 
care can be triggered when a COVID-19 diagnosis code is present on a 
claim and does not need to be the primary diagnosis code to trigger the 
episode of care. These commenters explained that this will be critical 
as there has been a large amount of variability in the manner in which 
COVID-19 diagnoses are listed on claims, due to the often ``multi-
system'' nature of COVID-19 related illnesses.
    More generally, several commenters cited concerns that inaccuracies 
in coding of COVID-19 diagnoses, or variations in coding, will affect 
the accuracy of CMS' adjustment for episodes of care for treatment of 
COVID-19.
    One commenter encouraged CMS to evaluate the accuracy of the 
episode-based exclusion in capturing true COVID-19 impacts, such as by 
comparing the episode of care results to regional COVID-19 prevalence.
    Response: As we explained in an FAQ,\89\ we will identify claims 
for treatment of COVID-19, for use in identifying episodes of care, 
when the diagnosis code B97.29 or U07.1 is present in any diagnosis 
code field. Further, we believe some of the comments reflect a concern 
that our approach could under-identify episodes of care for the 
treatment of COVID-19 in the event of inaccuracies in coding. We note 
that it is incumbent upon providers to accurately code diagnoses and to 
ensure the accuracy of information submitted on claims based on 
established coding guidelines. For additional information, refer to 
guidelines for providers for coding encounters related to COVID-19,\90\ 
and CMS claims processing instructions.\91\
---------------------------------------------------------------------------

    \89\ CMS, ``COVID-19 Frequently Asked Questions (FAQs) on 
Medicare Fee-For-Service (FFS) Billing'', available at https://www.cms.gov/files/document/03092020-covid-19-faqs-508.pdf. Refer to 
section U ``Medicare Shared Savings Program--Accountable Care 
Organizations (ACO)'' question 31.
    \90\ See for example, CDC, ``ICD-10-CM Official Coding and 
Reporting Guidelines: April 1, 2020 through September 30, 2020'', 
available at https://www.cdc.gov/nchs/data/icd/COVID-19-guidelines-final.pdf.
    \91\ See for example, CMS, MLN Matters, ``July 2020 Quarterly 
Update to the Inpatient Prospective Payment System (IPPS) Fiscal 
Year (FY) 2020 Pricer'', available at https://www.cms.gov/files/document/mm11764.pdf.
---------------------------------------------------------------------------

    As previously described in this section of this final rule, 
following the issuance of the May 8th COVID-19 IFC, CMS announced 
additional requirements for a positive COVID-19 laboratory test 
documented in the patient's medical record, in order for inpatient 
services furnished by an IPPS hospital to qualify for the 20 percent 
DRG adjustment.\92\ For purposes of the adjustments to expenditures for 
episodes of care for the treatment of COVID-19 under the Shared Savings 
Program, this requirement could further ensure the accuracy of the 
adjustment for episodes of care for inpatient services identified based 
on discharges for inpatient services eligible for the 20 percent 
adjustment, according to Sec.  425.611(b)(1)(i). This requirement would 
potentially rule out certain episodes of care that would otherwise 
trigger the adjustment under Sec.  425.611 of the Shared Savings 
Program regulations.
---------------------------------------------------------------------------

    \92\ Refer to CMS, MLN Matters, ``New Waivers for Inpatient 
Prospective Payment Systems (IPPS) Hospitals, Long-Term Care 
Hospitals (LTCHs), and Inpatient Rehabilitation Facilities (IRFs) 
due to Provisions of the Cares Act'' (revised September 11, 2020), 
available at https://www.cms.gov/files/document/se20015.pdf.
---------------------------------------------------------------------------

    We appreciate the commenter's suggestion that CMS evaluate the 
accuracy of the episode-based exclusion in capturing true COVID-19 
impacts, and we anticipate continuing to monitor and evaluate the 
impact of COVID-19 on program calculations, to help inform potential 
future policy modifications to the Shared Savings Program.
    Comment: One commenter expressed concern about how CMS defines an 
episode of care as ending with the month following the end of the 
inpatient stay as identified by the discharge date. The commenter 
explained that an increasing body of evidence suggests that COVID-19 
infection may cause a host of lingering

[[Page 84782]]

health effects including serious circulatory, respiratory, and 
neurologic conditions. The commenter also believes additional health 
issues associated with COVID-19 will likely be identified as more 
research is done on COVID-19 positive patients. Given the unknowns of 
this novel virus, the commenter asserts that neither it nor CMS can 
know that the one-month post discharge end date for a COVID-19 episode 
will fully address the increased resource demands required to treat 
these patients. The commenter requested that CMS evaluate and publicly 
report data on the impacts of COVID-19 on all service utilization for 
patients with and without an inpatient admission.
    Response: We agree with the commenter, regarding the importance of 
ongoing monitoring of Shared Savings Program calculations for the 
impact of healthcare utilization resulting from COVID-19 as research 
helps us better understand the effects of the virus on the Medicare FFS 
beneficiary population. At this time, we believe that defining an 
episode of care for the treatment of COVID-19 as set forth in Sec.  
425.611(b)(2), as the month in which the inpatient stay begins as 
identified by the admission date, all months during the inpatient stay, 
and the month following the end of the inpatient stay as indicated by 
the discharge date, is sufficient to remove the higher costs of care 
surrounding an inpatient service for the treatment of COVID-19 with a 
discharge date within the PHE for COVID-19. Further, to the extent that 
a beneficiary is subsequently admitted for inpatient care for 
complications related to COVID-19, following their initial discharge 
for inpatient services, a claim associated with the new hospitalization 
would trigger a new episode of care for treatment of COVID-19 if it 
meets the criteria we described elsewhere in this section of this final 
rule for identifying inpatient services that trigger an episode of care 
for treatment of COVID-19, including a discharge date within the PHE 
for COVID-19.
    Comment: One commenter stated its support for the exclusion of 
affected months associated with an episode of care from total person 
years used in per capita expenditure calculations.
    Response: We appreciate the support for the approach we described 
in the May 8th COVID-19 IFC (85 FR 27580) of excluding affected months 
associated with an episode of care from total person years used in per 
capita expenditure calculations. For consistency within program 
calculations, we will exclude months associated with episodes of care 
for the treatment of COVID-19 from program calculations that 
incorporate monthly data, including the following:
     Calculation of ACO, county, or national level weighted 
mean CMS-Hierarchical Condition Categories (HCC) prospective risk 
scores or demographic risk scores used in program risk adjustment 
calculations described in Sec. Sec.  425.601, 425.602, 425.603, 
425.604, 425.605, 425.606, and 425.610. CMS will exclude monthly 
prospective beneficiary CMS-HCC risk scores (based on diagnoses from 
the prior calendar year) from months associated with episodes of care 
for treatment of COVID-19. CMS will also exclude these months when 
computing person year values that are used to calculate weighted means 
of CMS-HCC and/or demographic risk scores across beneficiaries. Note, 
however, that CMS will continue to use diagnoses that meet risk 
adjustment criteria from claims submitted by FFS providers for items 
and services furnished during the months associated with episodes of 
care for treatment of COVID-19, when calculating final CMS-HCC risk 
scores for future years. For example, final CMS-HCC risk scores for 
2021 will include risk adjustment eligible diagnoses from all eligible 
claims in 2020, including claims from months associated with episodes 
of care for treatment of COVID-19. CMS calculates risk scores for all 
Medicare beneficiaries and these risk scores are used in a variety of 
calculations across the Medicare Program; CMS does not calculate 
separate CMS-HCC risk scores for use in Shared Savings Program 
calculations.
     Calculation of assigned beneficiary person years used in 
determining the proportion of the ACO's assigned beneficiaries in each 
county by Medicare enrollment type (ESRD, disabled, aged/dual eligible, 
aged/non-dual eligible) used to weight risk-adjusted county FFS 
expenditures as described in Sec. Sec.  425.601(d) and 425.603(f).
     Calculation of the weights applied to national and 
regional components of the blended growth rates used to trend forward 
benchmark year (BY) 1 and BY2 expenditures to BY3 according to Sec.  
425.601(a)(5) and to update the benchmark according to Sec.  
425.601(b).
     Calculation of assigned beneficiary enrollment proportions 
used to calculate the weighted average across the four Medicare 
enrollment types in order to obtain a single per capita updated 
benchmark and a single performance year per capita expenditure 
value.\93\
---------------------------------------------------------------------------

    \93\ For example, refer to the description of the calculation in 
Sections 4.1.4 and 4.3.1 of the Shared Savings and Losses and 
Assignment Methodology Specifications, Version 8, available at 
https://www.cms.gov/files/document/shared-savings-losses-assignment-spec-v8.pdf-0.
---------------------------------------------------------------------------

     Calculation of total person years used to calculate total 
benchmark expenditures and total performance year expenditures used in 
financial reconciliation calculations.\94\
---------------------------------------------------------------------------

    \94\ For example, refer to the description of the calculation in 
Section 4.3.1 of the Shared Savings and Losses and Assignment 
Methodology Specifications, Version 8, available at https://www.cms.gov/files/document/shared-savings-losses-assignment-spec-v8.pdf-0.
---------------------------------------------------------------------------

    Comment: One commenter asked for clarification of how adjustments 
to program calculations would be reflected in Shared Savings Program 
reports provided to ACOs. Specifically, the commenter asked if CMS 
would provide amended aggregate expenditure/utilization reports for 
Quarter 1 2020, if payment amounts and beneficiary months associated 
with episodes of care for treatment of COVID-19 are removed from 
program calculations going back to January 2020.
    Response: In response to the Shared Savings Program policy changes 
established in the May 8th COVID-19 IFC, CMS added several new report 
tables to the 2020 quarterly reports, and these modified reports were 
used to provide Q2 and Q3 2020 data to Shared Savings Program ACOs. 
Specifically these report changes reflect the adjustment for episodes 
of care for treatment of COVID-19, and changes to the definition of 
primary care services used in determining beneficiary assignment as 
specified in Sec.  425.400(c)(2) and described in section III.G.5.e of 
this final rule. We anticipate specifying the effects of these policies 
in quarterly and annual aggregate reports to which they apply. Although 
we are not reproducing quarterly reports for Q1 2020 to include these 
updated report variables, we note that the report periods of the Q2, 
Q3, and Q4 2020 reports include the months of January through March 
2020.
    Comment: One commenter expressed support for the clarification CMS 
provided that lump sum payments made to hospitals and other healthcare 
providers through the CARES Act Provider Relief Fund, that occur 
outside of Parts A and B claims, will not adversely impact ACO 
expenditures.
    Response: We appreciate the commenter's support for this 
clarification.
    Comment: One commenter suggested that CMS should use the financial

[[Page 84783]]

performance and quality data from 2020 to help stakeholders understand 
the impact of the global pandemic on ACOs' collective ability to 
deliver care under the modified coverage and payment policy rules 
implemented, as well as the impact of the stay-at-home and social 
distancing recommendations in place throughout the country. The 
commenter indicated that such data would greatly contribute to future 
work, including developing higher quality, more cost-efficient models 
of care after the current pandemic has been contained.
    Response: We appreciate the commenter's recommendation that CMS 
make public data that can assist stakeholders in understanding the 
impact of COVID-19 and the COVID-19 pandemic on ACOs. CMS makes public 
certain Shared Savings Program data, such as ACO financial performance 
data included in annual Shared Savings Program ACO public-use files 
(PUFs). We anticipate releasing a Shared Savings Program ACO PUF, with 
ACO-level performance year 2020 financial and quality performance data, 
in the fall of 2021, following financial reconciliation for performance 
year 2020. Additional information on program data, including a 
description of and link to the Shared Savings Program ACO PUF, is 
available through the Shared Savings Program's ``Program Data'' web 
page, available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/program-data. More generally, CMS' 
``Medicare COVID-19 Data Snapshot'' resources provide data on COVID-19 
cases, and hospitalizations for Medicare beneficiaries diagnosed with 
COVID-19.\95\
---------------------------------------------------------------------------

    \95\ CMS.gov, Preliminary Medicare COVID-19 Data Snapshot, 
available at https://www.cms.gov/research-statistics-data-systems/preliminary-medicare-covid-19-data-snapshot.
---------------------------------------------------------------------------

    Further, ACOs actively participating in the Shared Savings Program 
periodically receive data from CMS, which we believe supports their 
ability to detect and respond to developing trends. Under Sec.  
425.702, we provide ACOs with aggregate quarterly reports that identify 
prospectively and preliminarily prospectively assigned beneficiaries, 
provide aggregated metrics on the ACO's assigned beneficiary 
population, and utilization and expenditure data, including expenditure 
data for the national and regional assignable FFS populations. Under 
Sec.  425.704, we provide ACOs with monthly claim and claim line feed 
files with beneficiary-identifiable data, which include Parts A, B, and 
D data for prospectively and preliminarily prospectively assigned 
beneficiaries and other beneficiaries who receive primary care services 
from an ACO participant that submits claims for primary care services 
used in beneficiary assignment. We believe these program reports and 
data feeds will help ACOs in understanding the impact of COVID-19 on 
their assigned beneficiaries and the impact of the adjustment for 
episodes of care for treatment of COVID-19.
    Comment: Many commenters commenting on the Shared Savings Program 
policies adopted in the May 8th COVID-19 IFC suggested it is critical 
that CMS extend the June 30 deadline for ACOs to voluntarily terminate 
to avoid financial losses to no earlier than October 31, 2020, with no 
more than 30-days advance notice of termination, as is currently 
required under Sec.  425.220(a). The commenters asserted that ACOs need 
more time and data to make informed decisions about their 
participation. Commenters explained that absent this protection, ACOs 
in two-sided models may choose to leave the program given the 
uncertainty around the end date for the PHE for COVID-19, although the 
commenters were often unclear in indicating whether their concerns 
centered around the duration of the adjustment for episodes of care for 
treatment of COVID-19 or loss mitigation under the program's extreme 
and uncontrollable circumstances policy (as discussed in section 
III.G.5.c of this final rule), or both. In further explaining the need 
for ACOs to have additional time to determine whether to remain in the 
program, some commenters underscored the uncertainty around a 
resurgence of the virus in the fall of 2020. In addition, some 
commenters indicated this flexibility would provide ACOs with more time 
to focus on the pandemic, which would enable them to remain in the 
program.
    Some commenters suggested that CMS provide two-sided model ACOs the 
opportunity to voluntarily terminate and avoid financial losses until 
90 days following the effective date of the May 8th COVID-19 IFC (which 
would be approximately August 6, 2020, given the May 8, 2020 effective 
date of the IFC) to allow these ACOs time to consider the policies 
established with the IFC. One commenter requested that ACOs in two-
sided models be given an opportunity to exit the Shared Savings Program 
without penalty once the rule is finalized. This commenter (an ACO) 
explained that the ACO faces a very difficult decision about its 
continued participation, without enough information, and does not wish 
to act impulsively.
    Response: At this time, we decline to make additional modifications 
to the Shared Savings Program's policy on payment consequences of early 
termination. At the time of this final rule, the PHE for COVID-19 has 
been renewed for a further 90 days, with an effective date of October 
23, 2020. Unless the PHE for COVID-19 is terminated early, CMS 
anticipates mitigating shared losses for the duration of 2020 under the 
Shared Savings Program's extreme and uncontrollable circumstances 
policy. We believe this mitigation of shared losses addresses the 
concerns of ACOs and other program stakeholders regarding the payment 
consequences of early termination for the remainder of performance year 
2020.
    Further, we believe we struck an appropriate balance with the 
combination of policies we established in the May 8th COVID-19 IFC, 
which provide greater certainty to ACOs and thereby encourage their 
continued participation in the Shared Savings Program, in particular: 
Allowing eligible ACOs in the BASIC track's glide path to maintain 
their current level of participation for performance year 2021 
(described in section III.G.5.b of this final rule); adjustments to 
program calculations for episodes of care for treatment of COVID-19 
(described in this section of this final rule); and changes to the 
Shared Savings Program's assignment methodology (described in section 
III.G.5.e of this final rule). We believe the stabilizing effect of 
these policies, along with the application of the program's extreme and 
uncontrollable circumstances policy for mitigating shared losses 
beginning in January 2020 and for duration of the PHE for COVID-19 
(described in section III.G.5.c of this final rule), is evidenced by 
the fact that only 4 ACOs (including only 2 ACOs under two-sided 
models) terminated with an effective termination date on or before June 
30, 2020, and therefore, will not be reconciled for performance year 
2020. Approximately 35 ACOs, including 12 two-sided model ACOs, have 
voluntarily terminated their participation, and have requested an end-
of-year termination date, and therefore will be reconciled for their 
performance in the program in performance year 2020.
    Comment: Commenters suggested modifications to the Shared Savings 
Program's benchmarking methodologies, which went beyond the 
modifications to the program's regulations established in the May 8th 
COVID-19 IFC.

[[Page 84784]]

Commenters' suggestions included the following:
    Some commenters, concerned with anomalies in expenditures and 
revenue for 2020, suggested alternative approaches to how CMS could 
treat 2020 data when 2020 is used as a benchmark year in future 
benchmark calculations.
    Some commenters suggested that CMS exclude all 2020 data from 
future benchmarking calculations, such as excluding 2020 as a benchmark 
year or excluding 2020 data from the calculation of adjustments to the 
benchmark. Some commenters suggested alternative approaches to 
identifying benchmark years, which would avoid reliance on 2020 data. 
For example, for ACOs entering agreement periods beginning on January 
1, 2022, one commenter suggested CMS either use 2017, 2018, and 2019 as 
the benchmark years (instead of 2019, 2020 and 2021), or combine 2019 
and 2021 data.
    One commenter suggested that CMS consider changing benchmark year 
weighting, to limit the impact of 2020 data.
    Instead of looking at performance over a single year, one commenter 
suggested that CMS collaborate with program stakeholders to develop a 
benchmarking and financial reconciliation methodology for ACOs that 
spans multiple years.
    Some commenters suggested CMS revise the methodology for 
incorporating factors based on regional FFS expenditures into ACO 
benchmarks through future rulemaking. Some commenters noted their 
concern that the blended national and regional expenditure growth rates 
used to trend and update an ACO's historical benchmark (for agreement 
periods beginning on July 1, 2019, and in subsequent years) 
overemphasize the national trend component for ACOs that comprise a 
large market share in their ACO regional service area, and disadvantage 
these ACOs. Some commenters expressed concern that including an ACO's 
assigned beneficiaries in the population used to determine regional FFS 
expenditures will mean the ACO is compared to itself twice: Once using 
historical ACO spending and another time by including ACO spending in 
regional spending. Commenters suggested that CMS revise the program's 
benchmarking methodology to exclude the ACO's assigned beneficiaries 
from the population of assignable beneficiaries used to determine 
regional FFS expenditures, typically in combination with a suggestion 
that CMS replace the blended national and regional expenditure growth 
rates with a fully regional trend.
    Some commenters were concerned about the risk adjustment approach 
that applies to ACOs in agreement periods beginning on July 1, 2019, 
and in subsequent years, and suggested that CMS revise this methodology 
in future rulemaking. Under the current approach, CMS uses full CMS-HCC 
risk adjustment for all assigned beneficiaries between the benchmark 
period (benchmark year 3) and the performance year, subject to a cap of 
positive 3 percent for the agreement period, and CMS does not apply a 
cap on negative risk score changes. A few commenters stated that 
controlling for outliers in risk score increases and decreases is 
important, explaining this is necessary in the context of the COVID-19 
pandemic because of the utilization disruptions and health implications 
that will affect risk scores. Commenters described the 3 percent cap on 
risk score increases as ``unreasonably low'' when applied across the 
agreement period, particularly in light of the higher acuity of 
beneficiaries resulting from COVID-19 and the other effects of the 
COVID-19 pandemic such as beneficiaries avoiding preventive services 
and screenings as well as routine primary care. Commenters explained 
that the absence of a floor on risk score decreases does not account 
for artificially low risk scores resulting from circumstances 
surrounding the COVID-19 pandemic. For example, commenters noted that 
the two new ICD-10-CM diagnosis codes for COVID-19, ``U07.1 COVID-19, 
virus identified'' and ``U07.2, COVID-19, virus not identified,'' are 
not mapped to a Hierarchical Condition Code (HCC), and could therefore 
cause risk scores to look artificially low. Some commenters suggested 
that CMS revise the Shared Savings Program's risk adjustment 
methodology in future rulemaking, such as by increasing the 3 percent 
cap on risk score growth, such as to 4 percent or 5 percent or 
eliminating the cap altogether and implementing a floor for risk score 
decreases, such as between zero (which would prevent any risk score 
decreases from impacting the benchmark) and negative 5 percent.
    Some commenters pointed to concerns that the 3 percent cap on risk 
score increases under in the risk adjustment methodology for ACOs in 
agreement periods beginning on July 1, 2019, and in subsequent years, 
is especially problematic for ACOs whose ACO regional service area 
includes a population of beneficiaries whose risk scores rise more than 
the cap. One commenter encouraged CMS to adopt a policy of applying a 
cap on risk score growth after accounting for regional increase in risk 
scores.
    Response: Although the commenters' suggested modifications to the 
Shared Savings Program's benchmarking methodologies went beyond the 
scope of the modifications to the program's regulations established in 
the May 8th COVID-19 IFC, we thank the commenters for their input. We 
believe it would be premature to specify additional modifications to 
the program's benchmarking methodology at this time. As we have 
described elsewhere in this section of this final rule, we believe it 
is important to continue to monitor the program's calculations and, in 
particular, the factors used to establish, trend and update the 
benchmark, to understand the impact of any anomalies in Medicare FFS 
expenditures resulting from the costs of treating COVID-19, as well as 
changes in healthcare utilization by Medicare FFS beneficiaries 
resulting from the COVID-19 pandemic. As we have also indicated 
elsewhere in this section of this final rule, it is important to gain 
additional experience with the benchmarking methodology, established in 
the Shared Savings Program December 2018 final rule (83 FR 68005 
through 68030) and specified in Sec.  425.601, which we believe 
provides for appropriate incentives for Shared Savings Program ACOs, 
before making further revisions to the benchmarking methodology. 
However, we will continue to monitor the impact of the benchmarking 
methodology and other program policies as part of our efforts to 
continue to improve and strengthen the program.
    Following consideration of the comments received in response to the 
May 8th COVID-19 IFC on the adjustments to Shared Savings Program 
calculations to address the COVID-19 pandemic, we are finalizing the 
regulation at Sec.  425.611, with a modification. As described 
previously in this section of this final rule, we are revising the 
regulation at Sec.  425.611(b)(1)(ii) to specify that CMS identifies 
episodes of care for treatment of COVID-19 based on discharges for 
acute care inpatient services for treatment of COVID-19 from facilities 
that are not paid under the inpatient prospective payment system, such 
as CAHs, when the date of discharge occurs within the Public Health 
Emergency as defined in Sec.  400.200. For the reasons discussed in 
this section, we are using our authority under section 
1871(e)(1)(a)(ii) of the Act to apply this change retroactively to the 
start of the

[[Page 84785]]

PHE for COVID-19. Further, we anticipate monitoring program 
calculations for the impact of any anomalies in Medicare FFS 
expenditures resulting from the cost of treating COVID-19, as well as 
changes in healthcare utilization by Medicare FFS beneficiaries 
resulting from the COVID-19 pandemic. We may revisit, in future notice 
and comment rulemaking, the need to make other modifications to the 
program's financial methodology to address the impact of COVID-19 and 
the COVID-19 pandemic on ACOs.
e. Expansion of Codes Used in Beneficiary Assignment
(1) Background
    Section 1899(c)(1) of the Act, as amended by the 21st Century Cures 
Act (Pub. L. 114-255, enacted December 13, 2016) and the Bipartisan 
Budget Act of 2018 (BBA 2018) (Pub. L. 115-123, enacted February 9, 
2018), provides that for performance years beginning on or after 
January 1, 2019, the Secretary shall assign beneficiaries to an ACO 
based on their utilization of primary care services provided by 
physicians participating in the ACO and all services furnished by RHCs 
and Federally Qualified Health Centers (FQHCs) that are ACO 
participants. However, the statute does not specify which kinds of 
services may be considered primary care services for purposes of 
beneficiary assignment.
    For performance years beginning on January 1, 2019, and subsequent 
performance years, we defined primary care services in Sec.  
425.400(c)(1)(iv) for purposes of assigning beneficiaries to ACOs under 
Sec.  425.402 as the set of services identified by the following HCPCS/
CPT codes:
    CPT codes:
     99201 through 99215 (codes for office or other outpatient 
visit for the evaluation and management of a patient).
     99304 through 99318 (codes for professional services 
furnished in a NF; services identified by these codes furnished in a 
SNF are excluded).
     99319 through 99340 (codes for patient domiciliary, rest 
home, or custodial care visit).
     99341 through 99350 (codes for evaluation and management 
services furnished in a patient's home for claims identified by place 
of service modifier 12).
     99487, 99489 and 99490 (codes for chronic care 
management).
     99495 and 99496 (codes for transitional care management 
services).
     99497 and 99498 (codes for advance care planning).
     96160 and 96161 (codes for administration of health risk 
assessment).
     99354 and 99355 (add-on codes, for prolonged evaluation 
and management or psychotherapy services beyond the typical service 
time of the primary procedure; when the base code is also a primary 
care service code).
     99484, 99492, 99493 and 99494 (codes for behavioral health 
integration services).
    HCPCS codes:
     G0402 (code for the Welcome to Medicare visit).
     G0438 and G0439 (codes for the annual wellness visits).
     G0463 (code for services furnished in ETA hospitals).
     G0506 (code for chronic care management).
     G0444 (code for annual depression screening service).
     G0442 (code for alcohol misuse screening service).
     G0443 (code for alcohol misuse counseling service).
    On March 17, 2020, we announced the expansion of payment for 
telehealth services on a temporary and emergency basis pursuant to 
waiver authority added under section 1135(b)(8) of the Act by the 
Coronavirus Preparedness and Response Supplemental Appropriations Act, 
2020 such that Medicare can pay for telehealth services, including 
office, hospital, and other visits furnished by physicians and other 
practitioners to patients located anywhere in the country, including in 
a patient's place of residence, starting March 6, 2020. In the context 
of the PHE for COVID-19, we recognize that physicians and other 
healthcare professionals are faced with new challenges regarding 
potential exposure risks, including for Medicare beneficiaries, for 
healthcare providers, and for members of the community at large. For 
example, the CDC has urged healthcare professionals to make every 
effort to interview persons under investigation for COVID-19 infection 
by telephone, text messaging system, or video conference instead of in-
person. In the March 31st COVID-19 IFC, to facilitate the use of 
telecommunications technology as a safe substitute for in-person 
services, we added, on an interim basis, many services to the list of 
eligible Medicare telehealth services, eliminated frequency limitations 
and other requirements associated with particular services furnished 
via telehealth, and clarified several payment rules that apply to other 
services that are furnished using telecommunications technologies that 
can reduce exposure risks (85 FR 19232).
    Section 1834(m) of the Act 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. When furnished under the telehealth 
rules, many of these specified Medicare telehealth services are still 
reported using codes that describe ``face-to-face'' services but are 
furnished using audio/video, real-time communication technology instead 
of in-person. As such, the majority of the codes for primary care 
services included in the additional telehealth services added in the 
March 31st COVID-19 IFC on an interim basis for the duration of the PHE 
for COVID-19 are already included in the definition of primary care 
services for purposes of the Shared Savings Program assignment 
methodology in Sec.  425.400(c)(1)(iv).
    The March 31st COVID-19 IFC also established flexibilities for 
certain services that are furnished virtually using technologies but 
that are not considered Medicare telehealth services such as virtual 
check-ins and e-visits as well as telephone E/M services, for which 
payment has been authorized during the PHE for COVID-19. Prior to the 
PHE, the codes for these virtual services were not included in the 
definition of primary care services for purposes of the Shared Savings 
Program assignment methodology. We explained in the May 8th COVID-19 
IFC (85 FR 27582) that we believe it is critical to include these 
additional codes in the definition of primary care services to ensure 
these services are included in our determination of where beneficiaries 
receive the plurality of their primary care for purposes of beneficiary 
assignment, so that the assignment methodology appropriately reflects 
the expanded use of technology that is helping people who need routine 
care during the PHE for COVID-19 and allowing vulnerable beneficiaries 
and beneficiaries with mild symptoms to remain in their homes, while 
maintaining access to the care they need. By including services 
provided virtually, either through telehealth, virtual check-ins, e-
visits or telephone, in the definition of primary care services, we 
ensure that physicians and other practitioners can offer options to 
beneficiaries whom they treat, while also allowing this care to be 
included in our consideration of where beneficiaries receive the 
plurality of their primary care for purposes of assigning

[[Page 84786]]

beneficiaries to ACOs. As a result, revising the definition of primary 
care services used in assignment to include these services further 
allows for continuity and coordination of care. We also reiterated our 
policy defined at Sec.  425.404(b) that, for performance years starting 
on January 1, 2019, and subsequent performance years, under the 
assignment methodology in Sec.  425.402, CMS treats a service reported 
on an FQHC/RHC claim as a primary care service performed by a primary 
care physician.
(2) Use of Codes for Virtual Check-Ins, Remote Evaluation E-Visits, 
Telephone Evaluation and Management Services, and Telehealth in 
Beneficiary Assignment
    As we described in the May 8th COVID-19 IFC (85 FR 27583 through 
27586), based on feedback from ACOs and the expansion of payment, on an 
interim basis, for the virtual services discussed above, we revised the 
definition of primary care services used in the Shared Savings Program 
assignment methodology for the performance year starting on January 1, 
2020, and for any subsequent performance year that starts during the 
PHE for COVID-19, as defined in Sec.  400.200, to include the following 
additions: (1) HCPCS code G2010 (remote evaluation of patient video/
images) and HCPCS code G2012 (virtual check-in); (2) CPT codes 99421, 
99422 and 99423 (online digital evaluation and management service (e-
visit)); and (3) CPT codes 99441, 99442, and 99443 (telephone 
evaluation and management services).
    We explained that because the services are similar to and may 
replace an E/M service for a beneficiary, we believed it would be 
appropriate to include these CPT and HCPCS codes in the definition of 
primary care services used for assignment because the services 
represented by these codes are being used in place of similar E/M 
services, the codes for which are already included in the list of codes 
used for assignment. We explained our belief that it is important to 
include these services in our assignment methodology because we 
determine assignment to ACOs based upon where beneficiaries receive the 
plurality of their primary care services or whether they have 
designated an ACO professional as their primary clinician, responsible 
for their overall care, and hold ACOs accountable for the resulting 
assigned beneficiary population. Including these codes in the 
definition of primary care services used in assignment for performance 
years during the PHE for COVID-19 results in a more accurate 
identification of where beneficiaries have received the plurality of 
their primary care services.
    In the May 8th COVID-19 IFC (85 FR 27583), we also clarified that 
CPT codes 99304, 99305 and 99306, 99315 and 99316, 99327 and 99328, 
99334 through 99337, 99341 through 99345, and 99347 through 99350 will 
be included in the assignment methodology when these services are 
furnished using telehealth, consistent with additions to the Medicare 
telehealth list for the duration of the PHE for COVID-19 as discussed 
in the March 31st COVID-19 IFC (85 FR 19235 through 19237). We use the 
assignment methodology described in Sec. Sec.  425.402 and 425.404 for 
purposes of assigning beneficiaries to ACOs for a performance year or 
benchmark year based on preliminary prospective assignment with 
retrospective reconciliation (including quarterly updates) or 
prospective assignment.
    We explained that with the emergence of the virus that causes 
COVID-19, there is an urgency to expand the use of technology to allow 
people who need routine care, vulnerable beneficiaries, and 
beneficiaries with mild symptoms to remain in their homes, while 
maintaining access to the care they need. Limiting community spread of 
the virus, as well as limiting beneficiaries' exposure to other 
patients and healthcare staff members, will slow viral spread. We 
explained that we anticipated that the patterns and types of care 
provided during the PHE for COVID-19 would be different, and that it 
was important to capture these changes in the methodology used to 
assign beneficiaries to ACOs as soon as possible. We explained this was 
particularly important for ACOs under preliminary prospective 
assignment with retrospective reconciliation for PY 2020, so that they 
can understand the beneficiary population for which they will be 
responsible during PY 2020.
    As discussed in the March 31st COVID-19 IFC (85 FR 19244), in the 
CY 2019 PFS final rule, we finalized separate payment for a number of 
services that could be furnished via telecommunications technology, but 
that are not Medicare telehealth services. Specifically, beginning with 
CY 2019, we finalized separate payment for remote evaluation of video 
and/or images, HCPCS code G2010 (Remote evaluation of recorded video 
and/or images submitted by an established patient (e.g., store and 
forward), including interpretation with follow-up with the patient 
within 24 business hours, not originating from a related E/M service 
provided within the previous 7 days nor leading to an E/M service or 
procedure within the next 24 hours or soonest available appointment), 
and virtual check-in, HCPCS code G2012 (Brief communication technology-
based service, e.g. virtual check-in, by a physician or other qualified 
health care professional who can report E/M 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).
    These codes were finalized as part of the set of codes that is only 
reportable by the physicians and practitioners who can furnish E/M 
services. Per the March 31st COVID-19 IFC, on an interim basis for the 
PHE for COVID-19, we allow these codes to be used for new patients. In 
the March 31st COVID-19 IFC (85 FR 19244), we explained that, in the 
context of the PHE for COVID-19, when brief communications with 
practitioners and other non-face-to-face services might mitigate the 
need for an in-person visit that could represent an exposure risk for 
vulnerable patients, we believe that these services should be available 
to as large a population of Medicare beneficiaries as possible. In some 
cases, use of telecommunication technology could mitigate the exposure 
risk, and in such cases, the clinical benefit of using technology to 
furnish the service is self-apparent. This would be especially true 
should a significant increase in the number of people or healthcare 
professionals needing treatment or isolation occur in a way that would 
limit access to brief communications with established providers. 
Therefore, on an interim basis, during the PHE for COVID-19, we 
finalized that these services, which may only be reported if they do 
not result in a visit, including a telehealth visit, can be furnished 
to both new and established patients
    As discussed in the March 31st COVID-19 IFC (85 FR 19254), in the 
CY 2019 PFS final rule (83 FR 59452), we finalized payment for new 
online digital assessment services, also referred to as ``E-Visits,'' 
beginning with CY 2020 for practitioners billing under the PFS. These 
are non-face-to-face, patient-initiated communications using online 
patient portals. These digital assessment services are for established 
patients who require a clinical decision that otherwise typically would 
have been provided in the office. Per the March 31st COVID-19 IFC (85 
FR 19244), while the code descriptors for these e-visit codes refer to 
an ``established patient'', during the PHE for COVID-19, we are 
exercising enforcement

[[Page 84787]]

discretion on an interim basis to relax enforcement of this aspect of 
the code descriptors. Practitioners who may independently bill Medicare 
for E/M visits (for instance, physicians and NPs) can bill the 
following codes:
     99421 (Online digital evaluation and management service, 
for an established patient, for up to 7 days, cumulative time during 
the 7 days; 5-10 minutes.)
     99422 (Online digital evaluation and management service, 
for an established patient, for up to 7 days cumulative time during the 
7 days; 11- 20 minutes.)
     99423 (Online digital evaluation and management service, 
for an established patient, for up to 7 days, cumulative time during 
the 7 days; 21 or more minutes.)
    In the May 8th COVID-19 IFC (85 FR 27584), we explained that we 
also considered adding additional e-visit HCPCS codes that are used by 
clinicians who may not independently bill for E/M visits and who are 
not included in the definition of ACO professional in Sec.  425.20 (for 
example, PTs, OTs, SLPs, CPs). However, because these services are not 
furnished by ACO professionals, we determined it was not necessary to 
include the following codes in our definition of primary care services 
for use in assignment:
     G2061 (Qualified non-physician healthcare professional 
online assessment and management service, for an established patient, 
for up to seven days, cumulative time during the 7 days; 5-10 minutes.)
     G2062 (Qualified non-physician healthcare professional 
online assessment and management service, for an established patient, 
for up to seven days, cumulative time during the 7 days; 11-20 
minutes.)
     G2063 (Qualified non-physician qualified healthcare 
professional assessment and management service, for an established 
patient, for up to seven days, cumulative time during the 7 days; 21 or 
more minutes.)
    As discussed in the March 31st COVID-19 IFC (85 FR 19264 through 
19265) and in the May 8th COVID-19 IFC, CMS finalized, on an interim 
basis for the duration of the PHE for COVID-19, separate payment for 
CPT codes 99441 through 99443 and 98966 through 98968, which describe 
E/M and assessment and management services furnished via telephone. 
While the code descriptors for these services refer to an ``established 
patient'', CMS has indicated in the COVID-19 Frequently Asked Questions 
(FAQs) on Medicare Fee-for-Service (FFS) Billing (https://www.cms.gov/files/document/03092020-covid-19-faqs-508.pdf) that during the PHE for 
COVID-19 we are exercising enforcement discretion on an interim basis 
to relax enforcement of this aspect of the code descriptors. 
Practitioners who may independently bill Medicare for E/M visits (for 
instance, physicians and NPs) can bill the following codes:
     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.)
     99442 (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; 11-20 
minutes of medical discussion.)
     99443 (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; 21-30 
minutes of medical discussion.)
    In the May 8th COVID-19 IFC (85 FR 27584), we explained that we 
also considered adding the additional telephone assessment and 
management CPT codes that are used by clinicians who may not 
independently bill for E/M visits and who are not included in the 
definition of ACO professional in Sec.  425.20 (for example, PTs, OTs, 
SLPs, CPs). However, because these services are not furnished by ACO 
professionals, we determined it was not necessary to include these 
codes in our definition of primary care services for use in assignment:
     98966 (Telephone assessment and management service 
provided by a qualified non-physician health care professional to an 
established patient, parent, or guardian not originating from a related 
assessment and management service provided within the previous 7 days 
nor leading to an assessment and management service or procedure within 
the next 24 hours or soonest available appointment; 5-10 minutes of 
medical discussion.)
     98967 (Telephone assessment and management service 
provided by a qualified non-physician health care professional to an 
established patient, parent, or guardian not originating from a related 
assessment and management service provided within the previous 7 days 
nor leading to an assessment and management service or procedure within 
the next 24 hours or soonest available appointment; 11-20 minutes of 
medical discussion.)
     98968 (Telephone assessment and management service 
provided by a qualified non-physician health care professional to an 
established patient, parent, or guardian not originating from a related 
assessment and management service provided within the previous 7 days 
nor leading to an assessment and management service or procedure within 
the next 24 hours or soonest available appointment; 21-30 minutes of 
medical discussion.)
    We also explained that several codes, detailed below, that are 
included on the ``Covered Telehealth Services for PHE for the COVID-19 
pandemic, effective March 1, 2020'' list available at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Telehealth-Codes, are already included in the definition of primary 
care services used in the Shared Savings Program assignment 
methodology:
     99304 (Initial nursing facility 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 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. Typically, 25 minutes are 
spent at the bedside and on the patient's facility floor or unit.)
     99305 (Initial nursing facility 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

[[Page 84788]]

family's needs. Usually, the problem(s) requiring admission are of 
moderate severity. Typically, 35 minutes are spent at the bedside and 
on the patient's facility floor or unit.)
     99306 (Initial nursing facility 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. Typically, 45 
minutes are spent at the bedside and on the patient's facility floor or 
unit.)
     99315 (Nursing facility discharge day 
management; 30 minutes or less.)
     99316 (Nursing facility discharge day 
management; more than 30 minutes.)
     99327 (Domiciliary or rest home visit for the 
evaluation and management of a new 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 
presenting problem(s) are of high severity. Typically, 60 minutes are 
spent with the patient and/or family or caregiver.)
     99328 (Domiciliary or rest home visit for the 
evaluation and management of a new 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 
patient is unstable or has developed a significant new problem 
requiring immediate physician attention. Typically, 75 minutes are 
spent with the patient and/or family or caregiver.)
     99334 (Domiciliary or rest home visit for the 
evaluation and management of an established patient, which requires at 
least 2 of these 3 key 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 presenting problem(s) are self-limited or 
minor. Typically, 15 minutes are spent with the patient and/or family 
or caregiver.)
     99335 (Domiciliary or rest home visit for the 
evaluation and management of an established 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 presenting problem(s) 
are of low to moderate severity. Typically, 25 minutes are spent with 
the patient and/or family or caregiver.)
     99336 (Domiciliary or rest home visit for the 
evaluation and management of an established 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 presenting problem(s) are of moderate to 
high severity. Typically, 40 minutes are spent with the patient and/or 
family or caregiver.)
     99337 (Domiciliary or rest home visit for the 
evaluation and management of an established patient, which requires at 
least 2 of these 3 key components: A comprehensive interval history; A 
comprehensive examination; Medical decision making of moderate to 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. The patient may be unstable or may have 
developed a significant new problem requiring immediate physician 
attention. Typically, 60 minutes are spent with the patient and/or 
family or caregiver.)
     99341 (Home visit for the evaluation and management of a 
new patient, which requires these 3 key components: A problem focused 
history; A problem focused examination; and 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 
severity. Typically, 20 minutes are spent face-to-face with the patient 
and/or family.)
     99342 (Home 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; and 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.)
     99343 (Home visit for the evaluation and management of a 
new patient, which requires these 3 key components: A detailed history; 
A detailed 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 presenting problem(s) are of 
moderate to high severity. Typically, 45 minutes are spent face-to-face 
with the patient and/or family.)
     99344 (Home visit for the evaluation and management of a 
new 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 presenting problem(s) are of high 
severity. Typically, 60 minutes are spent face-to-face with the patient 
and/or family.)
     99345 (Home visit for the evaluation and management of a 
new patient, which requires these 3 key components: A comprehensive 
history; A comprehensive examination; and Medical decision making of 
high

[[Page 84789]]

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 new problem requiring immediate physician 
attention. Typically, 75 minutes are spent face-to-face with the 
patient and/or family.)
     99347 (Home visit for the evaluation and management of an 
established patient, which requires at least 2 of these 3 key 
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 
presenting problem(s) are self limited or minor. Typically, 15 minutes 
are spent face-to-face with the patient and/or family.)
     99348 (Home visit for the evaluation and management of an 
established 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 presenting problem(s) are of low to 
moderate severity. Typically, 25 minutes are spent face-to-face with 
the patient and/or family.)
     99349 (Home visit for the evaluation and management of an 
established 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 
presenting problem(s) are moderate to high severity. Typically, 40 
minutes are spent face-to-face with the patient and/or family.)
     99350 (Home visit for the evaluation and management of an 
established patient, which requires at least 2 of these 3 key 
components: A comprehensive interval history; A comprehensive 
examination; Medical decision making of moderate to 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. The patient may be unstable or may have developed a 
significant new problem requiring immediate physician attention. 
Typically, 60 minutes are spent face-to-face with the patient and/or 
family.)
    We clarified that because these CPT codes are already included in 
the definition of primary care services used in the Shared Savings 
Program assignment methodology, these CPT codes would continue to be 
included in the definition of primary care services used for 
assignment, including when they are furnished via telehealth during the 
PHE for COVID-19, beginning March 1, 2020. We explained our belief that 
it is important to include these services in our assignment 
methodology, regardless of whether they are furnished in-person or via 
telehealth, because we determine assignment based upon where 
beneficiaries receive the plurality of their primary care services or 
whether they have designated an ACO professional as their primary 
clinician, responsible for their overall care, and hold ACOs 
accountable for the resulting assigned beneficiary population. We 
explained that including these codes in the definition of primary care 
services used in assignment during the PHE for COVID-19, even when 
services are furnished via telehealth, would result in a more accurate 
identification of where beneficiaries receive the plurality of their 
primary care services.
    Accordingly, we added paragraph (c)(2) to our regulation at Sec.  
425.400, in which we specified additional primary care service codes 
that would be considered for purposes of beneficiary assignment for the 
performance year starting on January 1, 2020, and for any subsequent 
performance year that starts during the PHE for COVID-19, as defined in 
Sec.  400.200. Under this provision the existing CPT codes and HCPCS 
codes included in the definition of primary care services at Sec.  
425.400(c)(1) continue to apply for purposes of determining beneficiary 
assignment under Sec.  425.402.
    We received public comments on the revisions to the definition of 
primary care services for purposes of assignment that we adopted in the 
May 8th COVID-19 IFC, including the alternative considered with regard 
to adding codes used by non-ACO professionals. The following is a 
summary of the comments we received and our responses.
    Comment: Commenters generally supported the addition of the 
telemedicine, e-visits, and virtual services to the list of primary 
care services used for purposes of beneficiary assignment during the 
PHE for COVID-19. Commenters noted that the expansion of the definition 
of primary care services will allow ACOs to continue managing their 
patient populations but also advised CMS to monitor closely for 
unintended consequences. Commenters also noted that the expanded 
definition will allow CMS to accurately identify where beneficiaries 
receive the plurality of their primary care services during the PHE, 
which is critical for the stability of ACOs and primary care physicians 
transitioning into value-based payment arrangements. The revised 
definition also protects ACOs from undue declines in their assigned 
beneficiary populations due to the transition to telehealth services. 
Other commenters supported the expanded definition of primary care 
services used for assignment, as telehealth has proven to be critical 
for many independent physicians and practices during the pandemic. More 
patients than ever are using telehealth as a routine part of their 
care, and more clinicians and hospitals are offering it. Incorporating 
these services into the assignment methodology ensures that ACOs are 
rewarded for their efforts to transform their practices from in-person 
to virtual to support social distancing, as necessary during the PHE 
for COVID-19. Another commenter supported this change and appreciated 
the Agency's recognition of the increased delivery of care through 
telehealth due to the pandemic and the clarification that services 
included in the existing definition of primary care services would be 
considered in assignment when furnished in accordance with the 
telehealth rules.
    However, commenters cautioned against unintended consequences. One 
such unintended consequence could be assignment to ACOs of 
beneficiaries residing in states from which the ACO had not previously 
received assigned beneficiaries. One commenter encouraged CMS to 
develop clear guardrails for patient attribution that balance the 
expanded role of telehealth post-COVID-19 with the potential for 
healthcare providers to reach patients far outside their normal 
geographic region. Another commenter believed this expansion may result 
in a patient

[[Page 84790]]

being attributed to the ACO through a telehealth visit with an ACO 
professional, and that ACO subsequently becoming responsible for the 
cost and quality of care of that patient, who may not continue to see 
ACO professionals participating in that ACO once the pandemic ends. A 
few commenters expressed their belief that the expansion of virtual 
services provided during the PHE for COVID-19 will result in 
telemedicine continuing to be a significant mode of providing clinical 
services as the COVID-19 pandemic continues, and in the post-COVID-19 
era.
    Response: We appreciate the comment that the expansion of the 
definition of primary care services for the duration of the PHE for 
COVID-19 will allow ACOs to effectively manage their patient 
populations. We believe that the revised definition will allow ACOs and 
their ACO participants to make determinations regarding the appropriate 
and effective use of telehealth and in-person services based on the 
needs of the beneficiary balanced with safety considerations during the 
PHE for COVID-19. By expanding the definition, ACOs will not be 
penalized if they elect to furnish more services through telehealth and 
telemedicine during the PHE for COVID-19.
    We have continued to monitor assignment data for anomalies. In the 
first quarter of 2020, we observed a significant drop in the 
utilization of HCPCS and CPT codes used in assignment; however, as of 
the third quarter of 2020, utilization of these codes, including the 
new codes added in the May 8th COVID-19 IFC, has rebounded to near 
typical utilization.
    Further, as of the third quarter of 2020, we are seeing minimal 
decreases in assigned and assignable beneficiaries for ACOs 
participating under preliminary prospective assignment, similar to 
percentage decreases seen when comparing assignable and assigned 
beneficiaries in Q1 to assignable and assigned beneficiaries in Q3 of 
2019. For 2019, the Q1 to Q3 average decrease in assigned beneficiaries 
was less than 1 percent. For 2020, the Q1 to Q3 average decrease in 
assigned beneficiaries is 3 percent. The average decrease in assignable 
beneficiaries from Q1 to Q3 of 2019 was less than one percent while the 
average decrease in assignable beneficiaries from Q1 to Q3 of 2020 is 
less than 5 percent. These minor average differences indicate that the 
PHE for COVID-19 is not having a large impact on beneficiary assignment 
for ACOs under preliminary prospective assignment.
    We also continue to monitor rates of beneficiary churn, that is, 
the rate at which beneficiaries are assigned to an ACO and subsequently 
not assigned to that ACO; through the third quarter of 2020, rates of 
beneficiary churn remain consistent with rates seen prior to the PHE 
for COVID-19. The consistent rates of beneficiary churn indicate that 
the majority of beneficiaries continue to receive the plurality of 
their services from healthcare providers who participate in the ACO to 
which they were assigned at the start of the performance year. Our 
analyses also indicate that, on average, ACOs are losing fewer 
beneficiaries to competition with other ACOs and non-ACO affiliated 
healthcare providers during 2020 than were lost during 2019. Based on 
these findings, we believe that the PHE for COVID-19 is not having a 
significant impact on beneficiary retention.
    With regard to comments that ACOs may have beneficiaries assigned 
to them based on telehealth visits, including beneficiaries that reside 
outside the ACO's normal geographic region, and those beneficiaries may 
not receive in-person services from ACO professionals after the PHE for 
COVID-19 ends, we do not believe that this is a concern for the Shared 
Savings Program because we continue to determine assignment based upon 
where beneficiaries receive the plurality of their primary care 
services and whether beneficiaries have designated an ACO professional 
as their primary clinician. Our analysis through the third quarter of 
2020 indicates that the utilization of telehealth and telemedicine 
services is beginning to decrease, and in-person visits are beginning 
to rebound. To the extent that beneficiaries who had been receiving 
telehealth and telemedicine services from an ACO professional return to 
receiving in-person services from other healthcare providers (outside 
the ACO), assignment based on the plurality of primary care services 
will result in beneficiaries being assigned appropriately.
    Finally, we agree with commenters that telemedicine will likely 
continue to be a significant mode of providing clinical services and we 
will continue to refine the definition of primary care services, as 
appropriate, in future rulemaking.
    Comment: Several commenters requested that CMS clarify that the 
agency's existing policy has been to consider all codes listed in Sec.  
425.400(c)(1)(iv) when performing beneficiary assignment even when 
those services that are eligible for telehealth are delivered via 
telehealth. They suggested that such a clarification would mitigate 
confusion and emphasize the importance of these services in assignment.
    Response: We appreciate this request for clarification. CMS 
maintains a list of services that are payable under the Medicare 
Physician Fee Schedule when furnished via telehealth (https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Telehealth-Codes). Several of the codes included on the List of 
Telehealth Services are also included in the Shared Savings Program 
definition of primary care services for purposes of assigning 
beneficiaries. Specifically, we clarify that those HCPCS and CPT codes 
included in the List of Telehealth Services that are also included in 
the Shared Savings Program definition of primary care services for 
purposes of assignment are used for assignment regardless of whether 
they are furnished in person or via telehealth, provided they are 
billable and payable under Medicare FFS payment policies and a specific 
place of service exclusion is not included for the codes in our 
assignment methodology.
    Comment: One commenter expressed concern about the special 
assignment rules for services furnished in Electing Teaching Amendment 
(ETA) hospitals. Specifically, the commenter was concerned that only 
institutional claims (Part A claims) for services furnished in these 
hospitals are used in assignment calculations. The commenter expressed 
concern that beneficiaries who would have been assigned to an ACO in 
which an ETA hospital is participating based on in-person office visits 
at the ETA hospital will not be assigned to the ACO on the basis of 
telemedicine services, even if these services were provided by one of 
the physicians within its network, by which we assume the commenter 
means physicians that practice in the ETA hospital and bill through the 
ETA hospital's TIN that is included on the ACO's ACO participant list. 
This commenter urged CMS to examine the impact of this issue and to 
update the beneficiary assignment methodology immediately. This 
commenter also urged CMS to continue attributing Medicare beneficiaries 
to ACOs with Electing Teaching Hospitals (ETAs) as ACO participants 
through Institutional/Part A claims, but to include telehealth 
encounters billed under Institutional/Part A claims (that is, claims 
under HCPCS code Q3014).
    Response: We appreciate the commenter's concern regarding the 
special assignment rules for ETA hospitals that rely on institutional 
claims. However, because we did not

[[Page 84791]]

include institutional claims billed under HCPCS code Q3014 as part of 
the revisions to the definition of ``primary care services'' in the May 
8th COVID-19 IFC, or otherwise propose to add this code to the 
definition of primary care services used for assignment, we cannot 
finalize its inclusion as part of this final rule. We also note section 
1899(c) of the Act, which governs the assignment process under the 
Shared Savings Program, and the implementing regulations at part 425 
subpart E, make clear that assignment is based upon primary care 
services furnished by certain practitioners, and services reported on 
claims from FQHCs and RHCs, which are treated as primary care services 
performed by a primary care physician. Because HCPCS code Q3014 
describes a telehealth originating facility site fee that is billable 
by the site hosting the patient rather than the distant site physician 
or practitioner who is furnishing the service and does not identify the 
actual service that was furnished during the telehealth visit, it does 
not represent a primary care service that may be considered in the 
assignment methodology under the Shared Savings Program.
    Comment: Some commenters expressed concerns about anomalous CY 2020 
utilization patterns impacting beneficiary assignment. For example, as 
one commenter detailed, the COVID-19 pandemic could cause an overall 
decrease in assigned beneficiaries, and change the demographics of the 
assigned population (including beneficiaries' CMS-HCC risk profiles). 
Some commenters were especially concerned about the impact on ACOs 
under prospective assignment. For example, one commenter explained that 
these ACOs may experience a disproportionate increase in their average 
risk score, due to the loss of relatively healthy beneficiaries who 
were assigned to an ACO based on only 1-2 visits as beneficiaries' 
care-seeking behaviors have changed as a result of the pandemic (for 
example, receiving care through telehealth outside the ACO, sheltering 
in a different geographic location and receiving services from 
healthcare providers there, and deferring or foregoing routine care). 
Some commenters suggested that CMS address the impact of atypical 
patterns of care on beneficiary assignment by adjusting the data used 
in determining assignment. For instance, a few commenters suggested 
that CMS disregard 2020 data when determining assignment for benchmark 
or performance years, but did not provide detailed suggestions for an 
alternative approach. Some commenters suggested that CMS use an 
extended assignment window for determining PY 2021 prospective 
assignment, such as a 24-month or 18-month assignment window instead of 
a 12-month assignment window, which would include months during 2020. 
One commenter suggested that CMS carefully review the methodology to 
ensure that beneficiary assignment is fair and equitable.
    Response: We continue to monitor assignment trends. To date, we 
have seen minimal decreases in the overall number of beneficiaries 
assigned to ACOs participating in the Shared Savings Program, with a 
slight decrease (-3.0 percent) in the median number of beneficiaries 
assigned to individual ACOs between Q1 and Q3 2020. We interpret the 
comments suggesting that we disregard 2020 data in benchmark and 
performance year assignment to mean that CMS should not use fee-for-
service claims with dates of service in 2020 to assign beneficiaries, 
and instead determine alternate assignment windows that do not include 
2020. At this time, we are not adopting commenters' suggestions to 
disregard 2020 data in benchmark year and performance year assignment, 
or to redefine the assignment window for PY 2021 prospective assignment 
to include additional months, as our analyses of assignment and 
utilization trends indicate such policy updates are not necessary. We 
will continue to monitor the impact of the PHE for COVID-19 on 
assignment and may consider proposing changes in future notice and 
comment rulemaking if warranted.
(3) Applicability of Expanded Definition of Primary Care Services
    After further consideration of our existing beneficiary assignment 
methodology in part 425, subpart E, which includes the use of an 
assignment window to conduct beneficiary assignment for both benchmark 
and performance years, we have determined that it is necessary to 
modify Sec.  425.400(c)(2) to better reflect the way in which we 
conduct assignment for the Shared Savings Program.
    In the June 2015 final rule (80 FR 32699) we finalized the 
definition of ``assignment window'' under Sec.  425.20 to mean the 12-
month period used to assign beneficiaries to an ACO. As described in 
the December 2018 final rule, the assignment window for ACOs under 
prospective assignment is a 12-month period off-set from the calendar 
year, while for ACOs under preliminary prospective assignment with 
retrospective reconciliation, the assignment window is the 12-month 
period based on the calendar year (83 FR 67861). Operationally, in 
determining beneficiary assignment for each performance year and 
benchmark year, we identify allowed charges for services billed under 
the HCPCS and CPT codes included in the applicable definition of 
primary care services under Sec.  425.400(c), and according to the 
methodology specified in subpart E of the Shared Savings Program's 
regulations, during all months of the 12-month period of the assignment 
window.
    The new provision at Sec.  425.400(c)(2) states that we will apply 
the expanded definition of primary care services, which includes codes 
for virtual check-ins, remote evaluation e-visits, telephone E/M 
services, and telehealth, to determine beneficiary assignment for the 
performance year starting on January 1, 2020, and for any subsequent 
performance year that starts during the PHE for COVID-19 as defined in 
Sec.  400.200. We have determined it is necessary to modify the 
provision to make clear that the expanded definition of primary care 
services will apply not only to assignment for performance years during 
the PHE for COVID-19, but also to assignment for any benchmark years 
during the PHE.
    To further clarify the applicability of the expanded definition of 
primary care services, we believe it is necessary to specify when a 
performance year's or benchmark year's assignment is affected by the 
PHE for COVID-19, because the assignment window for such years may span 
a period which includes months during or outside the PHE for COVID-19. 
For consistency with our operational approach, we believe it is 
necessary to apply the definition of primary care services consistently 
to all months of the assignment window. Further, because the HCPCS and 
CPT codes included in the expanded definition of primary care services 
in Sec.  425.400(c)(2) capture the unique utilization patterns during 
the PHE for COVID-19, we believe that applying this expanded definition 
to all months of the assignment window will help ensure we are 
appropriately identifying the ACO's assigned population that will be 
used in determining ACOs' financial performance.
    As discussed in section III.G.2.a of this final rule, we are 
finalizing the inclusion of online digital E/M services CPT codes 
(99421, 99422, and 99423) and HCPCS codes G2010 (code for the remote 
evaluation of patient video/images) and G2012 (code for virtual check-
in) in the definition of primary care services under Sec.  
425.400(c)(1)(v), applicable for the performance year

[[Page 84792]]

starting on January 1, 2021, and subsequent performance years. The 
telephone E/M services CPT codes (99441, 99442, and 99443), included in 
the expanded definition of assignment under Sec.  425.400(c)(2) but not 
under Sec.  425.400(c)(1), are not payable under the Medicare Physician 
Fee Schedule payment rules outside of the PHE for COVID-19. We 
anticipate that applying the telephone E/M services CPT codes to months 
of the assignment window that occur outside of the PHE for COVID-19 
will have a limited impact on assignment.
    Therefore, we are revising Sec.  425.400(c)(2) to make clear that 
we will use the expanded definition of primary care services to 
identify allowed charges used in beneficiary assignment when the 
assignment window for a benchmark or performance year includes any 
month(s) during the PHE for COVID-19, as defined in Sec.  400.200. 
Furthermore, in determining beneficiary assignment, we will consider 
services billed under the additional primary care service codes 
specified in Sec.  425.400(c)(2) during all months of the assignment 
window, including months that occur outside of the PHE for COVID-19.
    The following example illustrates the applicability of the approach 
we are finalizing. For ACOs under prospective assignment, beneficiary 
assignment for PY 2021 will be based on the October 1, 2019, through 
September 30, 2020 assignment window, which includes months before the 
start of and during the PHE for COVID-19. Accordingly, we will consider 
any services billed under the additional primary care service codes 
specified in Sec.  425.400(c)(2) during this assignment window when 
conducting beneficiary assignment for PY 2021. Further, we will use 
this same approach in determining prospective assignment for 2021 when 
it serves as a benchmark year.
    We also wish to clarify that the expanded definition of primary 
care services specified in Sec.  425.400(c)(2) does not apply for 
purposes of determining prospective assignment for PY 2020, or under 
prospective assignment for 2020 when it serves as a benchmark year, 
because the months in the assignment window were not during the PHE for 
COVID-19. Prospective assignment is completed before the start of the 
performance year, according to Sec.  425.400(a)(3). Although we may 
make certain adjustments to remove beneficiaries from an ACO's 
prospective assignment list if they are no longer eligible for 
assignment according to Sec.  425.401(b), we do not add beneficiaries 
to an ACO's prospective assignment list after the start of the 
performance year, as described in earlier rulemaking (see for example, 
80 FR 32774 and 32775). Prospective assignment for PY 2020 was 
completed prior to the start of the PHE for COVID-19, based on services 
furnished during the assignment window from October 1, 2018, through 
September 30, 2019. As a result, we do not believe it is either 
necessary to address the change in care patterns during the PHE for 
COVID-19 or consistent with the prospective assignment methodology in 
Sec.  425.400(a)(3) to update PY 2020 beneficiary assignment for ACOs 
under prospective assignment to reflect utilization of the primary care 
services specified in Sec.  425.400(c)(2) during the assignment window 
for the performance year.
    Accordingly, for clarity and greater consistency with the 
beneficiary assignment methodology in part 425, subpart E, we are 
revising the text of the regulation at Sec.  425.400(c)(2) to specify 
that the additional primary care service codes will be used in 
conducting beneficiary assignment when the assignment window (as 
defined in Sec.  425.20) for a benchmark or performance year includes 
any month(s) during the PHE for COVID-19 defined in Sec.  400.200. We 
are also adding a new provision at Sec.  425.400(c)(2)(ii) to specify 
that we will apply the additional primary care service codes, specified 
in Sec.  425.400(c)(2)(i) (as renumbered), to all months of the 
assignment window (as defined in Sec.  425.20), when the assignment 
window includes any month(s) of the PHE for COVID-19 as defined in 
Sec.  400.200. We are also making conforming revisions to renumber the 
existing provisions of the regulation at Sec.  425.400(c)(2) to reflect 
this addition.
    In the May 8th COVID-19 IFC (85 FR 27583), we determined that there 
was good cause to waive prior notice and comment rulemaking in order to 
implement the expanded definition of primary care services in Sec.  
425.400(c) immediately for purposes of determining beneficiary 
assignment for PY 2020. In addition, we also explained that we believed 
it would be contrary to the public interest not to implement certain 
Medicare provisions in the IFC as soon as we were authorized to do so 
under the authority of section 1871(e)(1)(A)(ii) of the Act, that is, 
retroactively to either the start of the national emergency or the PHE 
for the COVID-19 pandemic, as applicable (85 FR 27609). Because the 
revisions we are making to Sec.  425.400(c)(2) in this final rule are 
intended to clarify the applicability of the expanded definition of 
primary care services to the determination of beneficiary assignment, 
we believe it is in the public interest to use our authority under 
section 1871(e)(1)(A)(ii) of the Act to apply this change retroactively 
to ensure that it applies to the determination of beneficiary 
assignment under Sec.  425.400(a)(2) for the performance year starting 
on January 1, 2020, for ACOs under preliminary prospective assignment 
with retrospective reconciliation. We note that this is consistent with 
the applicability date for the provision as originally adopted in the 
May 8th COVID-19 IFC (see 85 FR 27551, 27609).
    We will apply this expanded definition of primary care services, as 
revised, to determine beneficiary assignment for ACOs under prospective 
assignment according to Sec.  425.400(a)(3), and for ACOs under 
preliminary prospective assignment with retrospective reconciliation 
according to Sec.  425.400(a)(2). The revised definition is also 
applicable for purposes of determining beneficiary assignment for Track 
1+ Model ACOs in the same way in which it applies to Shared Savings 
Program ACOs under prospective assignment according to Sec.  
425.400(a)(3).\96\ We also note that we will apply this revised 
definition consistently when performing beneficiary assignment in 
program operations, which includes (for example), determining the ACO's 
performance year assigned population, determining the assigned 
population for purposes of producing quarterly assignment list reports 
and quarterly aggregate reports for ACOs, and determining assignment 
for benchmark years.
---------------------------------------------------------------------------

    \96\ Refer to the terms of the Track 1+ Model Participation 
Agreement, available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/track-1plus-model-par-agreement.pdf.
---------------------------------------------------------------------------

    In summary, following consideration of the comments received in 
response to the May 8th COVID-19 IFC, we are finalizing the regulation 
at Sec.  425.400(c)(2) with modifications. We are finalizing the use of 
the following additional primary care codes in determining beneficiary 
assignment when the assignment window (as defined at Sec.  425.20) for 
a benchmark or performance year includes any months during the PHE for 
COVID-19 defined in Sec.  400.200: (1) HCPCS code G2010 (remote 
evaluation of patient video/images) and HCPCS code G2012 (virtual 
check-in); (2) CPT codes 99421, 99422 and 99423 (online digital 
evaluation and management service (e-visit)); and

[[Page 84793]]

(3) CPT codes 99441, 99442, and 99443 (telephone evaluation and 
management services). Additionally, in this final rule we are revising 
the regulation to add a new provision at Sec.  425.400(c)(2)(ii) to 
specify that we will apply the additional primary care service codes, 
specified in Sec.  425.400(c)(2)(i) (as renumbered), to all months of 
the assignment window (as defined in Sec.  425.20), when the assignment 
window includes any month(s) during the PHE for COVID-19 defined in 
Sec.  400.200.
f. Applicability of Policies to Track 1+ Model ACOs
    In the May 8th COVID-19 IFC (85 FR 27586 and 27587), we provided a 
comprehensive discussion of the applicability of policies, either 
clarified or modified by the IFC, to Track 1+ Model ACOs. We explained 
which changes to Shared Savings Program regulations would apply to 
Track 1+ Model ACOs, and which changes in policies would become 
applicable to Track 1+ Model ACOs through an amendment to the ACO's 
Track 1+ Model Participation Agreement.\97\
---------------------------------------------------------------------------

    \97\ See for example, the Medicare ACO Track 1+ Model 
Participation Agreement, available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/track-1plus-model-par-agreement.pdf.
---------------------------------------------------------------------------

    Generally, comments regarding the application of policies discussed 
in the May 8th COVID-19 IFC, to Track 1+ Model ACOs have been addressed 
as part of the discussion of those policies elsewhere in section 
III.G.5 of this final rule. Accordingly, rather than repeating comments 
related to the applicability of these policies to ACOs participating in 
the Track 1+ Model, we refer readers to the relevant discussion in 
section III.G.5. of this final rule.

H. Notification of Infusion Therapy Options Available Prior To 
Furnishing Home Infusion Therapy Services

    Section 5012 of the 21st Century Cures Act (Cures Act) (Pub. L. 
114-255; enacted December 13, 2016) created a separate Medicare Part B 
benefit under section 1861(s)(2)(GG) and section 1861(iii) of the Act 
to cover home infusion therapy-associated professional services for 
certain drugs and biologicals administered intravenously or 
subcutaneously through a pump that is an item of durable medical 
equipment, effective for January 1, 2021. Section 5012 of the Cures Act 
also added section 1834(u) to the Act, which establishes the payment 
and related requirements for home infusion therapy under this benefit. 
Section 1834(u)(6) of the Act requires that, prior to the furnishing of 
home infusion therapy to an individual, the physician who establishes 
the plan of care described in section 1861(iii)(1) of the Act shall 
provide notification (in a form, manner, and frequency determined 
appropriate by the Secretary) of the options available (such as home, 
physician's office, HOPD) for the furnishing of infusion therapy under 
this part.
    As discussed in the 2021 PFS proposed rule, (85 FR 50074), we 
recognize there are several possible forms, manners, and frequencies 
that physicians may use to notify patients of their infusion therapy 
treatment options. We solicited comments in the CY 2020 PFS proposed 
rule (84 FR 40716) and the CY 2020 HH PPS proposed rule (84 FR 34694), 
regarding the appropriate form, manner, and frequency that any 
physician must use to provide notification of the treatment options 
available to their patient for the furnishing of infusion therapy (home 
or otherwise) under Medicare Part B. We also invited comments on any 
additional interpretations of this notification requirement. We 
summarized the comments received in the CY 2020 PFS final rule (84 FR 
62568) and the CY 2020 HH PPS final rule (84 FR 60478), and we stated 
we would take these comments into consideration as we continue 
developing future policy through notice-and-comment rulemaking.
    Many commenters stated that physicians already routinely discuss 
the infusion therapy options with their patients and annotate these 
discussions in their patients' medical records. For home infusion 
therapy services effective beginning CY 2021, physicians are to 
continue with the current practice of discussing options available for 
furnishing infusion therapy under Part B and annotating these 
discussions in their patients' medical records prior to establishing a 
home infusion therapy plan of care. We did not propose to create a 
mandatory form nor did we propose to require a specific manner or 
frequency of notification of options available for infusion therapy 
under Part B prior to establishing a home infusion therapy plan of 
care, as we believe that current practice provides appropriate 
notification. However, we noted that if current practice is later found 
to be insufficient in providing appropriate notification to patients of 
the available infusion options under Part B, we may consider additional 
requirements regarding this notification in future rulemaking. We 
referred stakeholders to the CY 2020 HH PPS final rule (84 FR 60478) 
for further information regarding the policies on home infusion therapy 
services beginning CY 2021 and for subsequent years.
    In response to the 2021 PFS proposed rule, (85 FR 50252), we 
received 14 public comments, all in support of physicians continuing 
with the current practice of discussing options available for 
furnishing infusion therapy under Part B and annotating these 
discussions in their patients' medical records prior to establishing a 
home infusion therapy plan of care. Two of these commenters mentioned 
other issues that were discussed in the CY 2020 HH PPS final rule (84 
FR 60478) regarding the general home infusion therapy services policy. 
After consideration of these comments, and since we did not propose any 
specific requirements, we are not adopting specific notification 
requirements in this final rule. Rather, as noted previously, if 
current practice is later found to be insufficient, we may consider 
additional requirements regarding this notification in future 
rulemaking. Stakeholders may refer to the CY 2020 HH PPS final rule (84 
FR 60478) for further information regarding the policies on home 
infusion therapy services beginning CY 2021.

I. Modifications to Quality Reporting Requirements and Comment 
Solicitation on Modifications to the Extreme and Uncontrollable 
Circumstances Policy for Performance Year 2020

    Following the hurricanes and wildfires during 2017, we issued an 
IFC, entitled ``Medicare Shared Savings Program: Extreme and 
Uncontrollable Circumstances Policies for Performance Year 2017,'' 
which appeared in the December 26, 2017 Federal Register (82 FR 60912) 
(hereinafter referred to as the ``December 2017 IFC''). The December 
2017 IFC established a policy for determining quality performance 
scores for ACOs, when the ACO was impacted by extreme and 
uncontrollable circumstances such as hurricanes, wildfires, or other 
triggering events, in performance year 2017, including the applicable 
quality reporting period for the performance year if the quality 
reporting period was not extended. In the CY 2019 PFS final rule, we 
extended the policies finalized in 2017 to performance year 2018 and 
subsequent performance years. In the March 31st COVID-19 IFC (85 FR 
19267 and 19268), we updated the extreme and uncontrollable 
circumstances policy to eliminate the restriction that the policy 
applies only if the quality reporting period is not extended.
    We determine whether an ACO has been impacted by an extreme and

[[Page 84794]]

uncontrollable circumstance using the following criteria:
     20 percent or more of the ACO's assigned beneficiaries 
reside in an area identified under the Quality Payment Program as being 
affected by an extreme and uncontrollable circumstance (Sec.  
425.502(f)(1)(i)).
     The ACO's legal entity is physically located in an area 
identified as being affected by an extreme and uncontrollable 
circumstance under the Quality Payment Program (Sec.  
425.502(f)(1)(ii)).
    Under the current regulation at Sec.  425.502(f)(2), ACOs that meet 
one or both of the above criteria will have their quality performance 
score set to equal the mean quality performance score for all Shared 
Savings Program ACOs for the relevant performance year. However, if an 
ACO that meets one or both of the criteria above completely and 
accurately reports all quality measures, we use the higher of the ACO's 
quality performance score or the mean quality performance score for all 
Shared Savings Program ACOs to calculate the ACO's quality performance 
score.
    The PHE for COVID-19 applies to all counties in the United States, 
and therefore, for performance year 2020 all ACOs are considered to be 
affected by an extreme and uncontrollable circumstance.
1. Changes to the CAHPS for ACOs Reporting Requirements for Performance 
Year 2020
    In the CY 2021 PFS proposed rule, we explained that as part of the 
March 31st COVID-19 IFC, we made updates to the Part C and Part D Star 
Rating Systems for 2021 and 2022 based on concerns that the PHE for 
COVID-19 would pose significant challenges and safety concerns in 
successfully completing the CAHPS survey. In the March 31st COVID-19 
IFC, we noted that many of the survey administration protocols could 
not be completed remotely, requiring staff to work in mail facilities 
and call centers where telephone interviewers assemble in close 
quarters to perform the telephone administration of the survey. 
Accordingly, to be in compliance with social distancing, travel bans, 
quarantine, and promoting health and safety of all involved in CAHPS 
data collection, we amended regulations in parts 417, 422, and 423 to 
eliminate requirements for collection of CAHPS data for performance 
year 2020 (85 FR 19271 and 19272).
    In order to maintain consistency with the public safety 
determinations made in the March 31st COVID-19 IFC with respect to the 
CAHPS survey that is used in the Part C and Part D Star Ratings 
Systems, as noted above, and to address concerns about the negative 
impacts of COVID-19 on sample size and performance scores, we proposed 
to modify our regulations to remove the requirement that ACOs field a 
CAHPS for ACOs survey for performance year 2020. Instead, we proposed 
that ACOs would automatically receive full credit for each of the CAHPS 
survey measures within the patient/caregiver experience domain for 
performance year 2020. We acknowledged that the proposal would be 
retroactive for performance year 2020. However, section 1871(e)(1)(A) 
of the Act allows for retroactive application of a substantive change 
when the failure to apply the change retroactively would be contrary to 
the public interest. Based on the concerns described in the proposed 
rule, we concluded it would be in the public interest not to require 
ACOs to field the CAHPS for ACOs survey. Accordingly, we proposed to 
amend Sec.  425.500(d) to add language stating that for performance 
year 2020 we would waive the CAHPS for ACOs reporting requirement and 
would automatically give all ACOs full credit for the CAHPS for ACOs 
survey measures (85 FR 50252 through 50254).
    We sought comment on the proposal to waive the CAHPS for ACOs 
reporting requirement and to give ACOs full credit for the CAHPS for 
ACOs survey measures for performance year 2020. The following is a 
summary of the comments we received and our response.
    Comment: A majority of commenters supported our proposal to waive 
the CAHPS for ACOs reporting requirement for performance year 2020 and 
to provide ACOs automatically with full credit for each of the CAHPS 
survey measures. Commenters pointed to inadequate sample size, an 
inability to generalize results of the survey due to safety measures 
implemented during the PHE for COVID-19, reduction of burden on 
Medicare ACO beneficiaries, and concerns that paper surveys were not a 
sanitary choice for gathering feedback, as reasons why they supported 
our proposal. Only one commenter urged CMS to require ACOs to 
participate in the CAHPS for ACOs survey in a pay-for-reporting 
capacity for PY 2020 or to at least encourage interested ACOs to 
voluntarily participate in the survey. The commenter explained that 
without the CAHPS for ACOs survey, ACOs will be unable to capture the 
experience of patients during the PHE for COVID-19, as well as continue 
internal performance improvement efforts.
    Response: We appreciate the support for our proposal to remove the 
CAHPS for ACOs survey reporting requirement for performance year 2020 
and to give ACOs automatic full credit for each of the CAHPS survey 
measures. We acknowledge the commenter's concern with regard to ACOs' 
inability to capture the experience of patients during the PHE for 
COVID-19; however, we note that outside of the Shared Savings Program 
requirements, each ACO is at liberty to determine if it wants to 
continue with the administration of the CAHPS for ACOs survey. 
Therefore, we are finalizing our proposal to waive the CAHPS for ACOs 
reporting requirement for performance year 2020 and to assign all ACOs 
automatic credit for each of the CAHPS survey measures within the 
patient/caregiver experience domain. We are adopting the proposed 
amendments to Sec.  425.500(d) without modification.
2. Comment Solicitation on Modifications to the Extreme and 
Uncontrollable Circumstances Policy for Performance Year 2020
    In the March 31st COVID-19 IFC (85 FR 19267-68), we noted that we 
would consider whether the current extreme and uncontrollable 
circumstances policy under which we assign an ACO the higher of the 
mean quality score across all ACOs and the ACO's own quality score, in 
the event the ACO is determined to be impacted by an extreme and 
uncontrollable circumstance would continue to be appropriate for PY 
2020 and beyond. We explained that any change to that current policy 
would be made through future notice and comment rulemaking. While we 
did not propose any specific changes to the extreme and uncontrollable 
circumstances policy for PY 2020 in the March 31st COVID-19 IFC, we did 
receive public comments in response to both the March 31st COVID-19 IFC 
and the May 8th COVID-19 IFC regarding the impact of the PHE for COVID-
19 on quality reporting and quality performance for PY 2020. The 
following is a summary of the comments we received in response to both 
the March 31st COVID-19 IFC and the May 8th COVID-19 IFC and our 
response.
    Comment: Many commenters urged CMS to make all ACO quality measures 
pay-for-reporting for PY 2020. Several of the commenters who suggested 
this approach stated that the current extreme and uncontrollable 
circumstances policy was better suited for focal disasters, such as 
hurricanes or floods. The commenters explained that as a result of the 
PHE for COVID-19, ACO participants have faced, and will continue to 
face, numerous challenges during 2020, such as prioritizing care

[[Page 84795]]

for COVID-19 patients, canceling in-person preventative and chronic 
condition management visits to prevent the spread of the virus, and 
supplying personal protective equipment for the safety of healthcare 
providers and patients. Commenters stated that a move towards pay-for-
reporting for 2020 would provide ACOs and their participating providers 
and suppliers the flexibility to respond to the PHE for COVID-19 while 
continuing to monitor and report these metrics. One commenter noted 
that the quality of care and patients' experience of care is as 
important as ever during these unprecedented times and encouraged CMS 
to continue to collect quality measure data as feasible and appropriate 
in 2020. The commenter explained that making quality measures pay-for-
reporting in PY 2020 would ensure that an ACO's quality score does not 
adversely impact its financial performance due to factors outside of 
the ACO's control, such as COVID-19 related shifts in care delivery 
sites and staffing, deferred routine care, and increased telehealth 
utilization. The commenter stated that reverting quality scores to pay-
for-reporting would also help to offset the anticipated deflationary 
impact of deferred care on the PY 2020 benchmark, which would lower the 
total amount of savings available to Shared Savings Program ACOs. 
Another commenter explained that pay-for-reporting for PY 2020 is 
warranted because, for the remainder of 2020, hospitals, group 
practices, and individual healthcare providers will be focused almost 
exclusively on urgent or emergent patients, as well as protecting 
themselves, their staff, and other patients from the coronavirus. One 
commenter stated that some measures would be difficult to satisfy if 
patients are not engaging with their healthcare providers in office or 
via telehealth and that, the restriction on elective procedures could 
make it difficult for patients to get their breast cancer, colon 
cancer, and various other screenings. The commenter noted that this 
problem could get worse if there is a resurgence of COVID-19 in the 
fall.
    For various reasons, many commenters asserted that the current 
extreme and uncontrollable circumstances policy, which assigns an ACO 
the higher of the mean quality score across all ACOs and the ACO's own 
quality score, is insufficient for PY 2020 and beyond. One commenter 
explained that given the massive shifts in care delivery sites and 
staffing, increased telehealth utilization, data collection challenges 
and other COVID-19 related impacts in 2020, the application of either 
an average quality score or an individual ACO's own quality score based 
on data from the 2020 performance year is neither feasible nor 
appropriate. Other commenters expressed concern that the current 
extreme and uncontrollable circumstances policy is insufficient to 
mitigate the vast impacts of the PHE for COVID-19 on ACO quality 
performance because many ACOs are deploying their quality improvement 
staff to provide clinical care and assist in triaging patients, 
detracting them from their more typical quality improvement and care 
coordination work. These commenters explained that while there is value 
in ACOs' reporting what data they can during this challenging time, 
ACOs should not be held accountable to typical quality performance 
standards during this highly irregular PHE for COVID-19.
    Several commenters expressed concerns about whether ACOs could meet 
the quality reporting requirements for PY 2020 because of the shift to 
providing services via telemedicine. One commenter stated that while 
CMS has expanded telehealth coverage for Medicare beneficiaries, 
several quality measures cannot be properly met in a remote setting 
such as immunizations and mammography screening, which are services 
that can only be performed in person. Another commenter requested that 
CMS allow patient-reported information provided during telehealth 
visits to satisfy quality measures where applicable. The commenter 
explained that per the quality measure specification for HTN-2 (NQF 
0018)(ACO-28): Controlling High Blood Pressure, only blood pressure 
readings performed by a clinician or a remote monitoring device are 
acceptable for numerator compliance with this measure and that CMS does 
not permit information reported or taken by the member. The commenter 
noted that Medicare beneficiaries may be reluctant to have an in-person 
office visit and may not have access to a remote monitoring device, as 
described in the measure specification, and their information may not 
be available for use in determining the ACO's performance on the 
measure.
    Other commenters suggested that CMS should allow ACOs to continue 
quality reporting efforts when possible, but that CMS should hold the 
ACOs harmless for any performance changes. Several commenters explained 
that it would not be appropriate to compare performance during 2020 to 
quality benchmarks established based on performance in previous years 
because the avoidance of care by patients and the postponement of 
certain critical services to preserve PPE will have lasting effects on 
quality. These commenters stated that they believe that ACOs will 
struggle to manage patients with chronic conditions and to provide 
proper preventive care during this time because patients are avoiding 
primary care, well visits, chronic care maintenance, and other health 
services. For these reasons, these commenters encouraged CMS to exclude 
2020 quality performance data from future quality benchmarking. One 
commenter suggested that CMS mirror past Shared Savings Program 
performance rates and essentially grade on a curve for 2020. The 
commenter explained that the quality benchmarks should be adjusted so 
that the average Shared Savings Program quality score mirrors the 
average Shared Savings Program quality score in 2018. The commenter 
stated that this approach would keep the focus on quality and allow CMS 
to use quality performance to differentiate among ACOs in 2020, but 
would not unfairly transfer savings from ACOs to CMS due to 
difficulties in maintaining high rates of performance on quality 
measures (particularly routine preventative measures) during the PHE 
for COVID-19.
    For PY 2021 and beyond, several commenters urged CMS to continue to 
study the impact of the PHE for COVID-19 on ACO quality performance in 
the months and years to come, as it is likely that additional policy 
changes will be necessary in the future. Other commenters encouraged 
CMS to consider how to mitigate the long-term impact of the PHE for 
COVID-19 on quality performance and stated that it might be necessary 
to modify quality measures that have narrow timelines for performance 
and to reset the measure targets in future years. One commenter 
suggested that CMS should commit to ongoing reevaluations of the Shared 
Savings Program and the other APMs it operates to adjust for any 
changes in patient risk and resource use in future financial and 
quality measurement methodologies. Another commenter requested that CMS 
collaborate closely with ACOs and health systems across the country to 
monitor and address the impacts of the PHE for COVID-19 on clinical 
quality and quality measure benchmarks in future performance years.
    Response: We appreciate the feedback from commenters and we 
understand that there are myriad concerns related to quality reporting 
and quality performance for performance year 2020. However, we believe 
that ACOs should

[[Page 84796]]

be in a position to report CMS Web Interface measures for performance 
year 2020 beginning in January 2021. All ACOs were determined to be 
impacted by the PHE for COVID-19, which was declared during the quality 
reporting period for performance years starting in 2019. Yet, 98.7 
percent of ACOs completely reported CMS Web Interface measures for 
2019, including all 65 ACOs that were also impacted by a natural 
disaster during 2019 or the quality reporting period. We want to 
encourage reporting for performance year 2020 while still being 
cognizant of the impacts that the PHE for COVID-19 could have on 
quality reporting and quality performance. Accordingly, we do not 
believe that it is necessary to make performance year 2020 a pay-for-
reporting year. Rather, we believe that maintaining our current extreme 
and uncontrollable circumstances policy, coupled with giving ACOs 
automatic full credit for the CAHPS for ACOs survey measures, offers 
appropriate relief to ACOs for performance year 2020, while still 
incentivizing ACOs to fully and completely report the remaining 
measures. All 10 CAHPS for ACOs survey measures are in one of the four 
domains used to calculate an ACO's quality performance score. This 
means 25 percent of an ACO's quality performance score for performance 
year 2020 would come from receiving full credit on the CAHPS for ACOs 
survey measures. In addition, each of the other three domains has at 
least one or more measures that is pay-for-reporting in performance 
year 2020, resulting in over 50 percent of the measures (14 out of 23) 
being assigned full points if the ACO completely and accurately reports 
quality data. Furthermore, because there is at least one measure in 
each domain for which ACOs would receive full points provided they 
completely report quality data, ACOs in their second or subsequent 
performance year would achieve the minimum attainment level on at least 
one measure in each domain as required under Sec.  425.502(d)(2)(iii) 
to be eligible to share in any savings. We believe this may address 
some of the concerns expressed by stakeholders about the impact of the 
PHE for COVID-19 on 2020 quality performance. We also believe it is in 
the public interest to encourage ACOs to report quality data because 
ACOs could otherwise share in any savings earned without being held 
accountable for the quality of care that they provide to the more than 
11 million beneficiaries who receive care through Shared Savings 
Program ACOs. In addition to incentivizing the reporting of quality of 
care measures, we believe it is critical to incorporate ACO performance 
on those measures into quality performance scoring for performance year 
2020 in a meaningful way that also considers the impact of the current 
PHE for COVID-19.
    Although we did not propose any specific modifications to the 
extreme and uncontrollable circumstances policy for performance year 
2020 in the CY 2021 PFS proposed rule, we did solicit comment on a 
potential alternative approach to scoring ACOs for performance year 
2020. The potential alternative modification we considered would be 
similar to the current policy for scoring quality performance under the 
extreme and uncontrollable circumstances policy, but would use the 
higher of an ACO's 2020 quality performance score or its 2019 quality 
performance score for ACOs that completely report web interface data 
for 2020. For new ACOs that completely report, we would continue to 
score them as pay-for-reporting and assign a quality score of 100 
percent. ACOs that do not complete quality reporting would receive the 
2020 ACO mean quality score as provided in Sec.  425.502(f)(2).
    Specifically, we solicited comments on the following potential 
modifications to the extreme and uncontrollable circumstances policy 
for performance year 2020:
    (1) If an ACO in a second or subsequent performance year completely 
and accurately reports the CMS Web Interface measures for performance 
year 2020, the ACO will receive the higher of its performance year 2020 
ACO quality performance score that would include automatic full credit 
for the CAHPS for ACOs survey measures, or the score used in 2019 for 
purposes of financial reconciliation. For re-entering ACOs that 
terminated in their second or subsequent agreement period, the ACO 
would receive the higher of its most recent prior ACO quality 
performance score or its 2020 quality performance score.
    (2) If an ACO in a second or subsequent performance year or a re-
entering ACO that terminated in its second or subsequent agreement 
period does not completely and accurately report the CMS Web Interface 
measures for performance year 2020, the ACO will receive the 2020 ACO 
mean quality performance score.
    (3) If an ACO in its first performance year in the program or a re-
entering ACO that terminated in its first agreement period and is now 
in its first performance year of a new agreement period completely and 
accurately reports the CMS Web Interface measures, it will receive a 
quality performance score of 100 percent that reflects automatic full 
credit for the CAHPS for ACO survey measures.
    (4) If an ACO in its first performance year or a re-entering ACO 
that terminated in its first agreement period and is now in its first 
performance year of a new agreement period, does not completely and 
accurately report the CMS Web Interface measures for performance year 
2020, it will receive the 2020 mean ACO quality performance score.
    We received public comments on this potential alternative approach 
to scoring ACOs under the extreme and uncontrollable circumstances 
policy for performance year 2020. The following is a summary of the 
comments we received and our response.
    Comment: While many commenters supported the alternative approach 
of assigning the higher of the ACO's 2019 or 2020 quality scores for 
ACOs that report quality, they explained that they considered this a 
``fallback option'' and that they would prefer CMS to convert all 
measures to pay-for-reporting for performance year 2020 due to the 
impact of the PHE for COVID-19.
    Response: The intent of the Shared Savings Program extreme and 
uncontrollable circumstances policy is to mitigate any negative impact 
of an extreme and uncontrollable circumstance on an ACO's quality 
performance or ability to report quality data to CMS and the resultant 
effect on financial reconciliation due to emergency circumstances 
outside of the ACO's control. As discussed above, given the high 
percentage of ACOs that completely reported CMS Web interface measures 
for 2019, we believe that ACOs should be in a similar position to 
report CMS Web Interface measures for performance year 2020 beginning 
in January 2021. While we understand commenters' concerns about the 
potential adverse impacts of the PHE for COVID-19 on quality reporting 
and quality performance scores, more than half of the measures in the 
Shared Savings Program quality measure set are pay-for-reporting for 
all ACOs for performance year 2020, which is higher than in previous 
years. We appreciate commenters' feedback on the potential alternative 
approach to scoring ACOs under the extreme and uncontrollable 
circumstances policy for performance year 2020. After careful 
consideration, however, we believe that our current extreme and 
uncontrollable circumstances policy, in addition to giving ACOs 
automatic full credit for the CAHPS for ACOs survey measures, will 
mitigate the negative effects of the

[[Page 84797]]

PHE for COVID-19 on quality performance for performance year 2020. 
Accordingly, pursuant to the current regulation at Sec.  425.502(f)(2), 
ACOs will have their quality performance score set to equal the mean 
quality performance score for all Shared Savings Program ACOs for 
performance year 2020. However, if an ACO completely and accurately 
reports all CMS Web Interface measures during the quality reporting 
period, we will use the higher of the ACO's quality performance score 
for performance year 2020 or the mean quality performance score for 
performance year 2020 for all Shared Savings Program ACOs to calculate 
the ACO's quality performance score.
3. Change to Medicare Shared Savings Program Extreme and Uncontrollable 
Circumstances Policy Provision Adopted in the March 31st COVID-19 IFC
    As noted previously in this section, in the March 31st COVID-19 
IFC, we modified the Shared Savings Program extreme and uncontrollable 
circumstances policy as it applies to disasters that occur during the 
reporting period to eliminate the restriction that the extreme and 
uncontrollable circumstances policy applies only if the reporting 
period is not extended (85 FR 19267 through 19268). The PHE for COVID-
19 was declared during the quality reporting period for performance 
years starting in 2019 and it applied to all counties in the United 
States. As we explained in the March 31st COVID-19 IFC, we believed 
that it was appropriate to offer relief under the Shared Savings 
Program extreme and uncontrollable circumstances policy to all Shared 
Savings Program ACOs that were unable to completely and accurately 
report quality for 2019 by the extended deadline due to the PHE for 
COVID-19. We explained that this policy needed to be effective starting 
with the quality reporting period for performance years starting in 
2019 to provide relief for Shared Savings ACOs who needed to focus 
resources on patient care during the PHE for COVID-19. Further, we 
acknowledged that, as illustrated by the current PHE for COVID-19, 
there could be unanticipated situations in the future, during which 
extension of a quality reporting window alone would not provide 
sufficient relief from reporting burden at a time when ACOs and their 
ACO providers and suppliers need to focus on patient care. Accordingly, 
in the March 31st COVID-19 IFC, we amended the regulation at Sec.  
425.502(f) to remove the phrase ``if the quality reporting period is 
not extended,'' effective for quality reporting for performances years 
starting in 2019.
    We received public comments on modifying the extreme and 
uncontrollable circumstances policy as it applies to disasters that 
occur during the reporting period for performance years starting in 
2019 to eliminate the restriction that the extreme and uncontrollable 
circumstances policy applies only if the reporting period is not 
extended. The following is a summary of the comments we received and 
our response.
    Comment: Commenters were supportive of providing relief to all ACOs 
during the reporting period for performance years starting in 2019 by 
eliminating the restriction that the extreme and uncontrollable 
circumstances policy applies only if the reporting period is not 
extended. Commenters stated that this was a thoughtful approach to 
addressing the quality submission challenges resulting from the PHE for 
COVID-19 and welcomed this change. One commenter stated that they 
appreciated the acknowledgment by CMS that the previously issued 30-day 
extension of the PY 2019 quality reporting period alone was 
insufficient relief from the reporting burden for ACOs and their ACO 
providers/suppliers during this public health emergency. Another 
commenter noted appreciation for this approach, explaining that a 
number of physicians may be unable to submit quality data in a timely 
manner due to the demands on their practices associated with the PHE 
for COVID-19.
    Response: We thank commenters for their positive feedback. We are 
finalizing, without modification, the revisions that were made to the 
regulation at Sec.  425.502(f) in the March 31st COVID-19 IFC to remove 
the restriction which prevented the application of the Shared Savings 
Program extreme and uncontrollable circumstances policy for disasters 
that occur during the quality reporting period if the reporting period 
is extended.

J. Removal of Selected National Coverage Determinations

    In the CY 2021 PFS proposed rule (85 FR at 50255), we proposed to 
use the notice and comment rulemaking to identify and remove older NCDs 
that we believed no longer contained clinically pertinent and current 
information or no longer reflected current medical practice. We 
explained that eliminating an NCD changes a substantive legal standard 
related to Medicare coverage and payment under section 1871(a)(2) of 
the Act because items that were covered nationally under Title XVIII 
would no longer be automatically covered by Medicare (42 CFR 405.1060). 
Instead, in the absence of an NCD, the coverage determinations for 
those items and services would be made by Medicare Administrative 
Contractors (MACs). We also noted that if the previous NCD barred 
coverage for an item or service under title XVIII (that is, national 
noncoverage NCD), a MAC would now be able to cover the item or service 
if the MAC determined that such action was appropriate under the 
statute. Removing a national non-coverage NCD may permit access to 
technologies that may be beneficial for some uses. We explained that as 
the scientific community continues to conduct research producing new 
evidence, the evidence base we previously reviewed may have evolved to 
support other policy conclusions. In the proposed rule, we also 
described the circumstances that we had used in determining whether an 
older NCD should be removed.
    We sought public comments that may identify other reasons for 
proposing to remove NCDs. We also noted that we were interested in 
whether the time-based threshold of ``older''--which had been 
designated as 10 years--continued to be appropriate or whether 
stakeholders believe a shorter period of time or some other threshold 
criterion unrelated to time would be more appropriate.
    We also described two previous times that we used an expedited 
public process for removing NCDs. The proposals and final decisions 
related to these removals are located in the Medicare Coverage 
Database, available at https://www.cms.gov/medicare-coverage-database/indexes/medicare-coverage-documents-index.aspx?MCDIndexType=7&mcdtypename=Expedited+Process+to+Remove+National+Coverage+Determinations&bc=AgAAAAAAAAAAAA%3d%3d&.
    As discussed in the proposed rule, we continue to recognize the 
need to periodically review our policies and processes to ensure that 
we remain effective and efficient as well as open and transparent. We 
noted that we are aware that clinical science and technology evolve and 
that items and services that were once considered state-of-the-art or 
cutting edge may be replaced by more beneficial technologies or 
clinical paradigms. Additionally, proactively removing obsolete broad 
non-coverage NCDs removes barriers to innovation and reduces burden for 
stakeholders and CMS. In light of the Supreme Court's decision in Azar 
v. Allina Health

[[Page 84798]]

Services, 587 U.S. ___, 139 S. Ct. 1804 (2019)), we have determined it 
would be appropriate to use the notice and comment rulemaking 
procedures described in section 1871(a)(2) of the Act to remove 
outdated or unnecessary NCDs.
    In Table 37 of the proposed rule, we listed the NCDs that we 
proposed to remove and described the mechanisms by which we identified 
NCDs for consideration. We solicited comment on the nine NCDs discussed 
in Table 41, as well as comments recommending other NCDs for CMS to 
consider for future removal. In the CY 2021 PFS proposed rule, we 
summarized each of the nine NCDs and provided a rationale for removal 
for each one. NCDs are listed in the Medicare National Coverage 
Determinations Manual located at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/internet-Only-Manuals-IOMs-Items/CMS014961.
[GRAPHIC] [TIFF OMITTED] TR28DE20.086

    In summary, we solicited comment on the proposals to remove each of 
the nine NCDs, as well as comments recommending other NCDs for CMS to 
consider for future removal. Additionally, we solicited public comments 
that may identify other reasons for proposing to remove NCDs. We 
solicited comments on whether the time-based threshold of ``older'' 
which was designated as 10 years in the 2013 notice continues to be 
appropriate or whether stakeholders believe a shorter period of time or 
some other threshold criterion unrelated to time is more appropriate. 
We requested commenters include a rationale to support their comments. 
We noted that we will use the public comments to help inform our 
decision to take one of three actions on the nine NCDs proposed for 
removal:
     Remove the NCD, as proposed, allowing for coverage to be 
determined by the MACs.
     Retain the current policy as an NCD.
     Reconsider the NCD. We also noted that comments suggesting 
that the NCD should be revised, rather than eliminated, should include 
previously unreviewed evidence in order to support a change in national 
coverage.
    We received more than 100 public comments on the proposed removal 
of selected NCDs, the process for identifying NCDs for removal, as well 
as the vehicle for removing NCDs. The following is a summary of the 
comments we received and our responses.
    Comment: Many commenters generally supported the proposal to 
periodically identify and remove NCDs that are no longer clinically 
relevant or are infrequently used and appreciated CMS seeking input 
from stakeholders. Commenters agreed with agency efforts to ensure that 
NCDs are based on current scientific evidence, are relevant to the 
Medicare population and some acknowledged that the Medicare coverage 
process is designed to provide greater contractor flexibility. Many 
also agreed with using rulemaking for removing outdated NCDs as a 
transparent way to gather input from stakeholders and ensure 
beneficiary access to services.
    Response: We thank commenters for their support for periodically 
removing outdated NCDs and for their support for using rulemaking.
    Comment: Several commenters noted that CMS should have other 
options for retirement of NCDs that do not include notice and comment 
rulemaking. One commenter stated that rulemaking does not provide 
enough flexibility for CMS to retire obsolete NCDs upon receipt of 
clinical data demonstrating that the NCD is no longer appropriate. 
Another commenter disagreed with CMS' legal interpretation of Supreme 
Court's decision in Azar v. Allina Health Services, 587 U.S. ___, 139 
S. Ct. 1804 (2019), and suggested that the statute provides for CMS to 
remove outdated NCDs through an expedited administrative process such 
as the process we described in 2013 (78 FR 48164). The commenters also 
noted that CMS should have a process that is nimble and flexible and 
requested that CMS finalize a policy that allows retirement of NCDs 
through a subregulatory process similar to the 2013 expedited 
subregulatory administrative process.
    Response: We do not agree that section 1871(a)(2) of the Act would 
permit the removal of multiple NCDs at one time through a subregulatory 
process. While not legally binding on the public, NCDs establish 
controlling coverage policies for particular items and services for 
Medicare contractors and adjudicators in the Medicare appeals process, 
Sec.  405.1060, and establish substantive legal standards related to 
coverage and payment. Given the importance of NCDs in notifying the 
public when particular items or services will (or will not) be covered 
under Title XVIII of the Act, we believe that a public process is 
necessary to remove those controlling policies. We note that Congress 
has separately established a public comment process in section 1862(l) 
of the Act, to be used in making NCDs and that NCDs are expressly 
exempt from the rulemaking requirements in section 1871(a)(2) of the 
Act. While the statute does not establish a specific process for 
removing NCDs, using the process required by section 1871(a)(2) of the 
Act is appropriate when changing a substantive legal standard governing 
the scope of benefits or payment for services. This result is 
consistent with the Supreme Court's

[[Page 84799]]

decision in Azar v. Allina Health Services, 139 S. Ct. 1804 (2019).
    Comment: A few commenters questioned whether we will now be using 
rulemaking for NCD reconsiderations in addition to removals and whether 
we will create new NCDs through rulemaking. One commenter questioned if 
an NCD specifies coverage and non-coverage for multiple indications 
under the NCD, would this process be used to remove non-covered 
indications under the NCD. The commenter also questioned how would CMS 
address situations when a specific non-coverage portion of the NCD 
could be considered for removal.
    Response: We thank commenters for their questions and the 
opportunity to clarify. As noted above, section 1871(a)(2) of the Act 
contains an exception for NCDs, and we are not required to use 
rulemaking procedures to establish or change a particular NCD. We will 
continue to use the NCD procedures established by section 1862(l) of 
the Act and that include an opportunity for public comment to 
reconsider or revise particular NCDs, as explained in the August 7, 
2013 Federal Register notice (78 FR 48164). We proposed to use 
rulemaking to remove multiple old NCDs at one time, which would be more 
efficient than reconsidering each NCD separately.
    Comment: A few commenters questioned whether CMS will use this 
process to remove and/or ``wrap up'' Coverage with Evidence Development 
(CEDs) as well as NCDs, given that CEDs are part of an NCD.
    Response: We may consider using the removal process for CED NCDs in 
the future, but we note that none of the NCDs we proposed for removal 
at this time are CED NCDs.
    Comment: Some commenters stated that CMS should rarely or never 
remove NCDs, but should retain and update them, optimizing appropriate 
use of NCDs rather than minimizing their use. Several commenters noted 
that CMS should only remove NCDs that provide for broad non-coverage, 
such as for items and services once considered experimental. These 
commenters noted that NCDs that provide even limited coverage for 
certain indications act as a floor and should be either retained or 
updated instead of allowing coverage determinations to be made at the 
local level.
    Response: We believe it is in the best interests of the Medicare 
program and Medicare beneficiaries to regularly evaluate both coverage 
and broad-noncoverage NCDs because medical science may change over 
time. When we identify outdated NCDs or stakeholders bring them to our 
attention, we use our discretion either to reconsider and update the 
NCD as appropriate or to propose to remove the NCD if appropriate to 
allow the coverage determination to be made by the local MACs. Removing 
outdated NCDs in some cases can remove barriers to innovation and can 
pave the way for a robust local determination. This flexibility will 
allow stakeholders to provide new evidence for our consideration to 
support either reconsideration or the removal of an outdated NCD. We do 
not agree that it is always in the best interests of beneficiaries to 
keep old NCDs as a coverage floor; there are instances when NCDs are 
outdated and the practice of medicine has changed to the extent that 
some covered indications are obsolete or potentially create coverage 
barriers if the information is no longer current.
    When we evaluate particular NCDs for removal, we take into account 
information gathered from stakeholders, the claims data for those items 
and services, and factors such as whether there may be documentation 
requirements within the NCD that are outdated and create a barrier to 
coverage. The rulemaking process will provide an opportunity to 
consider public input before the NCD would be removed. We could decide 
to retain those NCDs after considering public comments.
    Comment: One commenter suggested that CMS should collect quality 
data collected as a part of an NCD in order to evaluate and maintain 
quality care, particularly related to new technology, previously 
unstudied populations.
    Response: We thank the commenter for the suggestion about 
incorporating quality data into NCDs, though it is outside the scope of 
this proposal. Because there are many different quality programs 
established by the Medicare Act, it is difficult to evaluate in the 
abstract whether data collection through NCDs would be consistent with 
the existing statutory and regulatory requirements.
    Comment: Several commenters opposed removing NCDs, either 
generally, or with regard to specific NCDs in this rule, because they 
believed that Medicare Advantage (MA) Plans are not required to follow 
LCDs created by MACs. The commenters noted removing NCDs that provide 
for coverage or limited coverage will create access barriers for MA 
plan enrollees because they noted the MA plans will choose not to 
continue covering those services.
    Response: We appreciate the commenters' concerns, but believe there 
are sufficient beneficiary protections in place. Medicare Advantage 
plans (MA) are required to cover all Part A and Part B benefits for 
their enrollees, subject to limited exclusions such as for hospice care 
and kidney acquisition costs. The MA program regulation at 42 CFR 
422.101(b) requires, and has required since the inception of the MA 
program, MA plans to comply with the written coverage determinations 
(that is, LCDs) of the local Medicare contracts (that is, the MACs) in 
the geographic area where the MA plan provides coverage (63 FR 34986, 
35077). Section 1852(a)(1)(C) of the Act provides MA plans with the 
option to comply with the LCD that provides the more beneficial 
coverage to the plan's enrollees in cases where the MA plan service 
area includes more than one LCD area. All of this is further explained 
in the Medicare Managed Care Manual, Chapter 4, section 90, available 
at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/mc86c04.pdf.
    Comment: In response to our solicitation for public comments about 
other reasons that may support the removal of an NCD, a number of 
commenters support the continued use of the factors that CMS has used 
in removing outdated NCDs since 2013. Other commenters identified other 
factors that might be relevant for CMS to consider. One commenter 
stated that CMS needs to be more flexible and nimble in responding to 
changes in the standard of care and that the only criterion for removal 
should be presentation of sufficient clinical data to CMS to support 
retirement of an NCD irrespective of how old it is. The requestor 
recommended that CMS provide examples of what amount and type of 
information and clinical data would be ``sufficient'' to support 
removal. The commenter proposed an example of evidence-based 
professional society guidelines with a grade of evidence of A or B as 
sufficient to demonstrate whether an NCD should, and therefore could, 
be retired. Another commenter recommended that CMS assess and propose 
applying criteria similar to those under other Medicare programs, 
including for Medicare Part D.
    Response: We appreciate the commenters that supported the use of 
the factors that CMS had previously used in identifying outdated NCDs. 
We will continue to consider those factors as modified by the 
additional public suggestions. We also agree with the commenter that 
suggested we pay attention to the changes in the standard of care, and 
that some NCDs may need to be removed in those circumstances regardless 
of age. We will consider

[[Page 84800]]

changes in the standard of care in making these determinations. We also 
agree that changes in evidence-based professional society guidelines 
with a high grade of evidence could be a good example of information 
that may support removal of an NCD in some circumstances. In order to 
be more flexible and nimble, we do not intend to establish an exclusive 
list of criteria as decisions may depend on the particular changes in 
medical practice at the time. We are grateful for the helpful public 
suggestions.
    Comment: One commenter questioned whether the 10-year timeframe of 
``older NCDs'' is tied to the last effective date or to the NCD's 
original implementation date. They also questioned how CMS will 
consider NCDs that are greater than the 10-year timeframe, but have 
been updated to address clinical changes affecting the services.
    Response: To determine the age of NCDs we had used the effective 
date of the NCD, which, for some NCDs is the same date as the final 
decision memorandum was released. For determining the age of an NCD 
that has been reconsidered since the initial NCD was published, the 
clock restarts whenever a NCD reconsideration is conducted. For 
example, if we have an NCD for a particular service that was effective 
February 5, 2009, but was reconsidered in 2016 with an effective date 
of October 30, 2016, we would consider the NCD to be 4 years old.
    Comment: We received many comments and recommendations on the 10-
year threshold for identifying older NCDs for further evaluation for 
potential removal. A number of commenters stated that a specific 
threshold age, like 10-years, is arbitrary and does not reflect the 
rapid evolution of medical care in this century, and that age of the 
NCD should be a rule of thumb and not a categorical restriction. 
Several commenters stated that in many cases, even if an NCD is less 
than 10 years old, other evidence will be available that strongly 
suggests the NCD has most likely become outdated--such as when new and 
innovative therapies are released that substantially undermine core 
assumptions of an older NCD. While some commenters generally supported 
a definition of age at 10-years, we also received a wide variety of 
recommendations for timeframes ranging from annual review with 10 years 
as a maximum age, to reviewing NCDs at 3 years, 5 years or 7 years. 
Several commenters recommended that CMS adopt a shorter threshold and 
add a clinical evidence exception. These commenters stated that it 
would be appropriate to allow for the retirement of a NCD that is more 
than 5 years old, or a more recent NCD if there is new clinical 
evidence or FDA approval that causes the NCD to be outdated or to 
restrict beneficiary access to medically necessary items and services. 
One commenter noted that using 10 years as a look-back period may not 
be long enough for some items and services that have longer adoption 
timelines, or that may not be superseded by newer items and services.
    Response: We appreciate commenters' thoughtful recommendations. 
Commenters are correct that the 10-year factor was a general guideline 
to identify groups of potentially outdated NCDs for further evaluation 
for possible removal. We also could decide to retain the NCD or 
reconsider the NCD if the NCD needed to be substantively changed. We 
acknowledge the rapid pace of medical technology development and 
changes in standard of care and/or clinical evidence may occur more 
rapidly than every 10 years, and we will consider those factors as well 
as we evaluate whether existing NCDs should be removed.
    Comment: We received several comments supporting removal of each of 
the following NCDs: NCD 30.4 Electrosleep Therapy, NCD 100.9 
Implantation of Gastrointestinal Reflux Devices, and NCD 220.2.1 
Magnetic Resonance Spectroscopy. We also received several comments 
supporting removal of NCD 20.5 Extracorporeal Immunoadsorption (ECI) 
Using Protein A Columns, some including recommendations for 
corresponding changes to the claims processing instructions for this 
service related to removal of the NCD. We also received no comments for 
NCD 110.19 Abarelix for the Treatment of Prostate Cancer.
    Response: We thank commenters for their support and will finalize 
the removal of each of the 5 NCDs identified above as proposed. We note 
that we received no comments opposing removal of these specific NCDs. 
We appreciate the recommendations for corresponding changes to the 
claims processing instructions and we will consider them as we 
implement the removal of NCDs. We note that while the change in policy 
will be effective on the effective date of the final rule, implementing 
the change for NCD 20.5 Extracorporeal Immunoadsorption (ECI) Using 
Protein A Columns requires changes to national coding systems. The 
implementing Change Request (CR) will take the time discrepancies 
between effective and implementation dates into consideration and 
ensure claims are adjudicated appropriately retroactive back to the 
effective date of the NCD (in this case, the final rule).
    Comment: We received a number of comments supporting removal of NCD 
110.14 (Apheresis). Some commenters acknowledged that the NCD was 
outdated and does not currently reflect advances in apheresis medicine 
and patient care applications. Several commenters noted their previous 
support for removing the NCD when we last proposed its removal in 2015. 
Several expressed their intention to work together with other 
professional societies to educate the Medicare Administrative 
Contractors on the intricacies of apheresis care based on the current 
professional society guidelines.
    We also received several comments opposing removal of the apheresis 
NCD because they believe the NCD--while very outdated-- remains 
relevant and the NCD provides predictability of coverage for 
indications currently listed in the NCD. The commenters expressed 
concern that allowing MACs to determine coverage could create 
inconsistencies in coverage and could reduce access for beneficiaries 
across Medicare and other payers. Several commenters encouraged CMS to 
ensure that any changes to NCDs support flexibility, innovation, and 
patient care.
    Response: We thank commenters for their thoughtful and informative 
feedback, both in support of removing the NCD and for maintaining it. 
Since commenters shared multiple viewpoints on this issue, we will take 
more time to consider the specific issues raised by commenters and will 
not finalize removal of this NCD in this final rule. We will continue 
to engage with stakeholders on the issue and will consider whether to 
propose the NCD for removal in next year's PFS proposed rule.
    Comment: One commenter supported removing NCD 190.1 
(Histocompatibility Testing). The commenter noted their belief that 
local contractors should have the flexibility to cover not only 
conventional HLA cross-matching but also other techniques that have 
been developed and that are emerging. Several commenters did not 
support removing the NCD and requested that CMS retain or retain and 
update the NCD to expand the covered indications. While recognizing 
that it is very outdated, the commenters stated it provides 
predictability regarding coverage of histocompatibility testing for 
kidney and other types of transplant care, and other conditions. 
Several commenters requested that CMS closely monitor local contractor 
activity to ensure there is no disruption in access

[[Page 84801]]

and coverage for current critical applications if CMS decides to remove 
this NCD.
    Response: We appreciate commenter's thoughtful responses. Since 
commenters shared multiple viewpoints on this issue, we will take more 
time to consider the specific issues raised by commenters and will not 
finalize removal of this NCD in this final rule. We will continue to 
engage with stakeholders on the issue and whether to propose the NCD 
for removal in the CY 2022 PFS proposed rule.
    Comment: One comment supported removing NCD 190.3 (Cytogenetic 
Studies) stating that ``the NCD is decades old, and laboratories now 
are able to detect and locate specific DNA sequences on a chromosome 
using diagnostic techniques that did not exist or were not widely 
available when the NCD was issued, including next generation sequencing 
and fluorescence in situ hybridization (FISH).''
    Several commenters did not support removing the NCD and requested 
that CMS retain or retain and update the NCD because while recognizing 
that it is very outdated, they believe the NCD remains relevant as 
cytogenetic studies are in widespread use, and provides predictability 
of coverage, avoiding potentially disparate local coverage policies. 
Several requested that CMS update the NCD to remove outdated 
terminology that is now considered offensive. Commenters also stated 
that cytogenetic studies have not been replaced by Next Generation 
Sequencing (NGS), but that the tests are used in conjunction. One 
commenter mentioned that multiple professional guidelines and practice 
resources exist that support use of cytogenetic studies. Several 
commenters requested that CMS closely monitor local contractor activity 
to ensure there is no disruption in access if CMS decides to remove 
this NCD.
    Response: We thank commenters for pointing out that genetic 
sequencing is commonly used in conjunction with cytogenetic studies. 
Since commenters shared multiple viewpoints on this issue, we will take 
more time to consider the specific issues raised by commenters and will 
not finalize removal of this NCD in this final rule. We will continue 
to engage with stakeholders on the issue and will consider whether to 
propose the NCD for removal in next year's PFS proposed rule.
    Comment: We received many comments supporting removal of NCD 
220.6.16 (FDG PET for Inflammation and Infection) and allowing local 
contractor discretion to determine coverage for this service. A number 
of these comments raised a concern about language in NCD 220.6 
(Positron Emission Tomography (PET) Scans) that provides for non-
coverage, ``. . . that a particular use is noncovered unless this 
manual provides that such use is covered.'' Commenters requested that 
CMS also revise NCD 220.6 to ensure that local contractors can make 
coverage determinations for FDG PET for Inflammation and Infection. 
Commenters also requested that CMS revise this language to expand 
coverage and allow for MAC discretion to cover PET for existing and new 
uses beyond inflammation and infection, to include any non-oncologic 
condition that falls within an FDA approval and is not currently non-
covered by an NCD. A number of commenters offered drafts of revised 
language for the manual as well as current literature as support.
    Response: We will finalize removal of the NCD as proposed, and will 
modify the NCD manual to ensure that contractors have the authority to 
make a coverage determination when claims are submitted for PET for 
Inflammation and Infection. We will ensure MAC discretion is available 
by making two revisions in the NCD manual. First, we will revise the 
NCD manual at section 220.6.16 (FDG PET for Inflammation and Infection) 
to remove the current NCD language and replace it with the following 
statement of local contractor discretion: ``Effective January 1, 2021, 
CMS determined that no national coverage determination (NCD) is 
appropriate at this time for FDG PET for Inflammation and Infection. In 
the absence of an NCD, coverage determinations for FDG PET for 
Inflammation and Infection will be made by the Medicare Administrative 
Contractors (MACs).'' In addition, we will also make a non-substantive 
conforming change to NCD 220.6 (Positron Emission Tomography (PET) 
Scans, to add the following sentence to the note section: ``Effective 
for dates of service on or after January 1, 2021, local Medicare 
Administrative Contractors (MACs) may determine coverage within their 
respective jurisdictions for FDG PET for Infection and Inflammation 
(formerly NCD 220.6.16).'' We are making the conforming change to make 
it abundantly clear in both sections of the manual that contractors 
will make the section 1862(a)(1)(A) of the Act determination for this 
PET indication.
    While the change in policy will be effective on the effective date 
of this final rule (January 1, 2021), implementing this change requires 
changes to national coding systems and to the NCD manual. The 
implementing CR will take the time discrepancies between effective and 
implementation dates into consideration and ensure claims are 
adjudicated appropriately retroactive back to the effective date of the 
NCD (in this case, the final rule).
    With respect to the request to revise NCD 220.6 to remove the non-
coverage language and expand availability of PET for non-oncologic 
indications at MAC discretion, that revision would require a 
reconsideration of the NCD that is beyond the scope of this rulemaking. 
We note the process for submitting a formal reconsideration request is 
described in the August 7, 2013 Federal Register notice (78 FR 48164) 
and are outlined on the Medicare Coverage page at https://www.cms.gov/Medicare/Coverage/DeterminationProcess/howtorequestanNCD. These sources 
include the factors for considering a request to be complete as well as 
the electronic and mail methods for submitting a complete, formal 
request.
    Comment: Commenters recommended additional NCDs for future removal 
including: NCD 10.5 Autologous Epidural Blood Graft, NCD 90.1 
Pharmacogenomic Testing for Warfarin Response, NCD 150.10 Lumbar 
Artificial Disc Replacement (LADR), NCD 160.22 Ambulatory EEG 
Monitoring, NCD 210.3 Screening Computed Tomography Colonography (CTC) 
for Colorectal Cancer, and NCD 240.6 Transvenous (Catheter) Pulmonary 
Embolectomy. We note that NCDs 10.5, 210.3, and 240.6 each were 
recommended for removal by a number of commenters. In addition, one 
commenter requested that CMS revise NCD 210.12 Intensive Behavioral 
Therapy for Obesity to expand the eligible providers that are able to 
offer IBT to patients with obesity.
    Response: We thank commenters for their recommendations of NCDs for 
us to consider removing in the future. While we do not accept these 
comments as complete, formal requests, we will take the suggestions 
under advisement for future review and will continue to communicate 
with interested stakeholders. As noted above, the process for 
submitting a request for reconsideration is described in the 2013 
Federal Register notice and is outlined on the Medicare Coverage page 
at https://www.cms.gov/Medicare/Coverage/DeterminationProcess/howtorequestanNCD.
    With respect to the request to reconsider the eligible providers 
for NCD 210.12, that request is outside the scope of the proposed rule, 
but we note that interested parties may make a formal request for 
reconsideration following the process outlined at the website above.

[[Page 84802]]

    Comment: We received a number of general comments, concerns and 
suggestions for reforming the NCD and LCD processes used in making 
coverage determinations.
    Response: We thank stakeholders for their comments and suggestions, 
but those comments are outside the scope of the proposed rule.
    After considering the comments, we are not finalizing removal of 
NCD 110.14 Apheresis, NCD 190.1 Histocompatibility Testing, and NCD 
190.3 Cytogenetic Studies. We will take more time to consider the 
specific issues raised by commenters regarding these NCDs and will 
consider whether to propose them for removal in next year's PFS 
proposed rule. We are finalizing removal of six NCDs as proposed, 
including NCD 20.5 Extracorporeal Immunoadsorption (ECI) Using Protein 
A Columns, NCD 30.4 Electrosleep Therapy, NCD 100.9 Implantation of 
Gastrointestinal Reflux Devices, NCD 220.2.1 Magnetic Resonance 
Spectroscopy, and NCD 220.6.16 FDG PET for Inflammation and Infection. 
Local Medicare contractors will determine coverage under section 
1862(a)(1) of the Act for those specific items or services previously 
addressed through the NCDs. We will remove all six NCDs on the 
effective date of the final rule. However, changes in coverage require 
an implementation process in order to make required changes in manual 
guidance as well as coding/coverage/payment system edits for the items 
and services. While it typically takes a number of months to implement 
a change in coverage, the implementing CR will take the time 
discrepancies between effective and implementation dates into 
consideration and ensure claims are adjudicated appropriately 
retroactive back to the effective date of the final rule.

K. Requirement for Electronic Prescribing for Controlled Substances for 
a Covered Part D Drug Under a Prescription Drug Plan or an MA-PD Plan

1. SUPPORT Act Requirements
    Section 2003 of the SUPPORT Act generally mandates that the 
prescribing of a Schedule II, III, IV, or V controlled substance under 
Medicare Part D be done electronically in accordance with an electronic 
prescription drug program beginning January 1, 2021, subject to any 
exceptions, which HHS may specify. Section 2003 of the SUPPORT Act 
requires that the Secretary use rulemaking to specify circumstances and 
processes by which the Secretary may waive the EPCS requirement and 
provides the Secretary with authority to enforce and specify 
appropriate penalties for non-compliance with EPCS. The SUPPORT Act 
specifies some circumstances under which the Secretary may waive the 
electronic prescribing requirement with respect to controlled 
substances that are covered Part D drugs and also permits HHS to 
develop other appropriate exceptions. The circumstances that are listed 
in the statute under which the Secretary may waive the EPCS requirement 
are at section 1860D-4(e)(7) of the Act, as added by section 2003 of 
the SUPPORT Act, and include:
     A prescription issued when the practitioner and dispensing 
pharmacy are the same entity;
     A prescription issued that cannot be transmitted 
electronically under the most recently implemented version of the 
National Council for Prescription Drug Programs SCRIPT 2017071 
standard;
     A prescription issued by a practitioner who received a 
waiver or a renewal thereof for a period of time as determined by the 
Secretary, not to exceed one year, from the requirement to use 
electronic prescribing due to demonstrated economic hardship, 
technological limitations that are not reasonably within the control of 
the practitioner, or other exceptional circumstance demonstrated by the 
practitioner;
     A prescription issued by a practitioner under 
circumstances in which, notwithstanding the practitioner's ability to 
submit a prescription electronically as required by this subsection, 
such practitioner reasonably determines that it would be impractical 
for the individual involved to obtain substances prescribed by 
electronic prescription in a timely manner, and such delay would 
adversely impact the individual's medical condition involved;
     A prescription issued by a practitioner prescribing a drug 
under a research protocol;
     A prescription issued by a practitioner for a drug for 
which FDA requires a prescription to contain elements that are not able 
to be included in electronic prescribing, such as a drug with risk 
evaluation and mitigation strategies that include elements to assure 
safe use;
     A prescription issued by a practitioner--
    ++ For an individual who receives hospice care under this title; 
and
    ++ That is not covered under the hospice benefit under this title; 
and
     A prescription issued by a practitioner for an individual 
who is--
    ++ A resident of a nursing facility (as defined in section 
1919(a)); and
    ++ Dually eligible for benefits under this title and title XIX.
2. Current Public Health Emergency (PHE)
    On January 31, 2020, the Secretary determined that a PHE existed 
for the United States to aid the nation's health care community in 
responding to COVID-19 (hereafter referred to as the PHE for COVID-19). 
On March 13, 2020, President Trump declared the PHE for COVID-19. 
Effective October 23, 2020, the Secretary renewed the January 31, 2020 
determination that was previously renewed on April 21, 2020 and July 
25, 2020 that a PHE exists and has existed since January 27, 2020. 
Because of the PHE for COVID-19, and as the nation reopens, some 
individuals, such as those who are at high risk, may continue to 
practice self-isolation and social distancing.
    We have implemented many regulatory and policy actions to swiftly 
aid the nation's healthcare system to effectively address the PHE for 
COVID-19. These actions include new flexibilities for telehealth and 
other electronic technologies \98\ to ease the burden on providers and 
assure appropriate care in a range of settings for beneficiaries. Also, 
the DEA has adopted certain new temporary flexibilities to allow DEA-
registered practitioners to prescribe controlled substances without 
having to interact in person with patients, effective for the duration 
of the PHE for COVID-19.\99\ For example, during the PHE for COVID-19, 
DEA permits DEA-registered prescribers to issue controlled substance 
prescriptions to telemedicine patients who they have not seen in person 
under certain conditions, permits early refills of controlled 
substances permissible under state law, and allows prescribers to issue 
multiple prescriptions authorizing the patient to receive a total of up 
to a 90-day supply of a Schedule II controlled substance. DEA's COVID-
19 information page is available at https://www.deadiversion.usdoj.gov/coronavirus.html. The DEA has acknowledged the prevalence of paper 
prescribing and attempted to address some of the hardships it poses for 
prescribers and patients during the PHE for COVID-19.
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    \98\ See https://www.cms.gov/files/document/covid-19-physicians-and-practitioners.pdf.
    \99\ See https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-
023)(DEA075)Decision_Tree_(Final)_33120_2007.pdf.

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[[Page 84803]]

3. Electronic Prescribing of Controlled Substances (EPCS)
    As discussed in the CY 2021 PFS proposed rule (85 FR 50074), we 
noted that social distancing is likely to be at least in part, 
responsible for the increase in EPCS during this PHE for COVID-19. In 
2020, EPCS has increased to 50 percent of all prescription drug events 
(PDEs) for controlled substances being prescribed as compared to 38 
percent in 2019.\100\ With the use of electronic prescribing, once a 
patient and a provider have an established relationship, a medical 
visit can be conducted via telehealth and any necessary prescriptions 
can be electronically transmitted to the pharmacy without having to see 
each other in-person and risk transmitting COVID-19. Some insurers, 
including Part D plans, may be permitting medication refills, including 
for controlled substances, earlier than usual or for a more extended 
period of time than was previously allowed. Pharmacies that were not 
previously doing so may deliver medications, or deliver at no charge, 
and communities and individuals have worked together to design ways for 
vulnerable persons to continue to receive access to prescribed 
medications in tandem with these new government and private sector 
flexibilities.
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    \100\ Based on Prescription Drug Event data processed through 
April 30, 2020.
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    EPCS provides multiple advantages over the traditional processing 
of paper prescriptions.\101\ \102\ \103\ \104\ \105\ \106\ In addition 
to improving workflow efficiencies, electronic prescribing of 
controlled substances can deter and help detect prescription fraud and 
irregularities by requiring an extra layer of identity proofing, two-
factor authentication and digital signature processes. It can also 
provide more timely and accurate data than paper prescriptions by 
avoiding data entry errors and pharmacy calls to a prescriber to 
clarify written instructions. By allowing for the direct transmission 
of electronic prescriptions between providers and pharmacies or 
facilities, EPCS may also reduce the burden on prescribers who need to 
coordinate and manage paper prescriptions between staff, patients, 
facilities, other care sites, and pharmacies. In addition, EPCS 
(dispensed medication) data is transmitted to Prescription Drug 
Monitoring Programs (PDMPs), which can help inform providers of 
patients' medication history and can aid in clinical decision making at 
the time of prescribing and/or before the medication, is dispensed by a 
pharmacy. It is also important to continue the assurance of privacy and 
security in the prescribing process, such as by controlling prescriber 
access through improved identity controls and authentication protocols. 
EPCS can also assure prescribers' identity more easily and may permit a 
single workflow for prescribing both controlled and non-controlled 
drugs, improving the overall prescribing process.\107\
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    \101\ Phillips et. al. ``Market Guide for Identity Proofing and 
Corroboration.'' April 24, 2018. Gartner, Inc. Retrieved from 
https://www.fedscoop.com/gartner-guide-identity-proofing-corroboration-2018/ on April 30, 2020.
    \102\ Ryan, D. ``FinCEN: Know Your Customer Requirements.'' 
February 7, 2016. Harvard Law School Forum on Corporate Governance. 
Retrieved from https://corpgov.law.harvard.edu/2016/02/07/fincen-know-your-customer-requirements/#2b on April 30, 2020.
    \103\ Nix, M. ``Five Questions: Ken Whittemore Talks Past, 
Present & Future of E-Prescribing Controlled Substances.'' March 31, 
2020. SureScripts. Retrieved from https://surescripts.com/news-center/intelligence-in-action/opioids/five-questions-ken-whittemore-talks-past-present-future-of-e-prescribing-controlled-substances?utm_campaign=IIApercent2FBlogpercent20Subscription&utm_source=hs_email&utm_medium=email&utm_content85955401&_hsencp2ANqtz-8xs36u7xTFZ-ieOxJk3309SApbE7to_fnk1SZvz2jqwz0pA3k7TtW9byiOq2zBlheLInMOeajCMCKeQUTzcEDP79HEaeXI52QiadhAYAWU3Px2eZc&_hsmi=85955401 on April 30, 2020.
    \104\ Zhang et. al. ``T2FA: Transparent Two-Factor 
Authentication.'' June 15, 2018. IEEE Access. Retrieved from https://ieeexplore.ieee.org/stamp/stamp.jsp?tp=&arnumber=8386653 on April 
30, 2020.
    \105\ Konoth R.K., van der Veen V., Bos H. (2017) How Anywhere 
Computing Just Killed Your Phone-Based Two-Factor Authentication. 
In: Grossklags J., Preneel B. (eds) Financial Cryptography and Data 
Security. FC 2016. Lecture Notes in Computer Science, vol 9603. 
Springer, Berlin, Heidelberg. Retrieved from https://link.springer.com/chapter/10.1007 percent2F978-3-662-54970-4_24 on 
April 30, 2020.
    \106\ Cal and Zhu. ``Fraud detections for online businesses: a 
perspective from blockchain technology.'' Financial Innovation 
(2016) 2:20. Retrieved from https://link.springer.com/content/pdf/10.1186/s40854-016-0039-4.pdf on April 30, 2020.
    \107\ HHS Office of the National Coordinator, The ONC Doctors' 
Perspective: Electronic Prescribing of Controlled Substances (EPCS) 
Is on the Rise, and We Must Work Together to Address Barriers to 
Use: https://www.healthit.gov/buzz-blog/health-it/the-onc-doctors-perspective-electronic-prescribing-of-controlled-substances-epcs-is-on-the-rise-and-we-must-work-together-to-address-barriers-to-use.
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    From the patient standpoint, EPCS may reduce the logistical burden 
on patients who may otherwise be required to make multiple trips 
between providers and pharmacies to transport paper prescriptions when 
filling time-sensitive prescriptions while in pain or otherwise in need 
of medical treatment with controlled substances. EPCS can lessen the 
time needed to obtain prescriptions by minimizing trips to the 
physician to pick up paper prescriptions for refills and minimize 
transportation costs to and from the provider's office. EPCS identity 
and security requirements also assure prescribers, patients, and 
pharmacies that prescriptions are processed as intended. In addition to 
helping with the reduction in fraud previously described, EPCS 
minimizes the likelihood that prescriptions have been tampered with, 
since electronic prescriptions are securely transmitted directly to the 
pharmacy from health information technology, which minimizes the 
likelihood of exposure to patients or other third parties. In the 
Medicare Program: Electronic Prescribing for Controlled Substances; 
Request for Information issued on August 4, 2020 (85 FR 47151), we 
requested feedback on the appropriate waivers and whether CMS should 
impose penalties for noncompliance with the EPCS mandate in its 
rulemaking, and what should be the penalties. We plan to use the 
important public feedback we receive from the Request for Information 
in future standalone rulemaking.
    In our proposed rule, we proposed to enact regulations requiring 
EPCS by January 1, 2022 to strike the balance between not placing too 
large of a burden on providers and helping ensure that the benefits of 
EPCS are leveraged expeditiously. Furthermore, we noted that requiring 
EPCS by January 1, 2022 would allow time to solicit and consider 
important feedback from the previously discussed Request for 
Information that is necessary for implementation of the EPCS 
requirements for waivers from the

[[Page 84804]]

requirements and penalties. This included soliciting feedback from 
prescribers that we do not directly regulate under MA, and/or Part D, 
and who are not enrolled in Medicare or Medicaid. Section 1860D-
4(e)(2)(E) of the Act requires the Secretary to adopt electronic 
standards for mandatory use by Part D plans. As stated above, the 
statute provides the Secretary with the authority to develop any 
exceptions to EPCS that may be warranted, and to enforce and specify 
appropriate penalties for non-compliance with the requirement. We noted 
that we do not have an existing process for imposing penalties on non-
compliant prescribers for EPCS. In developing an entirely new penalty 
process, we must make sure that it enforces the new EPCS requirement, 
allows for exceptions only when needed, but does not reduce 
beneficiaries' access to needed drugs. Separate from this rule, we 
noted that we intend to conduct future standalone rulemaking that would 
address these topics.
    Based on these considerations, we proposed to amend 42 CFR 
423.160(a) by adding the requirement that all prescribers conduct 
electronic prescribing of Schedule II, III, IV, and V controlled 
substances covered under the Medicare prescription drug program using 
the NCPDP SCRIPT 2017071 standard by January 1, 2022, except in 
circumstances in which the Secretary waives the requirement. We 
proposed that prescribers would be required use the NCPDP SCRIPT 
2017071 standard because they are already required to use this standard 
when conducting e-Prescribing for covered Part D drugs for Part D 
eligible individuals, and we noted that we believe that prescribers 
should use the same standard for their electronic prescribing of 
controlled substances.
    We also solicited comments regarding the impact of the proposal on 
overall interoperability and the impact on medical record systems. 
Finally, we solicited comments on whether the change would be 
significant enough for a January 1 implementation date, which is 
required for all significant changes affecting Part D plans.
    We received 57 timely public comments in response to this proposed 
provision. We have summarized these comments and our responses below.
    Comment: A majority of commenters supported our proposal requiring 
that prescribers use the NCPDP SCRIPT 2017071 standard for EPCS 
prescription transmissions within the Part D program. Commenters echoed 
their support for many of the reasons set forth in our proposed rule 
including the increased security of the transmission of the 
prescription and reduction of the number of callbacks from pharmacists 
seeking to clarify handwritten prescriptions.
    Response: We thank commenters for their support. In light of the 
overwhelming majority of commenters supporting this proposal, we are 
finalizing the requirement that prescribers use the NCPDP SCRIPT 
2017071 standard for electronic prescribing of Schedule II, III, IV, 
and V controlled substances covered under Medicare Part D.
    Comment: A few commenters opposed e-Prescribing of controlled 
substances because they believed that EPCS would allow prescriptions to 
be written by a doctor electronically without seeing the patient. One 
commenter stated that such practices would lead to an increase in the 
opioid epidemic in our country.
    Response: The assumption that electronic prescribing means 
inappropriate prescribing is an incorrect one. In order for a 
prescription to be covered under Part D, it must be a valid 
prescription according to applicable federal and state laws. Under DEA 
rules,\108\ a prescription must be issued for a legitimate medical 
purpose in the usual course of professional practice by a practitioner 
who has conducted at least one in-person medical evaluation of the 
patient or a covering practitioner in general. Therefore, 
implementation of EPCS standard should not have an adverse impact on 
the appropriateness of controlled substances distributed.
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    \108\ See Title 21, Sec.  1300.04(3)(f) available at https://www.deadiversion.usdoj.gov/21cfr/cfr/1300/1300_04.htm.
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    Comment: Most commenters addressed our proposal to implement the 
EPCS requirement by January 1, 2022. A few commenters requested CMS to 
adhere to the January 1, 2021 date specified in the SUPPORT Act because 
of the many safety benefits associated with EPCS articulated in the 
rule. These commenters included Part D sponsors, companies involved in 
processing e-Prescribing transactions and most, but not all, 
pharmacies. A few commenters noted that there is an absolute and urgent 
need to implement section 2003 of the SUPPORT Act by the January 1, 
2021 deadline in the statute even if the requirement is not enforced. A 
commenter stated that they understood that CMS does not believe it will 
be able to enforce this requirement on prescribers starting in January 
2021, so proposed that CMS implement the requirement in mid-2021. 
Another option presented by the commenters was for CMS to make the rule 
effective January 1, 2021 but decline to enforce it until some later 
date. They stated that just having the rule in force would encourage 
EPCS and cited evidence from state experiences to support this 
position.
    Comments from nearly all prescribers indicate that implementation 
of EPCS by 2021 would not be feasible. For example, a large system 
commented that they had planned to implement EPCS by 2021 but were 
forced to reprioritize human and financial resources to support their 
colleagues and the patients and families impacted by, the PHE. Several 
other commenters stated that an EPCS mandate for a 2021 implementation 
date would undoubtedly cause some prescribers to simply stop 
prescribing controlled substances as part of their practice and this 
could inadvertently create patient suffering and harm.
    Some prescriber groups supported the proposed January 1, 2022 date, 
while others requested even more time for implementation. They 
expressed appreciation for the flexibility that CMS has provided for 
providers struggling with the challenges of the current PHE and the 
difficulties they are facing implementing new systems or upgrades. Some 
commenters noted that there are both cost and implementation efforts 
required to install EPCS and with the COVID-19 pandemic, physicians 
face financial and operational hardships which create burden upon those 
who need to install EPCS functionality. Several commenters expressed 
views that the delay is prudent and will allow additional time for 
providers impacted by COVID, rural providers, and small practices to 
install and become familiar with EPCS. The specific challenges listed 
by these commenters include upgrading EHR software in a short 
timeframe, implementing dual authentication measures while social 
distancing, and paying the cost involved with system upgrades. One 
commenter noted that their software vendor was not making visits to 
their practice during the PHE, rendering software upgrades unfeasible.
    Response: We appreciate the role that pharmacies, Part D plans and 
others have played in preparing for and advocating for EPCS. We 
understand that prescribers would prefer the proposed January 1, 2022 
effective date and appreciate concerns raised by commenters about 
having adequate time to implement EPCS. However, as stated in our 
proposed rule, approximately 98 percent of pharmacies in the US are 
ready to accept EPCS, and Part D plans that have been reporting 
electronically

[[Page 84805]]

to CMS have no concerns about their readiness.
    We also believe there are many benefits to EPCS that outweigh 
commenter concerns regarding readiness. EPCS can help deter and detect 
prescription fraud and irregularities by requiring an extra layer of 
identity proofing, two-factor authentication and digital signature 
processes. It can also help avoid data entry errors and pharmacy calls 
to a prescriber to clarify written instructions. By allowing for the 
direct transmission of electronic prescriptions between providers and 
pharmacies or facilities, EPCS may also reduce the burden on 
prescribers who need to coordinate and manage paper prescriptions 
between staff, patients, facilities, other care sites, and pharmacies. 
In addition, EPCS (dispensed medication) data is transmitted to 
Prescription Drug Monitoring Programs (PDMPs), which can help inform 
providers of patients' medication history and can aid in clinical 
decision making at the time of prescribing and/or before the medication 
is dispensed by a pharmacy. From the patient standpoint, EPCS may 
reduce the logistical burden on patients by lessening the time needed 
to obtain prescriptions, by minimizing trips to the physician to pick 
up paper prescriptions for refills, and by minimizing transportation 
costs to and from the provider's office. In addition, EPCS has 
important safety benefits in that it minimizes the likelihood that 
prescriptions have been tampered with. Because electronic prescriptions 
are securely transmitted directly to the pharmacy from health 
information technology, this minimizes the likelihood of exposure to 
patients or other third parties. We believe that an earlier effective 
date would encourage more timely implementation of EPCS in Part D, and 
therefore, bring these important benefits of EPCS faster to Part D 
prescribers, patients, and the Part D program.
    Regarding the concern that the January 1, 2021 implementation date 
may cause prescribers to stop prescribing necessary controlled 
substances, we understand that this may be an issue. In light of this 
concern, as well as other potential implementation issues, we plan on 
monitoring the PDE data to look for concerning prescribing patterns, so 
we can adjust the program accordingly. Due to the PHE, we also seek to 
mitigate concerns about the impact that the January 1, 2021 deadline 
would cause by establishing a compliance date in addition to the 
effective date that would allow prescribers who do not implement the 
NCPDP SCRIPT 2017071 standard for electronic prescribing of Schedule 
II, III, IV, and V controlled substances until January 1, 2022 to still 
be considered compliant.
    In consideration of the benefits of EPCS and in light of the 
comments received, we are modifying our proposal by finalizing this 
provision with an effective date of January 1, 2021 and a compliance 
date of January 1, 2022. With a January 1, 2022 compliance date, 
prescribers who do not implement the NCPDP SCRIPT 2017071 standard for 
electronic prescribing of Schedule II, III, IV, and V controlled 
substances until January 1, 2022 will still be considered compliant 
with the requirement. We believe that this phased approach strikes a 
balance of adhering to the timeframe set forth in the SUPPORT Act, 
supporting more rapid implementation of EPCS, and giving prescribers 
adequate time to comply with the EPCS implementation requirement.
    Comment: Several commenters mentioned the health care provider 
costs involved in implementing EPCS. One commenter recommended that CMS 
work with ONC to ensure that the cost of implementing the part D 
electronic prescribing standard is taken into account when EHR's are 
evaluated in accordance with one of ONC's EHR certification criteria, 
and to ensure that EHR developers cannot charge additional fees for 
building in this prescribing standard capability into their certified 
products. Accordingly, the commenter requested that HHS take steps to 
minimize the cost of EPCS requirements to physician practices. Another 
commenter stated that their practice has delayed implementing EPCS due 
to the need to upgrade their EHR software, which has proven to be 
costly. The commenter stated that given the pandemic impact that amount 
is now unaffordable for their small primary care practice. Another 
commenter acknowledged that EPCS implementation costs can be high, but 
that a prudent buyer of software support can find less expensive 
options.
    Response: We share concerns about high health care provider costs 
associated with implementing EPCS, particularly during the PHE. 
However, neither ONC nor CMS have the authority to dictate EHR vendor 
charges for implementing electronic prescribing capabilities that would 
meet EPCS criteria. We encourage those who provide software solutions 
to support EPCS to make their products as accessible as possible. As 
prescribers who do not implement the NCPDP SCRIPT 2017071 standard for 
electronic prescribing of Schedule II, III, IV, and V controlled 
substances until January 1, 2022 will still be considered compliant 
with the EPCS implementation requirement, software providers will have 
more time to review their costs, and providers will have more time to 
evaluate and choose among available options.
    Comment: One commenter noted that even with a delayed compliance 
date, not all practices or providers are currently using or planning to 
use this technology due to practice style, size, resources, capability 
and willingness to adopt new technology. The commenter stated that if 
modernization is required, alternative options should be available, or 
assistance should be provided to ease the burden of cost and 
implementation.
    Response: We recognize the difficulties that many providers may 
have in implementing an EHR or eRx that accommodates EPCS. However, the 
aforementioned benefits of EPCS, especially in light of current social 
distancing guidelines, outweigh the burden of implementing an EHR or 
eRx system for EPCS. Furthermore, based on our conversations with the 
industry and analysis, CMS believes that once the EHR and eRx systems 
are implemented, the burden of EPCS will be less than the current 
manual process.
    Comment: Several commenters recommended CMS work with other federal 
entities that are involved in eRx rules including ONC and the DEA.
    Response: We will continue to coordinate with our Federal partners 
and will continue to coordinate EPCS efforts to the extent possible 
based on our individual legal mandates.
    Comment: One commenter suggested CMS clarify whether the EPCS 
requirement will apply to inpatient settings as well.
    Response: Section 2003 of the SUPPORT Act mandates that the 
prescribing of a Schedule II, III, IV, or V controlled substance under 
Medicare Part D be conducted electronically in accordance with an 
electronic prescription drug program beginning January 1, 2021, subject 
to any exceptions, which HHS may specify. The proposal that we are 
finalizing includes all providers who prescribe medications that are 
Schedule II, III, IV, or V controlled substances that are covered Part 
D drugs. This generally includes medications dispensed in outpatient 
pharmacies but may also include medications dispensed to a patient who 
is being discharged to the home from an inpatient or emergency room 
setting, a long term care setting, or a Medicare hospice, or who is 
receiving care in a patient's home.

[[Page 84806]]

    Comment: One commenter encouraged CMS to provide technical 
assistance and resources for clinicians in order to streamline this 
transition.
    Response: As EPCS is permitted in every state, and will soon be 
required in 31 states, many state agency websites and state medical 
boards provide excellent resources for physicians to use. The DEA, on 
its website, has also posted frequently inquired about questions 
related to EPCS that can serve as a helpful resource. As a result, we 
do not believe that we need to provide any other resources, since they 
would merely duplicate the information on the websites.
    Comment: A few commenters raised concerns about the impact on 
beneficiaries who have to receive prescriptions electronically rather 
than via traditional paper prescriptions. One commenter speculated that 
EPCS would interfere with the patient's pharmacy choice. Others voiced 
concern that patients may want a paper prescription in hand so they can 
visit multiple pharmacies and compare prices. The commenter noted that 
e-Prescribing may harm cancer patients who may benefit from receiving 
prescriptions from their physicians where the likelihood of adherence 
and quality improvement increases.
    Response: Given that nearly all US pharmacies are ready to accept 
electronic prescriptions of controlled substances, this means that a 
prescriber can use EPCS and send the prescription where the patient 
instructs. We also recognize that the price of a given medication may 
impact a beneficiary's pharmacy choice. However, EPCS is being 
implemented in the Part D program at a time when patients and providers 
will have access to electronic real time benefit tools that can offer 
price transparency without requiring in person visits or calls to 
alternate pharmacies for price checking. As required in the May 2019 
final rule (84 FR 23851), which updated the Part D e-Prescribing 
standards, each Part D plan is required to adopt one or more prescriber 
real time benefit tools that are capable of integrating with at least 
one prescriber's e-Prescribing system or electronic health record no 
later than January 1, 2021. We encourage patients and providers to use 
these tools. We are unaware of any evidence to indicate that the act of 
a physician handing a prescription to a patient has a positive impact 
on medication adherence.
    Comment: One commenter expressed concern with the health care 
provider burden associated with reporting EPCS transactions to CMS.
    Response: We clarify that there is no added provider burden 
associated with reporting EPCS transactions to CMS as the NCPDP 
Telecommunications standard captures the source of a prescription 
transaction through the prescription origin code. A value of ``3'' in 
field 419-DJ indicates that a prescription was transmitted 
electronically; such information is sent to the Part D plan which then 
conveys that information to CMS through PDE data. No additional action 
on the part of the prescriber is needed.
    Comment: Some commenters questioned about complying with EPCS 
requirements when it is not reasonable or feasible. These circumstances 
include instances when NCPDP SCRIPT 2017071 does not support the 
prescription, systems downtime, lack of internet connectivity or when 
the patient needs a paper prescription to receive medication in advance 
of a vacation.
    Response: There may be instances when a prescriber is unable to 
transmit a particular prescription electronically using the named 
SCRIPT standard. Under those circumstances, paper prescriptions are 
compliant with CMS requirements. The NCPDP SCRIPT Implementation 
Recommendations document provides guidance on implementing the 
standard. We remind commenters that we have issued electronic standards 
for use in Medicare Part D since the program's inception, and have 
withheld issuing compliance actions under circumstances such as a 
sporadic downtime or lack of internet access that the covered entity 
might experience. Consistent with this previous practice, we do not 
anticipate issuing compliance actions when a prescriber is unable to 
transmit a particular prescription electronically using the named 
SCRIPT standard under such circumstances.
    Comment: A commenter suggested establishment of a list of mandated 
exemption codes and modifying existing NCPDP standards to enable 
tracking of paper prescriptions exemption codes Prescribers could then 
handwrite the exemption code(s) on paper prescriptions and/or input the 
codes in the EHR in notes or in a new custom field. Pharmacies would 
capture the exemption code(s) through use of the NCPDP telecom standard 
and convey the information to the payer and on to CMS through PDE data. 
They noted that this would take years to implement.
    Response: We thank the commenter for the suggestion. The proposed 
solution seems to be one way of leveraging technology to capture 
information about why EPCS is not being used to transmit a given 
prescription. However, we would be concerned about the burden that 
required exemption coding might place on prescribers and pharmacies. 
Prescribers would have to know the appropriate code to use and enter it 
onto the paper prescription and pharmacies would have to look for, and 
enter the code into their dispensing systems in order to convey that 
information to Part D plans. It is also unclear how the Part D 
exceptions may/may not overlap with exemptions allowed under state EPCS 
rules, which could cause confusion. However, as the adoption of EPCS 
progresses, we would rely on the NCPDP to work with prescriber groups 
to examine the suggestion in detail. We believe some providers and 
pharmacies may embrace this mode of communicating why a paper 
prescription for controlled substances is used, while others may not. 
We also caution that the absence of such a code would not be a valid 
reason for a pharmacy not to dispense a medication nor for a Part D 
plan to deny payment for an otherwise valid written prescription. We 
look forward to hearing about any discussions about this concept as 
they progress.
    Comment: One commenter requested CMS be specific in defining which 
NCPDP SCRIPT version 2017071 capabilities are expected to be used 
before a pharmacy or payer rejects incomplete prescriptions.
    Response: Section 2003 of SUPPORT Act makes it clear that the EPCS 
requirement should not be construed as requiring a sponsor of a 
prescription drug plan under Part D or a pharmacist to verify that a 
practitioner, with respect to a prescription for a covered Part D drug, 
has a waiver from the EPCS requirement under Part D. Consistent with 
the statute, nothing in our rule should cause the dispensing pharmacy 
to reject a prescription nor the Part D plan to deny payment for an 
otherwise valid written, oral, or fax prescriptions that is consistent 
with laws and regulations. As a result, we do not believe it is our 
place to define which of the standard's capabilities should be used 
before the rejection of an incomplete prescription.
    Comment: Several commenters expressed concerns that CMS' proposal 
assumes these functionalities to be successful, when in actuality they 
still require significant fixes and delayed implementation timelines. 
Perhaps the biggest challenge clinicians will face, commenters stated, 
is incorporating EPCS into their EHRs, and most clinician practices are 
not in a position to cover the costs and acquire the

[[Page 84807]]

necessary resources for technical or system upgrades required by EHR 
vendors--especially rural and small practices. Commenters stated that 
due to the COVID-19 pandemic, many practices have been forced to delay 
or cancel implementation altogether of EHRs that support EPCS due to 
the implementation cost. Commenters voiced the concern that practices 
that do not currently have the capability to prescribe electronically 
would be forced to purchase such a software. A commenter supported the 
intent to facilitate efficiency, convenience, and better security with 
the implementation of EPCS, but encouraged CMS to avoid unreasonable 
burden imposed upon clinicians and delay compliance until at least 
January 1, 2023.
    Response: We are aware of the difficulties that clinicians may face 
when implementing EPCS. However, with potentially broad public health 
implications, we believe a January 1, 2021 effective date complies with 
the statutory intent and would enable the safety and other benefits 
previously discussed to be put in place during the current pandemic. 
However, in order to help ensure that the burden on prescribers is not 
unreasonable, we are finalizing a compliance date of January 1, 2022 
such that prescribers who do not implement the NCPDP SCRIPT 2017071 
standard for electronic prescribing of Schedule II, III, IV, and V 
controlled substances until January 1, 2022 will still be considered 
compliant with the requirement.
    Comment: Many commenters stated their intent to comment on the EPCS 
request for information. We received a number of comments that 
requested CMS address the need for exceptions to the EPCS rule and to 
set forth an overview of the penalties to be used. Some commenters 
provided comments with regard to waivers, health professionals and 
practices and their ability to declare a hardship and to be exempt from 
EPCS requirements; others requested exclusions for those who are unable 
to electronically prescribe controlled substances by January 1, 2022 
for various reasons. A few commenters suggested that CMS explicitly 
clarify that the current exemptions at Sec.  423.160(a)(3)(iii) will 
continue to apply for prescriptions of controlled substances where the 
sender and the beneficiary are part of the same legal entity. Those 
commenters stated such an exemption would align with CMS' existing 
policy at Sec.  423.160(a)(1) regarding use of the NCPDP SCRIPT 
Standard because the prescriptions and prescription-related information 
for covered Part D drugs for Part D eligible individuals is not 
transmitted using electronic media, and previous clarifications CMS has 
issued as part of other electronic prescribing requirements. Commenters 
also stated that CMS should also align such an exception with CMS' 
existing policy at Sec.  423.160(a)(3)(iii), which allows the use of 
HL7 messages for transmitting prescriptions and prescription-related 
information internally by clarifying that exemption's applicability to 
prescriptions for controlled substances.
    Response: We thank the commenters for their feedback and will take 
all comments included in the Electronic Prescribing for Controlled 
Substances; Request for Information and comments received on the PFS 
proposed rule into account as we implement this program. The SUPPORT 
Act requires that CMS use rulemaking to determine any processes for 
enforcement, including on any prescriber waivers, penalties and 
appeals. CMS will continue to consider comments and recommendations 
received in response to both the proposed rule and the RFI and will 
propose any such processes in a future rule, to be effective no earlier 
than January 1, 2022. Based on detailed and thoughtful comments 
received in response to our proposed rule and the RFI, we understand 
that any future rulemaking may be better informed through additional 
inquiry, such as review of state EPCS program characteristics and 
insight gained from implementing the programs, consideration of the 
interactions between EPCS and PDMP workflows, and obtaining 
clarification of the implications of potential updates to the DEA's 
biometric standards for dual authentication on technical and workflow 
requirements. CMS will continue to review its own PDE data to better 
understand EPCS patterns across prescribers and provider groups and 
what this data can convey about the characteristics of Part D 
prescribers of controlled substances (such as geographic areas, 
specialties, and Part D prescribing volume and patient residence 
locations).
    After consideration of the comments received, we are finalizing the 
provision with an effective date of January 1, 2021 and a compliance 
date of January 1, 2022 to encourage prescribers to implement EPCS as 
soon as possible, while helping ensure that our compliance process is 
conducted thoughtfully.

L. Medicare Part B Drug Payment for Drugs Approved Through the Pathway 
Established Under Section 505(b)(2) of the Food, Drug, and Cosmetic Act

1. Background
    Medicare Part B covers drugs under a limited drug benefit that 
includes drugs and biologicals defined in section 1861(t) of the Act. 
Medicare Part B drugs and biologicals fall into three general 
categories: Drugs and biologicals furnished incident to a physician's 
services, drugs and biologicals administered via a covered item of 
durable medical equipment (DME), and other drugs and biologicals 
specified by statute. Payment amounts for most separately payable 
Medicare Part B drugs and biologicals are determined using the 
methodology in section 1847A of the Act, and in many cases, payment is 
based on the Average Sales Price (ASP) plus a statutorily mandated 6 
percent add-on.
    Drugs (not including biologicals or biosimilar biological products, 
as defined in section 1847A of the Act) paid using the methodology in 
section 1847A of the Act fall into two broad and mutually exclusive 
categories: Multiple source drugs and single source drugs. These terms 
are defined in statute and are further discussed in this section and 
the next section. In most cases the distinction between the multiple 
source drugs and single source drugs is fairly straightforward and is 
made as outlined in program instruction published in 2007 (https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/Downloads/051807_coding_announcement.pdf): The payment limit under section 1847A 
of the Act for that biological product or single source drug is based 
on the pricing information for products produced or distributed under 
the applicable FDA approval. However, for a subset of drug products 
approved through the pathway established under section 505(b)(2) of the 
Federal Food, Drug, and Cosmetic Act (FFDCA), the distinction is less 
straightforward.
    The drug approval pathway established under section 505(b)(2) of 
the FFDCA has existed since 1984, before the ASP payment methodology 
was established. The section 505(b)(2) pathway is provided for 
applications that contain full reports of investigations of safety and 
effectiveness, where at least some of the information for an approval 
comes from studies not conducted by or for the applicant and for which 
the applicant has not obtained a right of reference. An application 
submitted under section 505(b)(2) (which we refer to as a ``section 
505(b)(2) application'') may

[[Page 84808]]

rely on FDA's finding of safety and/or effectiveness for a listed drug 
(an approved drug product) or published literature provided that such 
reliance is scientifically justified and the section 505(b)(2) 
applicant complies with the applicable statutory and regulatory 
requirements, including patent certification if appropriate. Unlike an 
Abbreviated New Drug Application (ANDA) for a generic drug, a section 
505(b)(2) application is not required to have the same labeling as the 
listed (approved) drug(s) that the application relied upon. However, 
some drugs approved through the pathway established under section 
505(b)(2) of the FFDCA (which we refer to as ``section 505(b)(2) drug 
products'') share significant portions of their FDA-approved labeling 
with the listed (approved) drug(s) that the application submitted 
through section 505(b)(2) relied upon, for example prescribing 
information on safety, efficacy, and pharmacokinetics. In some cases, 
the section 505(b)(2) drug product shares significant portions of 
labeling with generic drugs that are paid as multiple source drugs 
under section 1847A of the Act. Examples of situations where a section 
505(b)(2) drug product shares similar labeling to listed (approved) 
products include a sterile injectable drug product that had been sold 
as a lyophilized powder in a vial and was then approved for sale as a 
concentrated liquid in a vial, as well as a ready-to-use IV bag.
    The number of drugs approved through the pathway established under 
section 505(b)(2) of the FFDCA has been growing, from about 40 per year 
from 2011 to 2016, to about 60 in 2017, and 70 in 2018. Some of these 
approvals include drugs paid under Part B. Although we have assigned 
some section 505(b)(2) drug products to separate single source billing 
and payment codes, our payment approach for newly marketed section 
505(b)(2) drug products, where an existing multiple source code 
descriptor describes the section 505(b)(2) drug product accurately, and 
where the active ingredient(s), the drug name, and portions of the 
prescribing information correspond to existing products that are 
assigned to and paid under a multiple source drug code, has been to 
assign the section 505(b)(2) drug products to the existing multiple 
source code. We believe that this approach, as described in more detail 
below, is consistent with statutory language in section 1847A of the 
Act. The definition of multiple source drug at section 1847A(c)(6)(C) 
of the Act states in part that for a multiple source drug, there are 
two or more drug products which are rated as therapeutically equivalent 
(under the FDA's most recent publication of ``Approved Drug Products 
with Therapeutic Equivalence Evaluations'' also known as the Orange 
Book). For purposes of Part B drug payment under section 1847A of the 
Act, we interpret this to mean that if there is an existing HCPCS 
billing code that includes two or more drug products which are rated 
therapeutically equivalent and meets the remaining conditions of the 
definition of a multiple source drug, that billing and payment code is 
a multiple source drug code, and the section 505(b)(2) drug product 
meets the definition of a multiple source drug in section 
1847A(c)(6)(C) of the Act. The statutory language in section 
1847A(b)(3) and (6) of the Act provides discretion for CMS to assign 
additional drug products to a multiple source drug code. In other 
words, if a multiple source drug code exists, we are permitted to 
assign other multiple source drug products to that code for the purpose 
of payment as a multiple source drug under section 1847A of the Act. We 
note that if the drug product is described by a multiple source code, 
it meets the definition of multiple source drug at section 
1847A(c)(6)(C) of the Act, and it does not meet the definition of a 
single source drug at section 1847A(c)(6)(D) of the Act, because the 
definition of a single source drug expressly excludes a multiple source 
drug in section 1847A(c)(6)(D)(ii) of the Act.
    We assigned section 505(b)(2) drug products to existing multiple 
source drug codes for Part B payment under section 1847A of the Act in 
limited situations, that is, where an existing multiple source code 
descriptor describes the section 505(b)(2) drug product, the active 
ingredient(s) correspond to one another, the section 505(b)(2) drug 
product's labeling, particularly the prescribing information, includes 
information (such as the drug description, dosage and administration, 
pharmacokinetics, and indications) from other drug products that are 
paid under the multiple source drug code, and the section 505(b)(2) 
drug product can be used and prescribed in a manner similar to other 
products in the multiple source drug code. This information is used to 
determine whether the section 505(b)(2) drug product can be billed and 
paid using the existing multiple source drug code. The determination is 
based on the discussion in the previous paragraph, that is, if there is 
an existing HCPCS billing code that includes two or more drug products 
which are rated therapeutically equivalent and meet the remaining 
conditions of the definition of a multiple source drug, that billing 
and payment code is a multiple source drug code. Consistent with the 
statutory language in section 1847A(b)(3) and (6) of the Act, which 
provides discretion for CMS to assign additional drug products to a 
multiple source drug code, a section 505(b)(2) drug product can be 
assigned to the multiple source drug code. The section 505(b)(2) 
product assigned to the multiple source drug code meets the definition 
of a multiple source drug in section 1847A(c)(6)(C) of the Act. Thus, 
for the purpose of payment under Medicare Part B, the section 505(b)(2) 
drug product can be billed and paid under that existing multiple source 
code. However, in situations where there is no existing multiple source 
drug code that describes a section 505(b)(2) drug product, the section 
505(b)(2) drug product is typically assigned to its own single source 
code.
2. Multiple Source Drug and Single Source Drug Codes
    Section 1847A of the Act uses the terms drug and drug product. 
Consistent with the statutory definitions discussed at section 
1847A(c)(6)(C) and (D) of the Act and program instruction published in 
2007 (https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/Downloads/051807_coding_announcement.pdf), we have applied the terms multiple 
source drug and single source drug at the billing and payment code 
level, meaning that ``drug'' corresponds to a HCPCS or other applicable 
billing code and its descriptor, which typically includes the active 
ingredient(s) of the drug. The term ``drug product'' corresponds to 
individual packages of the drug as identified by the National Drug Code 
(NDC) or other applicable alternative identifier.
    The terms multiple source drug and single source drug are defined, 
respectively, in section 1847A(c)(6)(C) and (D) of the Act. Section 
1847A(c)(6)(C) of the Act states that multiple source drug means, for a 
calendar quarter, a drug for which there are two or more drug products 
which are rated as therapeutically equivalent (under the FDA's most 
recent publication of ``Approved Drug Products with Therapeutic 
Equivalence Evaluations''); are pharmaceutically equivalent and 
bioequivalent, as determined by the FDA; and are sold or marketed in 
the United States during the quarter. Section 1847A(c)(6)(E) and (F) of 
the Act establish conditions under which pharmaceutical equivalence and

[[Page 84809]]

bioequivalence are met. The definition of multiple source drug in 
section 1847A of the Act can be interpreted to mean that once a 
multiple source drug code exists--that is, once there are two or more 
drug products that are therapeutically equivalent, pharmaceutically 
equivalent and bioequivalent, and CMS has assigned them to a multiple 
source drug code--then a subsequent product of the same drug--that is, 
a product that corresponds to the multiple source drug code's 
descriptor--can be assigned to such code even if the subsequent drug 
product is not, itself, therapeutically equivalent, bioequivalent or 
pharmaceutically equivalent. This is because in this case, the drug is 
multiple source, meaning that there are two or more products which are 
rated as therapeutically equivalent of that drug, as evidenced by the 
fact that the existing products are already assigned to the multiple 
source drug code. Once a drug product is assigned to a multiple source 
drug code, the product would not be assigned to a single source drug 
code because the definition of single source drug at section 
1847A(c)(6)(D)(ii) of the Act states, in part, that a single source 
drug is a drug which is not a multiple source drug. Thus, when 
assigning drug products to multiple source and single source drug codes 
for the purpose of payment under section 1847A of the Act, we consider 
whether the product is described by an existing multiple source drug 
code first, and if the product is assigned to an existing multiple 
source drug code, its payment allowance will be determined based on the 
volume-weighted average ASPs of all drug products assigned to the code, 
rather than based solely on its own ASP (for example under a new single 
source code).
    Section 1847A(b)(3) and (6) of the Act provide that payment for 
multiple source drugs is determined for all drug products included 
within the same multiple source drug billing and payment code. For 
multiple source drugs, we calculate a volume weighted average sales 
price across all drug products assigned to a billing and payment code. 
This typically means that the ASP-based payment amount for a multiple 
source drug code includes generic and branded drug products within an 
individual code.
    Consistent with section 1847A(b)(3) and (6) of the Act and our 
interpretation of the definition of multiple source drug in section 
1847A(c)(6) of the Act, we assign certain section 505(b)(2) drug 
products to existing multiple source drug codes. We determine whether 
to assign section 505(b)(2) drug products to multiple source or single 
source drug codes by comparing information about the section 505(b)(2) 
drug product to the descriptors for existing multiple source codes to 
which the drug products may be assigned for the purposes of payment 
amount determinations under section 1847A of the Act, as well as 
information about products already assigned to that descriptor. This 
information includes the products' active ingredients and labeling, 
particularly the prescribing information and, if necessary, additional 
sources such as the FDA's Approval Summary Review, which is a part of 
the FDA's application review files and is available at https://www.accessdata.fda.gov/scripts/cder/daf/, and drug compendia. The FDA's 
Approval Summary Review can provide additional details about 
information that is found in the drug's labeling and prescribing 
information and other compendia can supplement the information that is 
found in labeling and provide information about off label use of a 
drug.
    Our case by case determination about the assignment of certain 
section 505(b)(2) drug products to existing multiple source drug codes 
is based on the factors described in further detail in the bullet 
points below: First, the products' active ingredient(s), drug name and 
description; second, the products' labeling information; third, how 
they are ordered (prescribed) and used clinically. These factors are 
assessed as a whole, using the information (for example, active 
ingredient, labeling, compendia, and FDA Approval summary), to 
determine whether an existing multiple source drug code describes a 
section 505(b)(2) drug product and whether the product can be assigned 
to an existing multiple source drug code for the purpose of payment 
under section 1847A of the Act. The determination is based on the 
following:
     The active ingredient and drug name of the section 
505(b)(2) drug product and other drug products in an existing multiple 
source drug code.
     The drug description and indications, particularly whether 
differences such as the salt form, additional ingredients, or uses 
exist.
    The two bullet points above identify the section 505(b)(2) drug 
product and multiple source drug code and establish what is being 
compared so that the determination can proceed, if necessary. For 
example, if the active ingredients and drug names do not correspond, 
there would not be a reason to assign the section 505(b)(2) drug 
product to the multiple source drug code or to proceed further. We also 
note that the active ingredient of a drug is often included in the 
HCPCS code descriptor that is used to bill a drug product and to pay 
for it under section 1847A of the Act. The drug description is used, if 
necessary, to clarify what the actual active ingredient(s) are, whether 
there are minor differences, such as salt forms and other inactive 
ingredients that may affect how the product is used. This information 
may be helpful when considered with the information in the next two 
groups of bullet points as we consider labeling and uses of the drug 
products.
     The labeling information (and if necessary other material 
from sources such as the FDA's Application Review Files, including the 
FDA's Approval Summary Review, and drug compendia), particularly 
pharmacokinetics, indications, adverse reactions, drug interactions, 
contraindications, warnings, precautions and clinical studies.
    The bullet point above allows us to determine whether the same 
information, for example the same studies, were used to support the 
approval of the section 505(b)(2) drug product and to gauge how much of 
the labeling information from existing multiple source drug products 
appears in the section 505(b)(2) drug product's labeling. This 
information also supports the determination in the next bullet point. 
The more labeling information that a section 505(b)(2) drug product has 
in common with drug products in an existing multiple source drug code, 
the more likely it is that the existing code describes the section 
505(b)(2) drug product, such that CMS will assign it to that multiple 
source drug code for the purpose of payment under section 1847A of the 
Act.
     The dosage and administration, pharmacokinetics, 
indications, contraindications, warnings, drug interactions, and 
adverse reactions.
    The bullet point above allows us to determine whether the section 
505(b)(2) drug product is ordered and used in patient care in the same 
way as products assigned to a multiple source drug billing code. The 
dosage and administration, pharmacokinetics, and indications are 
particularly important because we consider whether a prescriber writes 
a prescription for the section 505(b)(2) drug product in the same way 
as drug products assigned to a multiple source drug code and whether 
the products could be used for the same uses. Typically, a prescription 
includes the following information: The drug, dose, route of 
administration, and frequency. The quantity of a drug (or duration of 
therapy) and refills are also

[[Page 84810]]

a part of a prescription, but are less of a factor for Part B where 
most drugs are used incident to a physician's services. Typically, 
drugs used incident to a physician's services are administered and 
billed as a very limited number of doses, often just one, are 
administered during a service, and the drug is not dispensed for the 
patient for use over an extended time period beyond an office visit or 
outpatient hospital visit. The elements in the bullet point reflect how 
a drug is used and administered in the care of patients and in turn 
determine how billing for the drug is accomplished; that is, whether an 
existing code descriptor describes a section 505(b)(2) drug product and 
can be used to bill for it.
    As a simple example of our approach, if the active ingredient, 
dose, route of administration and frequency of the section 505(b)(2) 
drug product are the same as those for drug products in a multiple 
source drug code, then it is likely that an existing code descriptor 
describes a section 505(b)(2) drug product and can be used to bill for 
it. The information does not have to be an exact match, for example 
different uses of a drug product may require different doses, routes of 
administration, or frequencies. However, if the section 505(b)(2) drug 
product and the multiple source drug products in the existing multiple 
source drug code could both be used for the same indication 
(potentially by way of off-label use), then billing for both with the 
existing HCPCS code would still be feasible. In such situations, 
similarities between labeling information such as whether the same 
studies were used to establish pharmacokinetic parameters may factor 
into the assessment. In summary, the information discussed above is 
used as a whole to determine whether the existing multiple source drug 
HCPCS code descriptor describes the section 505(b)(2) drug product or 
if a new HCPCS code would be needed describe the product for payment 
under Part B.
    The information described in the bullet points above is usually 
sufficient for our determinations, but from time to time we may reach 
out to the drug manufacturer, seek post marketing data, or review 
literature sources for additional information to assist us with 
understanding the information in the bullet points above and to assist 
with determinations in complicated situations, for example where 
indications vary, but it appears that the section 505(b)(2) drug 
product could still be used, administered and billed in the same manner 
as drug products assigned to an existing multiple source drug code.
    We are aware that some section 505(b)(2) drug products are very 
different from previously approved products that may be used to support 
their approval. We do not assign all section 505(b)(2) drug products to 
existing multiple source drug codes. In circumstances where an existing 
code does not describe the section 505(b)(2) drug product and use of 
the existing code would not be suitable for billing and payment of the 
section 505(b)(2) drug product under Part B based on the assessment 
described above, the section 505(b)(2) drug product would not be 
assigned to the existing multiple source drug code. The following 
examples illustrate how we distinguish section 505(b)(2) drug products 
that are assigned to an existing multiple source drug code from those 
that are not. If a section 505(b)(2) drug product has the same active 
ingredient, same dose and dosing interval, and prescribing information 
and includes the same clinical studies (for example, the same patient 
number, same response rates and same adverse reaction frequencies) as 
drug products assigned to an existing multiple source drug code, the 
section 505(b)(2) drug product would be assigned to the multiple source 
code. However, if the section 505(b)(2) drug product has different 
pharmacokinetics, for example if it is a sustained release version of a 
drug that permits less frequent dosing compared to drug products in an 
existing multiple source drug code, or if the section 505(b)(2) drug 
product has additional active ingredients not found in the drug 
products in an existing multiple source drug code, the section 
505(b)(2) drug product would not be described by the existing multiple 
source drug code. As a result, it would not be considered a multiple 
source drug under section 1847A(c)(6)(C) of the Act because there would 
not be at least two drug products for that drug that are 
therapeutically equivalent, pharmaceutically equivalent and 
bioequivalent; thus, the section 505(b)(2) drug product would be 
considered a single source drug and typically assigned to a single 
source drug code.
3. Codifying Existing Policy for Section 505(b)(2) Drug Products
    As we stated in the CY 2021 PFS proposed rule (85 FR 50264 through 
50265), our approach (described in section II.L.2 of this final rule) 
for the payment of section 505(b)(2) drug products has been in place 
for at least 12 years, and it is also consistent with the concept of 
paying similar amounts for similar services. It is based on the 
definitions of multiple source drug and single source drug in section 
1847A(c)(6)(C) and (D) of the Act and authority to assign drug products 
to billing and payment codes in section 1847A(b)(3) and (6) of the Act 
as discussed in the sections above. We explained that a number of 
section 505(b)(2) drug products that are described by an existing 
multiple source drug code are priced significantly higher than 
comparable products. Two recently introduced section 505(b)(2) drug 
products that appear to be comparable to drug products in existing 
multiple source drug codes (using the approach described in the section 
earlier) have Medicare payment allowances that are approximately 10 
times higher than that of the existing multiple source code. We stated 
that we believe that assigning section 505(b)(2) drug products that are 
described by existing multiple source drug HCPCS codes to those 
existing HCPCS codes is consistent with efforts to curb drug prices 
while limiting opportunities to ``game the regulatory process and the 
patent system in order to unfairly maintain monopolies.'' \109\ We 
stated that we believe our approach also encourages competition among 
products that are competitors--that is, when they are described by one 
billing code and share similar labeling.
---------------------------------------------------------------------------

    \109\ https://www.whitehouse.gov/briefings-statements/president-donald-j-trumps-blueprint-lower-drug-prices/.
---------------------------------------------------------------------------

    We stated our concern about high payments for section 505(b)(2) 
drug products if they are assigned to unique separate HCPCS codes 
despite being described by existing multiple source drug codes. We also 
stated our concern about the effect of high payment amounts on 
individual beneficiaries' cost sharing payments for these products.
    Therefore, for these reasons, in the CY 2021 PFS proposed rule (85 
FR 50265) we proposed to codify our long-standing process for assigning 
certain section 505(b)(2) drug products to existing multiple source 
drug codes if the section 505(b)(2) products are described by existing 
multiple source drug codes consistent with our interpretation of the 
definition of multiple source drug in section 1847A(c)(6)(C) of the Act 
and the approach described above. Specifically, we proposed that where 
a section 505(b)(2) product is not itself therapeutically equivalent, 
pharmaceutically equivalent, or bioequivalent, as determined by FDA, to 
another drug product, we would nonetheless consider it to meet the 
definition of multiple source drug if, based on an assessment of its 
active ingredient, labeling, compendia, and

[[Page 84811]]

other information, the product is described by the code descriptor for 
an existing multiple source drug code. That is, we would assess the 
section 505(b)(2) drug product's active ingredient(s), drug name, and 
description, whether the section 505(b)(2) drug product's labeling, 
particularly the prescribing information, includes information from 
other drug products that are paid under the multiple source drug code, 
and whether the section 505(b)(2) drug product is used and prescribed 
in a manner similar to other products in the multiple source drug code, 
in order to determine whether the section 505(b)(2) drug product is 
described by an existing multiple source drug code. We would not assign 
all section 505(b)(2) drug products to multiple source codes and would 
not assign section 505(b)(2) drug products to a single source drug code 
exclusively made up of single source drug products. We stated that we 
would also reevaluate and potentially revise previous payment (and 
coding) decisions to maintain consistency with our proposed approach, 
if finalized. Consistent with these proposals, we also proposed to 
revise the definition of multiple source drug in regulation text at 
Sec.  414.902 by amending the regulation text to state that multiple 
source drugs may include drug products described under section 
505(b)(2) of the FFDCA and adding Sec.  414.904(k) that describes the 
framework for our determination as discussed in this section of the 
preamble.
4. Summary of Comments
    The following is a brief summary of comments we received on these 
proposals. More detailed comments and responses follow this summary. We 
received approximately 37 timely comments on section 505(b)(2) drug 
products. In general, commenters, primarily manufacturers, stated that 
the proposal was contrary to the statute, conflicted with FDA's 
therapeutic equivalence ratings, would impair access for patients, 
underpay providers, and dampen innovation. Several comments from 
beneficiary advocate and provider groups generally repeated the same 
points, although some comments expressed support for curbing drug 
prices, particularly if the proposal did not affect patient access. 
Several comments appeared to take a middle ground that conditionally 
supported the proposals, particularly if more detail could be provided 
and if effects on patient access were considered. Several commenters 
supported the proposals without conditions.
    Comment: Several commenters contended that CMS lacks the statutory 
authority to adopt the proposals in the proposed rule, and some stated 
that the proposal was not consistent with subregulatory guidance from 
2007. These commenters stated that the language in the statute clearly 
defines multiple and single source drugs, that assigning non-
therapeutically equivalent drug products to a multiple source code 
contradicts the plain language of section 1847A of the Act, and that 
CMS's proposal is contrary to Congress' intent. Commenters also stated 
that the definition of multiple source drug in section 1847A(c)(6) of 
the Act requires each drug product assigned to a multiple source code 
to be therapeutically equivalent, pharmaceutically equivalent and 
bioequivalent to another product in the code, and that the only 
exception is a provision (sometimes referred to as the grandfathering 
provision) under section 1847A(c)(6)(C)(ii) of the Act.
    Response: We disagree that our proposed approach is inconsistent 
with the statute. The statute allows CMS to assign drug products to an 
existing multiple source code, and does not require that the code 
include only products that are therapeutically equivalent, 
pharmaceutically equivalent and bioequivalent to one another product. 
As outlined in the proposed rule, the definition of multiple source 
drug in section 1847A(c)(6)(C) of the Act can be interpreted to mean 
that once a multiple source drug exists--that is, once there are two or 
more drug products that are therapeutically equivalent, 
pharmaceutically equivalent and bioequivalent, and we have assigned 
them to a multiple source drug code--then a subsequent product of the 
same drug--that is, a product that corresponds to the multiple source 
drug's billing code descriptor--can be assigned to such code even if 
the subsequent drug product is not, itself, therapeutically equivalent, 
bioequivalent or pharmaceutically equivalent. In this case, the drug is 
already multiple source, meaning that there are two or more products of 
that drug which are rated as therapeutically equivalent, as evidenced 
by the fact that the existing products are already assigned to the 
multiple source drug code. Once a drug product is assigned to a 
multiple source drug code, the product would not be assigned to a 
single source drug code because the definition of single source drug at 
section 1847A(c)(6)(D)(ii) of the Act states, in part, that a single 
source drug is a drug which is not a multiple source drug. Also, we are 
not aware of any sources, such as Committee Reports that describe 
Congress' intent in detail, that conflict with our interpretation. The 
proposed approach focuses on assigning drug products to a drug code 
solely for Part B drug payment purposes and is consistent with the 
statutory definitions at section 1847A(c)(6)(C) and (D) of the Act. 
However, we do not agree that statutory language at section 
1847A(c)(6)(C)(ii) of the Act about an exception is relevant to this 
discussion. This grandfathering provision applies only to ``single 
source drugs or biologicals that are within the same billing and 
payment code as of October 1, 2003.'' The exception does not apply to 
multiple source drugs or the assignment of drug products to multiple 
source drug billing and payment codes.
    The proposals are also consistent with the program instruction 
published in 2007 (https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/Downloads/051807_coding_annoucement.pdf). In the program instruction, 
we addressed how we would identify ``single source drugs'' and 
``biological products'' using a multi-step process. We did not 
expressly address how we would identify multiple source drugs. The 
program instruction is not inconsistent with our proposal because in 
both cases, the determination of the ``drug'' is reflected at the HCPCS 
code level. In contrast, the term ``drug product'' corresponds to 
individual package sizes of the drug as identified by the NDC or other 
applicable alternative identifier. The proposals published in the CY 
2021 PFS proposed rule add to, rather than conflict with, the 2007 
program instructions and provide detail about how we approach Medicare 
Part B payment of section 505(b)(2) drug products.
    Comment: A number of commenters stated that our approach is not 
consistent with or does not take into account FDA's ratings of 
therapeutic equivalency for drugs and the application of the ratings 
for interchangeability determinations pertaining to these products.
    Response: We disagree with these comments. The therapeutic 
equivalence ratings published by FDA and its work associated with these 
ratings pertain to Part B drug payment only to the extent that they are 
used to define when two or more drug products are therapeutically 
equivalent, which is relevant to the determination of whether a drug is 
single source or multiple source as defined in section 1847A of the 
Act. FDA's therapeutic equivalence ratings do not themselves dictate 
payment under Medicare Part B.

[[Page 84812]]

Relatedly, our proposals for section 505(b)(2) drug products do not 
affect these ratings or this work; rather, our proposals apply only to 
drug payments under section 1847A of the Act. This is consistent with 
the different roles of FDA and CMS--the former assesses a drug 
product's safety and effectiveness, and the latter administers the 
Medicare program.
    As we discussed in the previous comment response, one condition for 
meeting the definition of a multiple source drug at section 
1847A(c)(6)(C) of the Act is that there be two or more drug products 
rated as therapeutically equivalent. However, a subsequent product of 
the same drug--that is, a product that corresponds to the multiple 
source drug code's descriptor--can be assigned to such code even if the 
subsequent drug product is not, itself, therapeutically equivalent. In 
other words, where there are two or more drug products that are rated 
as therapeutically equivalent in the Orange Book, the drug meets the 
definition of multiple source drug for purposes of Medicare Part B 
payment, and this has no bearing on any particular drug product's 
therapeutic equivalence rating. Where there is a multiple source drug 
(as defined in section 1847A(c)(6)(C)), other non-therapeutically 
equivalent drug products of that drug may be assigned to the HCPCS code 
for purposes of payment under section 1847A of the Act. Section 1847A 
of the Act does not mention interchangeability as a factor in 
determining payment for drugs, nor does it explicitly describe how 
multiple source drug products must be assigned to billing and payment 
codes or how they must be paid.
    We also disagree with comments that our proposal fails to take 
product interchangeability into account. Payment under Medicare Part B 
and interchangeability are separate issues--the former pertains to when 
Medicare will pay for a product, and the latter pertains to drug 
dispensing and clinical decisions. In Medicare Part B, where most drugs 
are used incident to a physician's services and are not dispensed 
through a retail pharmacy, what a provider administers to a patient is 
often determined by the prescriber or where that prescriber practices. 
For example, due to space and inventory budget limitations, a 
physician's office will generally stock a limited range of drug 
products that are administered incident to a physician's services. 
Section 1847A of the Act does not specify which drug products physician 
must stock or provide, nor does it dictate how prescribers may utilize 
drug products in patient care. Interchangeability governs the range of 
products that a pharmacist may dispense to fill a prescription and also 
is not addressed in section 1847A of the Act. Rather, 
interchangeability and pharmacy substitution are typically addressed in 
State law and may be affected by factors such as hospital bylaws, 
inventory and other matters that are outside of CMS' purview. As noted 
previously, our proposals pertain only to payment under Medicare Part 
B, and do not purport to dictate which drug products a prescriber may 
prescribe or a pharmacy may dispense.
    Comment: A few commenters noted that the assignment of section 
505(b)(2) drug products to multiple source codes was new and had never 
been applied by CMS. However, other commenters acknowledged CMS' 
longstanding policy with respect to these drug products.
    Response: We disagree with commenters that stated the proposals are 
a new policy that has not been applied to Part B drug payments. As we 
stated in the proposed rule, the policy has been in place for at least 
12 years. For example, this process has been applied to gemcitabine 
injection products that were first marketed as Gemzar(R), a sterile 
lyophilized powder packaged in vials. The brand products were assigned 
to a HCPCS code (J9201), and once generic gemcitabine products were 
marketed, they also were assigned to J9201, making J9201 a multiple 
source drug code. Later, liquid concentrates of gemcitabine injection 
were approved through the pathway established under section 505(b)(2) 
of the FFDCA. These concentrated liquid products also were assigned to 
the existing multiple source HCPCS code, J9201, even though they were 
not, themselves, therapeutically equivalent to the branded products in 
J9201. Subsequently marketed lyophilized powder and concentrated liquid 
gemcitabine injections, as well as gemcitabine products approved under 
ANDAs also have been assigned to HCPCS code J9201.
    ASP-NDC crosswalks that reflect these HCPCS assignments have been 
available to the public along with the quarterly ASP Drug Pricing files 
on the CMS website. We began including the concentrated liquid 
formulations in the ASP NDC crosswalks that were published for January 
2012. The January 2012 Drug Pricing Files and the ASP NDC-HCPCS 
crosswalk are available in the Related Links section at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/2012ASPFiles. Although we do not describe the 
crosswalks as a complete listing of all NDCs used in pricing 
determinations, the crosswalks serve as a guide to help the public 
understand which products are included in the weighted average 
calculation for a given HCPCS code. The crosswalk files are readily 
available to the public via the CMS website and illustrate which NDCs 
are assigned to HCPCS codes for payment under section 1847A of the Act.
    Comment: Several commenters discussed potential effects of the 
proposals on manufacturers. Commenters, primarily manufacturers that 
seek 505(b)(2) approvals for their products, expressed concerns that 
the proposals would dampen innovation, result in fewer drug approvals 
through the pathway, and contribute to a less efficient approval 
process, which could result in fewer choices for patients and 
prescribers and a less predictable marketplace. While some commenters 
expressed concerns about major effects on the industry and appeared to 
believe that all section 505(b)(2) drug products would be affected by 
the proposal, others suggested identifying situations where separate 
payment would be available in a predictable manner. Several commenters 
stated that if CMS moves forward with the proposal, CMS should exclude 
products with ``meaningful differences'' from the policy. One commenter 
encouraged CMS to continue an approach ``that allows for innovation, 
competition, and ultimately more therapeutic choices for Medicare 
beneficiaries.''
    Response: As mentioned in the proposed rule, we are aware that the 
section 505(b)(2) pathway has been in existence since the 1980s, well 
before the implementation of the payment methodology in section 1847A 
of the Act. We are also aware of the potential advantages of seeking 
approval through the pathway established under section 505(b)(2) of the 
FFDCA compared to seeking approval under the section 505(b)(1) pathway. 
Under the 505(b)(1) pathway, the application contains full reports of 
investigations of safety and effectiveness that were conducted by or 
for the applicant or for which the applicant has a right of reference 
or use. Because the approval of a product through the section 505(b)(2) 
pathway relies on at least some information from studies not conducted 
by or for the applicant and for which the applicant has not obtained a 
right of reference, the use of the 505(b)(2) pathway can minimize time, 
effort and expense associated with bringing a product to the market, 
although some additional study of the product is typically

[[Page 84813]]

required. From experience with the crosswalking process (the assignment 
of NDCs to HCPCS codes for payment determinations under section 1847A 
of the Act), we have observed that section 505(b)(2) drug products are 
heterogeneous. Some of the products are very different from previously 
marketed products that were used to support the approval through the 
section 505(b)(2) pathway. For example, the section 505(b)(2) drug 
product may include additional active ingredients, or may incorporate 
formulation changes that result in significant changes to the dosing 
schedule (for example, changing from 3 times per day to once per day 
administration). However, some section 505(b)(2) drug products are very 
similar to drug products that are assigned to multiple source drug 
codes.
    The application of our policy to determine assignment of section 
505(b)(2) drug products to a multiple or single source drug code has 
resulted in the assignment of a limited number of these drug products 
to multiple source drug codes and under our proposal we anticipate that 
the number of assignments of drug products to multiple source codes 
would continue to be limited. Many section 505(b)(2) drug products are 
paid using single source drug codes under section 1847A of the Act. We 
have examined 23 instances associated with the assignment of section 
505(b)(2) drug products to billing codes for payment under section 
1847A of the Act during the years 2017 to 2019. Eighteen of the 
instances led to products being assigned to single source drug codes. 
Products associated with the remaining five instances were not priced 
as separately payable Part B drugs (for example, because payment is 
bundled with physician services). Seventeen of the 18 products that 
were assigned to single source drug codes are included in either the 
ASP Drug Pricing Files, OPPS Addendum B or both files (the exception is 
a product that was not yet marketed). These 17 products include an 
older antibiotic that was combined with a new ingredient that extended 
its antibiotic spectrum, a new formulation of a drug that is used in 
the treatment of opiate use disorder, and novel formulations of older 
drugs that are specifically designed for less frequent administration 
or are administered by a different route (such as a drug that was 
previously approved only as an oral drug and not paid under Part B, but 
was then approved as a section 505(b)(2) drug product as an injectable 
drug). Thus we believe that our policy has not led to the frequent 
assignment of section 505(b)(2) drug products with significant 
modifications (like an additional active ingredient) to multiple source 
drug codes. Further, if manufacturers continue to market products that 
one commenter described as having ``meaningful differences'' from 
multiple source drugs, we anticipate that section 505(b)(2) drug 
products approved in the future will not be assigned to multiple source 
drug codes frequently. For these reasons, we do not believe the 
commenters' concerns that the policy would have a major negative impact 
on innovation, access to products or the speed and efficiency of 
product approval are justified, nor would the policy discourage the use 
of the section 505(b)(2) pathway for drug approvals.
    However, we have concerns about the consistency of how the policy 
has been applied recently. Of the 18 recently approved section 
505(b)(2) drug products discussed above, we believe that two that were 
mentioned in the proposed rule should be reevaluated to determine 
whether they should be paid as single source or multiple source drugs. 
For example, a diluted and ready to administer IV bag of gemcitabine 
injection was recently approved (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208313Orig1s000TOC.cfm). As discussed in a 
previous comment's response in this section, gemcitabine injection was 
originally sold as a lyophilized powder that is reconstituted and then 
further diluted for intravenous administration. Then concentrated 
liquids (which have to be further diluted before administration) were 
approved through the section 505(b)(2) pathway. The lyophilized powder, 
concentrated liquid and generic gemcitabine products are all assigned 
to HCPCS code J9201. Payment limits for this HCPCS code appear in the 
ASP Drug Pricing files and the various products appear in the 
corresponding ASP NDC-HCPCS crosswalk files; the October 2020 payment 
limit for HCPCS code J9201 for 2 grams of the drug, a commonly used 
dose, is $39.57. The newer gemcitabine injection product approved 
through the section 505(b)(2) pathway, which shares dosing, 
pharmacokinetics, adverse effect profile, and indications on labeling 
with the products assigned to J9201, but is packaged in a ready to 
administer IV bag, has a WAC (as reflected in pharmaceutical pricing 
compendia as of November 11, 2020) of $760 per 2 grams, about 19 times 
the payment allowance of J9201. At this time the newest gemcitabine 
product is not paid under HCPCS code J9201, and we believe that its 
assignment to a single source drug billing and payment code should be 
reevaluated.
    Applying our proposal to all gemcitabine injection products, that 
is, the lyophilized powders, the concentrated injection and the newest 
diluted injection formulation, reveals that all products are 
gemcitabine injections, all products share the same labeled indications 
(treatment of ovarian, breast, non-small cell lung, and pancreatic 
cancers), product labeling is very similar (for example, the clinical 
studies referred to in the package insert appear to be the same, 
survival rates, adverse reaction rates, contraindications and warning 
sections of the labeling include virtually identical information), and 
based on dosage and administration, pharmacokinetics, indications and 
other sections of the product labeling, we expect these drug products 
to be used and prescribed in the same way. The result of the 
application of our proposal is that we would determine that the new 
gemcitabine product meets the definition of multiple source drug and 
assign it to the existing multiple source HCPCS code and the payment 
allowance for all the products in the code would be based on the 
volume-weighted average of the ASPs of all the NDCs of such products.
    As discussed earlier in this comment response, we believe that this 
policy approach would not negatively affect innovation. We also believe 
that our approach could help prevent situations where any change to a 
product that distinguishes a 505(b)(2) drug product from a previous 
product approved under an ANDA, no matter how trivial (for the purpose 
of Medicare Part B drug payment), can result in very high prices and 
Part B payments for inexpensive, small molecule drugs that are similar 
to other inexpensive products in the market. Also, assigning section 
505(b)(2) drug products to corresponding multiple source drug codes 
could encourage competition among products that are competitors--that 
is, when the products are described by one billing code and share 
similar labeling.
    Comment: Several commenters expressed concerns about how grouping 
potentially expensive to acquire section 505(b)(2) drug products into 
multiple source drug codes may create situations where a provider's 
Medicare payment would be less than the acquisition cost and that this 
situation could lead to drugs not being available through some 
providers. One commenter pointed out that this could be more 
problematic for smaller practices.

[[Page 84814]]

    Response: As discussed in a previous comment response, we believe 
that the application of our proposal would result in a limited number 
of section 505(b)(2) drug products being assigned to multiple source 
drug codes. Also, when products are assigned to HCPCS codes for payment 
under section 1847A of the Act, the products' sales volume and averages 
sales price may affect the weighted average ASP-based payment limit.
    Since 2005, average sales price-based payment limits described in 
section 1847A of the Act have been determined using sales volume 
weighted averages. Each calendar quarter, a product's average sales 
price as reported by the manufacturer and the number of units sold by 
the manufacturer are included in the statutorily mandated payment 
calculation with other products that are assigned to a given HCPCS 
code. The ASP-based payment limit depends on the manufacturer reported 
volume of sales for a given product within a code and the reported ASP. 
Thus, as more units of a product are sold, that product's contribution 
to the weighted average increases.
    We understand that in some cases a payment limit that is determined 
based on a weighted average can result in payment amounts that are 
below the acquisition costs of products that are sold at prices that 
are much higher than the ASP-based payment allowance. However, as noted 
previously, our policy would apply only to those section 505(b)(2) drug 
products that meet the definition of multiple source drug based at 
section 1847A(c)(6)(C), and manufacturers remain free to develop 
section 505(b)(2) drug products that would not meet the definition of 
multiple source drugs under our proposed approach, in which case such 
section 505(b)(2) drug products would not be assigned to multiple 
source billing and payment codes, and the concern about underpayment 
relative to acquisition cost would be mitigated. Also, in situations 
where a section 505(b)(2) drug product is assigned to a multiple source 
code, the section 505(b)(2) drug product can significantly influence 
payment limit calculations for a code if it competes successfully with 
similar products assigned to the multiples source drug code and 
achieves high sales volume (relative to the other products), 
particularly in situations where only a few low sales volume products 
are assigned to the code.
    We also note that other factors can also influence acquisition 
cost. We do not have control over factors that can affect a provider's 
acquisition costs, for example, high launch prices set by 
manufacturers, sudden and unexpected price increases from 
manufacturers, markups from intermediaries such as wholesalers, lack of 
discounts (including volume discounts to smaller providers) and price 
differences for various classes of trade.
    Comment: Several commenters expressed concern about the proposals' 
effects on patients. Most of these commenters focused on the effects on 
manufacturers, such as potential for less innovation by manufacturers 
leading to fewer drug approvals, fewer options for the treatment of 
patients, and impaired access. One commenter also requested that we 
consider the overall financial effects on patients, including effects 
on drug availability. This commenter expressed concerns about 
manufacturers' attempts to secure high payments for drugs and 
recognized CMS' concerns about manufacturers gaming the payment system 
in a manner that negatively affects consumers and results in diminished 
competition, but the commenter was also concerned about whether the 
policy may also have negative effects on patients.
    Response: We have replied to concerns about the impact on 
manufacturers, innovation, providers and effects on access in general 
in previous comment responses. We do not believe that there is a strong 
justification for such concerns about access because of the limited 
scope of the proposals. That is, the proposals would result in limited 
number of section 505(b)(2) drug products being assigned to multiple 
source drug codes.
    Much of our concern about negative effects on patients is related 
to increases in Part B drug spending that have been occurring for many 
years. From 2011 to 2016, Medicare FFS drug spending increased from 
$17.6 billion to $28 billion under Medicare Part B, representing a 
compound annual growth rate (CAGR) of 9.8 percent, with per capita 
spending increasing 54 percent, from $532 to $818. The number of 
Medicare Part B FFS beneficiaries and the number of these beneficiaries 
who received a Part B drug increased over the 5-year period (2011 
through 2016). However the increase in total Medicare drug spending 
during this period is more fully explained by increases in the prices 
of drugs and mix of drugs for those beneficiaries who received them 
than by increases in Medicare enrollment and drug utilization. The CAGR 
in the number of Medicare Part B FFS beneficiaries is less than 1 
percent between 2011 and 2016 (83 FR 54549 through 50).
    We have concerns that if incentives to develop minimally modified 
products with high prices are not minimized, spending on such products 
will increase and contribute to increases in overall Part B drug 
spending. For individual patients, cost sharing amounts for section 
505(b)(2) drug products, particularly for patients who do not have 
supplementary insurance, could increase as illustrated by the 
gemcitabine example discussed in a previous comment where there is a 
very substantial (approximately 19 times) difference between payments 
for a multiple source drug code and a corresponding product approved 
under the pathway established under section 505(b)(2) of the FFDCA. If 
similar situations become more common, such differences in payment 
amounts may contribute to increases in overall spending that in turn 
contribute to increases in Part B premiums that help fund Part B 
payments. Increases in Part B drug spending could also lead to 
increases in premiums for those with supplementary insurance.
    Comment: A few commenters supported finalizing the proposals in 
order to curb drug prices and to pay similar amounts for similar 
services. The commenters agreed that products recently approved through 
the pathway established under section 505(b)(2) of the FFDCA were 
significantly more expensive than existing products and brought up the 
issue of ``evergreening'' (which includes actions such as securing 
patents or approvals for minimally modified versions of drugs to 
preserve high payments) and its effects on generic drug market by way 
of contribution to higher drug spending for products that do not 
improve outcome or quality. Not finalizing the proposal was 
characterized by a commenter as providing incentive for manufacturers 
to seek more section 505(b)(2) pathway approvals of higher priced 
products that are comparable to previously approved products. One 
commenter stated that the case by case determinations described in the 
proposed rule have been effective, have not sacrificed safety or 
access, and that continuing this approach would reduce opportunities 
for manufacturers to game FDA drug labeling in a manner that results in 
high, single source payments over extended periods of time for multiple 
source products.
    Response: We agree with the commenters and the concern about the 
potential negative impact on innovation that could occur if all section 
505(b)(2) drug products are paid as single source drugs under Part B. 
Permitting the payment of all section 505(b)(2) drug

[[Page 84815]]

products as single source drugs could continue to incentivize the 
development of minimally modified, high priced products, particularly 
injectable drug products used incident to a physician's services. This 
situation could shift manufacturers' focus from innovation to profit 
and thus contribute to high launch prices, high acquisition and 
inventory costs for providers, higher cost sharing and premiums in 
scenarios similar to the newer gemcitabine injection product approved 
through the section 505(b)(2) pathway that was discussed in an earlier 
comment response. This newer product shares dosing, pharmacokinetics, 
adverse effect profile, and indications on labeling with generic 
products but is packaged in a ready to administer IV bag, has a WAC (as 
reflected in pharmaceutical pricing compendia as of November 11, 2020) 
of $760 per 2 grams, about 19 times the payment allowance of the 
multiple source gemcitabine code, J9201.
    Comment: One commenter stated that the proposal will not reduce 
high launch prices.
    Response: We disagree. Although, the effect on launch prices is 
likely to be limited because we do not anticipate that many section 
505(b)(2) drug products will be paid under multiple source codes, in 
situations where payment under a multiple source drug code occurs, we 
believe that manufacturers would not have an incentive to set high 
launch prices.
    Comment: Several commenters expressed conditional or partial 
support for the proposal. This includes commenters who objected to 
finalizing the proposals for reasons discussed in previous comments but 
also stated that if CMS nevertheless finalized the proposals, CMS 
should provide more detail about the framework and the determination 
process and also should delay finalizing the proposal.
    Commenters that suggested a delay in finalizing or implementing the 
proposals provided a variety of reasons for doing so. Some commenters 
requested CMS to provide more details about the process, including more 
specifics on how factors described in the proposal, for example 
differences in the active ingredient and labeling, might be interpreted 
and which drug products might be affected. Several commenters also 
requested that CMS provide more time for assessing the proposals so 
that the public could better understand them and provide an 
opportunity, such as through future rulemaking, for public input both 
on the proposals and on decisions about specific drug products. The 
current public health emergency (PHE) for COVID-19 was also mentioned 
by some commenters as an obstacle to engaging with CMS on this issue or 
responding fully to the proposal, and a reason for why a delay in 
finalizing the proposal is warranted. Other commenters who expressed 
concerns about rising drug prices supported the proposals on the 
condition the beneficiary access was not impaired and that the 
financial impact on patients is considered.
    Response: We believe that we have proposed a clear process that 
includes a variety of factors such as drug names, labeling and 
indication to determine whether a section 505(b)(2) drug product meets 
the definition of multiple source drug at section 1847A(c)(6)(C) of the 
Act and thus should be assigned to an existing multiple source drug 
code. The proposals are also consistent with longstanding CMS drug 
payment policy.
    However, we appreciate commenters' concerns about implementing the 
proposals and requests for additional time for further evaluation and 
engagement. It appears that some commenters may have misunderstood the 
limited scope of our proposal because they believe that many 505(b)(2) 
drug products would be affected. We understand that providing more 
detail with respect to our proposal may be helpful to a variety of 
stakeholders and that a better understanding of the policy will assist 
with planning and more efficient product procurement during a period 
where time and other resources may be scarce.
    Comment: One commenter suggested that if finalized, the policy 
should be phased in, for example by changing the payment for a drug 
product by 25 percent increments over a 4-year time period to close the 
difference between a section 505(b)(2) drug product's current payment 
and the payment for the HCPCS code to which it would be assigned.
    Response: We thank the commenter for this suggestion. However, we 
do not believe that there is authority under section 1847A of the Act 
to adjust payment allowances in the manner the commenter suggests.
    Comment: Commenters also provided comments on the following issues: 
Payment to providers for the costs associated with the acquisition of a 
drug product; payments for the administration of section 505(b)(2) drug 
products; preferred coverage; formularies as well as the role of 
utilization management like step therapy and prior authorization for 
Part B drugs; the application of the process to biologicals; speeding 
up the coding process so that codes are available at product launch; 
payments for new technology; and the implementation of MedPAC 
recommendations.
    Response: These comments are considered to be out of scope of the 
proposed rule, and therefore, we are not addressing in this final rule.
5. Decision
    As discussed in the preceding responses to comments, we continue to 
believe that we have authority to assign certain section 505(b)(2) drug 
products to existing multiple source drug codes based on an 
interpretation of section 1847A of the Act and that our approach does 
not conflict with previously published program instruction or the FDA's 
therapeutic equivalency ratings.
    However, in response to commenters requesting more detail about our 
proposed approach and requests to delay finalizing a decision, we are 
not finalizing the section 505(b)(2) drug product proposals or the 
proposed corresponding regulation text changes for 2021. The delay will 
also provide time for CMS to further consider this issue. We thank 
commenters for their responses.

M. Updates To Certified Electronic Health Record Technology Due to the 
ONC 21st Century Cures Act Final Rule

1. Background
    The American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 
111-5, enacted February 17, 2009) authorized incentive payments to 
eligible professionals, eligible hospitals and critical access 
hospitals (CAHs), and Medicare Advantage (MA) organizations to promote 
the adoption and meaningful use of Certified Electronic Health Record 
Technology (CEHRT). In 2010, the Office of the National Coordinator for 
Health Information Technology (ONC) launched the Health IT 
Certification Program (ONC Health IT Certification Program) to provide 
for the certification of health IT. Requirements for certification are 
based on standards, implementation specifications, and certification 
criteria adopted by the Secretary. The ONC Health IT Certification 
Program supports the use of certified health IT under the programs that 
we administer, including, but not limited to, the Promoting 
Interoperability Programs (previously known as the Medicare and 
Medicaid EHR Incentive Programs), the Quality Payment Program (QPP), 
and the Hospital Inpatient Quality Reporting (IQR) Program. While these 
programs continue to require the use of certified health IT, the use of 
certified health IT

[[Page 84816]]

has expanded to other government and non-government programs. The 
Promoting Interoperability Programs and QPP require the use of CEHRT as 
defined at 42 CFR 495.4 and 414.1305, respectively. Since 2019, in 
general, this has consisted of EHR technology (which could include 
multiple technologies) certified under the ONC Health IT Certification 
Program that meets the 2015 Edition Base EHR definition (as defined at 
45 CFR 170.102) and has been certified to certain other 2015 Edition 
health IT certification criteria as specified in the definition. 
Similarly, the Hospital IQR Program began requiring that hospitals use 
only technology certified to the 2015 Edition certification criteria 
beginning with the CY 2019 reporting period/FY 2021 payment 
determination (83 FR 41607).
    The ``21st Century Cures Act: Interoperability, Information 
Blocking, and the ONC Health IT Certification Program'' final rule 
(hereinafter referred to as the ``ONC 21st Century Cures Act final 
rule''), published in the May 1, 2020 Federal Register (85 FR 25642 
through 25961), finalized a number of updates to the 2015 Edition of 
health IT certification criteria (hereinafter referred to as the 2015 
Edition Cures Update). We believe the 2015 Edition Cures Update will 
enhance interoperability and patients' access to their electronic 
health information, consistent with section 4006(a) of the 21st Century 
Cures Act (Pub. L. 114-255, enacted December 13, 2016). The ONC 21st 
Century Cures Act final rule revised, added new, and removed 
certification criteria that establish the capabilities and related 
standards and implementation specifications for the certification of 
health IT. In the CY 2021 PFS proposed rule (85 FR 50267), we proposed 
to require that technology used to meet the CEHRT definitions must be 
certified in accordance with the updated certification criteria in the 
ONC 21st Century Cures Act final rule.
    The 2015 Edition Cures Update represents a limited set of changes 
relative to the overall set of health IT certification criteria 
currently required for the Promoting Interoperability Programs and QPP. 
These changes incorporate technical standards, including an e-
prescribing standard required for alignment with other CMS programs, 
and other technical updates to existing 2015 Edition functionality used 
by many health care providers. For example, updates to 2015 Edition 
certification criteria referencing the United States Core Data for 
Interoperability (USCDI) standard, rather than the Common Clinical Data 
Set (CCDS) regulatory definition do not require extensive changes to 
user-facing aspects of health IT already certified to these criteria 
(85 FR 25665).
    For CY 2019 and subsequent years, the CEHRT definitions for the 
Promoting Interoperability Programs at Sec.  495.4, and for QPP at 
Sec.  414.1305, require the use of EHR technology that is certified 
under the ONC Health IT Certification Program and meets the 2015 
Edition Base EHR definition at Sec.  170.102. In addition, the CEHRT 
definitions require the technology to be certified to certain other 
2015 Edition health IT certification criteria, as specified in the 
definitions, including criteria necessary to be a meaningful EHR user 
under the Promoting Interoperability Programs, and criteria necessary 
to report on applicable objectives and measures specified under the 
MIPS Promoting Interoperability performance category (previously known 
as the Advancing Care Information performance category). The updates 
finalized by ONC in the ONC 21st Century Cures Act final rule (85 FR 
25642 through 25961) impact criteria in the different elements of the 
CEHRT definitions. This includes certification criteria included in the 
2015 Edition Base EHR definition, as well as the additional 
certification criteria necessary to report on applicable objectives and 
measures to be a meaningful EHR user under the Promoting 
Interoperability Programs and the MIPS Promoting Interoperability 
performance category.
    The ONC 21st Century Cures Act final rule outlines a number of 
timelines and compliance dates for health IT developers related to the 
2015 Edition Cures Update. The final rule finalized the removal of 
several certification criteria from the 2015 Edition that were included 
in the Base EHR definition, upon the effective date of the final rule 
(June 30, 2020). For other certification criteria, the final rule 
finalized a limited period during which ONC-Authorized Certification 
Bodies (ONC-ACBs) may continue to issue certificates for these criteria 
to health IT developers, after which certification will no longer be 
available.
    Where the ONC 21st Century Cures Act final rule finalized updates 
to existing 2015 Edition certification criteria, or introduced new 2015 
Edition certification criteria, ONC generally finalized that health IT 
developers have 24 months from the publication date of the final rule 
(until May 2, 2022) to make technology available that is certified to 
the updated, or new criteria. Subsequently, on April 21, 2020, in 
response to the PHE for COVID-19, ONC announced additional flexibility 
for health IT developers subject to the policies in the ONC 21st 
Century Cures Act final rule (https://www.healthit.gov/cures/sites/default/files/cures/2020-04/Enforcement_Discretion.pdf). Specifically, 
ONC announced that it would exercise enforcement discretion regarding 
new requirements in the ONC 21st Century Cures Act final rule, until 3 
months after each initial compliance date or timeline (August 2, 2022).
    In response to additional calls for increased flexibility in 
response to the PHE for COVID-19, ONC published an interim final rule 
with comment period at 85 FR 70064, on November 4, 2020 entitled 
``Information Blocking and the ONC Health IT Certification Program: 
Extension of Compliance Dates and Timeframes in Response to the COVID-
19 Public Health Emergency'' (hereinafter the ``ONC interim final 
rule''). In this rule, ONC finalized extended compliance dates for 
certain 2015 Edition certification criteria. Specifically, where the 
ONC 21st Century Cures Act final rule provided that developers of 
certified health IT have 24 months from the publication date of the 
final rule to make technology certified to new or updated criteria 
available, ONC extended the timeline until December 31, 2022 (and until 
December 31, 2023 for Sec.  170.315(b)(10), ``EHI export''). ONC stated 
that in order to reduce confusion, it has aligned these dates to the 
calendar year where they impact CMS program participants as aligning 
these compliance dates to the calendar year, also aligns them to the 
CMS program annual cycle. As noted in the CY 2021 PFS proposed rule, 
during this transition period, health IT developers are expected to 
continue supporting technology certified to the prior version of the 
certification criteria for use by their customers prior to implementing 
updates (85 FR 50266).
    Below is an overview of the updates finalized in the ONC 21st 
Century Cures Act final rule that impact certification criteria 
included in the CEHRT definitions, as well as a discussion of 
associated timelines finalized in the ONC 21st Century Cures Act final 
rule, as revised in the ONC interim final rule.
    The ONC 21st Century Cures Act final rule finalized removing the 
following criteria from the 2015 Edition certification criteria upon 
the effective date of the final rule (June 30, 2020), which included 
removing the following criteria from the 2015 Edition Base EHR 
definition (85 FR 25657 through 25660):
     ``Problem list'' at Sec.  170.315(a)(6);
     ``medications'' at Sec.  170.315(a)(7);
     ``medication allergies'' at Sec.  170.315(a)(8); and

[[Page 84817]]

     ``smoking status'' at Sec.  170.315(a)(11).
    The ONC 21st Century Cures Act final rule noted that the 
functionality associated with these criteria is now widespread among 
health IT products, and is expected to remain in products absent 
certification. Accordingly, ONC sought to reduce burden associated with 
the certification program by removing these criteria (85 FR 25657 
through 25660).
    The ONC 21st Century Cures Act final rule also removed the ``data 
export'' criterion at Sec.  170.315(b)(6) from the Base EHR definition, 
upon the effective date of the final rule (June 30, 2020) (85 FR 
25668). However, this criterion will continue to be available for 
certification until December 31, 2023, as finalized in the ONC interim 
final rule (85 FR 70064). The ONC 21st Century Cures Act final rule 
instead established a new criterion, ``electronic health information 
export'' at Sec.  170.315(b)(10), which requires a certified health IT 
module to electronically export all electronic health information 
(EHI), as defined in Sec.  171.102, that can be stored at the time of 
certification by the product of which the health IT module is a part. A 
health IT developer of certified health IT products, which, at the time 
presented for certification electronically stores EHI, must certify 
such products to this new criterion and make these products available 
to their customers by December 31, 2023. However, the new EHI Export 
criterion is not included in the Base EHR definition (85 FR 25690), and 
it is not associated with any objectives or measures in the Promoting 
Interoperability Programs, or the MIPS Promoting Interoperability 
performance category.
    In the ONC 21st Century Cures Act final rule, ONC finalized ``time-
limited'' certification for several additional certification criteria 
associated with measures under the Promoting Interoperability Programs 
and the MIPS Promoting Interoperability performance category from the 
2015 Edition:
     ``Drug-formulary and preferred drug list checks'' at Sec.  
170.315(a)(10);
     ``secure messaging'' at Sec.  170.315(e)(2); and
     ``patient-specific education resource'' at Sec.  
170.315(a)(13).
    In order to allow participants in the Medicaid Promoting 
Interoperability Program to continue to have access to technology 
meeting 2015 Edition certification criteria to meet the measures for 
that program, ONC stated in the ONC 21st Century Cures Act final rule 
that ONC-ACBs may continue to issue certificates for these criteria 
until January 1, 2022 (85 FR 25660 through 25662).
    Specifically, in the proposed rule we noted that the latter two 
criteria are necessary for participants to meet two of the measures in 
the Medicaid Promoting Interoperability Program. The ``secure 
messaging'' criterion at Sec.  170.315(e)(2) is required to meet 
Objective 6 (Coordination of Care through Patient Engagement) and 
Measure 2 (Secure Messaging) (80 FR 62852). Similarly, the ``patient-
specific education resource'' at Sec.  170.315(a)(13) is necessary to 
fulfill the requirements of Objective 5 (Patient Electronic Access to 
Health Information) and Measure 2 (Patient-Specific Education) (80 FR 
62846). We did not propose any changes to these measures in the CY 2021 
PFS proposed rule (85 FR 50265 through 50272), as the final year of the 
Medicaid Promoting Interoperability Program is CY 2021. Based on the 
phased approach that ONC finalized, Medicaid eligible professionals may 
continue to use certified technology meeting those two criteria in CY 
2021, which will enable them to report on these measures for the CY 
2021 Medicaid Promoting Interoperability Program EHR reporting period. 
Health IT developers are encouraged to maintain the certified 
functionality for those two criteria through CY 2021, even if they move 
forward with updates to other criteria. Furthermore, the Secure 
Messaging measure is one of three measures within Objective 6, and 
eligible professionals need only meet two of the measures (Sec.  
495.24(d)(6)(i)(B)). Even without the secure messaging functionality, 
an eligible professional could meet the other two measures and fulfill 
the objective. There is no similar option for the Patient-Specific 
Education measure, which is required to meet Objective 5.
    The ``drug-formulary and preferred drug list checks'' criterion is 
also currently associated with measures under the Electronic 
Prescribing objective for the Promoting Interoperability Programs and 
the MIPS Promoting Interoperability performance category (80 FR 62882 
and 83 FR 59817). As discussed below, since ONC will retire this 
criterion after January 1, 2022, this criterion would no longer be 
required for e-Prescribing measures for the Promoting Interoperability 
Programs and the MIPS Promoting Interoperability performance category, 
beginning in CY 2021 (85 FR 25678).
    The ONC 21st Century Cures Act final rule also finalized updates to 
a number of certification criteria, which are currently associated with 
objectives and measures under the Promoting Interoperability Programs 
and the MIPS Promoting Interoperability performance category, as well 
as criteria that are included in the 2015 Edition Base EHR definition. 
In general, ONC finalized that health IT developers have 24 months from 
the publication date of the final rule to make technology certified to 
these updated criteria available to their customers (until May 2, 
2022). Subsequently, in the ONC interim final rule published on 
November 4, 2020, ONC further extended these compliance dates until 
December 31, 2022, in response to the PHE for COVID-19. During this 
time, developers are expected to continue supporting technology 
certified to the prior version of the 2015 Edition certification 
criteria for use by their customers.
    The ONC 21st Century Cures Act final rule updated several criteria 
to include references to the USCDI standard, rather than the existing 
CCDS definition (85 FR 25670), and implemented related technical 
updates (85 FR 25671). These include the following criteria:
     ``Transitions of care'' at Sec.  170.315(b)(1);
     ``clinical information reconciliation and incorporation'' 
at Sec.  170.315(b)(2);
     ``view, download, and transmit to 3rd party'' at Sec.  
170.315(e)(1);
     ``transmission to public health agencies--electronic case 
reporting'' at Sec.  170.315(f)(5); and
     ``application access--all data request'' at Sec.  
170.315(g)(9).
    The USCDI standard establishes a set of data classes and 
constituent data elements required to support interoperability 
nationwide, designed to expand in an iterative and predictable way over 
time.\110\ In finalizing version 1 of the USCDI, the ONC 21st Century 
Cures Act final rule added three new data classes, ``allergies and 
intolerances,'' ``clinical notes,'' and ``provenance;'' and added 
several additional elements to ``patient demographics'' that were not 
defined in the CCDS (85 FR 25912).
---------------------------------------------------------------------------

    \110\ For more information about the USCDI, see https://www.healthit.gov/isa/united-states-core-data-interoperability-uscdi.
---------------------------------------------------------------------------

    With respect to the use of secure, standards-based application 
programming interface (APIs), the ONC 21st Century Cures Act final rule 
finalized a new standards-based API criterion at Sec.  170.315(g)(10), 
``standardized API for patient and population services,'' which 
requires the use of FHIR Release 4 and several implementation 
specifications (85 FR 25742). Developers must make technology certified 
to this criterion available by December 31, 2022, as finalized in the 
ONC interim final rule

[[Page 84818]]

(85 FR 70064). This criterion replaces the existing ``application 
access--data category request'' certification criterion at Sec.  
170.315(g)(8). However, ONC-ACBs may continue to issue certificates for 
Sec.  170.315(g)(8) until December 31, 2022, permitting certification 
to either criterion during this transition period. The ONC 21st Century 
Cures Act final rule also added the new API criterion at Sec.  
170.315(g)(10) to the 2015 Edition Base EHR definition.
    The ONC 21st Century Cures Act final rule also revised the 
``electronic prescribing'' criterion at Sec.  170.315(b)(3) to 
reference the NCPDP SCRIPT standard version 2017071 (85 FR 25678). As 
with the other updated criteria above, health IT developers have until 
December 31, 2022 to make technology certified to the updated criterion 
available to their customers, as finalized in the ONC interim final 
rule (85 FR 70064). However, we note that ONC has discontinued 
certification of new products to the former electronic prescribing 
criterion using the NCPDP SCRIPT standard version 10.6, in order to 
align with CMS requirements for use of the updated NCPDP SCRIPT 
standard under Part D, adopted as of January 1, 2020 (85 FR 25679). 
Products that were previously certified may maintain certification 
status until December 31, 2022 as developers are updating their 
products, and health care providers may continue to use these certified 
health IT modules for CMS program participation.
    Finally, the ONC 21st Century Cures Act final rule updated the 
certification criterion for clinical quality measures ``Clinical 
Quality Measures (CQMs)--Report'' at Sec.  170.315(c)(3), which is 
included in the CEHRT definitions (85 FR 25686). These updates remove 
the HL7 QRDA standard requirements from the criterion, and instead 
require support for the CMS QRDA Implementation Guides, upon the 
effective date of the final rule (June 30, 2020). In the ONC interim 
final rule, ONC issued a correction stating that health IT developers 
would have until December 31, 2022 to make technology available to 
their customers meeting the updated criterion.
    For further discussion, we refer readers to the ONC 21st Century 
Cures Act final rule (85 FR 25642 through 25961), and section 
III.M.3.b. of this final rule for discussion specific to the Hospital 
IQR Program.
    As noted above, in general, health IT developers have until the 
date finalized in the ONC interim final rule, December 31, 2022, to 
make technology certified to the updated criteria available to their 
customers. As described in the proposed rule (85 FR 50268), after this 
date, technology that has not been updated in accordance with the 2015 
Edition Cures Update will no longer be considered certified by ONC.
    ONC expects and requires that developers will notify customers when 
technology certified to the updated criteria is available, and that 
developers will introduce these updates into certified health IT 
products in the manner most appropriate for their customers, such as 
through the course of normal maintenance (85 FR 25642). As discussed in 
the ONC 21st Century Cures Act final rule (85 FR 25666), health care 
providers may use the Certified Health IT Product List (CHPL) to 
identify the specific certification status of a product at any given 
time. The CHPL distinguishes certification to the existing 2015 Edition 
certification criteria from certification to the updated criteria 
adopted in the ONC 21st Century Cures Act final rule, by referring to 
the new and revised criteria as the 2015 Edition Cures Update, allowing 
health care providers to identify when a specific Health IT Module was 
updated. (https://chpl.healthit.gov/)
2. Updates to 2015 Edition Certified Electronic Health Record 
Technology Requirements in the Promoting Interoperability Programs and 
Quality Payment Program, Due to the ONC 21st Century Cures Act Final 
Rule
    In consideration of the updates made to 2015 Edition certification 
criteria as described in the CY 2021 PFS proposed rule (85 FR 50265 
through 50272), we proposed that the technology used by health care 
providers to satisfy the definitions of CEHRT at Sec. Sec.  495.4 and 
414.1305 must be certified under the ONC Health IT Certification 
Program, in accordance with the updated 2015 Edition certification 
criteria as finalized in the ONC 21st Century Cures Act final rule (85 
FR 25642). We explained this includes technology used to meet the 2015 
Edition Base EHR definition at Sec.  170.102, technology certified to 
the criteria necessary to be a meaningful EHR user under the Promoting 
Interoperability Programs, and technology certified to the criteria 
necessary to report on applicable objectives and measures specified for 
the MIPS Promoting Interoperability performance category, as specified 
in the CEHRT definitions.
    As discussed above, the ONC 21st Century Cures Act final rule 
finalized compliance dates for health IT developers, and established 
which versions of certification criteria meet the certification 
requirements under the ONC Health IT Certification Program based on 
those compliance dates. In other words, the ONC 21st Century Cures Act 
final rule established timelines for (1) a transition period where 
technology certified to the prior or the updated versions of the same 
certification criteria would be considered certified, and (2) the date 
for which technology certified to only the updated version of the 
certification criteria would be considered certified. A health care 
provider must use technology certified under the ONC Health IT 
Certification Program to meet the CEHRT definitions. Therefore, we 
proposed that health care providers participating in the Promoting 
Interoperability Programs or QPP would be required to use only 
technology considered certified under the ONC Health IT Certification 
Program, according to the timelines finalized in the ONC 21st Century 
Cures Act final rule. For updated and new certification criteria 
included in the CEHRT definitions in Sec. Sec.  495.4 and 414.1305, ONC 
finalized that health IT may be certified to the current 2015 Edition 
certification criteria or the 2015 Edition Cures Update criteria for a 
period of 24 months, as described in timelines finalized in the ONC 
21st Century Cures Act final rule (85 FR 25670). ONC then announced an 
additional 3 months during which ONC stated it would exercise 
enforcement discretion in response to the PHE for COVID-19 and continue 
to allow health IT certified to either version of the criteria to be 
considered certified. We explained in the proposed rule that under our 
proposal, during that time period (up to 27 months from May 1, 2020, or 
until August 2, 2022), program participants would be able to use 
technology certified to either version, and that technology would be 
considered certified under the ONC Health IT Certification Program. 
Subsequently, in ONC's interim final rule, ONC extended the compliance 
dates for certification criteria finalized in the ONC 21st Century 
Cures Act final rule, finalizing that health IT may be certified to 
either the existing 2015 Edition certification criteria or the 2015 
Edition Cures Update until December 31, 2022. As the ONC interim final 
rule extended compliance dates for the updated certification criteria 
until December 31, 2022, technology certified by ONC under the ONC 
Health IT Certification Program to the existing 2015 Edition 
certification criteria, or certified to the 2015 Edition and updated to 
the 2015 Edition Cures Update will now be considered certified by ONC 
under the

[[Page 84819]]

ONC Health IT Certification Program until December 31, 2022.
    While the ONC 21st Century Cures Act final rule did not finalize a 
new Edition of certification criteria, this approach is similar to the 
prior policy for transition periods between Editions. For example, 
during the transition period in which the ONC Health IT Certification 
Program included both the 2014 Edition and the 2015 Edition, a health 
IT module certified to either Edition was considered certified, and 
technology certified to either Edition, or a combination of the two, 
could be used by health care providers to meet CEHRT definitions and 
demonstrate meaningful use (see 82 FR 38490 for a discussion of the CY 
2018 transition between 2014 and 2015 Editions for eligible hospitals 
and CAHs). After the end of the transition period, only health IT 
certified to the 2015 Edition could be used by health care providers to 
meet the CEHRT definitions and demonstrate meaningful use, and health 
IT modules certified to only the 2014 Edition were no longer considered 
certified under the ONC Health IT Certification Program. In the same 
manner, after the current transition period ends, health care providers 
must use technology certified to only the updated version of the 
certification criteria finalized by ONC for the ONC Health IT 
Certification Program to meet the CEHRT definitions and demonstrate 
meaningful use.
    Health care providers should refer to the Certification Criteria 
and Conditions and Maintenance of Certification requirements in 45 CFR 
part 170 for details about the updated certification criteria and 
timelines for health IT developers associated with the criteria. The 
ONC Health IT Certification Program regulations specify the 
requirements for what health IT developers must make available to 
customers and the associated timelines.
    In previous rulemaking, to assist readers in identifying the 
requirements of CEHRT for the Promoting Interoperability Programs and 
the MIPS Promoting Interoperability performance category objectives and 
measures, we provided tables identifying the 2015 Edition certification 
criteria required to meet those objectives and measures (see 83 FR 
59817 for the MIPS Promoting Interoperability performance category). We 
noted two instances in which updates in the ONC 21st Century Cures Act 
final rule affect information we have provided in past rulemaking 
regarding the certification criteria that support specific Promoting 
Interoperability objectives and measures.
    First, we noted that the ONC 21st Century Cures Act final rule is 
retiring the ``drug-formulary and preferred drug list checks'' 
criterion at Sec.  170.315(a)(10), which is currently identified as 
supporting measures under the Electronic Prescribing objective (80 FR 
62882 and 83 FR 59817). ONC finalized that this criterion requires 
certification until January 1, 2022, before being retired (85 FR 
25667). We noted that removing this criterion from the Certification 
Program will have negligible impact on health care providers. As 
discussed in prior rulemaking, health care providers have noted that 
formulary checks are a promising approach. However, the utility of the 
specific functionality that is certified is not necessarily 
consistently applicable for all prescriptions (80 FR 62833). In 
addition, as it does not remove the product from the market, any health 
care providers who are using the current functionality may continue to 
use this technology for their own purposes. Accordingly, we noted that 
this certification criterion would no longer be associated with the 
measures under the Electronic Prescribing objective for the Promoting 
Interoperability Programs and the MIPS Promoting Interoperability 
performance category, beginning with the CY 2021 reporting and 
performance periods.
    Second, we stated that under the new API certification criterion, 
``standardized API for patient and population services'' at Sec.  
170.315(g)(10), which requires the use of FHIR Release 4, health IT 
developers have 24 months from the publication date of the ONC 21st 
Century Cures Act final rule to make technology available that is 
certified to this new criterion, which is part of the 2015 Edition Base 
EHR definition. We stated that after 24 months, ONC will retire the 
current ``application access--data category request'' at Sec.  
170.315(g)(8), which is currently identified as supporting the 
``Provide Patients Electronic Access to Their Health Information'' 
measure (80 FR 62882 and 83 FR 59817). We stated that health IT meeting 
either criteria are considered certified during the 24-month period. 
Table 42, shows that either the existing criterion at Sec.  
170.315(g)(8), or the newly finalized criterion at Sec.  
170.315(g)(10), could be used by health care providers to complete the 
actions of the ``Provide Patients Electronic Access to Their Health 
Information'' measure for the Promoting Interoperability Programs and 
the MIPS Promoting Interoperability performance category. Allowing 
health care providers the flexibility of using EHR technology that is 
certified to either criterion during this transition period would allow 
early adopters of the newly finalized criterion at Sec.  
170.315(g)(10), as well as those using technology meeting the existing 
certification criterion, to be able to meet the requirements of the 
Promoting Interoperability Programs and the MIPS Promoting 
Interoperability performance category. As discussed above, in the ONC 
interim final rule, ONC updated compliance dates finalized in the ONC 
21st Century Cures Act final rule to extend the 24-month period 
described above to December 31, 2022.
    In light of the changes described above with respect to the ``e-
Prescribing'' and ``Provide Patients Electronic Access to Their Health 
Information'' measures we included Table 42 in the CY 2021 PFS proposed 
rule (85 FR 50270), shown below. Table 42 provided details on the 
measures for the Promoting Interoperability Programs for eligible 
hospitals and CAHs and the MIPS Promoting Interoperability performance 
category, and the certification criteria that support each measure. We 
also included in Table 42 the certification criteria that support the 
reporting of eCQMs. We noted that Table 42 is only applicable for the 
measures under the Promoting Interoperability Programs and for the 
Promoting Interoperability performance category of MIPS. Table 42 does 
not include all of the updated certification criteria included in the 
CEHRT definition as discussed in the CY 2021 PFS proposed rule (85 FR 
50265 through 50272). Last, Table 42 has been updated to include the 
Health Information Exchange (HIE)(alternative) Bi-Directional Exchange 
measure, as this was finalized in section IV.A.3.c.(4)(c)(ii)(B) of 
this final rule, under the MIPS Promoting Interoperability performance 
category. For further discussion of changes to criteria under the CEHRT 
definition, we referred readers to the ONC 21st Century Cures Act final 
rule (85 FR 25667).
BILLING CODE 4120-01-P

[[Page 84820]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.087

BILLING CODE 4120-01-C
    In the CY 2021 PFS proposed rule, we proposed to revise two 
definitions under Sec.  414.1305 (85 FR 50270). First, under the 
definitions of CEHRT, we proposed to replace the reference to the 
``Advancing Care Information'' performance category with the 
``Promoting Interoperability'' performance category, to reflect the 
performance category name change that we made previously (83 FR 59785). 
Second, under the definition of Meaningful EHR user for MIPS, we 
proposed to replace the reference to the ``Advancing Care Information'' 
performance category with the ``Promoting Interoperability''

[[Page 84821]]

performance category, to reflect the performance category name change 
that we made previously (83 FR 59785).
    We sought public comments on all of these proposals.
    Comment: Many commenters supported CMS' proposal that the 
technology used by health care providers to satisfy the definitions of 
CEHRT must be certified under the ONC Health IT Certification Program 
in accordance with the updated 2015 Edition certification criteria, as 
finalized in the ONC 21st Century Cures Act final rule. Commenters 
indicated the update would harmonize requirements, create more 
efficiencies, and facilitate true interoperability between EHRs. 
Commenters were also in favor of eliminating inconsistencies and 
reducing costs by having the ability to use technology certified to the 
existing 2015 Edition certification criteria, technology certified to 
the 2015 Edition Cures Update, or a combination of the two. One 
commenter observed that the alignment with the ONC 21st Century Cures 
Act final rule would reduce provider confusion.
    Response: We agree that this proposal will reduce confusion for 
health care providers, continue with our efforts to promote 
interoperability, and reduce burden by streamlining efforts across 
programs, and components of the Department.
    Comment: Several commenters expressed appreciation that, during the 
transition period, health care providers will have the flexibility to 
meet the CEHRT definition using technology certified to the existing 
2015 Edition certification criteria, technology certified to the 2015 
Edition Cures Update, or a combination of the two. Further, commenters 
stated that this alignment would reduce administrative burden, 
eliminate redundancies, streamline objectives and measures, ensure 
health care providers are using up-to-date technology, and encourage 
continued efforts to align reporting requirements across care settings.
    Response: We agree that health care providers participating in the 
Promoting Interoperability Programs and QPP will have flexibility 
during this transition period to use EHR technology certified to the 
existing 2015 Edition certification criteria, technology certified to 
the 2015 Edition and updated to the 2015 Edition Cures Update, or a 
combination of EHR technologies. We also agree with commenters that 
this alignment will reduce administrative burden, and support our 
efforts to achieve alignment across programs, care settings, and 
components of the Department.
    Comment: Several commenters stated that the August 2, 2022 
compliance date discussed in the CY 2021 PFS proposed rule occurs in 
the middle of a program year and would create additional challenges and 
complexity for planning. Commenters also expressed concern that the 
proposed mid-year requirement would limit reporting flexibility for 
providers participating in the Hospital IQR Program, the Advanced-APM 
track within QPP, and those opting to use eCQMs under MIPS. These 
commenters requested guidance regarding the relationship between the 
deadline and annual reporting requirements.
    Response: We appreciate commenters' concerns that the August 2, 
2022 compliance date discussed in the CY 2021 PFS proposed rule may 
introduce additional complexity for stakeholders who manage technology 
upgrades and program reporting based on the calendar year.
    As noted above, the ONC interim final rule has extended the 
compliance dates for health IT developers associated with the updated 
certification criteria finalized in the ONC 21st Century Cures Act 
final rule. Specifically, ONC has extended compliance dates that 
originally fell 24-months after the publication of the ONC 21st Century 
Cures Act final rule, to December 31, 2022. This means that technology 
meeting the existing 2015 Edition criteria will be considered certified 
under the ONC Health IT Certification Program through the end of 2022.
    With the extension of the compliance dates in the ONC interim final 
rule, we believe it is appropriate to align the transition period 
during which health care providers participating in the Promoting 
Interoperability Programs or QPP may use technology certified to either 
the existing or updated 2015 Edition certification criteria, with the 
extended compliance date of December 31, 2022. We believe that this 
extension of the transition period to include all of 2022 will address 
commenter concerns regarding the complexities associated with a mid-
year transition date. We are therefore finalizing a modification to our 
proposal, and extending the transition period to the new December 31, 
2022 compliance date as finalized in the ONC interim final rule. After 
this date, only certified technology updated to the 2015 Edition Cures 
Update will be considered certified and may be used by health care 
providers to meet the definitions of CEHRT for the Promoting 
Interoperability Programs and QPP.
    However, we reiterate that health care providers would not be 
required to demonstrate that they are using updated technology to meet 
the CEHRT definitions immediately upon the transition date of December 
31, 2022. In accordance with the reporting and performance period 
requirements of the Promoting Interoperability Programs and the MIPS 
Promoting Interoperability performance category, participants are only 
required to use technology meeting the CEHRT definitions during a self-
selected reporting or performance period of a minimum of any 
consecutive 90 days in CY 2022 (85 FR 58966 through 58967 and section 
IV.A.3.c.(4)(b) of this final rule, respectively). For instance, under 
this final policy, a health care provider could demonstrate meaningful 
use for any consecutive 90-days during CY 2022 using either technology 
certified to the existing 2015 Edition, or certified technology that 
has been updated to the 2015 Edition Cures Update, or a combination of 
non-updated and updated certified health IT modules to meet the CEHRT 
definition. Under the MIPS Promoting Interoperability performance 
category, as described in section IV.A.3.c.(4)(b) of this final rule, a 
MIPS eligible clinician could then choose a performance period of any 
consecutive 90 days to demonstrate meaningful use during 2023, up to 
the final 90 days of 2023. The MIPS eligible clinician would not be 
required to demonstrate meaningful use of technology meeting the 2015 
Edition Cures Update until the 90-day performance period they have 
selected. Moreover, we remind readers that a MIPS eligible clinician is 
not required to report on possession of certified technology for the 
90-day performance period they have selected, but instead, they are 
required to report on how many times they used certified technology for 
the completion of the action defined by each measure. Although we have 
not yet established an EHR reporting period in 2023 for eligible 
hospitals and CAHs under the Promoting Interoperability Program, we may 
consider adopting another 90-day period for 2023 in future rulemaking.
    With regard to alignment with other CMS programs that also require 
or reference the use of certified EHR technology, we expect to 
collaborate with these programs in the future to ensure alignment 
across CMS programs, and that the timelines for implementation 
discussed in this final rule are not adversely impacted by other CMS 
program requirements.
    Comment: Many commenters did not support our proposal to require 
the use of technology certified to the 2015 Edition Cures Update, due 
to concerns with health IT vendors. Specifically, commenters are 
concerned with vendors

[[Page 84822]]

being able to complete, and providers being able to adopt and 
implement, the changes associated with the 2015 Edition Cures Update by 
August 2, 2022, when only updated technology would be considered 
certified under the ONC Health IT Certification Program.
    Commenters specifically expressed concern that in aligning 
deadlines between health care providers and vendors, there would not be 
sufficient time for health care providers to adopt and implement the 
newly available technology. Some commenters requested additional time 
beyond the vendor deadline to select and implement certified health IT, 
test the new technology, customize the new technology for their 
specific practices, update workflows, and train staff.
    A few commenters expressed concern that complications associated 
with transitioning between versions of certified technology could 
negatively affect patient care, and lead to potential patient harm. 
Several commenters urged CMS to extend the transition period for using 
technology certified to either the current 2015 Edition or the 2015 
Edition Cures Update for CMS reporting and incentive-based programs. As 
alternatives, commenters recommended January 2023, August 2023, January 
2024, and August 2024 as potential deadlines.
    Response: We appreciate commenters' concerns related to the effort 
required for health care providers to adopt and implement updated 
technology to meet the CEHRT definition, after it is made available by 
health IT developers. However, we disagree that our proposal would not 
permit adequate time for implementing and using the 2015 Edition Cures 
Update in a manner similar to what commenters are requesting.
    Under our proposed rule, we stated that a health care provider must 
use technology that is considered certified under the ONC Health IT 
Certification Program to meet the CEHRT definitions, in accordance with 
updates to the 2015 Edition of health IT certification criteria, as 
finalized in the ONC 21st Century Cures Act final rule. In our proposed 
rule, we stated that this proposal would allow health care providers to 
use either technology certified to the existing 2015 Edition 
certification criteria, technology certified to the 2015 Edition Cures 
Update, or a combination of the two, prior to the date established by 
ONC, regardless of the health care provider choosing to update their 
certified technology in a phased-in approach, or at one time. 
Specifically, we stated that during CY 2022, a health care provider 
implementing updates in a phased approach could plan to use a 
combination of updated and non-updated certified health IT for any 
consecutive 90-day reporting or performance period prior to August 2, 
2022, and then complete their first reporting or performance period 
using only updated health IT modules in CY 2023. Similarly, we stated 
that if a health care provider was planning to update all of their 
certified technology at one time in order to engage in a more extensive 
testing and implementation period during CY 2022, they could complete 
their 90-day reporting or performance period for CY 2022, prior to 
August 2, 2022 using non-updated health IT, and then complete their 
first reporting or performance period using only updated health IT 
modules in CY 2023 (85 FR 50268).
    Under the revised compliance dates finalized in the ONC interim 
final rule, both technology certified to the existing 2015 Edition and 
technology certified to the 2015 Edition Cures Update would now be 
considered certified until December 31, 2022. As noted above, we are 
finalizing that health care providers may use health IT certified to 
the existing 2015 Edition certification criteria, certified health IT 
updated to the 2015 Edition Cures Update, or a combination of updated 
and not-yet updated health IT modules, for the full year in CY 2022. 
For a reporting or performance period after December 31, 2022, health 
care providers would need to use only technology certified to the 2015 
Edition Cures update to meet the CEHRT definitions.
    We believe the additional flexibility finalized in the ONC interim 
final rule as well as the performance period flexibilities permitted 
under the MIPS Promoting Interoperability performance category, as 
described in section IV.A.3.c.(4)(b) of this final rule, will allow 
sufficient time for health IT developers to make updated products 
available for health care providers to demonstrate meaningful use. This 
timeframe would allow developers and MIPS eligible clinicians as much 
as 3 years and 5 months (or, 41 months total) from the publication of 
ONC's 21st Century Cures Act final rule, before a MIPS eligible 
clinician seeking to demonstrate meaningful use would be required to 
use technology meeting the 2015 Edition Cures Update for their 90-day 
performance period in CY 2023 under the Promoting Interoperability 
performance category. We believe this is a sufficient amount of time 
for MIPS eligible clinicians to implement and use updated technology 
after it is made available by health IT developers. Historically, 
commenters have requested a total of 36 months from the publication of 
a new Edition of health IT certification criteria to the time it is 
required for use by health care providers participating in CMS 
programs. As discussed in the proposed rule, updates to the 
certification criteria that ONC finalized in the ONC 21st Century Cures 
Act final rule do not constitute a full new Edition of technology (85 
FR 25665), as the scope of updates did not warrant implementation of an 
entirely new Edition of certification criteria (85 FR 25664 through 
25665). Although we have not yet established an EHR reporting period in 
2023 for eligible hospitals and CAHs under the Promoting 
Interoperability Program, we may consider adopting another 90-day 
period for 2023 in future rulemaking.
    The updates finalized in the ONC 21st Century Cures Act final rule 
are limited in scope to build on existing functionality and standards 
in technology certified to the 2015 Edition, which participants in CMS 
programs have been using as part of clinical and administrative 
workflows since the 2019 program year. Specifically, as described in 
the ONC 21st Century Cures Act final rule (85 FR 25665), updates to the 
technology that require additional technical development by health IT 
developers, and which impact participants in CMS programs, include: (1) 
Updating eCQM and e-prescribing criteria to align with existing CMS 
requirements; (2) modifying existing interoperability criteria to 
reference the USCDI standard; and (3) updating certification of the API 
functionality for patient access. For eCQMs, the updates required in 
the ONC 21st Century Cures Act final rule bring the criterion in line 
with the updates already required for CMS quality programs, which are 
implemented on an annual basis. For the e-prescribing criterion, the 
updates required in the ONC 21st Century Cures Act final rule bring the 
criterion in line with the requirements for the Medicare Part D 
program, which required use of an updated e-prescribing standard 
beginning on January 1, 2020 (84 FR 23832). For the USCDI updates, ONC 
noted that the updates to the common clinical data set (CCDS) to create 
the USCDI were intentionally limited to a modest expansion that most 
health IT developers already supported, were already working toward, or 
should be capable of updating their health IT to support in a timely 
manner (85 FR 25665). Additionally, while there may be some development 
burden on health IT developers to update current criteria from the CCDS 
to the USCDI, there would be limited burden on health care

[[Page 84823]]

providers to send or receive additional data types or to provide 
additional data points to patients using the same health IT 
capabilities that currently support these workflows. Similarly, since 
2019, health care providers with systems certified to 2015 Edition 
certification criteria that participate in the Promoting 
Interoperability programs or the Promoting Interoperability performance 
category in MIPS have implemented workflows for patients to access 
their information using API technologies certified to the 2015 Edition 
for the purposes of reporting for the ``Provide Patients Electronic 
Access to their Health Information'' measure. The update to the FHIR-
based API should not be a significant change to these workflows for the 
provider, as these changes are technical modifications within the 
system rather than significant changes to clinical or administrative 
workflows.
    Therefore, while implementation and testing of updates in the 2015 
Edition Cures Update will be necessary, the updates to the eCQM and e-
prescribing criteria are already being implemented under existing CMS 
programs. In addition, we believe the updates for the USCDI and API 
will be largely seamless for health care providers and will not require 
substantial redesign of existing clinical and administrative workflows 
for health IT users. Instead, the majority of the burden associated 
with these updates falls on health IT developers of certified health 
IT, as discussed in the regulatory impact analysis in the ONC 21st 
Century Cures Act final rule (85 FR 25912).
    Regarding recommendations from commenters that we establish 
separate deadlines for health care providers to use technology meeting 
the 2015 Edition Cures Update, we do not believe that such timelines 
would be consistent with the level of burden described above or with 
HHS priorities to advance interoperability in a timely fashion. For 
instance, if we adopted the recommendation to not require health care 
providers to use updated technology until 2024, as recommended by some 
commenters, this could mean that a health care provider would not 
implement and use certified technology updated to the 2015 Edition 
Cures Update until 4 years after the publication of updated criteria in 
the ONC 21st Century Cures Act final rule. Therefore, the benefits of 
technology updates such as FHIR-based API capabilities, which can be 
implemented today, would not be available to patients for over 4 years 
from their inclusion in the ONC Health IT Certification Program. We do 
not believe that such a lengthy delay in improving patient access to 
their health information would be consistent with our priorities for 
the Promoting Interoperability Programs or QPP.
    We also wish to emphasize that, under the ONC 21st Century Cures 
Act final rule, health IT developers may make technology meeting 
updated criteria available to health care providers at any time prior 
to the compliance dates finalized in the ONC interim final rule, and 
may begin to support health care providers in implementing these 
updates. Our policy would allow health care providers to use either 
technology certified to the current 2015 Edition, technology certified 
to the 2015 Edition and updated to 2015 Edition Cures Update, or a 
combination of the two, to meet the CEHRT definitions beginning with 
the 2020 reporting and performance periods upon the effective date of 
this final rule.
    We declined to set an independent additional deadline for health 
care providers participating in the Promoting Interoperability Programs 
and the MIPS Promoting Interoperability performance category to use 
updated technology, as we believe that existing flexibility around when 
health care providers must demonstrate meaningful use during the 
calendar year will provide sufficient time for health care providers to 
implement and use updated certified technology. Moreover, we believe 
that any further extension of timeframes beyond what we have discussed 
in this final rule would result in unacceptable delays in making 
important technology updates available, which HHS has determined are 
critical for improving interoperability across the nation in a timely 
fashion and improving the quality of care for patients.
    Comment: Several commenters expressed concern that updated 2015 
Edition certified health IT would be cost prohibitive, and recommended 
that CMS allow additional time for health care providers to implement 
these updates, so that they would have an opportunity to recover from 
the financial effects of the PHE for COVID-19 before being required to 
implement technology meeting the 2015 Edition Cures Update. A few 
commenters stated that aligning deadlines between CMS and ONC could 
lead to significant financial burdens in an already compromised 
environment. Commenters expressed concern with vendors making excessive 
charges to clients to guarantee meeting required deadlines, or, vendors 
deciding not to issue an updated product thereby reducing market 
competition, and potentially further increasing the cost for available 
products. Several commenters stated that the costs to cover such 
expansive EHR upgrades were not approved in this fiscal years' budget, 
leaving little room for unexpected high costs.
    Response: We appreciate commenters' concerns regarding the 
financial impact of the PHE for COVID-19 on health care providers. We 
proposed that participants in the Promoting Interoperability Programs 
and QPP be required to use technology considered certified under the 
ONC Health IT Certification Program to meet the CEHRT definitions, 
consistent with the timelines finalized in the ONC 21st Century Cures 
Act final rule. As discussed above, the ONC interim final rule 
published in the November 4, 2020 Federal Register provided additional 
flexibility by extending compliance dates for updated certification 
criteria finalized in the ONC 21st Century Cures Act final rule to 
December 31, 2022. To align with this change, we are finalizing our 
proposal with a modified timeframe, as discussed in our previous 
responses to comments. We believe this extended timeframe will offer 
health care providers additional flexibility to manage the financial 
impacts of the PHE for COVID-19 with respect to when they implement and 
begin using technology updated to the 2015 Edition Cures Update.
    Regarding pass through and development costs, we would like to 
reiterate a few points as discussed above. First, with the extended 
timeline, health care providers have the ability to use technology 
certified to the existing 2015 Edition certification criteria or 
updated to the 2015 Edition Cures Update to demonstrate meaningful use, 
starting from the effective date of this final rule. Moreover, in many 
cases, we believe these updates will be implemented by health IT 
developers as part of routine cyclical updates, such as the annual 
updates to CMS eCQMs. We believe the ability to implement these changes 
through routine service and maintenance updates will reduce the 
pressure on health care providers to meet an expedited timeline. 
Second, as discussed above, the required updates are based on existing 
capabilities that vendors have already deployed as part of the 2015 
Edition, reducing the likelihood that developers will not pursue 
updates to their products. For health care providers who have concerns 
regarding their respective vendor, we again want to encourage the use 
of CHPL. As discussed above, the CHPL distinguishes certification to 
the existing 2015 Edition certification criteria from certification to 
the updated

[[Page 84824]]

criteria adopted in the ONC 21st Century Cures Act final rule, by 
referring to the new and revised criteria as the 2015 Edition Cures 
Update, allowing health care providers to identify when a specific 
health IT module was updated. (https://chpl.healthit.gov/) Last, to 
understand the impact on health IT developers associated with updating 
health IT products, we refer readers to the impact analysis presented 
in the ONC 21st Century Cures Act final rule at 85 FR 25912.
    Comment: A few commenters were supportive of our proposals, but 
asked that CMS and ONC continue to monitor the PHE for COVID-19, and 
adjust compliance deadlines as appropriate. A few concerns commenters 
shared surrounding the PHE for COVID-19 included administrative burdens 
for health care providers, potential risks to patients and their 
safety, and the financial burden for those already struggling 
financially and administratively amidst the PHE for COVID-19. As an 
alternative, commenters suggested implementing two separate timelines, 
allowing additional time to recoup financial costs and recover from the 
PHE for COVID-19. The first timeline being for developers to make 
updated 2015 Edition products available as finalized under the ONC 21st 
Century Cures Act final rule, immediately followed by a second timeline 
specifically for health care providers to adopt and implement these 
updated products.
    Response: We appreciate the concerns raised by commenters, but 
respectfully disagree. As mentioned above, our alignment with the 
additional flexibility finalized in the ONC interim final rule, coupled 
with the existing flexibilities permitted under the MIPS performance 
period requirements for the Promoting Interoperability performance 
category described in section IV.A.3.c.(4)(b) of this final rule, 
allows developers and MIPS eligible clinicians as much as 3 years and 5 
months from the publication of ONC's 21st Century Cures Act final rule 
before they must use certified technology updated to the 2015 Edition 
Cures Update. Given the limited scope of the updates and the importance 
of supporting patient access and care coordination, we believe a single 
aligned timeline for developers to make updates available and for 
subsequent provider implementation and use is appropriate. Health care 
providers have the option to use either technology certified to the 
existing 2015 Edition, or certified technology that has been updated to 
the 2015 Edition Cures Update, or a combination of non-updated and 
updated certified health IT modules through December 31, 2022, with the 
ability to choose a phased-in, or one time approach to implementing 
these updates. Additionally, as discussed above, MIPS eligible 
clinicians are only required to use technology meeting the CEHRT 
definition during any self-selected performance period of a minimum of 
any consecutive 90-days, including the last 90-days of 2023, for the 
Promoting Interoperability performance category in CY 2023 (see section 
IV.A.3.c.(4)(b) of this final rule). Although we have not yet 
established an EHR reporting period in 2023 for eligible hospitals and 
CAHs under the Promoting Interoperability Program, we may consider 
adopting another 90-day period for 2023 in future rulemaking.
    Regarding recommendations that we establish two separate 
implementation deadlines (one for health IT developers, and one for 
health care providers), we do not believe that such timelines would be 
consistent with the level of burden previously discussed, with HHS 
priorities to advance interoperability in a timely fashion, or our 
efforts to maintain alignment across programs and components of the 
Department. We further believe that a single timeline for health care 
provider use of updated technologies that is aligned to the compliance 
timelines for health IT developers allows for the most efficient 
transition for health care providers in planning and executing 
implementation of updates in preparation for a reporting period in CY 
2023.
    Comment: One commenter supported the alignment between CMS and ONC, 
but shared concerns with the ability of all health care providers to 
meet the proposed deadlines. The commenter instead suggested that early 
adopters be rewarded with bonus points and/or counting this as an 
improvement activity.
    Response: We will take these suggestions under consideration for 
future rulemaking.
    Comment: Several commenters urged CMS to work with ONC to ensure 
that health care providers are not held accountable for delays in 
implementation or adoption caused by the health IT vendors. One 
commenter said that health care providers cannot control vendor 
compliance, and urged CMS to work with ONC to ensure that health care 
providers are not harmed, either by being penalized for vendor non-
compliance or through high pass-through costs.
    Response: We remind commenters that under the Promoting 
Interoperability Programs for eligible hospitals and CAHs, CMS may 
grant, on a case-by-case basis, hardship exceptions for extreme and 
uncontrollable circumstances, which may include vendor issues or issues 
related to decertified EHR technology. Information on the hardship 
exception request process is available on the CMS Promoting 
Interoperability web page at https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/PaymentAdj_Hardship. Eligible 
clinicians participating in the MIPS Promoting Interoperability 
performance category may submit a hardship exception request through 
the QPP website at https://qpp.cms.gov/login. For more information on 
the hardship exception process under MIPS, please also refer to https://qpp.cms.gov/mips/exception-applications.
    Comment: Some commenters were not supportive of CMS' proposal to 
require updates to 2015 Edition certified health IT in accordance with 
the timeline set forth in the ONC 21st Century Cures Act final rule to 
meet the CEHRT definitions. Commenters expressed concern with, and lack 
of confidence in, any presumption that technology updated in accordance 
with the 2015 Edition Cures Update will facilitate seamless 
interoperability, as these updates encompass a significant development 
effort. Commenters encouraged CMS to consider alternative means to the 
proposed timelines.
    Commenters urged CMS to work in concert with federal partners that 
are working to address the same issues now to ensure its approach 
aligns with theirs, and to minimize compliance burdens on affected 
stakeholders. One commenter recommended that CMS engage clinicians in 
developing the requirements for future updates to certification 
criteria for health IT referenced by the CEHRT definitions.
    Response: We respectfully disagree with commenters that the updates 
to certification criteria finalized in the ONC 21st Century Cures Act 
final rule will not help to improve interoperability for health care 
providers and patients. As discussed in the CY 2021 PFS proposed rule, 
the updates to 2015 Edition certification criteria are primarily 
focused on incorporating standards that are broadly supported across 
industry as important steps to improve interoperability. For instance, 
the USCDI version 1, which is referenced in several updated 
certification criteria, adds clinical notes and provenance as data 
elements to the existing CCDS based on significant feedback from the 
industry. Both the free text portion of the clinical notes

[[Page 84825]]

and the provenance of data have been identified by clinicians as data 
that is important to clinicians but is often missing during electronic 
health information exchange.
    Similarly, we believe implementation and use of technology 
certified to the new certification criterion for a standards-based API 
in the 2015 Edition Cures Update will help to create an environment 
that promotes innovation for software developers to connect new tools 
and services that create efficiencies for health care providers 
throughout their course of care delivery. By enabling access to data 
through the new, standards-based API, clinicians will have increased 
access to applications that can help support use cases for population 
health analytics, clinical decision support, patient education, as well 
as to conduct administrative and financial tasks. For further 
information, we refer readers to the discussion of the benefits 
associated with increased interoperability enabled by APIs in the ONC 
21st Century Cures Act final rule (85 FR 25922).
    In response to commenters who expressed concerns that this 
alignment will not result in a seamless transition, we respectfully 
disagree and note that this approach avoids potential negative 
consequences of misalignment. As an example, not aligning the 
requirements for the use of certified technology under the Promoting 
Interoperability Programs and the MIPS Promoting Interoperability 
performance category with the updated 2015 Edition certification 
criteria finalized in the ONC 21st Century Cures Act final rule could 
lead to increased stakeholder confusion on how to meet individual 
program requirements, gaps in availability of essential functionality 
and standards, and lack of adoption of updated technology that supports 
patient safety and quality outcomes. This would increase burden by 
requiring health care providers to maintain the same health IT, but 
applied differently to two different program areas.
    In response to commenters requesting that CMS continue to work 
alongside Federal partners to ensure that we approach overlapping 
issues similarly, we agree. CMS and ONC will continue to work together 
keeping HHS' priorities to advance interoperability in a timely fashion 
as a priority. The theme of alignment is also integral across program 
areas, across components of the Department, and across the care-
continuum. We will continue to work together, and continue to highlight 
these areas of alignment for health care providers.
    For commenters recommending that CMS engage clinicians in 
developing the requirements for future updates to CEHRT, we appreciate 
this suggestion. Health care providers are welcome to submit 
suggestions via the Promoting Interoperability Call for Measures, for 
eligible hospitals and CAHs, or eligible clinicians. Health care 
providers are also encouraged to submit comments and suggestions in 
responses to proposed rules including the annual IPPS and PFS proposed 
rules. We also encourage health care providers to listen to, 
participate in, and submit questions or comments through Promoting 
Interoperability webinars for hospitals and CAHs, and eligible 
clinicians.
    Comment: Several commenters supported revising the two definitions 
referencing the ``Advancing Care Information'' performance category, 
and changing this to read the ``Promoting Interoperability'' 
performance category under Sec.  414.1305.
    Response: We would like to thank commenters for their support.
    Comment: One commenter recommended that CMS remove the 45 CFR 
170.315(c)(2) and (3) criteria from the CEHRT definition for MIPS and 
QPP, to allow more eligible clinicians to participate in A-APMs and 
other-Payer A-APMs that use CQM collection types without leveraging 
eCQM functionality. It was suggested that CMS and ONC make the CQM 
criteria optional for those who choose to use the eCQM collection type. 
The commenter stated this would allow additional eligible clinician 
types to use certified criteria as appropriate for their respective 
fields, without needing to possess and maintain technology that is not 
necessary.
    Response: We thank commenters for their input, and note that the 
CEHRT definitions already provide this type of flexibility for health 
care providers to obtain and implement only those criteria that they 
need to use based on specific program measures and submission methods. 
The CEHRT definitions do require the 45 CFR 170.315(c)(1) criterion, 
which is a part of the 2015 Edition Base EHR definition. However, 
implementation and use of both the 45 CFR 170.315(c)(2) criterion and 
the 45 CFR 170.315(c)(3) criterion is contingent upon what is necessary 
to report on applicable objectives and measures. These two criteria are 
required if the health care provider is reporting eCQMs directly from 
their EHR for their program participation. However, the criteria are 
not required if they are not required by the specific CQM reporting 
option that the health care provider chooses.
    After consideration of the public comments received, we are 
finalizing our proposals with a modification to align the transition 
period during which health care providers participating in the 
Promoting Interoperability Programs or QPP may use technology certified 
to either the existing or updated 2015 Edition certification criteria, 
with the December 31, 2022 date established in the ONC interim final 
rule for health IT developers to make updated certified health IT 
available.
    This will allow health care providers to use either not yet-updated 
technology certified to the existing 2015 Edition, or certified 
technology that has been updated to the 2015 Edition Cures Update, or a 
combination of non-updated and updated certified health IT modules, 
starting from the effective date of this final rule through the end of 
CY 2022. Health care providers would then be required to use only 
certified technology updated to the 2015 Edition Cures Update for a 
performance period in CY 2023. As discussed in our responses to 
comments, we note that, consistent with the MIPS Promoting 
Interoperability performance category performance period described in 
section IV.A.3.c.(4)(b) of this final rule, a MIPS eligible clinician 
is not required to demonstrate use of updated technology beginning on 
January 1, 2023. Rather, a MIPS eligible clinician participating in the 
Promoting Interoperability performance category may select a 
performance period of any consecutive 90-days as late as the last 90-
days in 2023 to meet the CEHRT definitions using technology meeting the 
2015 Edition Cures Update. Although we have not yet established an EHR 
reporting period in 2023 for eligible hospitals and CAHs under the 
Promoting Interoperability Program, we may consider adopting another 
90-day period for 2023 in future rulemaking.
3. Changes to Certification Requirements Under the Hospital IQR Program 
Due to the 21st Century Cures Act Final Rule
a. Background and Previously Finalized Certification Requirements
    To measure the quality of hospital inpatient services, we 
implemented the Hospital IQR Program, previously referred to as the 
Reporting Hospital Quality Data for Annual Payment Update (RHQDAPU) 
Program. We refer readers to the FY 2010 IPPS/LTCH PPS final rule (74 
FR 43860 through 43861) and the FY 2011 IPPS/LTCH PPS final rule (75 FR 
50180 through 50181) for detailed discussions of the history of the 
Hospital IQR Program, including the

[[Page 84826]]

statutory history, and to the FY 2015 IPPS/LTCH PPS final rule (79 FR 
50217 through 50249), the FY 2016 IPPS/LTCH PPS final rule (80 FR 49660 
through 49692), the FY 2017 IPPS/LTCH PPS final rule (81 FR 57148 
through 57150), the FY 2018 IPPS/LTCH PPS final rule (82 FR 38326 
through 38328 and 82 FR 38348), the FY 2019 IPPS/LTCH PPS final rule 
(83 FR 41538 through 41609), and the FY 2020 IPPS/LTCH PPS final rule 
(84 FR 42448 through 42509) for the measures we have previously adopted 
for the Hospital IQR Program measure set for the FY 2022 payment 
determination and subsequent years. We also refer readers to 42 CFR 
412.140 for Hospital IQR Program regulations.
    The Hospital IQR Program strives to put patients first by 
empowering patients to make decisions about their own healthcare along 
with their clinicians using information from data driven insights that 
are increasingly aligned with meaningful quality measures. We support 
technology that reduces burden and allows clinicians to focus on 
providing high quality healthcare for their patients. We also support 
innovative approaches to improve quality, accessibility, and 
affordability of care, while paying particular attention to improving 
clinicians' and beneficiaries' experiences when interacting with CMS 
programs. In combination with other efforts across HHS, we believe the 
Hospital IQR Program incentivizes hospitals to improve healthcare 
quality and value, while giving patients the tools and information 
needed to make the best decisions for themselves. The Hospital IQR 
Program measures assess clinical processes, patient safety and adverse 
events, patient experiences with care, care coordination, and clinical 
outcomes, as well as cost of care.
    For each Hospital IQR Program payment determination, we require 
that hospitals submit data on each specified measure in accordance with 
the measure's specifications for a particular period. Hospital IQR 
Program file format requirements have progressed over time to support 
quality reporting based on data submitted from EHRs that use relevant, 
up-to-date, standards-based structured data capture. We updated our 
requirements with the adoption of health IT certified to new Editions 
of certification criteria referenced in the CEHRT definition, 
originally requiring hospitals submitting eCQM data to use technology 
certified to the 2014 Edition certification criteria (79 FR 50252) and 
evolving to the current requirement that hospitals use technology 
certified to the 2015 Edition certification criteria for reporting 
eCQMs and hybrid measures (83 FR 41604 through 41607, and 84 FR 42507). 
In order to ease the transition between Editions of certified health 
IT, the Hospital IQR Program offered flexibility in file submission 
requirements, allowing the use of either the 2014 Edition or the 2015 
Edition for multiple reporting periods (80 FR 49705 through 49708; 81 
FR 57169 through 57170; 82 FR 38397 through 38391). As we stated in the 
FY 2017 IPPS/LTCH PPS final rule (81 FR 57111), our goal is to align 
electronic quality measure requirements of the Hospital IQR Program 
with various other Medicare and Medicaid programs, including those 
authorized by the Health Information Technology for Economic and 
Clinical Health (HITECH) Act, as much as feasible so that the reporting 
burden on healthcare providers will be reduced (82 FR 38392). In the 
past we noted that aligning the eCQM submission requirements of the 
Hospital IQR Program and the Promoting Interoperability Programs 
reduces burden for hospitals as they may report once and fulfill the 
requirements of both programs (84 FR 42599). We intend to continue to 
align the eCQM reporting requirements for the Hospital IQR Program and 
Promoting Interoperability Programs to reduce reporting burden (84 FR 
42598 through 42601; 82 FR 38479).
b. Revisions to the Existing Certification Requirements
    Recently, through the ONC 21st Century Cures Act final rule (85 FR 
25642 through 25961) published on May 1, 2020, ONC updated the 2015 
Edition of health IT certification criteria (``2015 Edition Cures 
Update''). Specifically, the ONC 21st Century Cures Act final rule 
finalized updates to existing 2015 Edition certification criteria and 
introduced new 2015 Edition criteria. As noted in section III.M.1. of 
this final rule, in general, the ONC 21st Century Cures Act final rule 
provided that health IT developers have up to 24 months from May 1, 
2020 to make technology certified to the updated and/or new criteria 
available to their customers. During this period, health IT developers 
are expected to continue supporting technology certified to the prior 
version of the certification criteria for use by their customers prior 
to updating their products (85 FR 25642 through 25961).
    In April 2020, ONC announced its intention to exercise enforcement 
discretion as to the compliance dates finalized in the ONC 21st Century 
Cures Act final rule in response to the PHE for COVID-19.\111\ As a 
result, where the ONC 21st Century Cures Act final rule required health 
IT developers to make technology meeting new and updated certification 
criteria available by May 2, 2022, ONC stated developers taking 
advantage of enforcement discretion would be permitted to delay making 
updated certified technology available until 3 months after each 
initial compliance date or timeline.
---------------------------------------------------------------------------

    \111\ https://www.healthit.gov/cures/sites/default/files/cures/2020-04/Enforcement_Discretion.pdf.
---------------------------------------------------------------------------

    Given the Hospital IQR Program's history of updating file 
submission requirements, we understand that transitioning to technology 
certified to a new Edition, or to an updated version of the same 
Edition of certification criteria, can be complex. Nevertheless, we 
believe that there are many benefits to using relevant, up-to-date, 
standards-based structured data capture with an EHR to support 
electronic clinical quality measurement. In addition, we believe it is 
important to continue to align with the eCQM reporting requirements for 
the Promoting Interoperability Programs (82 FR 38479, 84 FR 42598).
    Therefore, in the CY 2021 PFS proposed rule (85 FR 50270 through 
50272), for the Hospital IQR Program beginning with the CY 2020 
reporting period/FY 2022 payment determination \112\ and for subsequent 
years, we proposed to expand flexibility to allow hospitals to use 
either: (1) Technology certified to the 2015 Edition criteria as was 
previously finalized in the FY 2019 IPPS/LTCH final rule (83 FR 41537 
through 41608), or (2) certified technology updated consistent with the 
2015 Edition Cures Update as finalized in the ONC 21st Century Cures 
Act final rule (85 FR 25642 through 25961). We are clarifying in this 
final rule that this proposed flexibility applies to all Hospital IQR 
Program measures which use EHR data elements to calculate measure 
rates, including eCQMs and hybrid measures. We also refer readers to 
sections III.M.1. and III.M.2. of this final rule for background and 
more details about the 2015 Edition Cures Update. We proposed to adopt 
this flexible approach in order to encourage hospitals to implement the 
most up-to-date, standards-based structured data capture while also 
maintaining alignment with the Promoting Interoperability Program 
proposal. We noted that the proposal would allow hospitals that are 
early adopters of certified health IT that has

[[Page 84827]]

been updated to the 2015 Edition Cures Update to implement those 
changes while still meeting Hospital IQR Program requirements. We also 
noted that we will revisit this topic in future rulemaking as for 
further alignment with the ONC 21st Century Cures Act final rule. We 
sought public comment on our proposal.
---------------------------------------------------------------------------

    \112\ We note that the CY 2021 PFS proposed rule stated that 
this proposal would begin with CY 2020 reporting period/FY 2023 
payment determination (85 FR 50271). We are clarifying that this 
proposal will begin with the CY 2020 reporting period, which 
corresponds with the FY 2022 payment determination.
---------------------------------------------------------------------------

    We noted that, among other changes and of particular relevance to 
hospitals that participate in the Hospital IQR Program, the ONC 21st 
Century Cures Act final rule revises the clinical quality measurement 
criterion at Sec.  170.315(c)(3) to refer to CMS QRDA Implementation 
Guides and removes the Health Level 7 (HL7[supreg]) QRDA standard 
requirements (85 FR 25645). Under the Hospital IQR Program, we 
previously encouraged health IT developers to test any updates on an 
annual basis, including any updates to the eCQMs and eCQM reporting 
requirements for the Hospital IQR Program, based on the CMS QRDA I 
Implementation Guide for Hospital Quality Reporting (CMS Implementation 
Guide for QRDA) (82 FR 38393). The CMS Implementation Guide for QRDA, 
program specific performance calculation guidance, and eCQM electronic 
specifications and guidance documents are available on the eCQI 
Resource Center website at https://ecqi.healthit.gov/. To be clear, the 
ONC 21st Century Cures Act final rule removes the HL7[supreg] QRDA 
standards from the relevant health IT certification criteria, which now 
refers directly to the CMS Implementation Guides for QRDA standards 
bringing their requirements into closer alignment with what we 
encourage under the Hospital IQR Program. Based on our data, the 
majority of Hospital IQR Program participants already use the CMS QRDA 
I Implementation Guide for Hospital Quality Reporting for submission of 
eCQMs to the Hospital IQR Program. We noted that we believe this update 
results in health IT developers no longer needing to maintain 
certification to the Health Level 7 (HL7[supreg]) QRDA base standards 
in addition to using the CMS QRDA I Implementation Guide for the 
Hospital IQR Reporting.
    Since publication of the CY 2021 PFS proposed rule, in response to 
additional calls for increased flexibility in response to the PHE for 
COVID-19, on November 4th, 2020 ONC issued an interim final rule with 
comment entitled ``Information Blocking and the ONC Health IT 
Certification Program: Extension of Compliance Dates and Timeframes in 
Response to the COVID-19 Public Health Emergency'' (hereafter, ``ONC 
interim final rule'') (85 FR 70066). In the ONC interim final rule, ONC 
finalized extended compliance dates for certain 2015 Edition 
certification criteria. Specifically, where the ONC 21st Century Cures 
Act final rule provided that developers of certified health IT have 24 
months from the publication date of the final rule to make technology 
certified to updated criteria available to their customers, ONC 
extended the timeline until December 31, 2022 (85 FR 70064). After that 
date, technology that has not been updated in accordance with the 2015 
Edition Cures Update will no longer be considered certified.
    The following is a summary of the comments we received and our 
responses.
    Comment: Several commenters expressed support for our proposal to 
expand flexibility to allow hospitals to use either: (1) Technology 
certified to the 2015 Edition as was previously finalized in the FY 
2019 IPPS/LTCH final rule (83 FR 41537 through 41608); or (2) certified 
technology updated consistent with the 2015 Edition Cures Update as 
finalized in the ONC 21st Century Cures Act final rule (85 FR 25642 
through 25961) for the CY 2020 reporting period/FY 2022 payment 
determination and for subsequent years. A few commenters expressed 
their support and noted that CMS should consider the timeline for fully 
implementing the technology upgrades associated with the 2015 Edition 
Cures Update when considering requirements for future program years. 
One commenter noted their support for the required use of the CMS QRDA 
I Implementation Guide that will occur as a result of using the 2015 
Edition Cures Update because it reduces burden on EHR developers.
    Response: We agree that the standardization to use the QRDA I 
Implementation Guide will help in burden reduction for EHR developers. 
We will consider the timeline for fully implementing the technology 
upgrades associated with the 2015 Edition Cures Update when determining 
requirements for future program years. As noted above, in this final 
rule we are finalizing the proposed flexibility, which applies to all 
Hospital IQR Program measures, which use EHR data elements to calculate 
measure rates, including eCQMs and hybrid measures.
    Comment: A few commenters did not support our proposal due to 
concerns with the timeline and effort for health IT developers to 
certify and for providers to adopt the changes associated with the 2015 
Edition Cures Update. These commenters specifically expressed concern 
that aligning the deadline for providers to adopt technology certified 
to the 2015 Edition Cures Update with the deadline for vendors to have 
this Edition available would not provide sufficient time for providers 
to adopt the newly available version. Some commenters noted that they 
require additional time beyond the vendor deadline to select and 
implement certified health IT, test the new technology, customize the 
health IT for their specific practices, and update workflows and train 
staff. The commenters urged CMS to extend the flexibility for using 
both technology certified to the current 2015 Edition and certified 
technology updated consistent with the 2015 Edition Cures Update as 
acceptable versions to be used for CMS reporting and incentive-based 
programs through CY 2023 or later.
    Response: We emphasize that the proposal to allow hospitals to use 
either technology certified to the 2015 Edition or certified technology 
updated consistent with the 2015 Edition Cures Update beginning with 
the CY 2020 reporting period/FY 2022 payment determination allows for 
greater flexibility. We want to avoid penalizing providers 
participating in the Hospital IQR Program who wish to adopt the updated 
technology earlier than the mandated deadline for the ONC Health IT 
Certification Program finalized by ONC by ensuring the providers who 
adopt early are still in compliance with Hospital IQR Program data 
submission requirements. We clarify that, for the Hospital IQR Program, 
beginning with the CY 2020 reporting period/FY 2022 payment 
determination, using certified technology updated to the 2015 Edition 
Cures Update is an acceptable option, but so is use of technology 
certified to the 2015 Edition certification criteria. For those that 
cannot use certified technology updated to the 2015 Edition Cures 
Update, technology certified to the 2015 Edition continues to be 
acceptable.
    We understand commenters' concerns related to the effort it will 
take for providers to customize their health IT for their specific 
practices and to potentially update workflows and train staff when 
adopting updated certified technology once it is made available by 
health IT developers; however, we expect the burden of updating these 
criteria for providers to be no greater than that already required to 
comply with CMS annual updates. We recommend readers review section 
III.M.2. of this final rule, and the ONC 21st Century Cures Act final 
rule (85 FR 25667) for greater understanding of the scope of these 
updates and how this scope was considered in establishing the timelines 
for developer update.

[[Page 84828]]

Furthermore, as noted above, since publication of the CY 2021 PFS 
proposed rule, in response to additional calls for increased 
flexibility in response to the PHE for COVID-19, on November 4, 2020 
ONC issued an interim final rule with comment entitled ``Information 
Blocking and the ONC Health IT Certification Program: Extension of 
Compliance Dates and Timeframes in Response to the COVID-19 Public 
Health Emergency'' (hereafter, ``ONC interim final rule'') (85 FR 
70066). In the ONC interim final rule, ONC finalized extended 
compliance dates for certain 2015 Edition certification criteria. 
Specifically, where the ONC 21st Century Cures Act final rule provided 
that developers of certified health IT have 24 months from the 
publication date of the final rule to make technology certified to 
updated criteria available to their customers, ONC extended the 
timeline until December 31, 2022 (85 FR 70064).
    Comment: One commenter noted that hospital and delivery systems are 
experiencing disruptions due to the PHE for COVID-19, which makes 
digital updates difficult during this time.
    Response: We reiterate that our policy is intended to expand 
flexibility and avoid penalizing providers participating in the 
Hospital IQR Program who wish to adopt the updated technology earlier 
than the mandated deadline finalized by ONC by ensuring the providers 
who adopt early are still in compliance with Hospital IQR Program data 
submission requirements. We will accept data using either technology 
certified to the 2015 Edition criteria or certified technology updated 
consistent with the 2015 Edition Cures Update beginning with the CY2020 
reporting period/FY 2022 payment determination.
    In addition, if a hospital experiences an extraordinary 
circumstance that prevents it from reporting eCQMs they are able to 
submit an individual extraordinary circumstances exception (ECE) 
request under the Hospital IQR Program. Specifically, in the FY 2016 
IPPS/LTCH PPS final rule, we finalized a policy, effective starting 
with the FY 2018 payment determination, to allow hospitals to utilize 
the existing ECE form (OMB control number 0938-1022 (expiration date 
December 31, 2022)) to request an exception to the Hospital IQR 
Program's eCQM reporting requirement for the applicable program year 
based on hardships preventing hospitals from electronically reporting 
(80 FR 49695, 49713). We stated that such hardships could include, but 
are not limited to, infrastructure challenges (hospitals must 
demonstrate that they are in an area without sufficient internet access 
or face insurmountable barriers to obtaining infrastructure) or 
unforeseen circumstances, such as vendor issues outside of the 
hospital's control (including a vendor product losing certification (80 
FR 49695, 49713)). We assess a hospital's request on an individual 
basis to determine if an exception is merited (80 FR 49695, 49713). We 
also refer stakeholders to additional eCQM ECE resources on 
QualityNet.\113\ We also note that, in response to the PHE for COVID-
19, ONC announced additional flexibility for health IT developers. 
Specifically, in the ONC interim final rule, ONC further extended the 
deadline for health IT developers to make technology certified to the 
updated criteria available to their customers until December, 31, 2022 
(85 FR 70064).
---------------------------------------------------------------------------

    \113\ See https://www.qualitynet.org/inpatient/measures/ecqm/participation#tab2.
---------------------------------------------------------------------------

    Comment: A few commenters noted that the August 2, 2022 deadline 
for making technology meeting new and updated certification criteria 
available occurs in the middle of a program year, and therefore, limits 
flexibility for providers, including those participating in the 
Hospital IQR Program. These commenters requested guidance regarding the 
relationship between the deadline and annual reporting requirements for 
various programs including the Hospital IQR Program.
    Response: In the proposed rule we discussed ONC's compliance date 
of August 2, 2022 for health IT developers to make updated certified 
health IT products available to their customers.\114\ However, as 
mentioned above, since publication of the CY 2021 PFS proposed rule, 
ONC issued an interim final rule, which extended the date for health IT 
developers to make technology certified to the updated criteria 
available to their customers until December 31st, 2022 (85 FR 70064). 
For the CY 2022 reporting period/FY 2024 payment determination, 
hospitals must report the required number of quarters of eCQM data from 
the January 1, 2021 to December 31, 2022 reporting period, by 2 months 
following the close of the calendar year. (85 FR 58940). We refer 
readers to QualityNet.org for more information related to important 
dates and deadlines for the Hospital IQR Program.\115\ We believe the 
change finalized in the ONC interim final rule, which aligns the 
compliance date for updating certified health IT under the ONC Health 
IT Certification Program with the calendar year, addresses the 
commenters' concern regarding misalignment with the annual reporting 
requirements for the Hospital IQR program.
---------------------------------------------------------------------------

    \114\ https://www.healthit.gov/cures/sites/default/files/cures/2020-04/Enforcement_Discretion.pdf.
    \115\ QualityNet.org, Hospital IQR Program Participation. 
Available at https://www.qualitynet.org/inpatient/iqr/participation.
---------------------------------------------------------------------------

    After consideration of the public comments, we are finalizing our 
proposal as proposed.

N. Establishing New Code Categories

1. Background
    Currently, there are four existing Level II HCPCS codes for 
buprenorphine/naloxone products (J0572-J0575), which describe groupings 
of products by different strengths as indicated on their FDA labels. 
When many payers assign a single payment rate to a single code, they 
typically do so under the expectation that the products can be 
substituted for one another in most clinical scenarios. As discussed in 
the CY 2021 PFS proposed rule (85 FR 50272), we have received feedback 
from stakeholders that there is variability in bioequivalence between 
the products within the range of strengths listed in each code 
descriptor, meaning that products within a current code are not 
necessarily substitutes for one another. Therefore, to facilitate more 
accurate coding and more specific reporting of the variety of 
buprenorphine/naloxone products on the market, we proposed an expanded 
series of codes to identify buprenorphine/naloxone products.
    Specifically, we proposed to establish 15 new code categories for 
use to report all currently marketed buprenorphine/naloxone products, 
based on strength as well as therapeutic equivalence reflected in Table 
43.

[[Page 84829]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.088

    As the existing 4 codes would be replaced with more specific codes 
in the new code series, we also proposed to discontinue the existing 
codes in Table 44.
[GRAPHIC] [TIFF OMITTED] TR28DE20.089

    The new code series would permit physicians and clinics to 
accurately bill insurers for the drug and dose utilized. For example, 
state Medicaid agencies would be able to more easily identify the drug 
dispensed, which would facilitate more efficient and accurate rebate 
invoicing for the Medicaid Drug Rebate Program. The expanded code 
series would also facilitate more specific and meaningful tracking of 
utilization of buprenorphine/naloxone products within and across their 
respective health insurance programs. We noted that these coding 
proposals would not change Medicare coverage or payment policies for 
oral or sublingual buprenorphine codes. The drug products described by 
these codes are not separately payable under Medicare Part B.
    We received the following comments on the proposal to establish new 
code categories.
    Comment: Several commenters supported our proposal to establish new 
code categories.
    Response: We appreciate the comments in support of establishing the 
new code categories.
    Comment: A few commenters suggested retaining the existing four 
codes and recommended that we not establish new code categories, on the 
basis that the proposed, expanded list of codes may result in confusion 
and additional work on the part of providers.
    Response: We appreciate the comment in support of retaining the 
existing code categories and not establishing new code categories. As 
discussed below, in order to further consider the effects of an 
expanded code series, we have decided not to finalize our proposals at 
this time.
    As a result of our review of the comments, some in favor of more 
granular coding and some in favor of less granular coding, we would 
like to further consider the appropriate level of coding granularity 
for buprenorphine/naloxone products. Thus, we have decided not to 
finalize our proposal to establish the 15 new code categories set forth 
in Table 43 or our proposal to discontinue the existing four HCPCS

[[Page 84830]]

codes (J0572, J0573, J0574 and J0575) listed in Table 44 at this time. 
The existing four codes in Table 44 will remain in effect on January 1, 
2021.

O. Medicare Diabetes Prevention Program (MDPP)

    In the CY 2021 PFS proposed rule (85 FR 50074), we proposed to 
amend our regulation at Sec.  410.79(e) to describe the policies that 
will apply during certain emergencies (Emergency Policy). In addition, 
we proposed to amend Sec.  424.210 to modify the definition of 
``beneficiary engagement period'' and to address beneficiary engagement 
incentives that are furnished to MDPP beneficiaries who are receiving 
MDPP services virtually pursuant to the Emergency Policy.
1. Revisions to Sec.  410.79(b)
    We proposed to amend the Medicare Diabetes Prevention Program 
(MDPP) expanded model to revise certain MDPP policies adopted in the 
March 31st COVID-19 IFC (85 FR 19230) that would apply during the 
remainder of the PHE for COVID-19 and/or any future emergency period, 
and in an emergency area, as such terms are defined in section 1135(g) 
of the Act, where the Secretary has authorized section 1135 waivers for 
such emergency area and period (hereinafter referred to as an ``1135 
waiver event'') where such 1135 waiver event may cause a disruption to 
in-person MDPP services (hereinafter referred to as an ``applicable 
1135 waiver event''). We proposed that we would determine that an 1135 
waiver event could disrupt in-person MDPP services if MDPP suppliers 
would likely be unable to conduct classes in-person, or MDPP 
beneficiaries would likely be unable to attend in-person classes, for 
reasons related to health, safety, or site availability or suitability. 
Health and safety reasons may include avoiding the transmission of 
contagious diseases, compliance with laws and regulations during an 
1135 waiver event, or the physical safety of MDPP beneficiaries or MDPP 
coaches during an 1135 waiver event. We proposed that if we determine 
that an 1135 waiver event may disrupt in-person MDPP services, we would 
notify all impacted MDPP suppliers via email and other means as 
appropriate. Such notice would include the effective date when 
flexibilities described in Sec.  410.79(e) would be available. We 
proposed that the applicable 1135 waiver event would end on the earlier 
of the end of the emergency period (as defined in section 1135(g) of 
the Act) or the date we determine that the 1135 waiver event no longer 
disrupts in-person MDPP services under the proposed standard described 
above.
    We temporarily amended the MDPP expanded model to revise certain 
MDPP policies in the March 31st COVID-19 IFC. These changes apply only 
during the PHE for COVID-19. The March 31st COVID-19 IFC permits 
certain beneficiaries to obtain the set of MDPP services more than once 
per lifetime, waives the 5 percent weight loss eligibility 
requirements, and allows certain MDPP suppliers to either suspend the 
delivery of services or deliver virtual MDPP sessions on a temporary 
basis. We believe that establishing an Emergency Policy that applies 
more broadly will improve the current flexibilities for the remainder 
of the PHE for COVID-19 and provide MDPP suppliers and MDPP 
beneficiaries with flexibilities to address any future applicable 1135 
waiver events.
    The changes proposed in the CY 2021 PFS proposed rule would 
preserve the March 31st COVID-19 IFC MDPP flexibilities and apply them 
to future section 1135 waiver events, provide for additional 
flexibilities that would apply during the PHE for COVID-19 and future 
1135 waiver events, clarify certain policies adopted in the IFC, and 
prospectively end a flexibility that would become unnecessary in light 
of our other proposals. We stated that the proposed flexibilities, if 
finalized, would supersede the flexibilities adopted in the March 31st 
COVID-19 IFC for the PHE for COVID-19. Thus, the proposed changes would 
be available for the remainder of the PHE for COVID-19 and for all 
future applicable 1135 waiver events, effective January 1, 2021.
    We proposed these changes to address MDPP supplier and MDPP 
beneficiary needs in response to the PHE for COVID-19 and any future 
1135 waiver events that result in an interruption to expanded model 
services delivered by MDPP suppliers and preventing MDPP beneficiaries 
from attending in-person sessions. Throughout the original rulemaking 
for the MDPP expanded model, we sought to ensure that the set of MDPP 
services would be delivered in-person, in a classroom-based setting, 
within an established timeline. During that rulemaking, CMS prioritized 
establishing a structured service that, when delivered within the 
confines of the rule, would create the least risk of fraud and abuse, 
increase the likelihood of success for beneficiaries, and maintain the 
integrity of the data collected for evaluation purposes. Based on 
lessons learned during the PHE for COVID-19, we proposed to allow 
temporary flexibilities that prioritize availability and continuity of 
services for MDPP suppliers and beneficiaries affected by extreme and 
uncontrollable circumstances that CMS determines may disrupt in-person 
MDPP services during an applicable 1135 waiver event using the standard 
articulated above. The overall intent of the proposed Emergency Policy 
is to minimize disruption of services for MDPP suppliers and 
beneficiaries.
    The proposed flexibilities would be applicable to MDPP 
beneficiaries and MDPP suppliers (as such terms are defined in Sec.  
410.79(b)) as described herein. Our Emergency Policy does not permit an 
MDPP supplier to furnish MDPP services virtually during the PHE for 
COVID-19 or an applicable 1135 waiver event unless the MDPP supplier's 
preliminary or full CDC Diabetes Prevention Recognition Program (DPRP) 
recognition authorizes the supplier to furnish services in-person. The 
MDPP supplier requirements at Sec.  424.205 set forth parameters for 
suppliers to enroll in Medicare, including having any preliminary 
recognition established by the CDC for the purposes of the DPRP or full 
CDC DPRP recognition. The DPRP refers to a program administered by the 
CDC that recognizes organizations that are able to furnish the National 
Diabetes Prevention Program (National DPP) services, follows a CDC-
approved curriculum, and meets CDC's performance standards and 
reporting requirements. The CDC assigns to each DPRP-recognized 
supplier an organizational code that specifies the service delivery 
mode (for example, in-person, online, distance learning, or 
combination). Because MDPP services are covered under Medicare only 
when they are furnished at least in part in-person, a supplier that 
does not have an organizational code authorizing in-person services 
(``virtual-only suppliers'') may not provide MDPP services, either 
virtually or in-person. We do not believe it is appropriate to permit 
virtual-only suppliers to furnish MDPP services when the proposed 
Emergency Policy is in effect. This is because MDPP suppliers must 
remain prepared to resume delivery of MDPP services in-person to start 
new cohorts and to serve beneficiaries who wish to return to in-person 
services when the proposed Emergency Policy is no longer in effect. 
Given the difficulty of predicting when the PHE for COVID-19 or any 
applicable 1135 waiver event will end, virtual-only suppliers may not 
have sufficient time to obtain the CDC's authorization to furnish in-
person

[[Page 84831]]

services. Permitting virtual-only suppliers to furnish MDPP services 
during the PHE for COVID-19 or an applicable 1135 waiver event could 
disrupt the provision of services to MDPP beneficiaries when services 
resume on an in-person basis. Virtual only suppliers are not permitted 
to provide the set of MDPP services because MDPP beneficiaries may 
elect to return to in-person services after the PHE for COVID-19 or 
other applicable 1135 waiver event ends, and MDPP suppliers need to be 
able to accommodate their request. In addition, we are still requiring 
the MDPP suppliers to resume furnishing in-person the set of MDPP 
services after the applicable 1135 waiver event.
    We proposed to amend the MDPP regulations to provide for certain 
changes, including allowing MDPP suppliers to start new cohorts during 
the remainder of the PHE for COVID-19 or a future applicable 1135 
waiver event and allowing MDPP suppliers to either deliver MDPP 
services virtually, or suspend in-person services and resume services 
at a later date during an applicable 1135 waiver event. The proposed 
changes would permit certain MDPP beneficiaries to obtain the set of 
MDPP services more than once per lifetime, for the limited purposes of 
allowing a suspension in service due to an applicable 1135 waiver event 
and to provide the flexibilities that will allow MDPP beneficiaries to 
maintain eligibility for MDPP services despite a break in attendance.
    In the March 31st COVID-19 IFC, we stated that we would allow MDPP 
suppliers to either deliver MDPP services virtually or suspend in-
person services and resume services at a later date. In addition, we 
also provided in the March 31st COVID-19 IFC that the once per lifetime 
requirement waiver is only applicable to MDPP beneficiaries whose 
sessions were suspended or cancelled due to the PHE for COVID-19 (that 
is, MDPP beneficiaries who were receiving the set of MDPP services as 
of March 1, 2020). However, we do not believe it is necessary to permit 
all MDPP beneficiaries to restart the set of MDPP services in all 
applicable 1135 waiver events. Therefore, we proposed that MDPP 
beneficiaries who elect to receive MDPP services virtually in 
accordance with the MDPP Emergency Policy are not eligible to restart 
the set of MDPP services at a later date. As proposed, the policy would 
ensure that MDPP beneficiaries who continue to receive the set of MDPP 
services virtually during an applicable 1135 waiver event cannot repeat 
the set of MDPP services at a later date, in accordance with the 
general once per lifetime limitation for the set of MDPP services 
established in Sec.  410.79(c)(1)(i)(B).
    We proposed the following approach for permitting MDPP 
beneficiaries to resume or restart the set of MDPP services in the 
event in-person sessions are suspended, and the MDPP beneficiary does 
not elect to receive MDPP services virtually. MDPP beneficiaries who 
are in the first 12 months of the set of MDPP services as of the start 
of an applicable 1135 waiver event would be eligible to restart the set 
of MDPP services at the beginning, or resume with the most recent 
attendance session of record, after the applicable 1135 waiver event 
has ended. Beneficiaries who are in the second year of the set of MDPP 
services as of the start of an applicable 1135 waiver event would be 
eligible to restart the ongoing maintenance session interval in which 
they were participating at the start of the applicable 1135 waiver 
event or would be permitted to resume with the most recent attendance 
session of record. MDPP beneficiaries who are in the second year of the 
set of MDPP services would not be allowed to restart the set of MDPP 
services at the beginning.
    We noted that we do not believe allowing MDPP beneficiaries who are 
already in the ongoing maintenance phase of MDPP to restart from the 
beginning aligns with the performance-based payment strategy upon which 
the expanded model relies to achieve savings. MDPP suppliers with 
beneficiaries who have successfully completed over half of the set of 
MDPP services have already benefited from the bulk of the permitted 
total performance-based payments. Allowing MDPP beneficiaries in the 
ongoing maintenance interval phase to restart the expanded model would 
result in an MDPP supplier being reimbursed for close to double the 
intended payment amount. Not only might this have a negative impact on 
the long term expanded model savings, this could result in 
beneficiaries being unfairly coerced into electing to start over 
instead of resuming the set of MDPP services where they left off. The 
proposal would apply prospectively only. Under the current MDPP 
regulations, as amended in the March 31st COVID-19 IFC, we waived the 
once per lifetime requirement for MDPP beneficiaries who were receiving 
the set of MDPP services as of March 1, 2020 and whose sessions were 
suspended or canceled due to the PHE for COVID-19 to obtain the set of 
MDPP services more than once per lifetime by electing to restart the 
set of MDPP services or resume with the most recent attendance session 
of record. We proposed to retain that flexibility for those MDPP 
beneficiaries who were receiving the set of MDPP services as of March 
1, 2020 (and as discussed in greater detail below, are modifying this 
flexibility to apply to MDPP beneficiaries who were receiving the set 
of MDPP services as of March 31, 2020). Finally, we proposed that 
beneficiaries who elect to suspend the set of MDPP services at the 
start of an applicable 1135 waiver event and subsequently choose to 
restart the MDPP set of services at the beginning or to resume with the 
most recent attendance session of record, may only make such an 
election once per applicable 1135 waiver event. The proposed policy was 
intended to ensure that MDPP beneficiaries may not suspend and re-start 
the MDPP set of services multiple times during the same applicable 1135 
waiver event, which would be contrary to the overall goal of the MDPP 
Emergency Policy, and to the goals of the MDPP expanded model as a 
whole.
    We proposed that the limit placed on the number of virtual make-up 
sessions described at Sec.  410.79 would not apply during the remainder 
of the PHE for COVID-19 or during any future applicable 1135 waiver 
event, so long as the virtual services are furnished in a manner that 
is consistent with the CDC DPRP standards for virtual sessions, follow 
the CDC-approved National DPP curriculum requirements, and the supplier 
has an in-person DPRP organizational code.
    We proposed to amend the regulations to clarify that all sessions, 
including the first core session, may be offered virtually, not as 
``virtual make-up sessions,'' but as a virtual class consistent with 
the in-person class curriculum, during the remainder of the PHE for 
COVID-19 and any future applicable 1135 waiver event. The MDPP supplier 
could still only furnish a maximum of one session on the same day as a 
regularly scheduled session and a maximum of one virtual make-up 
session per week to the MDPP beneficiary. We proposed that virtual 
sessions may be furnished to achieve both attendance goals and achieve 
weight-loss goals in the event that a qualifying weight measurement was 
obtained by one of the methods described herein. We proposed that an 
MDPP supplier may offer to an MDPP beneficiary: 16 virtual sessions 
offered weekly during the core session period; 6 virtual sessions 
offered monthly during the core maintenance session interval periods; 
and 12 virtual sessions offered monthly during the ongoing

[[Page 84832]]

maintenance session interval periods. MDPP suppliers may only furnish a 
maximum of one regularly scheduled session virtually and a maximum of 
one virtual make-up session per week to an MDPP beneficiary. As 
proposed, the number of allowable virtual core sessions would increase 
from 15 to 16. This change is due to the added proposed flexibility to 
allow MDPP suppliers to obtain weight measurements remotely (as 
described below) and to deliver the first core session virtually.
    Under these temporary flexibilities, we proposed that the 
requirement for in-person attendance at the first core-session would 
not apply. We proposed that during the remainder of the PHE for COVID-
19 and any future applicable 1135 waiver events, MDPP suppliers may 
obtain weight measurements from MDPP beneficiaries through the 
following methods: (1) In-person, when the weight measurement can be 
obtained safely and in compliance with all applicable laws and 
regulations; (2) via digital technology, such as scales that transmit 
weights securely via wireless or cellular transmission (commonly 
referred to as ``BluetoothTM enabled''); or (3) self-
reported weight measurements from a participant's own at-home digital 
scale. We proposed that self-reported weights must be submitted via 
video, by the MDPP beneficiary to the MDPP supplier. The video must 
clearly document the weight of the MDPP beneficiary as it appears on 
his/her digital scale on the date associated with the billable MDPP 
session. Due to this additional flexibility, we proposed that the 
waiver of the minimum weight loss requirements for beneficiary 
eligibility in the ongoing maintenance session intervals described in 
Sec.  410.79(e)(3)(iv) of the March 31st COVID-19 IFC (85 FR 19230) be 
ended. Thus, effective January 1, 2021, all MDPP beneficiaries would be 
required to achieve and maintain the required 5 percent weight loss 
goal in order to be eligible for the ongoing maintenance sessions, even 
if the PHE for COVID-19 remains in place as of that date.
    We proposed to amend Sec.  410.79(e). We sought comment on these 
proposals. We received public comments on the proposed changes to Sec.  
410.79(b). The following is a summary of the comments we received and 
our responses.
    Comment: Several commenters requested clarification regarding 
whether beneficiaries are required to use digital scales to collect 
their body weights at home. Commenters expressed concern that some 
participants in MDPP would be unable to document their weight because 
they do not have either digital scales or smart phones to capture a 
photograph or video of their weight on a digital scale. For example, 
several commenters indicated that requiring beneficiaries to capture 
their weights via a digital scale by video, and then sending the video 
in a HIPAA-compliant manner to their MDPP supplier, may prove too 
burdensome for patients and create additional barriers to MDPP 
participation. Furthermore, commenters stated that MDPP beneficiaries 
may have limited access or ability to use the technology required to 
meet this method of reporting. These commenters contended that if 
beneficiaries are unable to present in-person for their MDPP sessions 
or secure digital transmissions of their weights, this could limit them 
from meeting the eligibility requirements to participate. Several 
commenters requested that we consider other options of self-reporting 
such as allowing patients to take their weight at home on the date of 
the MDPP session and report via a telehealth visit, via a phone call to 
the MDPP supplier, or securely communicate the weight measurement thru 
the Electronic Health Record secure messaging portal.
    Response: We agree with the commenters that some beneficiaries may 
lack access to scales and phones with photograph or video capabilities. 
We proposed additional methods by which MDPP suppliers may obtain 
weight measurements from beneficiaries and allowing MDPP suppliers to 
obtain weight measurement from MDPP beneficiaries either in-person or 
via the use of technology, such as a Bluetooth-enabled scale or self-
reported weight measurements using the MDPP beneficiary's digital scale 
and video technology.
    After considering these comments, we are modifying the proposed 
Sec.  410.79(e)(3)(iii)(C) to allow MDPP suppliers to accept self-
reported MDPP beneficiary weight measurements via a photograph of their 
digital scale. In addition, Sec.  424.210 allows MDPP suppliers to 
furnish MDPP beneficiaries with certain engagement incentives, 
including technological tools such as Bluetooth-enabled scales that 
support the goals of the expanded model and satisfy other conditions. 
We believe these options allow for MDPP beneficiaries with varying 
resources and comfort with technology to have their weight measured, 
and to participate in virtual MDPP services, in most circumstances. We 
also note that virtual participation in MDPP during an applicable 1135 
event is voluntary. Beneficiaries may suspend and restart the set of 
MDPP services at a later date consistent with the policies we are 
adopting in this rule.
    Comment: Multiple commenters urged CMS to add the MDPP set of 
services to the Medicare telehealth list, either temporarily during the 
PHE for COVID-19 or permanently. Commenters stated that access to 
telehealth services is critical beyond the PHE for COVID-19, as it 
helps address barriers such as program delivery in rural areas and 
transportation issues. Commenters stated that research shows that 
Medicare beneficiaries with prediabetes are at high risk for many 
chronic and comorbid conditions, including COVID-19. These commenters 
stated that many beneficiaries will not participate in in-person 
prediabetes prevention programs during the PHE due to social distancing 
rules or stay-at-home directives. The commenters noted that access for 
Medicare beneficiaries to telehealth MDPP services are essential during 
this PHE for access to MDPP services that can increase and maintain 
healthy lifestyles to prevent diabetes and comorbidities.
    Similarly, other commenters urged CMS to increase access to virtual 
MDPP generally, or to make the flexibilities finalized in the March 
31st COVID-19 IFC or in this rule applicable to circumstances outside 
of the PHE for COVID-19 or an applicable 1135 waiver event. One 
commenter states that, given the length of the current public health 
emergency, it is likely that additional data on satisfaction and 
efficacy of virtual DPP options will soon be available. Another 
commenter urged CMS to undertake a renewed actuarial analysis of 
virtual MDPP. This commenter also encouraged CMS to permit Medicare 
Advantage (MA) plans to use virtual MDPP encounters, in addition to in-
person MDPP encounters, and to permit virtual DPP programs to register 
as Medicare suppliers in order to meet network adequacy requirements 
and satisfy the requirement to provide MDPP services.
    Response: We appreciate the interest in adding the set of MDPP 
services to the Medicare telehealth list and allowing access to virtual 
MDPP outside the PHE for COVID-19 or other applicable 1135 waiver 
event. Inclusion of MDPP services on the Medicare telehealth list is 
not appropriate because virtual MDPP services do not qualify as 
telehealth services. The provisions we are finalizing in this rule are 
intended to ensure that beneficiaries participating in the set of MDPP 
services during the PHE for COVID-19 or any future applicable 1135 
waiver event can maintain consistent access to care via virtual 
delivery of services with

[[Page 84833]]

minimal disruption throughout their entire set of MDPP services. The 
MDPP expanded model was actuarially certified for primarily in-person 
delivery. We are not allowing additional virtual delivery of the set of 
MDPP services beyond the Emergency Policy described in this final rule. 
We continue to explore options for making virtual MDPP services more 
widely available.
    Comment: In general, commenters agreed that the final rule should 
permit MDPP beneficiaries to continue to participate in MDPP virtually 
during applicable 1135 waiver events. Other commenters indicated that 
beneficiaries should have a choice between receiving MDPP services 
virtually and waiting for in-person sessions to resume. In addition, 
beneficiaries who initially elect to receive MDPP services virtually, 
but later determine that virtual services do not work for them (for 
example, due to technological challenges, if the MDPP supplier is 
unable to offer a high quality program virtually, or if virtual 
services are not an effective tool for the beneficiary), or 
unforeseeable circumstances occur that do not allow them to continue or 
be successful virtually, they should have the option to suspend 
services at that time and resume in-person sessions at a later date.
    Response: We agree with the suggestions made in this comment and 
are modifying our policy regarding the election of virtual services and 
its impact on the once-per-lifetime benefit for those beneficiaries 
receiving the MDPP set of services on or after January 1, 2021 during 
an applicable 1135 event or PHE. The final rule includes modifications 
that support the provision of virtual MDPP services and permit new 
cohorts to start. We are modifying our policy in this rule to allow 
MDPP beneficiaries participating in the set of MDPP services during the 
PHE for COVID-19 or any future applicable 1135 waiver event to continue 
receiving the set of MDPP services virtually even after the PHE for 
COVID-19 or other applicable 1135 waiver event ends. Please note that 
MDPP beneficiaries who opt to continue to receive the set of MDPP 
services virtually during an applicable 1135 waiver event cannot repeat 
the set of MDPP services at a later date, in accordance with the 
general once per lifetime limitation for the set of MDPP services 
established in Sec.  410.79(c)(1)(i)(B). However, MDPP beneficiaries 
may decide to suspend virtual MDPP services and later resume the set of 
in-person MDPP services with the most recent attendance session of 
record once in-person services are available.
    In addition, this rule allows certain beneficiaries to restart the 
set of MDPP services at the beginning. MDPP beneficiaries who are in 
the first 12 months of the set of MDPP services as of the start of an 
applicable 1135 waiver event are eligible to restart the set of MDPP 
services at the beginning, or resume with the most recent attendance 
session of record, after the applicable 1135 waiver event has ended. 
MDPP beneficiaries who are in the second year of the set of MDPP 
services as of the start of the applicable 1135 waiver event, are only 
permitted to restart the ongoing maintenance session interval in which 
they were participating at the start of the applicable 1135 waiver 
event or resume the set of MDPP services at the most recent attendance 
session of record. MDPP beneficiaries who are in the second year of the 
set of MDPP services are not allowed to restart the set of MDPP 
services at the beginning.
    In the March 31st COVID-19 IFC, we waived the once per lifetime 
requirement for MDPP beneficiaries who were receiving the set of MDPP 
services as of March 1st, 2020 (changed in this rule to March 31st, 
2020) and whose sessions were suspended or canceled due to the PHE for 
COVID-19. These MDPP beneficiaries may obtain the set of MDPP services 
more than once per lifetime by electing to restart the set of MDPP 
services. Alternatively, these MDPP beneficiaries can resume with the 
most recent attendance session of record, in which case they would not 
be eligible to restart thereafter. Finally, MDPP beneficiaries who 
suspend the set of MDPP services at the start of an applicable 1135 
waiver event (or after virtual services have started) and subsequently 
choose to restart the MDPP set of services (to the extent they are 
eligible to do so) or resume with the most recent attendance session of 
record, may only make such an election once per applicable 1135 waiver 
event. Table B-N 45 summarizes the beneficiary options during an 
applicable 1135 waiver event.
BILLING CODE 4120-01-P

[[Page 84834]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.090


[[Page 84835]]


[GRAPHIC] [TIFF OMITTED] TR28DE20.091

BILLING CODE 4120-01-C
    In addition, the rule permits MDPP suppliers to start new cohorts 
during the PHE for COVID-19 and any future applicable 1135 waiver 
events as long as

[[Page 84836]]

a weight measurement for MDPP beneficiaries in the cohort can be 
obtained during the first core session. We proposed additional methods 
by which MDPP suppliers may obtain weight measurements from MDPP 
beneficiaries by allowing MDPP suppliers to obtain weight measurement 
from MDPP beneficiaries either in-person or via the use of technology, 
such as a Bluetooth-enabled scale or self-reported weight measurements 
using the MDPP beneficiary's digital scale and photograph or video 
technology.
    Finally, taking into account comments concerning beneficiaries' 
access to scales that transmit weights securely via wireless or 
cellular transmission (commonly referred to as ``BluetoothTM 
enabled'' or phones with video capabilities we are modifying proposed 
Sec.  410.79(e)(3)(iii)(C) to allow MDPP suppliers to accept self-
reported MDPP beneficiary weight measurements via a photograph with 
time stamp of their digital scale. When appropriate, in accordance with 
the Sec. Sec.  414.84 and 410.79, MDPP suppliers may use the weight 
measurements obtained through any of the methods outlined in Sec.  
410.79(e)(3)(iii)(C) to submit claims to CMS for reimbursement for the 
first core session and any weight-loss based performance goals achieved 
during the set of MDPP services. Collectively, the flexibilities 
permitted during the PHE for COVID-19 or other applicable 1135 waiver 
events will allow beneficiaries with options to access the set of MDPP 
services in a manner that best suits their particular circumstances.
    Comment: Several commenters supported our proposal to allow MDPP 
suppliers the option to deliver sessions virtually, or to suspend in-
person services and resume in-person services at a later date. These 
commenters also supported the proposal that the limit placed on the 
number of virtual make-up sessions would not apply during the remainder 
of the PHE for COVID-19 or during any future applicable 1135 waiver 
events, and the proposed waiver of the once per lifetime limit that is 
applicable during the PHE for COVID-19 or an applicable 1135 waiver 
event. Multiple commenters urged CMS to remove the once-per-lifetime 
limit for MDPP services altogether and the 5 percent weight loss 
requirement for the ongoing maintenance period in Year 2. One commenter 
opposed ending the waiver of the minimum weight loss requirement for 
the ongoing maintenance sessions during applicable 1135 waiver events. 
They indicated that more individuals are struggling with weight loss/
maintenance for many reasons. For example, many are not able to attend 
gyms or engage in other physical activity that puts them at risk for 
infection. These commenters stated that during the PHE for COVID-19, 
beneficiaries may not have the transportation options to travel to 
areas with healthy food options. One commenter encouraged CMS to 
continue this flexibility until July 2021 at a minimum to account for 
the next wave of the virus, combined with uncertainty in our economy, 
reopening, and the availability of a vaccine. Another commenter 
expressed concern about the ongoing health disparities during the PHE 
for COVID-19 in relation to a beneficiary's ability to meet the 5 
percent weight loss requirement, referencing stress and anxiety that 
may have significant effects on weight loss. Another commenter 
advocated that the final rule not require beneficiaries to meet 
eligibility requirements for MDPP services again, regardless of whether 
they restart at the beginning or resume with the most recent attendance 
session of record. For an example, if a beneficiary lost weight or 
reduced their A1C or blood glucose value from MDPP class participation 
prior to the PHE, then under the proposed rule, they might not be 
eligible to restart MDPP when the PHE ends because they no longer meet 
the eligibility requirements.
    Response: The provisions we are finalizing in this rule are 
intended to ensure that MDPP services can continue to be delivered 
during the remainder of the PHE for COVID-19 and any future applicable 
1135 waiver events. We agree that the PHE for COVID-19 presents unique 
challenges to beneficiaries in terms of meeting and maintaining a 5 
percent weight loss. However, the provisions we are finalizing in this 
rule permit virtual delivery of services, the virtual collection of 
body weight measurements, and provide access to appropriate beneficiary 
incentives, which collectively provide sufficient flexibilities to give 
MDPP beneficiaries the skills to successfully achieve the 5 percent 
weight loss goal. MDPP beneficiaries receiving the set of MDPP services 
prior to January 1, 2021 will not need to meet the 5 percent weight 
loss goal to resume the set of MDPP services with the most recent 
attendance session of record or to continue into the second year of set 
of MDPP services. Beneficiary eligibility will not be impacted by any 
changes to the beneficiary's body mass index (BMI) or reduction in 
hemoglobin A1c, fasting plasma glucose, or 2-hour plasma glucose test 
values achieved during the set of MDPP services or the intervening time 
in which a beneficiary has suspended the set of MDPP services. 
Beneficiaries who elect to suspend MDPP services may restart or resume 
services as described in the rule. Beneficiaries are eligible to 
restart or resume services regardless of their weight measurement or 
glucose level as of the date on which they elect to restart or resume 
services. Beneficiaries are encouraged to continue practicing the 
skills they have learned in the set of MDPP services to maintain a 
healthy lifestyle until they can restart or resume services.
    Effective January 1, 2021, the 5 percent weight loss eligibility 
waiver described in Sec.  410.14(g)(3)(iv) will end for MDPP 
beneficiaries starting after this date. However, the 5 percent weight 
loss eligibility waiver will remain in effect for MDPP beneficiaries 
who were receiving the set of MDPP services prior to January 1, 2021. 
MDPP beneficiaries who were receiving MDPP services prior to January 1, 
2021 are not required to meet or maintain a 5 percent weight loss to 
maintain eligibility for the ongoing maintenance year and may resume or 
restart services without meeting the 5 percent weight loss requirement.
    However, MDPP beneficiaries who start the set of MDPP services on 
or after January 1, 2021 will be required to meet and maintain the 5 
percent weight loss goal to be eligible for the ongoing maintenance 
year described in Sec.  410.79(c)(1)(ii)(B) and (c)(1)(iii)(B). The 
waiver of the requirement for beneficiaries to achieve 5 percent weight 
loss was intended to be a temporary flexibility to account for various 
state and local lock-down orders that prevented MDPP suppliers from 
obtaining weight measurements from beneficiaries to verify eligibility. 
The flexibilities we are finalizing in this final rule establish new 
remote and virtual methods for obtaining weight measurements. As such, 
the waiver of the 5 percent weight loss requirement is no longer 
necessary for the administration of the MDPP set of services. We are 
finalizing this policy as proposed.
    When submitting claims to CMS for MDPP services, MDPP suppliers 
should use the following weight measurements as the baseline weight for 
purposes of determining all weight-loss achievements: For an MDPP 
beneficiary who began receiving the set of MDPP services before March 
31, 2020, has suspended services during an applicable 1135 waiver 
event, and then elects to restart the set of MDPP services at the first 
core session, the MDPP supplier must record a new baseline weight on 
the date of first core session that restarts

[[Page 84837]]

the set of MDPP services. For an MDPP beneficiary who began receiving 
the set of MDPP services on or after January 1, 2021, has suspended 
services during an applicable 1135 waiver event, and then resumes the 
set of MDPP services either as the most recent attendance session of 
record or during the ongoing maintenance session interval in which they 
were participating at the start of the applicable 1135 waiver event, 
the MDPP supplier must use the baseline weight recorded at the 
beneficiary's first core session. For MDPP beneficiaries who were 
receiving MDPP services prior to January 1, 2021, as noted previously, 
the waiver of the 5 percent weight loss requirement still applies, so 
MDPP suppliers should submit a claim during each interval of the 
ongoing maintenance sessions in which the beneficiary has attended two 
sessions using the ``Attend 2 sessions (with at least 5% WL)'' HCPCS/G-
codes.
    Comment: One commenter stated that CMS' proposed policy of not 
allowing beneficiaries who elect to receive MDPP services virtually to 
restart the set of MDPP services at a later date is too restrictive. 
The commenter stated that this provision will contribute to health 
disparities because not all beneficiaries will be able to engage 
successfully in virtual MDPP sessions, such as issues with technology 
or internet connections. The commenter requested more flexibility in 
this policy and recommended that CMS allow beneficiaries who elect to 
receive MDPP services virtually retain eligibility to participate in 
in-person MDPP services after the end of the PHE for COVID-19 or 
applicable 1135 waiver event. The commenter also requested that CMS 
provide the opportunity to change an election if an applicable 1135 
waiver event extends beyond a certain length (for example, greater than 
6 months). Another commenter stated that there are many scenarios where 
an MDPP beneficiary would elect to receive virtual services but due to 
unforeseen circumstances those virtual session were not of a quality to 
impart the benefit of MDPP (for example, issues with technology, smart 
phone/computer availability, bandwidth). The commenter indicated many 
accounts from MDPP suppliers working in the field about in-person 
sessions that were moved to virtual sessions; some MDPP beneficiaries 
``stuck with it'' while the barriers were too much for others and they 
had to drop out.
    Response: We agree that prohibiting beneficiaries who elect to 
receive MDPP services virtually to restart the set of MDPP services at 
a later date is too restrictive. As such, we are amending our policy to 
allow MDPP beneficiaries receiving the MDPP set of services virtually, 
to suspend MDPP services and later resume the set of in-person MDPP 
services with the most recent attendance session of record once in-
person services are available. However, we note that MDPP beneficiaries 
who opt to receive the set of MDPP services virtually during an 
applicable 1135 waiver event cannot repeat the set of MDPP services at 
a later date, in accordance with the general once per lifetime 
limitation for the set of MDPP services established in Sec.  
410.79(c)(1)(i)(B).
    Comment: One commenter supported our proposal to allow MDPP 
suppliers to suspend in-person delivery of the set of MDPP services as 
necessary and resume upon the effective end date of the applicable 1135 
waiver event or the date that CMS determines the 1135 waiver event no 
longer disrupts in-person MDPP services. The commenter requested 
additional flexibilities to accommodate a PHE or 1135 waiver event that 
may affect different populations of individuals, states or regions in 
different ways, with different timelines. The commenter stated that 
when CMS makes such a determination, the consequences may not only be 
different across regions/communities but may affect beneficiaries at 
both the cohort and individual level. The commenter expressed concern 
that CMS's decision could be arbitrary as it applies to a specific 
community. For example, if an MDPP beneficiary completes two virtual 
sessions but then may be required to return to in-person sessions 
before it is safe to do so in their area. The commenter recommended 
that CMS allow MDPP beneficiaries engaged in a virtual cohort of MDPP 
beneficiaries to continue virtual sessions until the end of the cohort, 
and not mandate a return to in-person MDPP services for cohorts in 
progress. The commenter also requested more clarification of how CMS 
will determine an applicable 1135 waiver event no longer disrupts in-
person MDPP services. Another commenter requested a grace period to 
allow time for MDPP suppliers to transition back into providing in-
person services.
    Response: We agree that the impact of an applicable 1135 waiver 
event on in-person MDPP services can vary by population and locations. 
We disagree that decisions regarding the timeline to return to in-
person services would be an arbitrary decision made by CMS. The 
emergency period is defined in section 1135(g) of the Act and in 
general, the emergency period for an 1135 waiver event lasts until the 
affected geographic area is substantially recovered from the event. In 
response to these comments, we are making one modification to the 
proposed provisions outlined in the proposed rule to address the 
concerns about the return to in-person services at the end of an 
applicable 1135 waiver event. During the PHE for COVID-19 or any future 
applicable 1135 waiver event, we will allow beneficiaries who switch to 
virtual MDPP or begin the set of MDPP services virtually to elect to 
continue receiving services virtually until the conclusion of their 
services. Our prior policy that MDPP is primarily an in-person service 
has had to be modified to accommodate the nature and length of the 
current PHE for COVID-19. While MDPP is still primarily an in-person 
service, allowing MDPP beneficiaries who switch to or begin the MDPP 
set of services virtually during an applicable 1135 waiver event to 
continue receiving the services virtually will allow the MDPP 
beneficiaries affected by an applicable 1135 waiver event to receive 
the set of services in a consistent modality. In response to the 
comment requesting a grace period after the end of the applicable 1135 
event, we do not believe that an additional grace period would be 
necessary in most cases, given that the emergency period of an 1135 
waiver event typically lasts for a duration that would permit affected 
providers to resume normal operations. However, we provided in our 
proposed regulation text at Sec.  410.79(e)(3)(v) that MDPP suppliers 
could suspend in-person delivery of the set of MDPP services until the 
effective date of the 1135 waiver event (that is, the end of the 
emergency period under section 1135(g) of the Act) or upon a date 
specified by CMS. Therefore, our proposed regulation text contemplated 
that we could provide a grace period beyond the end of the emergency 
period. We anticipate that we would grant a grace period, which we 
would anticipate would not be longer than 90 days after the end of 
emergency period, if an MDPP supplier can demonstrate that it needs 
additional time to resume in-person services for reasons related to 
health, safety, or side availability or suitability. These 
flexibilities recognize that the effects of the PHE for COVID-19 or 
future applicable 1135 waiver events can vary in intensity based on 
location.
    Comment: One commenter stated that their MDPP coaches have shared 
that many beneficiaries do not have video capability. Several 
commenters requested that beneficiaries be able to send in a photo of 
their weight

[[Page 84838]]

measurement instead. The commenter also expressed concerns with 
requesting a weight via email, which may not be compliant with HIPAA, 
and that requiring printed or faxed documentation will be a barrier for 
participants, because many people do not have access to printing or 
faxing when participating in the MDPP set of services from home.
    Response: We agree that some MDPP beneficiaries may lack the 
technology required to provide a video or live feed of their weight 
measurement. In response to these comments, we are modifying the 
allowable weight measurement methodologies to include photo 
documentation. This final rule broadens the methods by which MDPP 
suppliers may obtain weight measurements from MDPP beneficiaries by 
allowing MDPP suppliers to obtain weight measurement from MDPP 
beneficiaries either in-person or via the use of technology, such as a 
Bluetooth-enabled scale or self-reported weight measurements using the 
MDPP beneficiary's digital scale and video technology. We are modifying 
proposed Sec.  410.79(e)(3)(iii)(C) to allow MDPP suppliers to accept 
self-reported MDPP beneficiary weight measurements via a date stamped 
photograph or video recording of the beneficiary's weight with the 
beneficiary visible on the scale, submitted by the MDPP beneficiary to 
the MDPP supplier. The photo or video must clearly document the weight 
of the MDPP beneficiary as it appears on his/her digital scale on the 
date associated with the billable MDPP session. A beneficiary may 
communicate his/her own information to a provider without violating the 
Health Insurance Portability and Accountability Act (HIPAA). 
Beneficiaries who are not comfortable transmitting their health 
information in this format can choose to suspend the set of MDPP 
services until in-person services are available. We encourage suppliers 
to utilize HIPAA compliant communication platforms. However, it is the 
organization's responsibility to comply with any federal, state, and/or 
local laws governing individual-level identifiable data, including 
those laws related to HIPAA, data collection, data storage, data use, 
and disclosure.
    Comment: One commenter urged CMS to reconsider the timeframe for 
which flexibilities under the March 31st COVID-19 IFC are available. 
The commenter stated that there are MDPP beneficiaries who began 
receiving services between March 1, 2020, and March 15, 2020 because 
state timelines for shelter-in-place requirements varied across the 
country, but that most requirements were effective as of March 15, 
2020. The commenter requested clarification that the flexibilities 
available under this final rule include participants who began the MDPP 
set of services between March 1 and March 15, 2020. This commenter also 
requested greater clarification between the requirements for 
beneficiaries who are in the ongoing maintenance phase of the MDPP set 
of services during the PHE for COVID-19 and any future 1135 waiver 
events, and questioned whether beneficiaries have until December 31, 
2020 to restart the program, or if after that date, such beneficiaries 
will no longer have that flexibility.
    Response: We agree with the commenter's recommendation. In 
response, we have made a modification to the regulation text at 
proposed Sec.  410.79(e)(3)(v)(A) to specify that any beneficiary who 
began MDPP services on or before March 31, 2020--the effective date of 
the March 31st COVID-19 IFC--can elect to restart the set of MDPP 
services at the beginning or resume with the most recent attendance 
session of record upon the MDPP supplier's resumption of services. The 
modification to the date will extend the March 31st COVD-19 IFC 
flexibilities to all MDPP beneficiaries who started the MDPP set of 
services prior to the effective date of the March 31st COVID-19 IFC.
    To clarify the requirements for MDPP beneficiaries who are in the 
ongoing maintenance phase: MDPP beneficiaries enrolled in the set of 
MDPP services prior to January 1, 2021 will not need to meet the 5 
percent weight loss eligibility requirement to resume the set of MDPP 
services.
    Effective January 1, 2021, the 5 percent weight loss eligibility 
waiver described in Sec.  410.14(c)(3)(vi) will end for all MDPP 
beneficiaries starting after this date. However, the 5 percent weight 
loss eligibility waiver will remain in effect for MDPP beneficiaries 
who were receiving the set of MDPP services prior to January 1, 2021. 
MDPP beneficiaries who were receiving MDPP services prior to January 1, 
2021 are not required to meet or maintain a 5 percent weight loss to 
maintain eligibility for the ongoing maintenance year and may resume or 
restart services without meeting the 5 percent weight loss requirement. 
However, MDPP beneficiaries who start the set of MDPP services on or 
after January 1, 2021 will be required to meet and maintain the 5 
percent weight loss goal to be eligible for the ongoing maintenance 
year described in Sec.  410.79(c)(1)(ii)(B) and (c)(1)(iii)(B).
    The changes we are adopting in this final rule are effective 
January 1, 2021 and apply to the remainder of the PHE for COVID-19 and 
any future applicable 1135 waiver event. This means that MDPP 
beneficiaries who were receiving MDPP services as of March 31, 2020 may 
elect once to restart the set of MDPP services at the first core 
session, or resume in-person with their most recent session attendance 
of record as a result of the PHE for COVID-19 once at any time during 
the remainder of their set of MDPP services. However, MDPP 
beneficiaries who begin the set of MDPP services on or after January 1, 
2021 will only be permitted to elect to restart the program at the 
first core session during the first 12 months of the set of MDPP 
services (and only if they do not switch to virtual MDPP services, if 
offered, during the applicable 1135 waiver event). MDPP beneficiaries 
who have restarted the set of MDPP services as a result of the PHE for 
COVID-19, and reside in an area that is subsequently impacted by a 
future 1135 waiver event, may elect to suspend in-person services, 
switch to virtual services, and restart or resume in-person services as 
provided in this rule.
    Comment: One commenter supported the proposal to clarify that all 
MDPP sessions, including the first core session, may be offered 
virtually, not as ``virtual make-up sessions,'' but as virtual classes 
consistent with the in-person class curriculum. The commenter requested 
that CMS work with CDC on how MDPP suppliers should report this 
delivery type to the CDC, given that CDC has instructed in-person MDPP 
suppliers to report session delivery as virtual make-up sessions.
    Response: In accordance with this rule, all MDPP sessions may be 
offered virtually, including the first core session, during an 
applicable 1135 waiver event. MDPP suppliers may also furnish virtual 
make-up sessions consistent with the Sec.  410.79(d). All claims 
submitted to CMS for payment for MDPP services delivered virtually must 
include the Virtual Modifier ``VM'' on the claims submission form. We 
will work with CDC to ensure clarity and alignment for MDPP suppliers 
when reporting session delivery type to CDC.
    Comment: One commenter suggested the following additional changes 
to the MDPP expanded model: (1) Address regulatory barriers to 
organizations becoming suppliers, including the requirement for 
Medicare suppliers to submit Social Security Numbers (SSN) to CMS, 
which raises privacy concerns for some organizations, and has resulted 
in some organizations choosing not to move forward with Medicare 
supplier enrollment; (2) revise the reimbursement structure to front-
load

[[Page 84839]]

payments to ensure suppliers' upfront costs of serving the Medicare 
population, given that many MDPP suppliers are community-based 
organizations with scarce resources to wait for outcomes-based 
payments; (3) align the program model with the model test and the 
evidence, which would result in changing MDPP to a 1-year model that 
aligns with the CDC's NDPP curriculum; and (5) address special 
populations to avoid cherry picking, taking into account the 
socioeconomic barriers that prevent low-income individuals from 
achieving the full 5 percent weight loss required for ongoing 
maintenance services. The commenter requested that CMS offer modest 
relief from the 5 percent weight loss requirement, or provide payment 
adjustments to enable MDPP suppliers to address barriers beneficiaries 
face to participating in MDPP, such as a lack of transportation.
    Response: We appreciate the commenter's recommendations but they 
are outside the scope of this final rule. We will consider these 
recommendations in the future.
    After consideration of the comments received, we are finalizing our 
proposals with the following modifications:
     We will add allowable virtual weight measurement methods. 
In addition to the methods proposed, MDPP beneficiaries may self-report 
their weights in the following ways: By submitting a time and date-
stamped photo or video of their home scale with their current weight 
measurement, or by using synchronous, online video technology such as 
video chatting or video conferencing with an MDPP coach, where the 
coach can clearly observe the self-recorded weight of the beneficiary. 
The second change is ensuring that flexibilities initially finalized in 
the March 31st COVID-19 IFC (85 FR 19230) are extended to all 
beneficiaries who were receiving MDPP services as of March 31, 2020, in 
order to include those beneficiaries who started MDPP services in the 
month of March, given that state shelter-in-place orders varied 
significantly.
     We will allow beneficiaries who begin the set of MDPP 
services virtually, or who change from in-person MDPP services to 
virtual during the PHE for COVID-19 or an applicable 1135 waiver event, 
to continue the MDPP set of services virtually, even after the PHE or 
1135 waiver event has concluded.
     We added Sec.  410.79(e)(3)(v)(B) to the rule to clarify 
the baseline weight measurement that must be used by an MDPP supplier 
when an MDPP beneficiary restarts or resumes the set of MDPP services 
following a suspension in services.
     We are updating the cross reference, Sec.  
410.79(e)(4)(iii), found in the proposed rule in paragraph (e)(3)(ii) 
to correctly reflect the proper cross reference at paragraph 
(e)(3)(iii).
     We are making a few edits for technical clarity. We edited 
the proposed paragraph (e)(3)(v) to remove the phrase ``must be 
furnished in compliance with the requirements in accordance with'' and 
will replace it with ``must be furnished in accordance with.'' We 
edited paragraphs (e)(3)(v)(B) and (C) to include ``and who elect not 
to continue with MDPP services virtually.'' In addition, we edited 
paragraph (e)(3)(v)(D) to improve the clarity.
     Finally, we did not intend to eliminate the waiver as 
specified in paragraph (e)(3)(iii), of the minimum weight loss 
requirements for beneficiary eligibility in the ongoing maintenance 
session intervals described in paragraphs (c)(1)(ii)(B) and 
(c)(1)(iii)(B) for MDPP beneficiaries who were receiving the MDPP set 
of services prior to January 1, 2021. As such we have added the 
language into the final rule, redesignted as paragraph (e)(3)(vi)
2. Revisions to Sec.  424.210
    Under Sec.  424.210(b), an MDPP supplier may furnish in-kind 
beneficiary engagement incentives to an MDPP beneficiary if certain 
requirements are satisfied. Among other requirements, the in-kind item 
or service must be furnished only during the ``engagement incentive 
period.'' The definition of ``engagement incentive period'' at Sec.  
424.210(a) states that the period begins when an MDPP supplier 
furnishes any MDPP service to an MDPP eligible beneficiary, and it ends 
on the earliest of the following: (1) When the MDPP services period 
ends as described in Sec.  410.79(c)(3); (2) when the MDPP supplier 
knows the MDPP beneficiary will no longer be receiving MDPP services 
from the MDPP supplier; or (3) the MDPP supplier has not had direct 
contact, either in-person, by telephone, or via other 
telecommunications technology, with the MDPP beneficiary for more than 
90 consecutive calendar days during the MDPP services period. We 
recognize that the disruption to MDPP services caused by an applicable 
1135 waiver event may cause an MDPP supplier not to have contact with 
an MDPP beneficiary for more than 90 consecutive calendar days. 
Therefore, we proposed to amend the definition of ``engagement 
incentive period'' to further qualify when the period ends in the case 
of the PHE for COVID-19 or an applicable 1135 waiver event. 
Specifically, we proposed to amend paragraph (iii) in the definition of 
``engagement incentive period'' to state that the MDPP supplier has not 
had direct contact, either in person, by telephone, or via other 
telecommunications technology, with the MDPP beneficiary for more than 
90 consecutive calendar days during the MDPP services period, unless 
the lack of direct contact is due to the suspension or cancellation of 
MDPP services under Sec.  410.79(e) and the MDPP services are 
eventually resumed or restarted in accordance with Sec.  410.79(e).
    We solicited comments on when the engagement incentive period 
should end if the MDPP services are not eventually resumed. We noted 
that we were considering whether we should deem the incentive 
engagement period to end if the applicable 1135 waiver event or the PHE 
for COVID-19 remains in effect for a certain period of time, such as 1 
year. At that point, for purposes of beneficiary engagement incentives, 
it may be more appropriate to terminate the engagement incentive period 
and permit a new engagement incentive period to begin if services are 
resumed or restarted in accordance with Sec.  410.79(e). Alternatively, 
we noted that the engagement incentive period can also end when the 
MDPP supplier knows that the MDPP beneficiary will no longer be 
receiving services from the MDPP supplier. We solicited comments on 
whether that provision eliminates any need to further clarify in 
regulation text when the engagement incentive period ends if MDPP 
services are not eventually resumed or restarted.
    We also proposed to amend Sec.  424.210(b) to add a requirement 
governing the provision of an in-kind item or service as a beneficiary 
engagement incentive during the PHE for COVID-19 or during an 
applicable section 1135 waiver event. Specifically, we proposed that if 
the item or service is furnished during the PHE for COVID-19 or an 
applicable 1135 waiver event that CMS has determined may disrupt in-
person MDPP services, and the item or service is furnished to an MDPP 
beneficiary who is receiving MDPP services virtually, the MDPP 
beneficiary must be capable of using the item or service during the PHE 
for COVID-19 or the applicable 1135 waiver event, as applicable. We 
proposed this usability requirement to deter abuse and to ensure that 
the incentives furnished during an applicable 1135 waiver event will 
achieve their intended purpose and serve the goals of the MDPP expanded 
model. We stated that usable beneficiary engagement incentives would 
include

[[Page 84840]]

vouchers for healthy food, wearable technology or ``wearables'' used to 
monitor an MDPP beneficiary's health such as heart rate, calories 
burned, or steps walked. We also noted that gym memberships during 
lockdowns and stay-at-home orders would not constitute beneficiary 
engagement incentives that are usable during an applicable 1135 waiver 
event. We solicited comments on whether this additional requirement is 
necessary in light of other requirements set forth in Sec.  424.210(b).
    Finally, for purposes of the proposed usability requirement at 
Sec.  424.210(b)(9), we proposed to define ``COVID-19 Public Health 
Emergency'' to mean the emergency period and emergency area, as such 
terms are defined in section 1135(g) of the Act, related to the PHE for 
COVID-19 declared by the Secretary on January 31, 2020. Effective 
October 23, 2020, the Secretary renewed the January 31, 2020 
determination that was previously renewed on April 21, 2020, that a PHE 
exists and has existed since January 27, 2020. Similarly, we proposed 
to define ``1135 waiver event'' to mean an emergency period and 
emergency area, as such terms are defined in section 1135(g) of the 
Act, for which the Secretary has authorized waivers under section 1135 
of the Act. We noted that these definitions were consistent with how we 
proposed to define the terms for purposes of Sec.  410.79(e).
    The following is a summary of the public comments we received and 
our responses.
    Comment: One commenter appreciated the flexibility of the proposed 
change to paragraph (iii) of the definition, indicating that the 
engagement incentive period should not automatically end if an MDPP 
supplier's failure to have direct contact with an MDPP beneficiary for 
more than 90 days was due to the suspension or cancellation of MDPP 
services during an applicable 1135 waiver event and the MDPP services 
were resumed during such 1135 waiver event. The commenter stated that 
the final rule should clarify when the engagement incentive period ends 
if MDPP services are not eventually resumed. The commenter supported 
the addition of a provision under which the engagement incentive period 
would be deemed to end if MDPP services are not resumed or restarted 
within 1 year after the PHE for COVID-19 or applicable 1135 waiver 
event has been in effect. The commenter also stated that, if MDPP 
services are thereafter resumed or restarted, CMS should permit a new 
engagement incentive period to begin.
    Response: After further consideration, we are not finalizing the 
proposed changes to paragraph (iii) of the definition of engagement 
incentive period. That provision will continue to specify that the 
engagement incentive period will end if the MDPP supplier has not had 
direct contact with the MDPP beneficiary, whether in person, by 
telephone, or via other telecommunications technology, for more than 90 
consecutive calendar days during the MDPP services period. Under this 
provision, the engagement incentive period will not end with respect to 
an MDPP beneficiary who begins to receive MDPP services virtually 
within 90 days after the occurrence of an 1135 waiver event that CMS 
determines is likely to disrupt the furnishing of in-person MDPP 
services. We are mindful of the potential for abuse with beneficiary 
incentives, and in the absence of any continued direct contact with the 
MDPP beneficiary for 90 days during an applicable 1135 waiver event, we 
do not believe that the MDPP supplier should be permitted to furnish 
additional beneficiary engagement incentives. However, we note that the 
existing definition of engagement incentive period specifies that the 
period begins ``when an MDPP supplier furnishes any MDPP service to an 
MDPP eligible beneficiary.'' Accordingly, even if an MDPP beneficiary's 
engagement incentive period ends during an applicable 1135 waiver event 
due to lack of direct contact with the MDPP supplier, the beneficiary 
would begin a new engagement incentive period consistent with the 
existing definition when he or she resumes or restarts MDPP services in 
accordance with Sec.  410.79(e).
    Comment: One commenter stated that revising the definition of 
engagement incentive period as proposed would increase the 
recordkeeping and tracking burden on MDPP suppliers, who the commenter 
asserted will need to track the start and end dates of the PHE or 1135 
waiver event, the election of the MDPP beneficiary to suspend or cancel 
MDPP services, the date of the resumption or restart of services, and 
more. The commenter requested that CMS specify the documentation and 
tracking requirements for this change.
    Response: As noted above, we are not finalizing the proposed 
changes to the definition of engagement incentive period. We did not 
propose and are not finalizing any modifications to the documentation 
requirements described in Sec.  424.210(e). However, we note that Sec.  
424.210(e) requires MDPP suppliers to maintain documentation regarding 
in-kind items and services furnished as beneficiary engagement 
incentives, including the date on which the item or services was 
furnished and whether it was furnished during the engagement incentive 
period. In addition, it is a prudent business practice to document 
compliance with Medicare regulations, and the information cited by the 
commenter would be relevant to compliance with Sec.  410.79 and Sec.  
424.210.
    Comment: One commenter did not believe that the usability 
requirement at proposed Sec.  424.210(b)(9) was necessary considering 
the other requirements set forth in Sec.  424.210(b), but stated that 
if the requirement is retained in the final rule, it should be revised 
for clarity. Specifically, this commenter questioned whether a 
beneficiary engagement incentive that is furnished during an 1135 
waiver event must be usable by the MDPP beneficiary for the remaining 
duration of the 1135 waiver event or only at the time the incentive is 
furnished. As an example, the commenter noted that an MDPP supplier 
might provide a gym membership voucher during an 1135 waiver event at a 
time when gyms are open, but the membership could become unusable at a 
later time during the 1135 waiver event. The commenter advocated that 
if the final rule includes a requirement regarding the usability of an 
incentive during the PHE for COVID-19 or an 1135 waiver event, the 
requirement should expressly state that the MDPP beneficiary must be 
capable of using the item or service ``at the time of delivery.'' 
Another commenter requested clarification that that a gym membership 
would satisfy the proposed usability requirement even if it was 
furnished when a lockdown or stay-at-home order was in effect, as long 
as the gym offered virtual fitness classes. In addition, a commenter 
sought clarification that in-kind items or services that may be useable 
in one region may not be useable in another region. The commenter 
expressed concern that documenting compliance with the usability 
requirement would place undue burden on MDPP suppliers.
    Response: Upon further review, we agree that the usability 
requirement is not necessary in light of other requirements set forth 
at Sec.  424.210(b). Specifically, under paragraph (b)(2), the in-kind 
beneficiary engagement incentive must be reasonably connected to the 
CDC-approved DPP curriculum furnished to the MDPP beneficiary during a 
core session, core maintenance session, or ongoing maintenance session. 
In addition, under paragraph (b)(3), the in-kind beneficiary engagement 
incentive must be a ``preventive care item or service'' or an

[[Page 84841]]

item or service that advances a clinical goal for an MDPP beneficiary 
by engaging him or her in better managing his or her own health. We 
would not consider either of these requirements to be satisfied if the 
MDPP beneficiary is incapable of using the item or service at the time 
it is furnished. Accordingly, because an unusable in-kind item or 
service could not satisfy all of the conditions set forth at paragraph 
(b), it is not necessary to finalize the additional proposed 
requirement for in-kind items and services furnished to an MDPP 
beneficiary who is receiving MDPP services virtually during the PHE for 
COVID-19 or an 1135 waiver event. Because we are not finalizing the 
proposed usability requirement, the commenters' remaining concerns are 
moot and need not be addressed.
    Comment: One commenter supported the proposed definitions of 
``COVID-19 Public Health Emergency'' and ``1135 waiver event.''
    Response: We appreciate the commenter's support. However, as 
finalized, Sec.  424.210 does not refer to either term. Accordingly, we 
are not finalizing these definitions.
    After consideration of the comments received, we are not finalizing 
the proposed usability requirement nor the proposed definitions of 
``COVID-19 Public Health Emergency'' and ``1135 waiver event'' proposed 
at Sec.  424.210(b).

IV. Summary of the Quality Payment Program Proposed Provisions, 
Analysis of and Responses to Public Comments, and Provisions of the 
Final Rule

A. CY 2021 Updates to the Quality Payment Program

1. Executive Summary
a. Overview
    This section of the final rule sets forth changes to the Quality 
Payment Program starting January 1, 2021, except as otherwise noted for 
specific provisions. The 2021 performance period/2023 payment year of 
the Quality Payment Program continues a transition as we build on the 
first few years of implementation of the Quality Payment Program to 
focus better on our measurement efforts, and to reduce barriers to 
entry into Advanced APMs.
    Participation in the Quality Payment Program rose in the third 
year. We saw 99.99 percent of eligible clinicians participate in MIPS 
in 2019 with 954,614 eligible clinicians receiving a payment 
adjustment, which exceeded our 2018 participation rates. In addition, 
97.6 percent of eligible clinicians participating in MIPS received a 
positive payment adjustment for 2021 based on 2019 performance year 
results. Regarding performance in Advanced APMs, for the 2019 QP 
Performance Period, 195,564 eligible clinicians earned Qualifying APM 
Participant (QP) status while another 27,995 eligible clinicians earned 
partial QP status.\116\ We note that due to the Public Health Emergency 
(PHE) for COVID-19, 65,237 (or about 6.83 percent of 954,614) MIPS 
eligible clinicians received reweighting for performance year 2019 of 
one or more MIPS performance categories due to our MIPS extreme and 
uncontrollable circumstances policy.
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    \116\ QPP Participation in 2019: Results at-a-Glance released 
10/27/2020 at https://qpp-cm-prod-content.s3.amazonaws.com/uploads/1190/QPP%202019%20Participation%20Results%20Infographic.pdf.
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    We plan to continue developing Quality Payment Program policies 
that more effectively reward high-quality treatment of patients and 
increase opportunities for Advanced APM participation. We are moving 
forward with MIPS Value Pathways (MVPs) policy development as MVPs 
allow for a more cohesive participation experience by connecting 
activities and measures from the 4 MIPS performance categories that are 
relevant to a specialty, medical condition, or a particular population. 
The MVPs use promoting interoperability as a foundational element and 
incorporate population health claims-based measures as feasible along 
with relevant measures and activities for the quality, cost, and 
improvement activities performance categories. We intended to begin 
transitioning to MVPs in the 2021 MIPS performance year; however, due 
to the PHE for COVID-19 and resultant need for clinician focus on the 
response, our timeline changed accordingly such that the proposal for 
initial MVPs is delayed until at least the 2022 performance year. In 
addition, we support clinicians on the front lines by providing burden 
relief via extreme and uncontrollable circumstances policy exceptions 
for 2019, 2020 and 2021.
    In response to the PHE for COVID-19, a number of additional 
flexibilities were issued via interim final rules with comment periods 
(IFCs) (85 FR 19276 through 19278, 85 FR 27617, and 85 FR 54847 through 
54851). We extended the deadline for applying for reweighting due to 
extreme and uncontrollable circumstances for the 2019 performance 
period from December 31, 2019 to April 30, 2020 in order to provide 
greater flexibility for clinicians impacted by the PHE for COVID-19 and 
modified our existing policy for the 2019 performance period such that 
MIPS data submissions would not effectively void a reweighting 
application. We added a new ``COVID-19 Clinical Trials'' improvement 
activity to the CY 2020 Improvement Activities Inventory, applicable 
beginning January 2020 that would provide high-weighted credit in the 
Improvement Activities performance category and then modified the 
activity in the third IFC (March 31st COVID-19 IFC (85 FR 19276 through 
19277)). We provided QCDRs an additional year, by 2022, to meet the 
QCDR measure requirements of measure testing and data collection. Due 
to COVID-19 we also modified our definition of primary care services 
used in the MIPS beneficiary assignment methodology for the CMS Web 
Interface and CAHPS for MIPS Survey to include online and telephone 
digital E/M codes, and remote evaluation of patient video/images and 
virtual check in codes. These included previously finalized ``face-
face'' codes that are instead furnished using audio/video, real-time, 
interactive communications technology instead of in person in light of 
the PHE. We are finalizing all IFC policies except for the COVID-19 
Clinical Trials activity for 2020, which is finalized with a 
modification as presented in the third IFC. See section IV.A.3.c.(3)(b) 
of this final rule for the modified COVID-19 Clinical Trials activity 
for CY 2020 as described in the September 2, 2020 IFC (85 FR 54848 
through 54851).
    As we make long-term improvements, evolve MIPS policies, and plan 
to implement MVPs in the future, we support our objectives within the 
Patients Over Paperwork initiative and the National Quality 
Roadmap.117 118 In carrying out these initiatives, we are 
removing regulatory obstacles that get in the way of health care 
clinicians spending time with patients. As we develop MVP policies, we 
look to reduce MIPS reporting burden and increase efficiencies.
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    \117\ https://www.cms.gov/About-CMS/story-page/patients-over-paperwork.
    \118\ https://www.hhs.gov/sites/default/files/national-health-quality-roadmap.pdf.
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    On May 15, 2020 the Department of Health and Human Services 
published the National Quality Roadmap (https://www.hhs.gov/sites/default/files/national-health-quality-roadmap.pdf) as directed by E.O. 
13877, Improving Price and Quality Transparency in American Healthcare 
to Put Patients First. The purpose of the Roadmap is to improve patient 
outcomes through enhanced effectiveness and efficiency of the 
healthcare quality system. The Roadmap is a means to accelerate change 
and advance the Administration's goals of ``improving transparency, 
reducing provider burden, allowing informed

[[Page 84842]]

consumer decision-making, and ultimately improving the health of all 
Americans''. The Roadmap, which provides a public-private partnership 
opportunity, describes a strategy for establishing, adopting, and 
publishing common quality measurements, aligning inpatient and 
outpatient measures, and eliminating low-value or counterproductive 
measures. Specific actions are identified to drive change through 
coordinated governance and oversight, modernized data collection and 
reporting, and aligned measures reformation in federal quality 
programs. One of the actions called for is a systematic review of 
federal quality reporting and value-based payment programs, to identify 
opportunities leading to recommendations to reduce burden, promote 
efficiency and effectiveness, and accelerate the shift to value. The 
Roadmap also calls for stakeholder engagement through public convening 
and a Request for Information. Actions will be undertaken with the 
underpinning of the following principles:
     Quality Information is Available and Meaningful.
     Balance Administrative Burden with the Goal of Obtaining 
Meaningful Information.
     Alignment of Measurement Priorities.
     Cohesive Measurement Stewardship.
     Reward Innovation and Improvement.
     Leverage What Works and Reform the Rest.
    The planned implementation of MVPs is noted in the Roadmap and we 
look forward to recommendations resulting from other Roadmap activities 
for streamlining quality reporting and value-based purchasing programs 
that can inform the implementation of the MVPs and promote alignment of 
quality measures across federal programs.
    As we work within MIPS to reduce barriers to clinician 
participation in Advanced APMs and meet CMS pay for value objectives, 
we are aligned with the Health Care Payment Learning & Action Network 
goal to accelerate the percentage of health care payments tied to 
quality and value in each market segment through the adoption of two-
sided risk APMs.\119\ MVPs will link quality and cost performance 
measurement and help clinicians begin to assess their ability to take 
on risk as in APMs.
---------------------------------------------------------------------------

    \119\ https://hcp-lan.org/.
---------------------------------------------------------------------------

    In the May 1, 2020 Federal Register, HHS published two 
transformative rules: The 21st Century Cures Act: Interoperability, 
Information Blocking, and the ONC Health IT Certification Program final 
rule (85 FR 25642 through 25961); and the Medicare and Medicaid 
Programs; Patient Protection and Affordable Care Act; Interoperability 
and Patient Access for Medicare Advantage Organization and Medicaid 
Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIP 
Managed Care Entities, Issuers of Qualified Health Plans on the 
Federally-facilitated Exchanges, and Health Care Providers final rule 
(85 FR 25510 through 25640) that will give patients unprecedented safe, 
secure access to their health data. The two rules implement 
interoperability and patient access provisions of the bipartisan 21st 
Century Cures Act (Cures Act) and support the MyHealthEData initiative. 
MyHealthEData is designed to empower patients around a common aim, 
giving every patient access to their medical information so they can 
make better healthcare decisions. We expect that these rules, once 
implemented, will complement our future MVPs in providing more 
meaningful information to clinicians and patients.
b. Summary of Major Provisions
(1) Major MIPS Provisions
    The MIPS program aims to drive value through the collection, 
assessment, and public reporting of data that informs and rewards the 
delivery of high-value care. Within MIPS we intend to pay for health 
care services in a way that drives value by linking performance on 
cost, quality, and the patient's experience of care. We believe 
implementing the MVP framework will move MIPS along the ``path to 
value,'' transforming the MIPS program by better informing and 
empowering patients to make decisions about their healthcare and 
helping clinicians to achieve better outcomes, and by promoting robust 
and accessible healthcare data, and interoperability. In the CY 2020 
PFS proposed rule (84 FR 40732 through 40745), we offered our vision of 
an MVP framework for a new evolution of the MIPS program based on this 
concept.
    As discussed in the CY 2021 PFS proposed rule at 85 FR 50277, we 
have built the MIPS program to provide broad flexibility for clinician 
choice of measures and activities, data collection and submission 
types, and individual or group level participation. While these 
flexibilities contributed to very high participation levels, we believe 
the flexibility has inadvertently resulted in a complex MIPS experience 
for clinicians that is not producing the level of robust clinician 
performance information we envision that would meet patient needs and 
support clinician care improvements. We have heard from clinicians that 
MIPS requirements are confusing, burdensome, and that it is difficult 
to choose measures from the several hundred MIPS and QCDR quality 
measures that are meaningful to their practices and have a direct 
benefit to patients. We have also heard concerns from stakeholders that 
MIPS does not allow for sufficient differentiation of performance 
across practices due in part to clinician quality measure selection 
bias. These aspects detract from the program's ability to effectively 
measure and compare performance, provide meaningful feedback, and 
incentivize quality. MVPs are intended to lead to a simplified MIPS 
clinician experience, improve value, reduce burden, and better inform 
patient choice in selecting clinicians. We noted that the MVP framework 
would connect measures and activities across the 4 MIPS performance 
categories, incorporate a set of administrative claims-based quality 
measures that focus on population health, provide data and feedback to 
clinicians, and enhance information provided to patients. We intend to 
focus the future of MIPS on MVP implementation. We are finalizing 
proposed provisions as discussed in section IV.A.3. of this final rule 
related to:

 Developing MVPs
 Implementing the APM Performance Pathway (APP) for APM 
participant MIPS eligible clinicians to report to MIPS
 Updating the MIPS performance measures and activities; cost 
and quality category weights; and scoring policies
 Terminating the APM scoring standard.
(a) MIPS Value Pathways and APM Performance Pathway
    We are finalizing the proposed MVP framework guiding principles as 
discussed in section IV.A.3.a.(1) of this final rule and the proposed 
MVP development criteria and processes as discussed in section 
IV.A.3.a.(2) of this final rule as we look towards the 2022 performance 
period to begin MVP implementation. We are finalizing in section 
IV.A.3.b. of this final rule each of the proposed quality measures 
included in the APP quality measure set effective January 1, 2021. We 
are also delaying the sunsetting of the CMS Web Interface by one year 
and allowing APM entities to report via the CMS Web Interface measure 
set for the 2021 MIPS

[[Page 84843]]

performance period. Submitters reporting through the APP will be scored 
on the ACO MCC measure, Hospital-wide Readmission measure, and CAHPS 
for MIPS survey, if available for that submitter type. In addition, 
each submitter will also be required to report on either the three 
eCQMs/MIPS CQMs or, for APM Entities, the Web Interface. The APP will 
be a voluntary pathway for reporting and scoring under MIPS that allows 
APM participants to receive an improvement activities credit and have 
the cost performance category reweighted. We are finalizing proposed 
MIPS performance category weighting and scoring in the APP and a 
scoring hierarchy that recognizes the APP in section IV.A.3.e.(2) of 
this final rule. We are also finalizing in section IV.A.3.c.(5)(a) of 
this final rule the elimination of the APM scoring standard for the 
2021 performance year beginning January 1, 2021. This allows APM 
participants to participate in MIPS as individuals, groups, Virtual 
Groups, or APM Entities, with reporting through any MIPS reporting and 
scoring pathway, see section IV.A.3.b.(3) of this final rule. We are 
also finalizing in section IV.A.3.c.(5)(e) of this final rule, an 
extreme and uncontrollable circumstances exception policy proposal that 
would be applicable to APM Entities beginning with the 2022 MIPS 
payment year.
    In response to our MVP RFI in the 2020 PFS proposed rule (84 FR 
40732 through 40745), we received a number of comments about the 
opportunity to participate in the development of MVPs and concerns 
about the speed of a transition to a new MVP framework. We have taken 
these concerns into consideration when developing the proposed MVP 
policies. We had stated our intent to begin the transition to MVPs in 
2021 by introducing initial MVPs, however, we noted at 85 FR 50284 
through 50285 that due to the PHE for COVID-19, the timeline has 
changed. As we move forward with the transformation of the MIPS program 
in a manner that does not take away from the nation's response to the 
PHE for COVID-19, we limited the MVP-related proposals to those 
necessary for the collaborative development of MVPs.
    We are finalizing in section IV.A.3.a.(2) of this final rule, the 
proposed process for collaboration on the development of MVPs that 
builds on our discussions with clinician experts about developing MVPs 
for future MIPS rulemaking. We believe that collaboration with 
clinician experts will build a more cohesive and comprehensive set of 
MVPs. We are finalizing the proposed process for MVP candidate 
submissions in section IV.A.3.a.(2)(a)(iii) of this final rule.
    We recognize that the transition to MVPs will take time and we will 
continue to evaluate the readiness of clinicians in making this 
transition, while balancing our strong interest in improving 
measurement and making MIPS more focused on value.
(b) Other MIPS and APM Policies
    We are finalizing with modification our web interface and quality 
measure proposals as discussed in sections IV.A.3.c.(1)(c) and 
IV.A.3.c.(1)(d) of this final rule, respectively, after consideration 
of comments. Additionally, are finalizing in section IV.A.3.d.(1)(b) of 
this final rule the proposed continuation of policies for scoring 
quality measures based on achievement, as well as policies for measures 
that do not meet case minimum, data completeness requirements, or have 
a benchmark. For the Promoting Interoperability performance category, 
we are finalizing the proposed new optional Health Information Exchange 
(HIE) bi-directional exchange measure as discussed in section 
IV.A.3.c.(4)(c)(ii)B of this final rule.
    Additionally, after considering public comments, we are finalizing 
the following provisions for MIPS beginning with the 2021 performance 
period in this final rule.
     As discussed in section IV.A.3.c.(1)(c) of this final 
rule, we are finalizing our proposal to remove the CMS Web Interface 
submission method under MIPS for groups and virtual groups with a one 
year delay. Specifically, we will sunset the Web Interface in 2022 
instead of 2021.
     As discussed in section IV.A.3.c.(1)(d) of this final 
rule, we are finalizing the proposals to incorporate 2 new 
administrative claims outcome quality measures, address substantive 
changes to 112 existing MIPS quality measures, address changes to 
specialty sets, remove measures from specific specialty sets. We are 
finalizing a modified proposal to remove 11 instead of 14 quality 
measures from the MIPS program. We refer readers to Table Group C of 
Appendix 1 for a list of final quality measures and further 
information. Retaining three additional measures means that we are 
finalizing a modified proposed total of 209 rather than 206 quality 
measures starting in the 2021 performance year.
     As discussed in sections IV.A.3.c.(1)(e) and 
IV.A.3.c.(2)(b) of this final rule, we are finalizing the proposals to 
include services provided via telehealth in quality and cost 
measurement.
     As discussed in section IV.A.3.c.(2)(a) of this final 
rule, we are finalizing the proposals that the cost performance 
category will make up 20 percent of a MIPS eligible clinician's final 
score for the 2023 MIPS payment year and 30 percent for the 2024 MIPS 
payment year as required by section 1848(q)(5)(E)(i)(II)(aa) of the 
Act, and the quality performance category weight will be 40 percent and 
30 percent for each of those years, respectively (see section 
IV.A.3.c.(1)(b) of this final rule). For the 2023 MIPS payment year, we 
are finalizing the proposed performance category redistribution 
policies discussed in section IV.A.3.d.(2)(b)(iii) of this final rule.
     As discussed in section IV.A.3.c.(3)(b) of this final 
rule, we are finalizing our proposals to: (1) Allow an exception to the 
Annual Call for Activities nomination period timeframe during a PHE; 
(2) add a new criterion for nominating new improvement activities; (3) 
implement a process for HHS-nominated improvement activities; and (4) 
modify two existing improvement activities. We are also finalizing 
policies from IFCs and the removal of one obsolete improvement activity 
and policies from IFCs.
     As discussed in section IV.A.3.c.(4) of this final rule, 
we are finalizing the proposals that establish a performance period for 
the Promoting Interoperability performance category of 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 the 2024 MIPS payment year and each subsequent MIPS 
payment year; update two Promoting Interoperability measures; and 
continue reweighting the Promoting Interoperability performance 
category for non-physician MIPS eligible clinicians for the 2021 
performance period. We are finalizing at section IV.A.3.c.(4)(c)(ii) of 
this final rule the proposal to add a new Promoting Interoperability 
performance category Health Information Exchange (HIE) bi-directional 
exchange measure that would allow an eligible clinician to attest to 
participation in bi-directional exchange through an HIE using CEHRT 
functionality.
     As discussed in section IV.A.3.d.(1)(b) of this final 
rule, we are finalizing the proposed continuation of quality category 
scoring and bonus policies that add flexibility for when measure 
specification or coding changes occur during the performance year and 
continue improvement scoring of the

[[Page 84844]]

quality performance category comparing clinicians to a 30 percent 
baseline score if clinicians scored 30 percent or less. We are 
finalizing in section IV.A.3.d.(1)(b)(iii) of this final rule the 
proposal for an exception to the 20-case minimum for all administrative 
claims-based measures. The exception states that for administrative 
claims-based measures, the minimum case requirement is specified in the 
annual list of MIPS measures.
     As discussed in section IV.A.3.d.(2)(a)(iii) of this final 
rule, we are finalizing the proposal to increase the maximum number of 
points available for the complex patient bonus for one year, the 2020 
performance period/2022 MIPS payment year, due to the increase in 
patient complexity resulting from the PHE for COVID-19.
     As discussed in section IV.A.3.g. of this final rule, we 
are finalizing the proposals to modify third party intermediary 
requirements, remedial actions and termination policies. We are also 
finalizing policies issued via IFC.
     As discussed in section IV.A.4.b. and IV.A.4.c. of this 
final rule, we are finalizing the proposals that clarify the APM 
Incentive Payment amount calculation basis and implement a hierarchy 
for recipient TIN affiliation identification when making the APM 
Incentive Payment. We are also finalizing proposed provisions in 
section IV.A.4.c. of this final rule that provide a process for 
requesting updated APM Incentive Payment information in situations 
where a payee TIN cannot be identified, and address in section 
IV.A.4.d. of this final rule situations where the QP's APM Incentive 
Payment was determined based solely on supplemental services payments 
and no Medicare claims for covered professional services were submitted 
during the incentive payment base period.
     As discussed in section IV.A.4.e.(3) of this final rule, 
we are finalizing the proposed change to the methodology for addressing 
prospectively aligned beneficiaries for Threshold Score calculations 
and QP determinations and establish a targeted review process in 
section IV.A.4.e.(4) of this final rule for QP determinations.
    After consideration of public comments, we are not finalizing the 
following proposals:
     As discussed in sections IV.A.3.d.(1)(b)(ii) and 
IV.A.3.d.(1)(b)(v) of this final rule, we are not finalizing using 
performance period benchmark policies for performance year 2021 and 
will instead continue with the existing policy to use historical 
benchmarks and our topped out scoring policy after considering comments 
and the impact of the PHE for COVID-19.
     As discussed in section IV.A.3.e.(3) of this final rule, 
we are not finalizing the proposal to reduce the performance threshold 
for the 2021 MIPS performance period/2023 MIPS payment year from 60 
points to 50 points, as we believe that we best incentivize clinician 
performance through retaining the previously finalized performance 
threshold of 60 points.
2. Definitions
    At Sec.  414.1305, we are finalizing definitions of the following 
terms:
     Attestation (revision).
     Certified Electronic Health Record Technology (CEHRT) 
(revision).
     Collection type (revision).
     Full TIN APM (deletion).
     Low volume threshold (revision).
     Meaningful EHR user for MIPS (revision).
     MIPS APM (revision).
     Physician Compare (addition).
     Primary Care Services (addition).
     Submission type (revision).
    These terms and definitions are discussed in detail in the relevant 
sections of this final rule.
3. MIPS Program Details
a. Transforming MIPS: MIPS Value Pathways
(1) Overview
    We are finalizing proposed updates to the MIPS Value Pathways (MVP) 
guiding principles (see 85 FR 50280 through 50281) and MVP development 
criteria and process (see 85 FR 50281 through 50284) that will guide 
MVP implementation beginning with the 2022 MIPS performance period/2024 
MIPS payment year.
    In the CY 2020 PFS final rule, we stated our intent to apply the 
MVP framework in PY 2021 (84 FR 62946); however, due to the PHE for 
COVID-19, our timeline has changed (see 85 FR 50284 through 50285). We 
want to move forward with the transformation of the MIPS program in a 
manner that does not take away from the nation's response to the PHE 
for COVID-19, and so have limited our MVP related proposals in this 
rule to guidance necessary for the collaborative development of MVPs. 
We deferred MVP implementation to a future year. In particular, we 
intend to propose an initial set of MVPs and implementation policies in 
our CY 2022 rulemaking cycle. We continue to envision a transformed 
MIPS program that increasingly makes MVPs available to clinicians with 
a burden reduction focus.
    We intend to implement the MVPs while maintaining the MIPS 
participation options established through rulemaking for MIPS 
performance years 1 through 5. For purposes of this discussion, we 
refer to the established MIPS participation options collectively as 
``traditional MIPS''.
    As described in earlier rulemaking (84 FR 40732 through 40734), we 
are moving to MVPs to improve value, reduce burden, help patients 
compare clinician performance to inform patient choice in selecting 
clinicians, and reduce barriers to movement into APMs. We refer to 
``value'' as a measurement of quality and patient experience of care as 
related to cost, and intend to promote value by paying for health care 
services in a manner that directly links performance on cost, quality, 
and the patient's experience of care. The MVP framework will move MIPS 
forward on the path to value through connecting the MIPS performance 
categories and by better informing and empowering patients to make 
decisions about their healthcare and helping clinicians to achieve 
better outcomes using robust and accessible healthcare data and 
interoperability.
    We believe that MVPs can help address previous feedback from 
clinicians that MIPS is too complex and burdensome. Feedback related to 
confusing MIPS requirements, inadequate alignment of the MIPS 
performance categories, need for better performance comparability 
across all clinicians and for more meaningful data for patients has 
informed development of the MVP framework. MVPs will make MIPS more 
meaningful by allowing a more cohesive participation experience by 
connecting activities and measures from the 4 MIPS performance 
categories that are relevant to a patient population, standardizing 
performance measurement of a specialty or a medical condition, and 
reducing the siloed nature of the traditional MIPS participation 
experience. We intend that MVPs help clinicians and practices prepare 
to take on and manage financial risk, as in Advanced APMs, as they 
build out their quality infrastructures that align with the MIPS 
performance categories and gain experience with cost measurement. 
Performance measure reporting for specific populations as in MVPs 
encourages practices to build an infrastructure with capabilities to 
compile and analyze population health data, a critical capability in 
assuming and managing risk. We believe that experience with MVPs, in 
which there is aligned measurement of quality (of care and of 
experience of care) and cost,

[[Page 84845]]

continuous improvement/innovation within the practice, and efficient 
management and transfers of information, will help remove barriers to 
APM participation. We refer readers to the infographic at https://qpp.cms.gov/mips/mips-value-pathways, which provides an overview of our 
vision for the MIPS path to value future state (see 85 FR 50279).
    We envisioned that MVPs will be optional for clinicians when the 
included measures and activities within the MVP are applicable and 
available to their practice. Over the course of future performance 
periods as we transition to MVPs, the traditional MIPS participation 
option will continue to be available. We noted that we believe MVP 
reporting will reduce selection burden associated with choosing MIPS 
quality measures and activities to report; reduce reporting burden 
associated with fewer MIPS quality measures, cost measures and/or 
improvement activities to report than the traditional MIPS 
participation method; and further align across performance categories 
the measures and activities identified by specialists and patients as 
being meaningful and relevant. We noted that we intended to build a 
robust inventory of MVPs which are meaningful to clinicians and expect 
that in the future we may propose that all MIPS eligible clinicians 
would be required to participate in MIPS either through an MVP or an 
APM Performance Pathway (APP).
    In the CY 2021 PFS proposed rule (85 FR 50280 through 50281), we 
proposed to update the MVP guiding principles from the CY 2020 PFS 
proposed rule (84 FR 40734) to incorporate RFI comments and the 
evolution of the MVP framework. We refer readers to the CY 2021 PFS 
proposed rule for a discussion of the RFI comments. We proposed to add 
a new fifth guiding principle pointing to an important Meaningful 
Measures element of our future vision for reducing MVP reporting 
burden; the use of digital performance measure data submission 
technologies to indicate our commitment to leveraging digital 
innovations that reduce MIPS related clinician burden. Digital Quality 
Measures (dQMs) originate from sources of health information that are 
captured and can be transmitted electronically and via interoperable 
systems. We refer readers to the CY 2021 PFS proposed rule (85 FR 
50280) for a discussion of dQMs. We proposed to retain guiding 
principle 4 (84 FR 40734) and update guiding principles 1, 2, 3 and 5, 
as shown in italics, so that the guiding principles for MVPs reflect 
the following:
    1. MVPs should consist of limited, connected complementary sets of 
measures and activities that are meaningful to clinicians, which will 
reduce clinician burden, align scoring, and lead to sufficient 
comparative data.
    2. MVPs should include measures and activities that would result in 
providing comparative performance data that is valuable to patients and 
caregivers in evaluating clinician performance and making choices about 
their care; MVPs will enhance this comparative performance data as they 
allow subgroup reporting that comprehensively reflects the services 
provided by multispecialty groups.
    3. MVPs should include measures selected using the Meaningful 
Measures approach and, wherever possible, the patient voice must be 
included, to encourage performance improvements in high priority areas.
    4. MVPs should reduce barriers to APM participation by including 
measures that are part of APMs where feasible, and by linking cost and 
quality measurement.
    5. MVPs should support the transition to digital quality measures.
    We described our proposed method of creating MVPs in the CY 2020 
PFS proposed rule (85 FR 50281 through 50283). We noted that we intend 
to grow the number of available MVPs using the processes described in 
that section, maximizing our opportunity for expert input on the most 
meaningful measures and activities.
    We noted that we continue our efforts to improve the healthcare of 
Medicare patients by allowing clinicians to focus on providing care for 
their patients and the measures and activities that best reflect their 
care. We also noted that we look forward to continuing to work with 
stakeholders to improve the program and implement the vision of MVPs.
    We received public comments on this proposal. The comments we 
received and our responses are set forth below.
    Comment: Many commenters supported the MVP guiding principles as 
proposed with some commenters voicing support for all the guiding 
principles and some commenters highlighting support for subsets of the 
guiding principles. Commenters voiced a number of reasons for their 
support of the guiding principles related to moving towards MVP goals 
of burden reduction, meaningful performance measurement, capturing the 
patient voice, and/or moving to higher value care.
    Response: We appreciate the commenters' support of MVP guiding 
principles that will move us towards our goals of improving value, 
reducing burden, helping patients compare clinician performance to 
inform patient choice in selecting clinicians, and reducing barriers to 
movement into APMs. We agree with commenters that the MVP guiding 
principles will help realize these goals.
    Comment: While agreeing with the proposed and existing MVP guiding 
principles, a few commenters had questions about how they would be 
operationalized. A few commenters supported guiding principle 4. A few 
commenters questioned how MVPs would help reduce barriers to APM 
participation and one commenter suggested that we work with specialty 
societies to develop implementation approaches such as an APM blueprint 
with guidance for clinicians and further cost measure development. A 
few commenters voiced a concern that many medical specialties, for 
example, dermatology, do not have any APMs to work towards.
    Response: We appreciate the support for previously finalized 
guiding principle 4, MVPs should reduce barriers to APM participation 
by including measures that are part of APMs where feasible, and by 
linking cost and quality measurement. Experience with MVPs that measure 
quality of care and patient experience of care, cost, continuous 
practice improvement, and effective management and transfers of health 
information will help to reduce barriers to APM participation (84 FR 
40732 through 40733 and 84 FR 62947). We believe that MVPs, which 
better align cost and quality measurement and use measures meaningful 
to clinician practice performance, will help clinicians develop skills 
and processes that increase their readiness for APM participation. This 
experience with MVPs may stimulate clinician care improvement 
processes, a growth of data handling infrastructures, and increase 
clinician understanding of delivery of high value care. That is, MVP 
experience with cost and quality measurement may help improve clinician 
readiness to take on financial risk in APMs. This increased clinician 
understanding of the quality and cost relationship and improvement 
approaches derived through MVP use may increase clinician confidence 
and capacity to engage in APMs. We intend to develop MVPs in 
collaboration with stakeholders that align with the guiding principles. 
We anticipate these low burden, meaningful MVPs will move clinicians 
along the value continuum and facilitate movement into APMs by 
leveraging APM measures where feasible, and linking cost and quality. 
We acknowledge, that given the number

[[Page 84846]]

of Advanced APMs that are now available and the large number of 
specialty types, some specialists do not currently have an APM they 
could participate in. New APMs continue to be developed both inside and 
external to CMS and we envision that the number of APMs will grow in 
the future. We encourage specialists to collaborate with CMS and within 
the Health Care Payment Learning Action Network (HCPLAN) to help drive 
progress towards value-based care. We will continue to engage with 
stakeholders, including specialty societies, on how MVPs may reduce 
barriers to APM participation in the future. We are holding a MVP Town 
Hall meeting on January 7, 2021 (see 85 FR 74729 through 74730) that 
will provide stakeholders with an opportunity to provide feedback on 
MVP topics, including how MVPs can help reduce barriers to APM 
participation.
    Comment: One commenter suggested that in guiding principle 1 the 
term ``limited'' could be used to define MVPs too narrowly and exclude 
specialties from being assessed on relevant episodes of care and that 
we should balance the interests of multiple specialties under each 
proposed MVP.
    Response: The word ``limited'' in this guiding principles means 
that the number of performance measures and activities in each MVP will 
be small as compared to, for example, the more than 200 MIPS quality 
measures a clinician may choose from, we do not use ``limited'' here to 
constrict the overall number of MVPs as the commenter suggests. While 
the ``limited'' wording was in our previously finalized guiding 
principle 1, we proposed adding the words ``connected complementary'' 
to describe MVP sets of measures and activities that are meaningful to 
clinicians including specialists. We intend to balance performance 
measurement standardization with measures that are meaningful to 
clinicians as we develop MVPs in collaboration with stakeholders.
    Comment: A few commenters voiced their support for the concept of 
subgroup reporting as proposed in guiding principle 2, due to the 
flexibility it provides to specialists and the more meaningful 
performance data that results. A few commenters suggested that subgroup 
reporting be extended to traditional MIPS. A few commenters supported 
subgroup reporting only if it is optional for multispecialty groups and 
suggested that incentives be created for subgroup reporting to counter 
the additional reporting burden. A few commenters expressed interest in 
the potential of subgroup reporting as related to their specific 
specialties, which include anesthesiologists, electrophysiologists, 
endocrinologists, occupational therapists, and otolaryngologists. One 
commenter provided conditional support of the subgroup reporting 
concept depending on how a combined final score would be calculated and 
whether feedback would be provided at the pathway level for 
subspecialties to be able to receive tailored feedback. One commenter 
suggested a transition period to incentivize subgroup participation.
    Response: We appreciate the support of proposed guiding principle 
2. We envision subgroup reporting would be implemented as an option for 
multispecialty groups reporting MVPs in the future. We did not propose 
to add a subgroup reporting option to traditional MIPS and believe that 
the subgroup reporting option within MVPs is sufficient as we expect 
that eventually the majority of MIPS clinicians will transition to MVP 
reporting in the future. We have not proposed the details of subgroup 
reporting, data feedback, scoring or incentives for subgroup reporting 
but will consider all comments on subgroup reporting as we develop and 
propose MVP subgroup reporting implementation policies in the future. 
In terms of a transition period, we intend to implement MVPs 
incrementally with voluntary participation, which we believe will allow 
clinicians to transition, as they are ready, into MVP and subgroup 
reporting.
    Comment: Several commenters did not support the concept of subgroup 
reporting due to concerns related to added program complexity, added 
burden, and the need for clinicians to compare the scoring advantages 
of group, subgroup, and individual reporting. One commenter suggested 
that some specialties may not have a corresponding MVP to report and it 
may be unrealistic to report performance data on the entire 
multispecialty group. One commenter suggested that it is possible to 
develop or identify measures that could result in valuable comparative 
data comparing a few MVPs but believes that it may be challenging to 
identify measures that are comparable across all MVPs. One commenter 
had a concern that a future requirement for subgroup reporting that 
requires a minimum percent clinician representation would be burdensome 
and discourage MVP participation. One commenter suggested that testing 
the attribution methodology for sub-group reporting is critical. One 
commenter suggested that subgroup reporting would deter team-based 
care, increase competition, and produce unintended consequences. This 
commenter suggested that applying Promoting Interoperability 
requirements to a subgroup rather than a group would discourage MVP 
selection.
    Response: Multispecialty groups, especially groups with many 
clinicians, often provide an array of services that may not be captured 
in a single set of measures or in a single MVP. We proposed a modified 
MVP Guiding Principle 2 as we intend to propose subgroup MVP reporting 
in the future which would allow clinicians who want to voluntarily 
report measures that better represent the services they provide to do 
so. Regarding measure challenges related to comparable measures across 
all MVPs, within traditional MIPS we require performance measure and 
activity reporting across four categories (quality, costs, Promoting 
Interoperability, and improvement activities) and believe there is 
opportunity to improve comparative data within MVPs as we move in the 
direction of standardization. We agree with the commenter that it may 
be challenging to identify measures that are comparable across all MVPs 
but believe that a future state where clinicians who deliver similar 
services and report the same MVP will be an improvement over 
traditional MIPS where wide choices of performance measures and 
activities, produce challenges in obtaining comparative data. We intend 
to work with stakeholders to develop MVPs that include meaningful 
measures and build a portfolio of MVPs that improve comparative data 
within and across MVPs. We have not proposed implementation details or 
any minimum criteria for subgroup reporting. We acknowledge that since 
we plan to incrementally implement MVPs in future years, that some 
specialties will not initially have a respective MVP. The policies 
related to operational aspects of subgroup MVP reporting will be 
developed through future rulemaking with input from stakeholders and we 
will seek to mitigate concerns such as those voiced by commenters that 
include complexity, burden, attribution challenges, Promoting 
Interoperability requirements, unintended consequences, and whether 
subgroup reporting incentives are warranted. We are holding a MVP Town 
Hall meeting on January 7, 2021 (see 85 FR 74729 through 74730) that 
will provide stakeholders with an opportunity to provide feedback on 
MVP topics, including subgroup reporting.

[[Page 84847]]

    Comment: A few commenters suggested that the group reporting option 
continue to be available. One commenter suggested there could be undue 
burden on multi-specialty groups when each specialty/clinician reported 
separately and this resulted in separate payment adjustments, as it 
would be difficult to keep up with the scoring methodology and payment 
adjustments and would also create confusion for consumers in 
determining how well a group is performing.
    Response: As we implement MVPs and propose to implement subgroup 
reporting, we intend to continue the group reporting option. We thank 
the commenters for their feedback and understand their concerns around 
reporting, scoring, and payment adjustment. We believe that the statute 
requires CMS, to the extent feasible, to make group reporting 
comprehensive. We would balance more comprehensive reporting with 
concerns about complex reporting and scoring and separate payment 
adjustments. Though we are considering if, in a future state, it would 
be feasible to require multispecialty groups to report through 
subgroups and therefore not report as a single group, we do not believe 
that it would be feasible in the initial years. We are holding a MVP 
Town Hall meeting on January 7, 2021 (see 85 FR 74729 through 74730) 
that will provide stakeholders with an opportunity to provide feedback 
on MVP topics, including subgroup reporting.
    Comment: One commenter requested that CMS place a cap on the amount 
of measures that any one TIN would have to report. One commenter stated 
their belief that it will be difficult for developers and CMS to meet 
the 2nd guiding principle of providing valuable information to patients 
and caregivers if the MVP components are not meaningful to patients and 
caregivers.
    Response: We do not believe that the suggested cap on number of 
measures a TIN must report is necessary as subgroup reporting will be 
optional for multispecialty groups during the MVP transition years. We 
intend that MVP components be meaningful to patients and caregivers and 
refer the commenter to our MVP development criteria finalized in 
section IV.A.3.a.(2)(a)(i) of this final rule that ensures meaningful 
MVPs that are comprehensible and understandable.
    Comment: One commenter voiced concern related to linking cost and 
quality measurement in MVPs for specialties that rarely receive 
attribution in the cost performance category and urged CMS to be 
transparent in our cost attribution methodology.
    Response: Regarding the commenter concern about linkage of 
specialty cost and quality measurement challenges in MVPs, as 
referenced in guiding principle 4, we refer the commenter to MVP 
Development criteria, section IV.A.3.a.(2)(a)(i) where we state that in 
cases where there are not relevant cost measures for a specific type of 
care being provided, a broadly applicable cost measure should be 
considered for MVP inclusion. We are also interested in focused 
feedback on what additional cost measures should be prioritized for 
future development and inclusion in the MVP candidate.
    Comment: One commenter recommended that CMS revise guiding 
principle 2 to read: MVPs should include measures and activities that 
would result in providing comparative performance data that is valuable 
to patients and caregivers in evaluating clinician performance and 
making choices about their care ``and their overall health and well-
being.''
    Response: We expect the guiding principles to work together to 
promote our overall goals and we include a meaningful measures 
principle which looks to improve clinician performance. While MVP 
comparative data will help patients make clinician selection choices, 
it is not clear that the comparative data would be available at a level 
that explicitly helps patients' over-all health and well-being. 
Therefore, we are not adding the suggested wording to guiding principle 
2.
    Comment: One commenter encouraged CMS to provide additional guiding 
principle 2 guidance on how ``sufficient comparative data'' will be 
ensured, for example, by using single or a limited set of sources to 
aggregate, analyze and submit data within a given domain.
    Response: We proposed to update MVP guiding principle 2 to 
highlight the importance of more comprehensive multispecialty reporting 
through subgroups as a step in improving comparative performance data. 
The movement towards standardization of measures reported within MVPs 
will improve our ability to ensure comparative clinician performance 
data. We intend to develop policies related to ensuring comparative 
data and subgroup reporting with stakeholder input and plan to provide 
further information related to implementation of this guiding principle 
in the future. We believe that subgroup reporting allows increased 
comprehensiveness of multispecialty group performance data as more 
services can be represented when more than one MVP can be reported.
    Comment: Several commenters requested clarifications and details of 
how subgroups would work operationally. Topics listed for clarification 
include scoring methodology, subgroup election process, and 
attribution, and thresholds. One commenter suggested that we mitigate 
the risk of subgroup payment penalties during transition years. One 
commenter urged CMS to continue clarifying how MVPs will benefit 
multispecialty physician practices.
    Response: We proposed allowing subgroup reporting as a part of our 
MVP guiding principles and have not developed or proposed subgroup 
operational processes. As stated previously in this final rule, we 
intend to work with stakeholders to develop subgroup reporting policies 
and processes and intend to make subgroup MVP reporting available in 
future years. Stakeholder input into scoring, subgroup election 
processes, attribution, and minimal thresholds (if any) will be 
considered as we move ahead with subgroup reporting policy proposals in 
the future. MVPs will benefit multispecialty physician practices in 
that as more MVPs become available, groups will be able to continue to 
participate in MIPS via subgroups to more fully reflect the breadth of 
services provided by the various clinician types within the group. We 
intend that subgroup reporting will assist in improving the meaning and 
robustness of the performance data used to incentivize high quality and 
cost-effective care and providing information that patients can use to 
select clinicians.
    Comment: One commenter seemed to suggest that subgroup reporting 
was an unnecessary step towards more comprehensive performance data by 
suggesting that electronic health records can capture individual 
clinician performances that aggregate into group performance, which 
they believe many practices have reported to CMS these past few years. 
The commenter further suggested that instead of changing from group 
reporting to individual reporting, we should consider a mechanism to 
collect performance details that obtain individual performances while 
maintaining group reporting option and scoring. One commenter suggested 
an alternate to subgroup reporting saying it may be more meaningful to 
have cross[hyphen]cutting specialty measures for reporting, and 
provided an example of diabetes chronic condition care, which involves 
expertise from ophthalmologists, endocrinologists,

[[Page 84848]]

primary care providers, cardiologists and nephrologists.
    Response: We intend that subgroup reporting would not be restricted 
to a single data submission type, for example, EHRs, and would like to 
leverage current and developing technologies, as indicated by MVP 
guiding principle 5, to reduce reporting burden as MVPs and subgroup 
reporting is implemented. We encourage stakeholders to share with us 
new technologies and opportunities to further our goal of comprehensive 
and comparative performance data while limiting or reducing clinician 
MVP reporting burden. Regarding the cross-cutting specialty measures 
suggestion, we note that our MVP development criteria in section 
IV.A.3.a.(2)(a)(i) of this final rule, includes an appropriateness 
element related to whether the MVP is reportable by multiple 
specialties. Our MVP criteria state that to the extent feasible, 
specialty and sub-specialty specific quality measures are incorporated 
into the MVP and that broadly applicable (cross-cutting) quality 
measures may be incorporated if relevant to the clinicians being 
measured (refer to section IV.A.3.a.(2)(a)(i) of this final rule). 
While we appreciate the commenter's interest in cross cutting 
performance measurement, we do not believe it is an alternative to 
subgroup reporting, which allows multispecialty groups to voluntarily 
report on MVPs that have more clinical relevance to various specialties 
and health priorities.
    Comment: One commenter, referring to guiding principle 3, requested 
clarification of whether each MVP developer will be required to 
incorporate the patient voice. Another commenter recommended that with 
appropriate guidance from CMS, and integration of growing patient 
engagement practices, the inclusion of the patient voice should be 
mandatory.
    Response: We proposed modifying guiding principle 3 to read, MVPs 
should include measures selected using the Meaningful Measures approach 
and, wherever possible, the patient voice must be included, to 
encourage performance improvements in high priority areas. We emphasize 
in the guiding principle that the patient voice should be captured 
whenever possible and if not possible, the reason should be clear, for 
example, if for a certain non-patient facing specialty MVP, there are 
no relevant patient reported measures currently available. As a part of 
the MVP development process, we believe that it is important to develop 
MVPs in a manner that takes into consideration the patient's 
experience, satisfaction, and outcomes and capturing the patient voice 
will be used as a criterion as we assess candidate MVPs.
    Regarding the commenter recommendation about guiding principle 3 
language, ``whenever possible, the patient voice must be included'' and 
their belief that the patient voice should be mandatory, we refer the 
commenter to our MVP criteria, incorporation of the patient voice, in 
section IV.A.3.a.(2)(a)(i) of this final rule and our capturing the 
patient voice in section IV.A.3.a.(2)(a)(ii) of this final rule which 
make clear our commitment to inclusion of the patient voice both in our 
MVP criteria and during MVP development. In addition to including 
patients as a part of the MVP development process, we encourage 
stakeholders to utilize several approaches to incorporate the patient 
perspective, such as using focus groups, in-depth interviews with 
patients, and informal listening sessions, to the extent feasible, for 
a comprehensive patient perspective. We have finalized in this rule the 
expectation of patient voice inclusion in MVP measurement and MVP 
development.
    Comment: A few commenters suggested that we add language to the MVP 
guiding principles to recognize social determinants of health, with one 
commenter suggesting that the MVP guiding principles explicitly 
recognize that healthcare outcomes and cost are shaped by, but go 
beyond, physicians and the care they provide and are substantially 
attributable to social factors. One commenter again (85 FR 50280) 
recommended that we supplement guiding principle 3 by stating 
explicitly measurement of ``high priority areas of morbidity and 
mortality.''
    Response: We aim to implement MVPs that incentivize high value care 
and encourage clinicians to make care improvements based on performance 
measurement data. The Assistant Secretary for Planning and Evaluation 
(ASPE) Report to Congress: Social Risk Factors and Performance in 
Medicare's Value-Based Purchasing Program explored how the social 
determinants of health impact clinician performance data and value-
based programs.\120\ This report was publicly released in June 2020 and 
builds on the analyses included in an earlier report and provides 
additional insight for addressing risk factors in MIPS and other value-
based payment programs. As we continue to review the analyses and 
findings of the report, we are considering its recommendations, along 
with any updated data that would become available, for future 
rulemaking. We plan to continue working with ASPE, the public, and 
other key stakeholders on this important issue to identify longer term 
policy solutions that achieve the goals of attaining health equity for 
all beneficiaries and minimizing unintended consequences. As this work 
progresses, we will assess whether adding any social determinants of 
health wording to our MVP guiding principles is appropriate. We note 
that in support of social factor impacts we are finalizing in section 
IV.A.3.a.(2)(a)(i) of this final rule the proposed MVP criteria related 
to MVP developer consideration of patients in rural and underserved 
areas.
---------------------------------------------------------------------------

    \120\ ASPE Second Report to Congress. https://aspe.hhs.gov/pdf-report/second-impact-report-to-congress.
---------------------------------------------------------------------------

    We do not believe it is appropriate to add the recommended 
``morbidity and mortality'' wording in guiding principle 3 as we do not 
want to restrict what we mean by ``high priority areas'' to only 
morbidity and mortality performance improvements (85 FR 50281); we want 
to encourage performance improvements in a variety of high priority 
areas.
    Comment: A few commenters requested clarification of a definition 
of ``digital quality measures'' and the associated criteria for MVP 
measures. One commenter suggested that while digital measures would 
reduce burden for some, they would increase burden for others and 
another commenter suggested equity be considered in the use of eCQMs 
and digital measures for clinicians. One commenter would like to see 
digital quality measure exceptions for small practices which are not 
fully electronic. Another commenter suggested clinician choice in 
selection of dQMs to report. One commenter suggested that as we 
implement guiding principle 5, we expand the scope to incentivize 
building an infrastructure of digital systems that track patients 
longitudinally, inform care decisions, and support their quality 
improvement efforts. One commenter requested clarification as to 
whether our examples of dQMs suggested that eCQMs and MIPS CQMs will 
eventually be collapsed into a single undifferentiated collection type 
of dQM and that this could lead to a more optimally hybridized 
environment of quality measure development, collection and reporting. 
One commenter suggested that MVP digital measures should include all 
potential validated data sources, particularly patient reported 
outcomes and remote patient monitoring data, not just administrative 
data. One commenter suggested that we

[[Page 84849]]

need to better define ``digital'' technologies and the associated 
measure reporting requirements. One commenter, referring to guiding 
principle 5, encouraged us to more broadly recognize use of electronic 
data, such as MIPS credit for wearable devices initiatives. One 
commenter urged CMS to continue investing in further developing 
standards that support accurate data quality. A few commenters did not 
support proposed guiding principle 5 citing EHR, IT and cybersecurity 
burden concerns for small and rural practices. One commenter requested 
that we consider MVP development criteria that take into account those 
clinicians who may not be able to satisfy electronic reporting 
requirements.
    Response: We proposed adding new MVP guiding principle 5, MVPs 
should support the transition to digital quality measures, to 
communicate our future vision for reducing MVP reporting burden through 
leveraging digital innovation. Digital Quality Measures (dQMs) 
originate from sources of health information that are captured and can 
be transmitted electronically and via interoperable systems. Examples 
of digital sources include electronic health records (EHR), health 
information exchanges (HIEs), clinical registries, case management 
systems, electronic administrative claims systems, electronically 
submitted assessment data, and wearable devices. Electronic clinical 
quality measures or eCQMs (data derived from electronic medical 
records) are a subset of dQMs (85 FR 50281). As we develop MVPs and 
incorporate dQMs into MVPs we will consider the operational elements, 
transitional factors and how movement to dQMs impacts clinician burden, 
office protocols, cross-MVP equity, and small practices in keeping with 
our intent to reduce burden. We believe including dQMs in MVPs will 
incentivize the building of clinician infrastructures of digital 
systems. We intend to continue supporting the development of dQMs and 
look forward to inclusion of these measures in MVPs in the future.
    After consideration of public comments, we are finalizing our 
proposals as proposed.
(2) MVP Development
(a) Process of Developing MVPs
    In the CY 2020 PFS final rule (84 FR 62948), we finalized at Sec.  
414.1305 the definition of a ``MIPS Value Pathway'' to mean a subset of 
measures and activities established through rulemaking. We also 
clarified our intention to develop MVPs, to the extent feasible, in 
collaboration with stakeholders (84 FR 62947). Commenters suggested us 
to work in tandem with clinicians and specialty societies to develop 
MVPs (84 FR 62948) and have supported the development of MVPs with 
robust stakeholder input and feedback opportunities. Stakeholders have 
also clearly emphasized the need for input during the design and 
implementation of MVPs. We believe it is important to emphasize that 
the transition to MVPs must occur gradually, without immediate 
elimination of the current MIPS program, as we continue to work 
collaboratively with stakeholders regarding MVP development. As MVPs 
are developed collaboratively and in a manner that involves dialogs 
with stakeholders, they must be created utilizing a consistent set of 
parameters and criteria, to ensure that MVPs are constructed and 
implemented in a uniform manner. In addition, we believe it is 
important to outline the methods in which collaboration and engagement 
may occur with stakeholders. Lastly, we intend on formulating a 
standardized process in which stakeholders can submit formal MVP 
candidates for CMS' consideration.
(i) MVP Development Criteria
    In response to the RFI in the CY 2020 PFS final rule, we have 
received stakeholder comments that supported the move to MVPs with 
considerations to departing from the traditional reporting requirements 
of the existing MIPS program, such as reporting 6 quality measures for 
the Quality performance category. We also received stakeholder comments 
through the RFI that supported the use of electronically available 
measures such as eCQMs and the use of QCDR measures to the extent 
feasible. Stakeholders also expressed that it is important that the 
collection type of quality measures be considered as MVPs are designed. 
As a part of the MVP development process, consideration should be given 
to the four performance categories in MIPS, and whether the MVP has a 
clearly defined intent, offers value, and opportunity for improvement. 
We believe that as a part of MVP development, it is important to 
clearly identify linkages between the measures and activities within an 
MVP which will demonstrate the relevancy of measures and activities to 
the clinicians being captured within the MVP. Furthermore, as MVPs are 
developed it is important to factor in the appropriateness of the 
measures and activities being included and the comprehensibility of the 
MVP to clinicians and patients. Lastly, considerations must be given to 
existing criteria for measure and activity inclusion or removal, as 
established for each of the performance categories. For example, as 
described in the CY 2019 PFS final rule (83 FR 59763) for the quality 
performance category, quality measures that are identified as extremely 
topped out (reaching an average performance rate between 98 to 100 
percent) will likely be removed from the program. We refer readers to 
the CY 2020 PFS final rule (84 FR 62949 through 63006) for discussion 
of previously finalized measure and activity requirements across the 
Quality, Cost, Improvement Activity, and Promoting Interoperability 
performance categories. In addition, we also referred readers to 
section IV.A.3.c. of the CY 2021 PFS proposed rule for updates to the 
respective performance categories. Therefore, beginning with the 2022 
MIPS performance period, we proposed to develop and select MVPs using 
the following criteria:
     Utilization of Measures and Activities across Performance 
Categories.
    (a) MVPs should include measures and activities from the Quality, 
Cost, and Improvement Activities performance categories.
    (b) MVPs should include the entire set of Promoting 
Interoperability (PI) measures.
     Intent of Measurement:
    (a) What is the intent of the MVP?
    (b) Is the intent of the MVP the same at the individual clinician 
and group level?
    (c) Are there opportunities to improve the quality of care and 
value in the area being measured?
    (d) Why is the topic of measurement meaningful to clinicians?
    (e) Does the MVP act as a vehicle to incrementally phase clinicians 
into APMs? How so?
    (f) Is the MVP reportable by small and rural practices? Does the 
MVP consider reporting burden to those small and rural practices?
    (g) Which Meaningful Measure Domain(s) does the MVP address?
     Measure and Activity Linkages with the MVP:
    (a) How do the measures and activities within the proposed MVP link 
to one another? (For example, do the measures and activities assess 
different dimensions of care provided by the clinician?)
    (b) Are the measures and activities related or a part of the care 
cycle or continuum of care offered by the clinicians?

[[Page 84850]]

    (c) Why are the measures and activities most meaningful to the 
specialty?
     Appropriateness:
    (a) Is the MVP reportable by multiple specialties? If so, has the 
MVP been developed collaboratively across specialties?
    (b) Are the measures clinically appropriate for the clinicians 
being measured?
    (c) Do the measures capture a clinically definable population of 
clinicians and patients?
    (d) Do the measures capture the care settings of the clinicians 
being measured?
    (e) Prior to incorporating a measure in an MVP, is the measure 
specification evaluated, to ensure that the measure is inclusive of the 
specialty or sub-specialty?
     Comprehensibility:
    (a) Is the MVP comprehensive and understandable by the clinician or 
group?
    (b) Is the MVP comprehensive and understandable by patients?
     Incorporation of the Patient Voice:
    (a) Does the MVP take into consideration the patient voice? How?
    (b) Does the MVP take into consideration patients in rural and 
underserved areas?
    (c) How are patients involved in the MVP development process?
    (d) To the extent feasible, does the MVP include patient-reported 
outcome measures, patient experience measures, and/or patient 
satisfaction measures?
     Measures and Improvement Activities Considerations: MIPS 
Quality Measures.
    We were not prescriptive on the number of quality measures that are 
included in an MVP. In selecting quality measures, we stated that we 
believe that consideration should be given to the following:
    (a) Do the quality measures included in the MVP meet the existing 
quality measure inclusion criteria? (For example, does the measure 
demonstrate a performance gap?)
    (b) Have the quality measure denominators been evaluated to ensure 
the eligible population is consistent across the measures and 
activities within the MVP?
    (c) Have the quality measure numerators been assessed to ensure the 
measure is applicable to the MVP topic?
    (d) To the extent feasible, does the MVP include outcome measures, 
or high priority measures in instances where outcome measures are not 
available or applicable? We encourage stakeholders to utilize our 
established pre-rulemaking processes, such as the Call for Measures, 
described in the CY 2020 PFS final rule (84 FR 62953 through 62955) to 
develop outcome measures relevant to their specialty if outcome 
measures currently do not exist and for eventual inclusion into an MVP.
    (e) To the extent feasible, does the MVP include electronically 
specified clinical quality measures?
    (f) To the extent feasible, does the MVP avoid including quality 
measures that are topped out?
    (g) What collection types are the measures available through?
    (h) What role does each quality measure play in driving quality 
care and improving value within the MVP? Provide a rationale as to why 
each quality measure was selected.
    (i) How do the selected quality measures relate to other measures 
and activities in the other performance categories?
    (j) To the extent feasible, specialty and sub-specialty specific 
quality measures are incorporated into the MVP. Broadly applicable 
(cross-cutting) quality measures may be incorporated if relevant to the 
clinicians being measured.
     Measures and Improvement Activities Considerations: Cost 
Measures.
    (a) What role does the cost measure(s) play in driving quality care 
and improving value within the MVP? Provide a rationale as to why each 
cost measure was selected.
    (b) How does the selected cost measure(s) relate to other measures 
and activities in other performance categories?
    (c) If there are not relevant cost measures for specific types of 
care being provided (for example, conditions or procedures), does the 
MVP include broadly applicable cost measures (that are applicable to 
the type of clinician)?
    (d) What additional cost measures should be prioritized for future 
development and inclusion in the MVP?
     Measures and Improvement Activities Considerations: 
Improvement Activities.
    (a) What role does the improvement activity play in driving quality 
care and improving value within the MVP? Provide a rationale as to why 
each improvement activity was included.
    (b) Describe how the improvement activity can be used to improve 
the quality of performance in clinical practices for those clinicians 
who would report this MVP.
    (c) Does the improvement activity complement and/or supplement the 
quality action of the measures in the MVP, rather than duplicate it?
    (d) To the extent feasible, does the MVP include improvement 
activities that can be conducted using CEHRT functions? The use of 
improvement activities that specify the use of certified health IT will 
help to further align with the CEHRT requirement under the Promoting 
Interoperability performance category.
    (e) If there are not relevant specialty or sub-specialty specific 
improvement activities, does the MVP includes broadly applicable 
improvement activities (that is applicable to the clinician type) are 
used?
     Measures and Improvement Activities Considerations: 
Promoting Interoperability (PI) Measures.
    (a) Must include the full set of PI measures.
    The MVP development criteria was developed primarily with 
consideration with the MVP guiding principles, discussed above. In 
addition, we considered the spectrum of measures and activities 
available for MVP development, and the criteria used to include 
measures and activities within each of the respective performance 
categories. Through the collaborative process of co-developing MVPs 
with stakeholders, we have realized how crucial it is to establish a 
set of MVP development criteria that would standardize what is expected 
of MVPs and provide our evaluation criteria in a transparent manner. We 
stated that we believe that the aforementioned criteria will lead to 
the development of MVPs in a manner that is consistent and reliable. We 
sought comment on the MVP development criteria.
    We received public comments on the MVP development criteria 
proposal. The following is a summary of the comments we received and 
our responses.
    Comment: A few commenters broadly supported the MVP criteria.
    Response: We agree and thank the commenters for their support on 
the MVP criteria. We believe that the establishment of MVP development 
criteria will allow stakeholders to better understand of our vision for 
MVPs and ensure that MVPs are constructed in a consistent manner.
    Comment: Several commenters broadly supported the MVP criteria. One 
commenter suggested CMS to continue to prioritize interoperability as a 
foundational requirement in the new MVP Program. One commenter agreed 
that MVPs should include criteria related to utilization, intent, and 
linkage of measures because this would help develop new MVPs. One 
commenter suggested CMS provide flexibility for innovative MVPs.
    Response: We thank the commenters for their support on the MVP 
criteria,

[[Page 84851]]

we believe there is importance to establishing criteria in which MVPs 
will be developed and implemented for consistency purposes. We also 
agree that interoperability is an important priority, and should 
therefore, be included in MVPs as a foundational requirement. We also 
agree that criteria related to utilization, intent, and linkages would 
assist in the development of MVPs. Lastly, we continue to encourage 
stakeholders to be innovative as they partake in MVP development and 
collaboration with CMS while aligning with the MVP development criteria 
as described. We do not believe additional flexibility beyond what is 
described in the MVP development criteria is needed, as we emphasize 
that MVPs should be developed utilizing a standardized framework.
    Comment: Commenters expressed that MVPs should be tailored for 
participating clinician specialists', such as anesthesiologists, 
neurosurgeons, rehabilitation medicine, occupational therapists, 
physical therapists, and speech-language pathologists. A few commenters 
stated that MVPs should be collaboratively developed by specialties 
before submission to CMS. One commenter expressed that MVPs could be 
considered condition-specific (when specialists are part of a larger 
core team) or specialty-specific (when specialists are treating 
patients with a wide range of diagnoses). One commenter expressed that 
specialty organizations would have difficulty contributing measures to 
MVPs that are not specialty specific.
    Response: We agree that MVPs should be developed around specialties 
that participate in the MIPS program to offer clinicians a more 
meaningful method of reporting. We also strongly agree and would 
encourage that MVPs should be collaboratively developed amongst 
specialties, in instances where an MVP covers an episode of care that 
involves multiple clinician types, such as surgeons and 
anesthesiologists. Furthermore, we agree that MVPs could be condition-
specific or specialty-specific; it will depend on the clinical topic 
being measured and envision the specialty organizations would suggest 
specialty specific measures for MVPs over broadly applicable measures. 
While broadly applicable measures, such as closing the referral loop, 
can be considered for inclusion in an MVP, because they cover quality 
actions that are a part of the care continuum, these are not required 
to be included should more meaningful and relevant specialty specific 
measures exist. We believe the measures included in an MVP should be 
relevant and meaningful to the clinical practice of the specialties 
being measured. We are open to considering candidate MVPs that are 
created utilizing the MVP development criteria, for specialties 
including physical and occupational therapy.
    Comment: Several commenters expressed that the proposed MVP 
criteria should include other elements such as the number of measures 
and activities required. A few commenters recommended CMS work 
collaboratively with MVP developers and one commenter specified that 
CMS's MVP approval process should be transparent with the MVP 
developers so that specialty societies do not invest resources without 
assurances of success.
    Response: As described in the CY 2021 PFS proposed rule (85 FR 
50282), we are not prescriptive on the number of measures or activities 
included in MVPs. We emphasize that the measure and activities should 
be relevant and meaningful to the topic being measured through the MVP. 
We intend to provide educational material including plans to host a 
public facing webinar to help stakeholders better understand and be 
prepared to implement the MVP development criteria. In addition, we 
emphasize it is our intention to work collaboratively by having dialogs 
with stakeholders to develop MVPs that are meaningful and relevant to 
their given clinical specialties. Lastly, while we intend to continue 
to work with stakeholders in an iterative manner that fosters 
transparency, CMS will ultimately determine if and when an MVP 
candidate is ready for implementation. We intend to follow our normal 
processes of notice and comment rulemaking to make stakeholders and the 
public aware of which MVPs we believe are ready for implementation for 
the upcoming performance period.
    Comment: One commenter recommended CMS clearly define a pathway to 
phase clinicians into APMs.
    Response: We intend that MVPs will assist clinicians and practices 
as they prepare to take on and manage financial risk, as in Advanced 
APMs, as they build out their quality infrastructures that align with 
the MIPS performance categories and gain experience with cost 
measurement. We believe that experience with MVPs, in which there is 
aligned measurement of quality (of care and of experience of care) and 
cost, continuous improvement/innovation within the practice, and 
efficient management and transfers of information, will help remove 
barriers to APM participation.
    We refer readers to the infographic at https://qpp.cms.gov/mips/mips-value-pathways, which provides an overview of our vision for the 
MIPS path to value future state (see 85 FR 50279). We believe that 
MVPs, which better align cost and quality measurement and use measures 
meaningful to clinician practice performance, will help clinicians 
develop skills and processes that increase their readiness for APM 
participation. This experience with MVPs may stimulate clinician care 
improvement processes, a growth of data handling infrastructures, and 
increase clinician understanding of delivery of high value care. We 
believe another example of how MVPs may provide a pathway to phase 
clinicians into APMs may be to consider the inclusion of quality 
measures in MVPs, which are used in APMs such as the new APM 
Performance Pathway (APP). The familiarity of reporting those measures, 
may lead to a smoother glide path for clinicians into APMs.
    Furthermore, MVPs should reduce barriers to APM participation by 
including measures that are part of APMs where feasible, and by linking 
cost and quality measurement. Experience with MVPs that measure quality 
of care and patient experience of care, cost, continuous practice 
improvement, and effective management and transfers of health 
information will help to reduce barriers to APM participation (84 FR 
40732 through 40733 and 84 FR 62947). We anticipate these low burden, 
meaningful MVPs will move clinicians along the value continuum and 
facilitate movement into APMs by leveraging APM measures where 
feasible, and linking cost and quality. We will continue to engage with 
stakeholders on how MVPs may reduce barriers to APM participation in 
the future. We are holding a MVP Town Hall meeting on January 7, 2021 
that will provide stakeholders with an opportunity to provide feedback 
on MVP topics, including how MVPs can help reduce barriers to APM 
participation. (See the November 23, 2020 Federal Register (85 FR 74729 
through 74730) for additional information on the January 7, 2021 
meeting.)
    Comment: One commenter requested that CMS define an MVP governance 
structure that would include a central point of contact and 
responsibility to prevent the removal of a measure or an improvement 
activity that would negatively affect stakeholders and specialties.
    Response: All MVPs are subject to notice and comment rulemaking 
with regards to the proposal of new MVPs,

[[Page 84852]]

changes to existing MVPs (in the future), and removal of MVPs or 
components of an MVP (such as a quality measure or improvement 
activity). CMS is the central point of contact with regards to MVPs. If 
there are potential changes to an established MVP, we will consider the 
potential impacts on all stakeholders prior to proposing the changes. 
Stakeholders will be able to provide comments on the proposed changes 
through the public comment period for CMS to consider prior to 
finalizing the MVPs or changes to the MVPs.
    Comment: One commenter requested that CMS clarify if it would 
withhold MVP approval for a specialty specific MVP if patient reported 
outcome measures for the specialty specific MVP are not available.
    Response: While it is our preference to include outcome and patient 
reported outcome measures in MVPs, we have stated we would do so to the 
extent feasible, as we understand that there may be limited 
availability of patient reported outcome measures for all specialties. 
Therefore, we encourage the use of other measures that consider the 
patient voice in MVPs, such as patient surveys, patient satisfaction, 
or patient experience measures in the interim. It is our vision that 
MVPs will be made up of a majority of outcome measures and will include 
a patient reported outcome measure that would represent the patient 
voice. We continue to encourage stakeholders to use their innovative 
means to develop and submit through our established pre-rulemakings 
processes patient reported outcome measures that are meaningful to 
their specialties, and consider the incorporation of tools such as the 
PROMIS tool into their measure development.
    Comment: One commenter requested that CMS clarify how MVPs will 
incorporate new technology, such as FHIR (Fast Healthcare 
Interoperability Resource), into data collection.
    Response: As mentioned in the previous section of this final rule, 
within our MVP guiding principles, we indicate that MVPs should support 
the transition to digital measures to the extent feasible. The 
inclusion of digital measures within MVPs may facilitate future use of 
new technologies such as FHIR, in an effort to provide reporting 
options that reduce reporting burden for clinicians and groups.
    Comment: A few commenters opposed including the full set of 
promoting interoperability (PI) measures in MVPs and recommended CMS 
emphasize that improvement activities must utilize certified electronic 
health record technology (CEHRT). One commenter noted that hospitalists 
or clinicians who do not interact with patients would not be able to 
collect and report PI data and that MVPs should be designed to reflect 
this at the outset by allowing groups to attest to using CEHRT. One 
commenter suggested CMS maintain the existing PI hardship exceptions as 
a proxy for the PI measurement requirement.
    Response: We believe that interoperability is a foundational 
element of MVPs. In the CY 2020 PFS final rule (84 FR 62948) we stated 
that we envision an initial uniform set of Promoting Interoperability 
measures in each MVP and will consider customizing MVP Promoting 
Interoperability measures in future years. We believe that eligible 
clinicians could benefit from more targeted approaches that assess the 
meaningful use of health IT in alignment with clinically relevant MVPs. 
As we gain additional years of experience with MVPs, we may be able to 
consider MVP Promoting Interoperability measures in each MVP, but we 
want to spend some time assessing what criteria should be used in 
determining which Promoting Interoperability measures fit or do not fit 
within a given MVP and why. Furthermore, we agree that the 
establishment and inclusion of improvement activities (IAs) that 
require the utilization of certified health IT in MVPs would create a 
stronger linkage between the PI and IA performance categories. Lastly, 
the existing bases for reweighting the PI performance category under 
traditional MIPS also will be available through MVPs.
    Comment: A few commenters expressed that many small and rural 
practices cannot afford implementing electronic health records (EHRs), 
including the information technology and cybersecurity staff required 
to maintain EHR security and recommended CMS maintain the Promoting 
Interoperability performance category small practice hardship 
exception.
    Response: We understand that there may be some barriers for small 
and rural practices in implementing CEHRT, and do intend on maintaining 
the hardship exception for small practices as we establish the MVP 
reporting option. In addition, we intend on applying the existing 
Promoting Interoperability performance category reweighting policies 
under Sec.  414.1380(c)(2) as we establish MVPs, with any revisions 
addressed through future notice and comment rulemaking.
    Comment: Several commenters suggested overall measure requirements 
regarding the number of measures and requested measure clarification. A 
few commenters requested that MVPs include a limited number of 
measures. One commenter suggested that clinicians report six quality 
measures and one outcome measure or high-priority measure. One 
commenter suggested that specialties and sub-specialties with less than 
six quality measures should be required to report on all cross-cutting 
measures.
    Response: As mentioned in the CY 2021 PFS proposed rule (85 FR 
50282), to date, we have not been prescriptive on the number of quality 
measures that are included in a given MVP. The measures that are being 
considered for inclusion of the MVP should meet the standards of the 
MIPS quality measures and QCDR measures inclusion criteria. Measures 
incorporated into an MVP should be clinically relevant to the topic 
being measured. Through the gradual transition to MVPs, we intend on 
allowing for clinicians to report on smaller but more meaningful sets 
of measures and activities. We appreciate the feedback regarding MVP 
reporting requirements, and encourage stakeholders to participate in 
our MVP Town Hall meeting to provide additional feedback with regards 
to the number of measures clinicians should be required to report in an 
MVP. As noted previously in this section, we are holding a MVP Town 
Hall meeting on January 7, 2021 (85 FR 74729 through 74730) that will 
provide stakeholders with an opportunity to provide feedback on this 
amongst other MVP topics. We thank the commenters on their suggestions 
in regards to reporting requirements for specialties and sub-
specialties with less than six quality measures, and will take the 
comment into consideration for future rulemaking.
    Comment: One commenter requested clarification on whether every MVP 
measure and improvement activity should have the same denominator.
    Response: To clarify, every measure and improvement activity does 
not have to have the same denominator. However, we encourage 
stakeholders to consider the denominator eligible population across the 
measures being considered for inclusion in the quality and cost 
component of the MVP. In addition, we also encourage stakeholders to 
review the measure specifications to validate that the places of 
service they would like reflected within the MVP, for example, 
inpatient or outpatient are included. We encourage this review, so that 
stakeholders are cognizant of incorporating measures that are widely

[[Page 84853]]

applicable to the clinicians they intend to measure through the MVP. 
Furthermore, improvement activities do not utilize numerators and 
denominators like measures do. Therefore, we encourage stakeholders to 
utilize improvement activities that are complementary to the quality 
actions captured by the quality measures and cost measures included 
within the MVP candidate.
    Comment: One commenter stated CMS should ensure there are enough 
measures to create MVPs applicable for the more than 1 million eligible 
clinicians that currently participate in the MIPS program, specifically 
specialists.
    Response: In the MIPS program, we have implemented two inventories 
of measures, which include MIPS quality measures that are submitted 
through the Call for Measures following the pre-rulemaking process that 
are eventually proposed and finalized through notice and comment 
rulemaking. The other inventory of available measures are developed by 
CMS approved Qualified Clinical Data Registries (QCDRs). We refer 
readers to the Quality Payment Program (QPP) resource library: https://qpp.cms.gov/about/resource-library for details on the available 
inventories of quality measures and QCDR measures for the 2020 
performance period. The measure inventories for the 2021 MIPS 
performance period will be posted to the prior to the start of the 
performance period in the QPP resource library. We believe the existing 
inventories of measures are enough to start creating applicable MVP 
candidates. Moreover, we continue to encourage measure stewards and 
QCDRs to innovatively develop measures and keep in mind our desire to 
transition our inventory of measures to be largely based on outcome 
measures and develop measures that are outcome, intermediate outcome, 
or patient reported outcome based.
    Comment: Another commenter recommended allowing specialties to 
rapidly test and replace obsolete measures.
    Response: We agree and highly encourage stakeholders, such as 
specialty groups and measure developers to participate in measure 
development and submit measures through the Call for Measures as soon 
as possible to replace retired measures with measures that are more 
robust and outcomes based. In following the pre-rulemaking guidelines 
to ensure their measures can be considered, the process also includes 
measure testing amongst other requirements. We refer readers to the 
pre-rulemaking website for a comprehensive list of measure development 
requirements and resources at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Pre-Rulemaking-MUC.
    Comment: Commenters recommended that CMS incorporate patient-
reported outcomes measures (PROMs) into MVPs and expressed that these 
measures not only improve the quality of care but also help patients 
make more informed decisions. Commenters also recommended that PRO 
tools such as PROMIS, SDM-Q-9, and CollaboRATE be incorporated into the 
MVP quality score.
    Response: We agree with the commenters that patient reported 
outcome measures provide value and improve the quality of care, and to 
the extent feasible, should be included in MVPs. We also agree that PRO 
tools are valuable, but need to be incorporated into a measure or 
activity in order to contribute to the MVP quality score per statutory 
requirements.
    Comment: One commenter requested CMS to clarify the number of MVPs 
per specialty and a few commenters recommended sub-specialty MVPs. For 
example, one commenter recommended CMS support the development of 
multiple surgical and procedural MVPs to represent anesthesia practice 
settings to provide sufficient MVP choices for ECs and groups.
    Response: To date we have not been specific as to the maximum 
number of MVPs a given specialty should have. We are cognizant of the 
potential need for MVPs that are sub specialized and that the number of 
MVPs available per specialty may vary. We believe discussions with the 
specialties will help to determine the best path forward, while keeping 
in mind our desire to avoid creating large volumes of MVPs per 
specialty, which may create more complexity and may lead to overwhelmed 
clinicians unsure of which MVP to report. After consideration of the 
public comments received, we are finalizing our proposals as proposed.
(ii) Capturing the Patient Voice
    As a part of the MVP development process, we believe that it is 
important to develop MVPs in a manner that takes into consideration the 
patient's experience, satisfaction, and outcomes. We believe that MVPs 
should be constructed in a manner that should not only be understood by 
clinicians, but by patients who may use the ascertained information to 
make informed decisions regarding their health care providers. 
Therefore, beginning with the 2022 performance period, we proposed that 
stakeholders that are developing MVPs to submit to CMS as candidate 
MVPs should include patients as a part of the MVP development process. 
We stated that stakeholders should incorporate patients and/or patient 
representatives through means that may include, but are not limited to 
technical expert panels or an advisory committee as they work to 
construct their candidate MVPs prior to reaching out to CMS with a 
candidate submission. The process of involving patients as a part of 
the stakeholder's MVP development would be considered a pre-requisite 
for CMS to consider the candidate MVP for the upcoming performance 
period. By including patients and/or patient representatives in the MVP 
development process, we stated we believe that patients will be able to 
voice how to make the outcomes of measurement meaningful to them. In 
addition to including patients as a part of the MVP development 
process, we encouraged stakeholders to utilize several approaches to 
incorporate the patient perspective, such as using focus groups, in-
depth interviews with patients, and informal listening sessions, to the 
extent feasible, for a comprehensive patient perspective. We sought 
comments on the proposal.
    We received public comments on the capturing the patient voice 
proposal. The following is a summary of the comments we received and 
our responses.
    Comment: Several commenters supported the inclusion of the patient 
voice in the MVP development process.
    Response: We thank the commenters for their support, and agree that 
there is importance in including the patient voice in the MVP 
development process. We believe that including patients as a part of 
the MVP development process will allow for the development of MVPs that 
provide data that is meaningful to patients as they select providers.
    Comment: One commenter opposed the addition of MVP development 
criteria, citing concern that these will delay MVP development. The 
commenter suggests that CMS subject each MVP candidate to a robust 
screening process that includes patient perspective, rather than 
putting the onus on developers to do so.
    Response: We disagree that the establishment of MVP development 
criteria will delay MVP development. We believe that the creation of 
MVP development criteria will allow for the implementation of MVPs that 
are created in a consistent manner that aligns with our vision of MIPS 
Value Pathways moving clinicians to more meaningful measurement that 
creates

[[Page 84854]]

betters opportunities for quality improvement. Furthermore, we disagree 
with the commenter's suggestion that CMS alone subject each MVP 
candidate to a screening process that includes patients. We believe 
that stakeholders who choose to create a MVP candidate around a 
clinical topic should consider the patient perspective as a part of the 
development process rather than waiting until the candidate MVP has 
completed development to obtain patient feedback. The consideration of 
the patient perspective in the midst of the development process allows 
stakeholders to consider the feedback and make changes to their 
development process that will help to result in a better quality MVP 
candidate.
    Comment: A few commenters recommended that CMS delay implementing 
the criteria that the MVP is comprehensive and understandable by 
patients. A few commenters requested a delay until the 2023 performance 
year so that a technical expert panel could be convened.
    Response: We disagree that this criteria should be delayed until 
the 2023 performance period. We believe all MVP candidates need to be 
developed with this criteria in mind to ensure that the data collected 
from MVPs are meaningful for patients to make informed decisions 
regarding their patient care. Furthermore, it is not a requirement that 
stakeholders convene technical expert panels, therefore, we disagree 
that there be a delay until the 2023 performance period. While we have 
established criteria to develop MVPs, it is to the discretion of the 
stakeholder to determine how elaborate of a development process they 
would like to undertake and when their MVP candidate is ready for CMS 
review and consideration.
    Comment: Several commenters recommended approaches for CMS to 
engage patients. One commenter expressed concern about how CMS will 
evaluate patient engagement during the MVP development process.
    Response: We thank the commenters for their recommendations; 
however, we note that the requirement is for stakeholders who wish to 
submit an MVP candidate to CMS. Those stakeholders must engage with 
patients as a part of their MVP development process prior to submitting 
the MVP candidate for CMS review and consideration. While we are not 
prescriptive that patient engagement occur using a single approach, we 
plan to recommend stakeholders to describe how they engaged patients in 
the MVP development process through the MVP candidate submission 
template to help us understand how the patient's perspective was 
considered in the development process.
    Comment: One commenter requested that CMS make exceptions for the 
inclusion of patient representatives in MVP development in cases where 
organizations are able to demonstrate that patient reported outcomes 
cannot be used. Another commenter requested clarity on whether each 
contributor or specialist to an MVP must include patient testing or 
interviews. The commenter also requested detail on how CMS will verify 
the inclusion of the patient voice.
    Response: We disagree with the commenter request that we make 
exceptions for the inclusion of patient representatives in the MVP 
development process in instances where organizations are unable to 
utilize patient reported outcome measures. We want to clarify that the 
requirements around the patient voice are complimentary. We are looking 
for stakeholders to involve patients or patient representatives as a 
part of the MVP development process, to ensure that patients are able 
to understand what the MVP is trying to measure. In addition, to the 
extent feasible, we suggested that patient reported outcome measures be 
included in MVPs. While it is our preference to include patient 
reported outcome measures in MVPs, we understand that there may be 
limited availability of patient reported outcome measures for all 
specialties. Therefore, we encourage the use of other measures that 
consider the patient in MVPs, such as patient surveys, patient 
satisfaction, patient experience, or patient safety measures. We 
continue to encourage stakeholders to use their innovative means to 
develop and submit through our established pre-rulemakings processes 
patient reported outcome measures that are meaningful to their 
specialties, and consider the incorporation of tools such as the PROMIS 
tool into their measure development.
    Comment: One commenter recommended that CMS develop patient-facing 
materials describing MVPs and requested that CMS lead education of 
patient groups on the goals and quality measurement of the MVP.
    Response: We thank the commenter for their recommendation. As a 
part of our education and outreach efforts we intend on developing 
educational materials and hosting webinars that are meaningful to all 
stakeholders, including patients. However, we also believe that 
stakeholders who choose to partake in MVP development should also 
educate and involve patients regarding quality care in a given area of 
clinical care improvement.
    Comment: One commenter requested CMS to provide equal focus on 
patient outcomes as patient experience and satisfaction. Another 
commenter stated that treating and reversing certain chronic conditions 
and achieving optimal health outcomes. One commenter recommended that 
MVPs include the Hospital-Wide 30-day All Cause Unplanned Readmission 
(HWR) Rate measure.
    Response: We agree and continue to emphasize our focus on outcomes, 
including patient reported outcomes, and our desire to move away from 
process measures. We also agree that attaining optimal health outcomes 
by treating, managing, and possibly overcoming chronic conditions 
should be captured in a future MVP. Furthermore, we agree that there is 
importance in including population health measures in the foundational 
layer of all MVPs as described below, and we do intend on finalizing 
the inclusion of the Hospital-Wide 30-day All Cause Unplanned 
Readmission (HWR) Rate for the Merit-Based Incentive Payment System 
Program (MIPS) Eligible Clinician Groups measure.
    After consideration of the public comments, we are finalizing our 
proposals as proposed.
(iii) Candidate MVP Co-Development, Solicitation Process, and 
Evaluation
    Through the Request for Information (RFI) on transforming MIPS in 
the CY 2020 PFS final rule we have learned of stakeholders interests in 
participating in the MVP development process. In summer 2019, we held 
numerous focus groups with front-line clinicians, specialty societies, 
advocacy groups, QCDRs, registries, and health IT vendors to listen to 
what stakeholders were looking for in regards to program 
simplification, burden reduction, and the intent of MVPs. In response 
to the CY 2020 PFS final rule, we received several requests from 
stakeholders who wanted to discuss their perspectives on MVPs and in 
some cases, walk us through potential MVP candidates from their 
specialty. Based on continuous stakeholder interest, we believe that a 
process must be implemented to ensure that stakeholder engagement and 
collaboration in the development of MVPs is consistent from an overall 
perspective.
    To consider MVP candidates developed by stakeholders, we believe it 
is important to implement a streamlined approach to receive and 
evaluate potential MVPs. Therefore, beginning

[[Page 84855]]

with the 2022 performance period, we proposed that stakeholders should 
formally submit their MVP candidates utilizing a standardized template, 
which will be published in the QPP resource library for our 
consideration for future implementation. Stakeholders should submit all 
information including a description of how their MVP abides by the MVP 
development criteria as described in the CY 2021 PFS proposed rule (85 
FR 50281 through 50283), and provide rationales as to why specific 
measures and activities were chosen to construct the MVP. We believe 
the utilization of a standardized template would help stakeholders 
understand what information is needed to evaluate the feasibility of 
the candidate MVP.
    On an annual basis, we intend on hosting a public facing MVP 
development webinar, to remind stakeholders of MVP development 
criteria, the timeline, and process in which to submit a candidate MVP. 
While we believe that engagement with stakeholders regarding MVP 
candidates may occur on a rolling basis throughout the year, at CMS' 
discretion we will determine if an MVP is ready for inclusion in the 
upcoming performance period. As MVP candidates are received, they will 
be reviewed, vetted, and evaluated by CMS and our contractors. We 
intend on utilizing the MVP development criteria (discussed above) to 
determine if the candidate MVP is feasible. In addition to the MVP 
development criteria listed above, we will also vet the quality and 
cost measures from a technical perspective to validate that the coding 
in the quality measures and cost measure(s) include the clinician type 
being measured, and whether all potential specialty specific quality 
measures or cost measures were considered, with the most appropriate 
included. We may reach out to the stakeholder on an as-needed basis, 
should questions arise as we review. In addition, once we complete our 
internal evaluation, we will reach out to select stakeholders whose 
candidate MVP may be feasible for the upcoming performance period, to 
schedule a feedback loop meeting to have a dialog regarding our 
feedback, and next steps that may include recommended modifications to 
the MVP candidate. Since MVPs must be established through rulemaking, 
as described at Sec.  414.1305, CMS will not communicate to the 
stakeholder whether an MVP candidate has been approved, disapproved, or 
is being considered for a future year, prior to the publication of the 
proposed rule. We sought comment on the proposed process to solicit MVP 
candidates.
    The following is a summary of the comments we received and our 
responses.
    Comment: A few commenters supported the use of an MVP candidate 
template with one believing it is as a way to reduce administrative 
burden. Another commenter requested that we release the MVP candidate 
template far in advance of MVP implementation.
    Response: We plan to release the MVP candidate template as soon as 
possible, and potentially in coordination with the publication of this 
final rule so it can be immediately available for use by stakeholders.
    Comment: One commenter voiced their appreciation for our MVP 
development discussions and feedback to date and supported the idea of 
a feedback loop on submitted MVPs and greater transparency in the 
process.
    Response: We thank the commenter for their support; we believe 
establishing a feedback loop with stakeholders will help to strengthen 
communications regarding MVP candidates that may be iteratively revised 
based on our review. While we intend to continue to work with 
stakeholders in an iterative manner that fosters transparency, CMS will 
ultimately determine if and when an MVP candidate is ready for 
implementation. We intend to follow our normal processes of notice and 
comment rulemaking to make stakeholders and the public aware of which 
MVPs we believe are ready for implementation for the upcoming 
performance period. If there are potential changes to an established 
MVP, we will consider the potential impacts on all stakeholders prior 
to proposing the changes. Stakeholders will be able to provide comments 
on the proposed changes through the public comment period for CMS to 
consider prior to finalizing the MVPs or changes to the MVPs.
    Comment: A few commenters objected to the idea that CMS would not 
communicate to the stakeholder developing a candidate MVP whether an 
MVP candidate has been approved, disapproved, or is being considered 
for a future year, prior to the publication of the annual QPP proposed 
rule. A few commenters suggested an interactive dialogue between the 
stakeholder who has submitted the candidate MVP and CMS would be 
helpful throughout the development process. One commenter suggested 
that CMS should provide feedback regardless of whether the MVP will be 
proposed for implementation and another requested feedback be provided 
throughout the MVP development process. One commenter believes a clear 
process and timeline for approving MVPs and new measures should be 
clearly delineated prior to implementation.
    Response: We agree that a dialog between the stakeholder who has 
developed the candidate MVP and CMS would be meaningful, to ensure that 
the MVP aligns with program goals and MVP criteria and that CMS 
provides meaningful feedback on how an MVP may be revised to better 
align with the aforementioned criteria before being considered for 
implementation. In some instances, discussions regarding a given MVP 
candidate may be iterative, and may call for a few meetings to discuss 
changes. Some MVP candidates may be identified as ready for 
implementation in the upcoming year, while others may require 
additional work. That is the reason why we would review MVPs on a 
rolling basis. In instances where an MVP may not be ready for 
implementation in the upcoming performance period, it may be ready by 
the following performance period. The timing in which an MVP may be 
ready for implementation will be dependent of the MVP's readiness and 
ability to meet the aforementioned MVP criteria. New measures will need 
to follow the existing pre-rulemaking processes or QCDR measure 
requirements to be considered for inclusion in an MVP. While we intend 
to continue to work with stakeholders in an iterative manner that 
fosters transparency, CMS will ultimately determine if and when an MVP 
candidate is ready for implementation. We intend to follow our normal 
processes of notice and comment rulemaking to make stakeholders and the 
public aware of which MVPs we believe are ready for implementation for 
the upcoming performance period.
    Comment: A few commenters requested more guidance around 
expectations, MVP candidate assessment processes and communications. 
One commenter requested CMS publish MVP development status updates 
while another commenter requested a CMS website that would provide 
information on MVPs under development and CMS' initial assessment data.
    Response: We intend on hosting a MVP development webinar that will 
provide additional clarity on expectations, the assessment process and 
communications between CMS and stakeholders who develop candidate MVPs. 
We thank stakeholders for their recommendations of how we can make the 
MVP development process more

[[Page 84856]]

transparent, and will take these suggestions under consideration for 
future implementation, as operationally feasible.
    After consideration of the public comments, we are finalizing our 
proposals as proposed.
(b) Implementing Meaningful Measures in MVPs
(i) Incorporating Population Health Measures Into MVPs
    In the CY 2020 PFS proposed rule (84 FR 40742 through 40743), we 
expressed our interest in incorporating population health measures 
calculated from administrative claims-based data as a part of the 
foundational layer within MVPs, in an effort to improve patient 
outcomes, reduce reporting burden and costs, better align clinician 
quality improvement efforts, and increase alignment with APMs and other 
payer performance measurement. Through the RFI, stakeholders expressed 
concerns with including population health measures due to concerns with 
reliability, validity, attribution, unintended consequences and/or risk 
adjustment of claims-based population health measures. We understand 
stakeholder concerns around the population health measures that were 
previously considered, and are looking into ways to address and 
mitigate those concerns. We also received some support from 
stakeholders who agreed that population health measures will reduce 
administrative burden with the belief that these measures are not any 
less relevant to specialists. In MIPS, we currently have one 
administrative-claims based measure, the All-cause Hospital Readmission 
measure, which is calculated and scored for groups with 16 or more 
clinicians that meet a 200-patient case minimum, as described in the CY 
2017 Quality Payment Program final rule (81 FR 77300). As described in 
Appendix 1 of the CY 2021 PFS proposed rule, we proposed to replace the 
All-cause Hospital Readmission measure with a Hospital-Wide, 30-day, 
All-Cause Unplanned Readmission (HWR) Rate for the Merit-Based 
Incentive Payment System Program (MIPS) Eligible Clinician Groups 
because the re-specified measure promotes a system level approach by 
clinicians, with a focus on high risk conditions such as COPD and heart 
failure. We referred readers to Appendix 1 of the proposed rule for 
detailed discussion of the newly proposed measure.
    The following is a summary of the comments we received and our 
responses.
    Comment: A few commenters support the use of population health 
measures in MVPs that are relevant to the population and clinical 
discipline and focus on preventive measures and early detection.
    Response: We thank the commenters for their support, and agree that 
population health measures should be relevant to the population and the 
clinical topic being measured. We encourage stakeholders to utilize our 
pre-rulemaking processes to develop additional clinically relevant 
population health measures. We also agree that prevention and early 
detection are two areas where population health measures can be focused 
on.
    Comment: Several commenters voiced their opposition to use of 
population health administrative claims-based measures in MVPs with 
some listing concerns about the applicability of MVP population health 
measures to physician groups or specialists, such as anesthesiologists, 
pathologists and ophthalmologists. A few commenters suggest that 
population health measures are not actionable with one commenter 
listing an example of the hospital-wide readmission measure as not 
actionable for surgeons. One commenter expressed that MVPs should 
include measures that are meaningful to group practices and their 
clinicians rather than administrative claims or population health 
measures, listing the following concerns: Attribution; retrospective 
analysis; inability to measure individual physicians; and reliability. 
A few commenters voiced a concern about performance comparison 
inequities in applying population health measures across different 
specialties. One commenter provided an alternative to population health 
measures that require a large sample that we work with specialty 
societies to explore ``better'' ways to tie claims data to more robust 
clinical data collected by registries.
    Response: We disagree with commenters who oppose the use of 
population health administrative claims-based measures in MVPs. 
Measures such as MIPS hospital wide readmission (HWR) should be used 
within MVPs. The HWR measure is not a traditional population health 
measure but is designed to incentivize shared responsibility for 
clinical outcomes.
    This measure is a re-specification of the All-Cause Readmission 
(ACR) measure currently within the MIPS program, which attributes 
outcomes solely to the primary care physician that provides the 
plurality of care during the measurement period, regardless of whether 
this care was provided before, during or after the inpatient stay. The 
primary care physician may not be the only clinician with opportunity 
to impact readmissions. The intent of this measure is to improve upon 
the attribution of the current ACR measure and incentivize 
collaboration of care across inpatient and outpatient settings by 
considering shared attribution to up to three eligible clinician groups 
that provide care for patients inside and outside of the hospital, and 
therefore are in position to influence patient risk of readmission.
    Our contractor convened a Technical Expert Panel (TEP) to seek 
detailed input from clinicians and patients to attribute the unplanned 
30-day readmission outcome to multiple clinicians with the ability to 
impact readmission risk through their care and communication. The TEP 
and clinical consultants, most of whom are clinicians themselves and 
include representatives from anesthesia and surgery, strongly supported 
the attribution model. They identified the primary inpatient clinician, 
discharge clinician, and primary outpatient clinician as important 
roles in providing appropriate care, practical recommendations, and 
care transitions and with ability to influence readmission risk.
    As such, we disagree with the commenter that the HWR measure is not 
actionable for these clinicians. Specifically, the primary inpatient 
clinician is responsible for the medical care provided during the 
admission, referring patients to inpatient specialists and prescribing 
medications; the delivery of their care during the hospital admission 
can influence whether the patient returns with unresolved medical 
issues or side effects from inappropriate medication or dosage. The 
discharge clinician is responsible for preparing the patient for 
discharge, including determining the patient is well enough to leave 
the hospital, understands their condition and treatments, and has been 
referred to outpatient specialists or therapy, as needed. Providing 
clear instructions and arrangements help ensure that the patient 
adheres to care, medication, and lifestyle changes outside of the 
hospital (Bowles et al, 2014, Philips et al, 2004, DeCaporale-Ryan et 
al, 2017, and Verhaegh et al, 2014). The primary outpatient clinician 
is responsible for the care of the patient outside of the hospital and 
can prevent readmissions by ensuring accessibility to care and 
availability for consultations within 30 days after discharge. Through 
their individual roles and together through coordinated care, these 
clinicians can reduce the risk of readmission.

[[Page 84857]]

    NQF panel and committee members have voted on this measure several 
times, all of which concluded in favor of endorsing the measure. Final 
endorsement of the measure was deferred to the Spring 2020 Consensus 
Standards Approval Committee (CSAC) due to efforts to reduce burden for 
committee members who may need to prioritize COVID-19 in their 
communities.
    Regarding the concern that the HWR measure cannot measure 
individual physicians, the intent of the HWR measure is to measure 
performance at the clinician group level where the group can assess and 
improve the performance across their practice. Regarding reliability, 
the HWR measure was found to have substantial signal to noise 
reliability, ranging from 0.82 for surgical to 0.92 for neurology 
specialty cohorts, when clinician groups were measured on at least 200 
patients, the minimum threshold for the current ACR measure. While it 
is true that clinician groups representing different specialties may 
have different baseline outcome rates because of different patient 
condition or procedure cohorts, the use of standardized outcome rates 
for measurement ensures comparability of measure scores across these 
different cohorts.
    After consideration of public comments, we are finalizing our 
proposal as proposed.
(ii) Incorporating QCDR Measures Into MVPs
    In the CY 2020 PFS final rule, we sought comments from stakeholders 
as to whether QCDR measures should be considered for integration within 
MVPs. Stakeholders were generally supportive of including QCDR measures 
within MVPs, but others expressed concern that including QCDR measures 
within MVPs would require clinicians to use certain third party 
intermediaries which may cause additional burden for clinicians who may 
need to change their current reporting method and undertake additional 
costs associated with reporting through QCDRs. Under the existing MIPS 
program and as described at Sec.  414.1330(a)(2), for a MIPS payment 
year, we can use approved QCDR measures as described under Sec.  
414.1400 to assess performance in the quality performance category. We 
continue to believe that the development of QCDR measures by QCDRs is 
important as it provides measures that are relevant, applicable, and 
meaningful to clinicians, and addresses gaps that are not addressed by 
measures available through the MIPS quality measure inventory. In 
envisioning MVP development for the 2022 performance period and future 
years, we believe it is important to consider the opportunity to 
include QCDR measures within MVPs. Prior to consideration of including 
the QCDR measure within a candidate MVP, QCDR measures must meet all 
existing criteria under Sec.  414.1400(b)(3) and the criteria described 
at Sec.  414.1400(b)(3)(v)(C)(4) that QCDR measures should be fully 
tested at the clinician level prior to the QCDR measure being included 
in an MVP. We referred readers to section IV.A.3.g.(2)(b)(iv) of the CY 
2021 PFS proposed rule for additional discussion of this requirement.
    Regarding the timeline to which MVPs and QCDR measures may be 
established, we have identified differences with the timelines that 
each of these processes follow. As described in the CY 2020 PFS final 
rule (84 FR 62948), we finalized the definition of an MVP at Sec.  
414.1305 to mean a MIPS Value Pathway is a subset of measures and 
activities established through rulemaking. Furthermore, as described in 
the CY 2019 PFS final rule (83 FR 59900) and at Sec.  414.1400(b)(1), 
entities that wish to self-nominate as a QCDR and submit QCDR measures 
for CMS consideration must do so within the 60-day self-nomination 
period that begins on July 1 of the calendar year prior to the 
applicable performance period and ending on September 1 of the same 
year. QCDR measures are typically reviewed and approved in the 
preceding months after the close of the self-nomination period. 
Therefore, we proposed that beginning with the with the 2022 
performance period, only QCDR measures that were approved in the 
previous year may be considered for inclusion within a candidate MVP. 
Furthermore, we proposed that the QCDR measures included within a 
candidate MVP must meet the existing criteria that are currently 
established at Sec.  414.1400(b)(3). In the traditional MIPS program, 
we stated that entities that meet the QCDR definition can develop QCDR 
measures to fulfill the quality performance category reporting 
requirements. We stated that we believe that QCDR measures can continue 
to fulfill the reporting requirements of the quality performance 
category within MVPs. Candidate MVPs should be submitted utilizing the 
process as described in section IV.A.3.a.(2)(a) of the CY 2021 PFS 
proposed rule. Candidate MVPs that are approved for inclusion in the 
upcoming performance period must be proposed and finalized through 
notice-and-comment rulemaking. Candidate MVPs that include QCDR 
measures will also need to be proposed and finalized through notice-
and-comment rulemaking in order to be available for reporting in the 
upcoming performance period. Therefore, in instances where MVPs are 
finalized through notice-and-comment rulemaking with QCDR measures, we 
proposed that those QCDR measures would be eligible for 2-year QCDR 
measure approval as described at Sec.  414.1400(b)(3)(vi).
    In the CY 2018 PFS final rule (82 FR 53813), we finalized that 
beginning with the 2018 performance period and for future program 
years, that QCDRs may seek permission from another QCDR to use an 
existing QCDR measure that is owned by another QCDR.
    The following is a summary of the comments we received and our 
responses.
    Comment: Several commenters supported inclusion of QCDR measures in 
MVPs.
    Response: We thank the commenters for their support; we believe 
that expanding the availability of QCDR measures that could be included 
into MVPs will allow for the development of more innovative and 
meaningful MVPs that are relevant to specialties and subspecialties.
    Comment: One commenter suggested that we consider separating dates 
for QCDR self-nomination and MVP candidate submission due to the amount 
of developer financial and administrative resources required.
    Response: To clarify, as described in the CY 2019 PFS final rule 
(83 FR 59898) the QCDR self-nomination starts on July 1st to Sept 1st 
of the year prior to the performance period. As described in the CY 
2021 PFS proposed rule (85 FR 50284), beginning with the 2022 
performance period, only QCDR measures that were approved in the 
previous year may be considered for inclusion in a candidate MVP. As 
stakeholders develop their MVP candidates, and consider the inclusion 
of their QCDR measures, only those that were approved for the 2022 
performance period could be considered for inclusion. We believe the 
existing differences in the timeline will help to alleviate some of the 
administrative resources required for both processes. For example, a 
QCDR will self-nominate a QCDR measure for the 2022 performance period 
sometime between July 1, 2021 and September 1, 2021. The 2022 
performance period QCDR measure approval decisions will be shared with 
the QCDRs in late Fall of 2021, with finalization of the QCDR measure 
specifications by the end of 2021. QCDR measures that are approved

[[Page 84858]]

for the 2022 performance period, and have been fully tested, may be 
considered for inclusion in MVPs for the 2023 performance period 
through the rulemaking process that will occur throughout CY 2022. MVPs 
that include QCDR measures, which are finalized through the CY 2023 PFS 
final rule, will be tracked to, and those QCDR measures will be given 
multi-year approval, so that the QCDR will not have to self-nominate 
that measure during self-nomination for the 2024 performance period.
    Comment: A few commenters supported approval of Qualified Clinical 
Data Registry (QCDR) measures for 2 years or longer to promote burden 
reduction and continuity. One commenter supported maintaining MVP QCDR 
measure approval for 2 years unless the measure steward agrees with a 
change in approval status. The commenter voiced support for removing a 
measure if it reflects an outdated clinical deadline or if the QCDR 
that nominated the measure is no longer in good standing but does not 
support CMS removing a measure before its second year for it being 
topped out or duplicative of a more robust measure.
    Response: We thank the commenters for their support, but note that 
a change in a QCDR measure's approval status will be left at the 
discretion of CMS, and as long as the QCDR measure continues to meet 
the criteria described at Sec.  414.1400(b)(3)(vi). We disagree that 
QCDR measures that are identified as topped out or duplicative of a 
more robust measure should not be removed as it is contradictory to the 
Meaningful Measure Framework. Measures that are topped out provide 
limited to no value to quality improvement, and duplicative measures 
serve no purpose in quality measurement.
    Comment: A few commenters did not support our proposal to require 
QCDR measures be approved for use in MIPS for a year prior to being 
included in an MVP voicing a concern that this will delay use of 
meaningful QCDRs measures in MVPs. Another commenter suggested that 
instead of the proposed 1-year period prior to measure inclusion in 
MVPs, that QCDR measures be tested entirely before inclusion in an MVP.
    Response: We disagree and believe that in order for a QCDR measure 
to be considered a QCDR measure, it must be approved as such through 
the Self-Nomination process prior to being proposed through notice and 
comment rulemaking as a part of an MVP. Measures that do not undergo 
this process are not considered QCDR measures until they are formally 
approved as such. Furthermore, to provide clarity, we proposed in the 
CY 2021 PFS proposed rule (85 FR 50284) that any QCDR measure that is 
being considered for inclusion in an MVP, must be fully tested before 
it can be included, as we want to ensure that the measures included in 
MVPs are a reliable subset of the MIPS measure inventory.
    Comment: One commenter suggested, as a way to shorten the timeline, 
that we consider allowing stakeholders to submit MVPs that include QCDR 
measures that are simultaneously undergoing approval with final 
inclusion in an MVP pending their meeting full testing and reliability 
requirements and receiving final approval.
    Response: We disagree, as the differences in the timelines between 
QCDR measure approvals through the Self-Nomination process and the 
timeline for notice and comment rulemaking differ, and would not allow 
for sufficient time to review the results to determine whether a QCDR 
measure is reliable, feasible, and valid enough for inclusion in an 
MVP. We are concerned with the unintended consequences of 
simultaneously including QCDR measures within MVPs before they are 
approved. If the QCDR measure is not approved through self-nomination, 
we would not be able to finalize the inclusion of the QCDR measure 
within the MVP. Time will be needed to determine the implications of 
the QCDR measure not being finalized in the MVP, and whether there are 
sufficient number of measures available in the MVP in the event that 
the QCDR measure cannot be included. Since MVPs will allow for the 
creation of focused subsets of measures and activities on a given 
clinical topic, thereby focusing the choices available to clinicians, 
we believe that all measures included in MVPs should have to meet and 
pass full measure testing criteria inclusive of reliability, validity, 
and feasibility. QCDR measures that pass measure testing are considered 
to be more reliable, we are concerned that incomplete testing will have 
downstream impacts to clinicians who may not be able to successfully 
report on measures, or that it may result in skewed results that may 
impact payment adjustments. Therefore, it would be appropriate to wait 
until the QCDR measure is officially approved through the self-
nomination process before it is considered and finalized for inclusion 
in an MVP through notice and comment rulemaking.
    Comment: One commenter suggested that we use the 2020 performance 
year QCDR measure approval standards for MVP QCDR measures, and stated 
that data for reliability and performance rates are often more robust 
after the QCDR measure has been available for MIPS reporting for at 
least 1 year.
    Response: We disagree. The 2020 performance period QCDR measure 
approval standards do not currently include QCDR measure testing 
requirements. Our preference is to include QCDR measures in MVPs only 
after they have been fully tested and are comparable in standard to the 
measures within the MIPS quality measure inventory that have undergone 
vigorous testing.
    Comment: One commenter requested further clarification related to 
how QCDR measures will be selected for MVPs to ensure measures are most 
relevant, applicable and meaningful to clinicians. The commenter 
requested that CMS clarify the impact to an MVP if CMS revokes the QCDR 
measure's second year of approval. The commenter voiced concerns 
related to the lack of incentives for clinicians to use new QCDR 
measures that require significant financial and administrative 
resources to develop and requested support for inclusion of these new 
QCDR measures.
    Response: QCDR measures can be included in MVPs at the discretion 
of the stakeholder developing the MVP candidate. We refer readers to 
our previously established policies in the CY 2018 PFS final rule (82 
FR 53813), where we finalized that beginning with the 2018 performance 
period and for future program years, that QCDRs may seek permission 
from another QCDR to use an existing QCDR measure that is owned by 
another QCDR. If a QCDR measure approval is revoked for an upcoming 
performance period, the QCDR measure will be simultaneously proposed 
for removal from the MVP. As a part of the MVP maintenance process, 
there may be consideration of including another measure in the QCDR 
measure's place. To clarify, new QCDR measures can be considered for 
inclusion in an MVP so long as the measure has met all requirements.
    Comment: One commenter voiced concerns regarding burden associated 
with completing the third party intermediary self-nomination 
application prior to publication of the QPP final rule and then 
selecting which MVPs to support after publication of the final rule. To 
address this concern, the commenter suggested a 1-year delay between 
selecting the MVPs that QCDRs and qualified registries can support and 
beginning the reporting for an MVP, and separating the dates for 
completion of the QCDR self-nomination and the MVP self-nomination.

[[Page 84859]]

    Response: We disagree that there would be additional burden 
associated with the process of having approved QCDRs and qualified 
registries indicate whether they are supporting any of the finalized 
MVPs once the final rule is published. We believe a 1-year delay would 
be a disadvantage, because it delays the timing in which a third party 
intermediary can support an MVP. The timing of when QCDRs would approve 
their qualified postings typically aligns with the timing of the 
posting of the final rule; therefore, QCDRs would be able to select the 
MVPs they wish to support for the upcoming performance period based on 
the final rule publication, and have those MVPs included in their 
qualified posting before it is published by January 1st of the 
performance period.
    After consideration of the public comments, we are finalizing our 
proposals as proposed.
(c) Reporting of MVPs Through Third Party Intermediaries
    Through the MIPS program, QCDRs, qualified registries, and Health 
IT vendors support the reporting of the Quality, Promoting 
Interoperability, and Improvement Activity performance categories, as 
proposed and codified at Sec.  414.1400(a)(2). We believe that third 
party intermediaries who support the aforementioned performance 
categories are able to support MVPs, since they will be comprised of 
measures and activities from these performance categories, as well as 
cost measures that are calculated by CMS (thereby requiring no 
additional effort by third party intermediaries). We believe allowing 
third party intermediaries to support MVPs will offer eligible 
clinicians and groups additional methods to report an MVP. We refer 
readers to section IV.A.3.g. of this final rule for additional 
discussion of the proposals.
    Since QCDR and qualified registry applicants would be submitting 
their self-nomination application prior to the publication of the final 
rule, we will work to establish a process to allow QCDRs and qualified 
registries to identify and select which MVPs they can support following 
the publication of the final rule. We sought comments on the proposal.
    The following is a summary of the comments we received and our 
responses.
    Comment: A few commenters agreed that third party intermediaries 
should be allowed to support MVP reporting.
    Response: We thank the commenters for their support, and agree that 
third party intermediaries should be allowed to support the reporting 
of MVPs. Clinicians and groups may find it beneficial to utilize a 
third party intermediary to report an MVP for the additional support 
they may provide.
    Comment: One commenter cautioned that the use of third party 
intermediaries for MVPs could result in financial burden for practices 
required to purchase additional measure submission services.
    Response: We understand that there may be some financial burden 
associated with utilizing a third party intermediary to report MVPs; 
however, we note that clinicians and groups are not required to utilize 
a third party intermediary to report an MVP. Clinicians and groups may 
use existing reporting options to report on the measures and activities 
within an MVP without utilizing a third party intermediary.
    After consideration of the public comments, we are finalizing our 
proposals as proposed.
(3) Transition to MVPs
(a) Timeline for MVP implementation
    In response to the RFI in the CY 2020 PFS final rule, we have 
received comments from stakeholders that indicated a gradual 
implementation of MVPs. Through the MVP development process, we seek to 
collaborate with stakeholders in the development of MVPs that are 
meaningful and applicable to clinicians and groups. Therefore, we 
understand the need for an incremental approach as we transition 
eligible clinicians and groups to MVP reporting as they are 
implemented. In light of the PHE of COVID-19, we have decided to delay 
the implementation of MVPs, and revisit potential MVP implementation 
through future rulemaking, possibly beginning with the 2022 performance 
period. Although we believe in the importance of transforming the MIPS 
program to create greater meaning for clinicians, we understand that 
there are clinicians who are on the frontlines taking care of COVID-19 
patients that should not be burdened with having to learn a new method 
of reporting for the MIPS program at this time. Overall, our goal is to 
gradually implement MVPs for all MIPS eligible clinicians and groups 
overtime, to ensure that MVPs are designed and available in a manner 
relevant to clinicians. We stated that we intend to continue to work 
closely with stakeholders to develop MVPs that are relevant to various 
specialties, and understand that a level of flexibility is needed to 
allow for meaningful reporting.
    The following is a summary of the comments we received and our 
responses.
    Comment: Many commenters supported the proposal to delay MVP 
Implementation as a result of the PHE for COVID-19, and recommended 
that CMS introduce MVPs gradually.
    Response: We thank commenters for their support, as described in 
the CY 2021 PFS proposed rule (85 FR 50279), we have delayed our 
timeline for MVP implementation in light of the PHE for COVID-19. We 
want to move forward with the transformation of the MIPS program in a 
manner that does not take away from the nation's response to the COVID-
19 pandemic. Furthermore, as described in the CY 2021 PFS proposed rule 
(85 FR 50284 through 50285), we understand the need for an incremental 
approach as we transition clinicians and groups to MVP reporting as 
they are implemented.
    Comment: A few commenters recommended that MVPs be delayed beyond 
2022 as well, yet did not cite specific reasons why.
    Response: While we appreciate the commenters concerns, we believe 
that further delay is not needed as we have emphasized the need for an 
incremental approach to transition clinicians and groups to MVP 
reporting.
    After consideration of public comments, we are finalizing our 
proposals as proposed.
b. APM Performance Pathway
(1) Overview
    In the CY 2020 PFS final rule (84 FR 62568), we finalized the MIPS 
Value Pathway framework as a means of reducing reporting burden, 
increasing meaningful measurement, and continuing to encourage movement 
through MIPS away from fee-for-service (FFS) payments and towards APMs. 
Burden reduction and meaningful measurement are important goals in 
relation to all eligible clinicians, and we recognize that the best 
means for achieving these goals may be different for MIPS eligible 
clinicians that have not yet joined an APM than for those MIPS eligible 
clinicians who already are participating in APMs, and therefore, have 
different reporting obligations. This is particularly true for eligible 
clinicians in Advanced APMs who are subject to MIPS either because they 
are Partial QPs for a year and elect to participate in MIPS or because 
they fall below the applicable Partial QP threshold for a performance 
year.
    We proposed at Sec.  414.1367 to establish an APM Performance 
Pathway (APP) under MIPS beginning in the

[[Page 84860]]

2021 MIPS performance year, designed to provide a predictable and 
consistent MIPS reporting standard to reduce reporting burden and 
encourage continued APM participation (85 FR 50285).
(2) Applicability
    We proposed that the APP will be in effect beginning January 1, 
2021, and would be an optional MIPS reporting and scoring pathway for 
MIPS eligible clinicians identified on the Participation List or 
Affiliated Practitioner List of any APM Entity participating in any 
MIPS APM on any of the four snapshot dates (March 31, June 30, August 
31, and December 31) during a performance period, beginning in the 2021 
MIPS performance period.
(a) Reporting Through the APM Performance Pathway
    We proposed that individual MIPS eligible clinicians who are 
participants in MIPS APMs may report through the APP at the individual 
level. Groups and APM Entities may report through the APP on behalf of 
their constituent MIPS eligible clinicians; however, the final score 
earned by the group through the APP would be applied only to those MIPS 
eligible clinicians who appear on a MIPS APM's Participation List or 
Affiliated Practitioner List on one or more snapshot dates. The final 
score applied to each individual MIPS eligible clinician would be the 
highest available final score for that clinician (TIN/NPI), or a 
Virtual Group score, if applicable, as discussed in the CY 2021 PFS 
proposed rule (85 FR 50315).
    As described further in the CY 2021 PFS proposed rule (85 FR 
50231), ACOs participating in the Medicare Shared Savings Program would 
be required to report through the APP for purposes of assessing their 
quality performance for that program, but MIPS eligible clinicians 
participating in these ACOs also would have the option of reporting 
outside the APP, or within it at an individual or group level, for 
purposes of being scored under MIPS, like all other MIPS APM 
participants. As the APP would be optional for purposes of MIPS 
scoring, under the proposal MIPS APM participants would be able to 
report through the APP or through any other available MIPS reporting 
mechanism they chose.
    We refer readers to the CY 2021 PFS proposed rule (85 FR 50315) for 
information concerning our proposed changes to the hierarchy that will 
apply when more than one final score is associated with a TIN/NPI.
    We received the following comments on these proposals.
    Comment: A few commenters supported the opportunity for individual 
MIPS eligible clinicians and groups that participate in MIPS APMs to 
report through the APP or through any other available MIPS reporting 
mechanism they choose. They believe this approach would enable them to 
earn a higher score where they perform above the APM Entity average.
    Response: We thank commenters for their support of this proposal. 
We agree that this approach should enable MIPS eligible clinicians and 
groups that strive to improve their performance to be rewarded with the 
MIPS score that reflects those efforts. We also believe that this 
policy approach will create more flexibility for multispecialty 
practices to report on measures that are the most meaningful to their 
clinicians.
    After considering public comment, we are finalizing this policy as 
proposed.
(b) MIPS APMs
    In the CY 2021 PFS proposed rule (85 FR 50285), we proposed to 
amend our definition of MIPS APM at Sec.  414.1305 as an APM that meets 
the criteria in Sec.  414.1367(b). We also proposed to codify the 
following MIPS APM criteria at the new Sec.  414.1367(b). We proposed 
to maintain two criteria for MIPS APMs that currently are included at 
Sec.  414.1370(b)(1) and (3) respectively, namely that: (1) An APM 
Entity participates in the APM under an agreement with CMS or through a 
law or regulation; and (2) the APM bases payment on quality measures 
and cost/utilization. However, under the proposed policy, for purposes 
of the MIPS performance period we would not depend on the availability 
of quality measure data reported directly to the APM, and we did not 
propose to continue requiring that MIPS APMs be in operation, and 
therefore, collecting quality data for the entirety of the performance 
period. We also noted that currently, to be a MIPS APM, Sec.  
414.1370(b)(2) requires that an APM must be designed such that its APM 
Entities include at least one MIPS eligible clinician on a 
Participation List, and does not include APMs that use only Affiliated 
Practitioner Lists. However, we believe that because we did not propose 
to require reporting through the APP be done exclusively at the APM 
Entity level, it is not necessary to limit use of the APP to APM 
Entities alone. Therefore, we proposed to expand the definition of MIPS 
APM to include those APMs in which there is only an Affiliated 
Practitioner List and that otherwise meet the proposed MIPS APM 
criteria.
    We did not receive any comments on these proposals and are 
finalizing as proposed.
(3) MIPS Performance Category Scoring in the APM Performance Pathway
    In general, MIPS reporting and scoring requirements are applicable 
to all MIPS eligible clinicians, including those reporting through the 
proposed APP. However, the following reporting and scoring rules would 
apply only to those MIPS eligible clinicians, groups, or APM entities 
reporting through the APP.
(a) Quality Performance Category
    We proposed that, beginning in the 2021 performance period, MIPS 
eligible clinicians scored under the APP would be scored on the quality 
measure set finalized for such MIPS performance period (85 FR 50285 
through 50286).
    For PY 2021, we proposed to use the measures listed in Table 46 for 
purposes of quality performance category scoring for the APP.

[[Page 84861]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.092

    For those MIPS eligible clinicians, groups, or APM Entities for 
whom a given measure is unavailable due to the size of the available 
patient population or who are otherwise unable to meet the minimum case 
threshold for a measure, we proposed to remove such measure from the 
quality performance category score for such MIPS eligible clinician, 
group, or APM Entity.
    For MIPS eligible clinicians, groups, or APM Entities reporting 
through the APP, we proposed not to apply the quality measure scoring 
cap at Sec.  414.1380(b)(1)(iv) in the event that a measure in the APP 
measure set is determined to be topped out. Because the measure set is 
fixed, we noted that we do not believe it is appropriate to limit the 
maximum quality performance category score available to them. Should an 
APP measure be determined to be topped out, we would at that time 
consider amending the APP quality measure set through future 
rulemaking, if appropriate.
    In the CY 2020 PFS proposed rule, we sought comment on aligning the 
Shared Savings Program version of the Multiple Chronic Conditions (MCC) 
measure (that is, the ACO MCC) with the MIPS version of the MCC measure 
(see 84 FR 40711 and 40712). We noted that the MIPS MCC claims-based 
measure is similar to the ACO MCC currently used to assess ACO quality 
under the Shared Savings Program. The MIPS MCC and ACO MCC measures are 
similar because they both target patients with multiple chronic 
conditions, but the cohort, outcome, and risk model for the MIPS MCC 
measure varies from the ACO MCC measure. The cohort for the ACO MCC 
measure includes eight conditions whereas the MIPS MCC measure includes 
nine conditions, with the additional condition being diabetes. The ACO 
MCC measure does not adjust for social risk factors whereas the MIPS 
MCC measure adjusts for two area-level social risk factors: (1) AHRQ 
socioeconomic status (SES) index; and (2) specialist density. In 2019, 
we added a revised ACO MCC measure to the 2019 Measure under 
Consideration list for the Shared Savings Program for consideration by 
the Measure Applications Partnership (MAP) Clinician Workgroup. The 
revised MCC measure specifications aligned with the MIPS MCC measure 
by: (1) Adding a diabetes cohort; (2) excluding any admissions within 
10 days of discharge from a hospital, skilled nursing facility, or 
acute rehabilitation facility; and (3) adjusting for the AHRQ SES index 
and specialist density social risk factors. The only remaining 
difference between the MIPS and Shared Savings Program versions of the 
measure would be attribution, which is program-specific. Attribution 
for Shared Savings Program ACOs uses the Shared Savings Program 
beneficiary assignment methodology, which emphasizes primary care. 
During the MAP discussion, it was noted that the original ACO MCC 
measure has been in use in the Shared Savings Program since 2015, and 
the MAP expressed no concerns with respect to feasibility and 
implementation of the revised MCC measure. A measure has high 
reliability if it produces consistent results from multiple 
measurements, in other words, it reflects a signal, rather than random 
error associated with measurement. Reliability values range between 
zero (all error, little signal) to 1.0 (no error, all signal).\121\ The 
median signal-to-noise reliability for all Shared Savings Program ACOs 
in 2018 was 0.96 ranging from 0.12 to 1.00 (IQR: 0.94-0.98), indicating 
an overall excellent reliability of the measure.\122\
---------------------------------------------------------------------------

    \121\ Adams, John L., Ateev Mehrotra, and Elizabeth A. McGlynn, 
Estimating Reliability and Misclassification in Physician Profiling. 
Santa Monica, CA: RAND Corporation, 2010. https://www.rand.org/pubs/technical_reports/TR863.html.
    \122\ CMS used the 2018 Shared Savings Program ACO beneficiary 
assignment data to test the revised MCC measure. Here, reliability 
refers to measure score reliability of the revised MCC measure.
---------------------------------------------------------------------------

    The MAP final recommendation for this measure was ``conditional 
support for rulemaking.'' \123\ We intended to take the revised measure 
through the National Quality Forum (NQF) endorsement process in 2020, 
but as a result of delays caused by the PHE for COVID-19, we will defer 
seeking NQF endorsement until 2021. Because the revisions would make 
the ACO MCC measure more aligned with the MIPS version and given the 
support received from the MAP, we proposed to include the revised All-
Cause Unplanned Admissions for Patients with Multiple Chronic 
Conditions measure in the APP measure set to be reported on by any 
Medicare ACO.
---------------------------------------------------------------------------

    \123\ https://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=91911.
---------------------------------------------------------------------------

    We received the following comments on the proposal.
    Comment: Some commenters requested clarification as to what would

[[Page 84862]]

happen if they were unable to report on one or more measures due to 
submitter type or case size limitations.
    Response: Individual MIPS eligible clinicians, groups, and APM 
Entities reporting through the APP will be scored only on those quality 
measures on which they are able to report. For example, an APM Entity 
that is not an ACO will not be scored on the ACO MCC measure; similarly 
a group that did not meet the minimum beneficiary sample size for the 
CAHPS for MIPS survey would not be required to report on this measure. 
In these cases that measure would be removed from the quality 
performance category score calculation entirely.
    Comment: Some commenters expressed concern that the proposed 
measures do not adequately reflect the scope of practice of all 
clinicians, particularly specialists, and suggested that we consider 
expanding the quality measure set to include specialty-specific quality 
measures, or retaining the use of the quality measures from their APMs, 
as was done under the APM scoring standard.
    Response: We recognize that there are limitations in the ability of 
the proposed APP quality measure set to fully represent the scope of 
practice of all specialties and clinicians. However, the goal of the 
APP quality measure set is not necessarily to reflect the specific 
quality measure work being done by these clinicians within their 
respective APMs, but rather to reduce the burden of reporting on 
quality measures twice: once to MIPS and once to their APMs. We believe 
by using this broadly applicable population health based measure set, 
we will enable MIPS APM participants to focus more of their energy and 
attention on the quality measures being reported through their APMs, 
while relying on a consistent measure set within the APP from one year 
to the next. We further refer readers to CY 2020 PFS final rule (84 FR 
63007) for a discussion around the operational infeasibility of 
continuing to use quality measure data reported directly to APMs.
    Comment: Some commenters noted confusion about which submission 
types would be permitted under the APP.
    Response: As defined at Sec.  414.1305, submission type refers to 
the mechanism by which the submitter type submits data to CMS, 
including, but not limited to: Direct, log in and upload, log in and 
attest, Medicare Part B claims and the CMS Web Interface. In Table 41 
of the CY 2021 PFS proposed rule (85 FR 50286) we proposed a list of 
quality measures that would be included in the APP. For those measures 
in this list that are already included in the MIPS quality measure 
inventory (Quality IDs 001, 134, and 236) the previously established 
submission types for each measure would continue to be accepted, 
including by the APM Entity, as applicable, which we proposed to add as 
a submitter type. We note that the CAHPS for MIPS survey may only be 
reported by a Third Party Intermediary. For those measures that are not 
already included in the MIPS quality measure inventory (Quality IDs 
TBD), the proposed measures are administrative claims-based and do not 
require data submission
    Comment: A few comments supported the proposed APP quality measure 
set for reducing burden on MIPS eligible clinicians who are also 
participating in MIPS APMs. Commenters noted that the measures selected 
represent a broad sampling of practice areas, and should be applicable 
to nearly any practice group.
    Response: We thank the commenters for their support.
    Comment: A few commenters objected to the use of two administrative 
claims measures, relative to the number of non-claims measures. These 
commenter noted a preference for more performance-based measurement 
that would be reported by the MIPS eligible clinician, group, or APM 
Entity.
    Response: We understand the concern about the use of more 
administrative claims measures in the APP quality set, in light of the 
fact that, historically, these measures produce somewhat lower scores 
than measures such as those in the CMS Web Interface which are largely 
topped-out. It is our intent to balance the goals of reducing reporting 
burden while incentivizing increased quality performance by including 
in the APP measure set measures that will represent quality performance 
without creating additional reporting burden. We believe the proposed 
measure set, and the relative weight of the different submission types, 
helps to strike that balance.
    Comment: Some commenters expressed support for the move to all-
payer data for scoring MIPS quality measures for ACOs. These commenters 
believe that the all-payer data will more accurately reflect the 
efforts they have made to improve quality performance across their 
practice.
    Response: We agree that by incorporating all-payer data into both 
the numerator and the denominator, we will be getting a better picture 
of each MIPS eligible clinician's quality performance across care 
settings, and incentivizing quality improvement for all patients.
    Comment: Commenters recommended that CMS seek NQF and MAP 
endorsement of any measure to be included in the APP before the measure 
is included in the APP. Additionally, commenters suggested that CMS 
seek additional stakeholder input and were concerned that the Measure 
Applications Partnership did not review these proposed changes.
    Response: With regard to the commenters' recommendations that we 
use measures that are NQF endorsed and have been reviewed by the AMP, 
we note that where possible CMS uses measures that have been NQF 
endorsed. In the APP measure set, the three eCQM/CQM measures are NQF 
endorsed and we plan to take the revised MCC measure that was reviewed 
by the MAP in December 2019 through the NQF endorsement process in 
2021.
    Comment: Several commenters have concerns with the Screening for 
Depression and Follow-up plan measure and recommended that CMS work 
with stakeholders to improve the measure specifications before this 
measure is used as part of a limited quality measure set. One commenter 
did not support the measure because it was not an outcome measure, and 
shared concerns that it had previous measurement challenges. 
Additionally, one commenter noted that depression screening can be 
difficult to achieve with the limited access that the PHE for COVID-19 
has created and suggested that measures be viewed through the lens of 
the current environment.
    Several commenters expressed concerns that this measure determines 
performance based on a single reading and that there are limitations in 
accepting patient reported home readings. The commenters also 
recommended that CMS work with stakeholders to improve the measure 
specifications before this measure is used as part of a limited quality 
measure set. Another commenter recommended that CMS consider including 
home visits in its measure sets. One commenter supported the 
Controlling High Blood Pressure measure, noting that successfully 
treating high blood pressure can save lives.
    One commenter was concerned that the Diabetes: Hemoglobin A1c 
(CbA1c) Poor Control measure is not appropriate for frail, seriously 
ill, or home limited patient populations. Another commenter supported 
this measure, citing the fact that uncontrolled diabetes leads to 
comorbidities.
    Response: We appreciate the commenters' feedback on these eCQM/CQM 
MIPS measures. This measure set was developed using stakeholder

[[Page 84863]]

feedback and in conjunction with CMS leadership to help achieve the 
goals of the APP. Each of the eCQM/CQM quality measures in the APP 
measure set is MIPS quality measures that has been in use for several 
MIPS performance years and have a track record of reliability that was 
taken into consideration when choosing the APP measure set. We believe 
that this particular set of measures best achieves our goal of reducing 
reporting burden while providing a quality measure set with measures 
that are meaningful and widely applicable to various provider types. As 
with all MIPS quality measures, we encourage continued stakeholder 
engagement in developing and improving upon measure use and 
specifications.
    Comment: One commenter provided general support for the concept of 
measuring outcomes for patients with multiple chronic conditions at the 
group practice level or higher and provided support for the specific 
methodological changes proposed, including incorporating additional 
risk factors related to socioeconomic status and social risk factors. 
Several commenters expressed concerns related to the Risk Standardized, 
All-Cause Unplanned Admissions for Multiple Chronic Conditions for ACOs 
measure. One commenter did not support using this measure to assess the 
quality performance of ACOs because they noted the Core Quality 
Measures Collaborative (CQMC) ACO/Patient-Centered Medical Home (PCMH) 
core measure set would be less burdensome and would align the measures 
across public and private payers, making it a better measure set for 
ACOs. Some commenters stated that this measure does not meet the -.8 
reliability threshold because the measure score reliability ranged from 
0.12 to 1.00 using data from the 2018 performance year. Therefore, this 
commenter recommended that CMS increase testing for risk adjustment, 
increase case minimums, and demonstrate face validity (whether these 
measures appear to measure what they claim to measure) and that the 
results are valid when attributed to an ACO. The commenter also 
recommended that CMS work with stakeholders to improve the measure 
specifications before this measure is used as part of a limited quality 
measure set. Another commenter opposed inclusion of this measure in the 
quality measure set under the APP due to limited information on how the 
measure performs and because it has not been endorsed by the NQF. The 
same commenter recommended that CMS increase the minimum sample size to 
produce a minimum reliability threshold of sufficient magnitude and 
encouraged CMS to validate the measure through additional testing, such 
as predictive and construct validity, to ensure that application of the 
measure to assess the quality performance of ACOs is appropriate and 
yields scores that are valid and useful.
    Another commenter was encouraged to see that the Agency for 
Healthcare Research and Quality (AHRQ) Socioeconomic Status (SES) index 
and density of physician specialists were included in the risk 
adjustment for the measure in the 2018-2019 Measures Application 
Partnership (MAP) review. This commenter emphasized that CMS should 
ensure that social risk factors are tested and included in the risk 
adjustment for the measure and that CMS should also consider including 
additional variables, such as dual eligibility, frailty, and age, prior 
to implementing the measure in the APP.
    Response: The All-Cause Unplanned Admissions for Patients with 
Multiple Chronic Conditions for ACOs)--the ``ACO MCC'' measure is 
currently being used to assess ACOs' quality performance under the 
Shared Savings Program. The proposed MCC measure was created by 
aligning the current ACO MCC measure with the current MIPS MCC measure 
by (1) adding a diabetes cohort; (2) excluding any admissions within 10 
days of discharge from a hospital, skilled nursing facility, or acute 
rehabilitation facility; and (3) adjusting for the AHRQ SES index and 
specialist density social risk factors. The MAP expressed no concerns 
with respect to implementing this measure and, as discussed in the CY 
2021 PFS proposed rule (85 FR 50286), the median signal-to-noise 
reliability for all ACOs scored on this measure in 2018 was 0.96 
ranging from 0.12 to 1.0 (IQR: 0.94-0.98), indicating an overall 
excellent reliability of the measure. This measure is currently under 
NQF review.
    We believe that this measure will provide a meaningful assessment 
of ACO quality performance with limited additional reporting burden.
    Comment: Many commenters were opposed to sun-setting the CMS Web 
Interface and its use under the APM scoring standard. Several 
commenters expressed concern about the timeline for preparing to report 
APM Entity level data for the 3 eCQM/MIPS CQMs in time for the 2021 
performance year. Specifically, ACOs may face difficulty in aggregating 
the data needed for reporting, particularly in light of the PHE for 
COVID-19.
    Response: We understand that implementing a new reporting system 
will require administrative time and coordination in order to be 
prepared not only for reporting APM Entity level data, but for 
collecting these data as early as January 1, 2021. Particularly in 
light of the circumstances surrounding the PHE for COVID-19, we believe 
that it is in the public interest to finalize our proposed quality 
measure set with a few modifications to include the CMS Web Interface 
for one year.
    After considering public comment, we are finalizing each of the 
quality measures included in the quality measure set listed in Table 41 
of the CY 2021 PFS proposed rule (85 FR 50286).
    In addition, we refer readers to section IV.A.3.c.(1)(c) of this 
final rule, where we are finalizing our proposal to remove the CMS Web 
Interface with a 1 year delay. As a result, the CMS Web Interface 
measure set will not be removed until the CY 2022 MIPS performance 
period. In response to public comments, we are finalizing the addition 
of the CMS Web Interface measure set to the proposed APP quality 
measure set for the CY 2021 MIPS performance period for ACOs only. We 
are limiting the extension of the CMS/Web Interface to those Entity 
types which, in the past, have used the CMS Web Interface for purposes 
of MIPS reporting, and may therefore benefit from a transitional year 
before reporting via a new submission type. Groups and other APM Entity 
types that have in the past been scored using different submission 
types do not face the same obstacles, and therefore do not require a 
transition year.
    Each individual MIPS eligible clinician, group, and APM Entity 
reporting through the APP will be scored on the ACO MCC measure, 
Hospital-wide Readmission measure, and CAHPS for MIPS survey, as 
applicable. In addition, individual MIPS eligible clinicians and groups 
reporting through the APP will be required to report on the three 
eCQMs/MIPS CQMs included in the APP quality measure set. APM Entities 
reporting through the APP will be required to report on either the 
three eCQMs/MIPS CQMs included in the APP quality measure set or on the 
CMS Web Interface measure set. We refer readers to Appendix 1 for 
additional measure specification information.
BILLING CODE 4120-01-P

[[Page 84864]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.093

BILLING CODE 4120-01-C
    We are finalizing at Sec.  414.1367(c)(1) the quality measure set 
for the APP, and are adding the option for ACOs to report on the CMS 
Web Interface for the 2021 performance year only.
(b) Cost
    In the CY 2017 Quality Payment Program final rule (81 FR 77256, 
77265), we finalized at Sec.  414.1370(g)(2) to waive the cost 
performance category under waiver authority at section 1115A(d)(1) of 
the Act for CMS Innovation Center APMs, and at section 1899(f) of the 
Act for the Medicare Shared Savings Program. We proposed to continue to 
waive the cost performance category under the same authorities for 
three reasons. First APM entities in MIPS APMs already are subject to 
cost performance assessment under their APMs, as the MIPS APM criteria 
would continue to include the assessment of participants based on cost. 
Second, MIPS APMs may measure cost performance in different ways than 
MIPS, for example, by basing cost on total cost of care, which measures 
a broader scope of cost or resource use than would necessarily be 
reflected in the narrower claims-based accountability standard under 
MIPS. Finally, MIPS APMs may attribute beneficiaries differently from 
MIPS for purposes of measuring cost, leading to an unpredictable degree 
of overlap between the sets of beneficiaries for whom the MIPS eligible 
clinicians

[[Page 84865]]

would be responsible under their APM and under MIPS. We noted that we 
believe that with an APM Entity's finite resources for engaging in 
efforts to improve quality and lower costs for a specified beneficiary 
population under the APM, it is necessary to give the APM Entity the 
ability to identify a single beneficiary population to prioritize in 
its cost-saving efforts. This is necessary so that the goals and 
evaluation associated with the APM are as clear and free of confounding 
factors as possible. With this flexibility, we noted that MIPS eligible 
clinicians who are attempting to strategically transform their 
respective practices would not jeopardize their ability to succeed in 
either MIPS or under the terms of their APM. Therefore, by 
participating through the APP, the APM participant may indicate their 
intent to focus their resources on the beneficiary population and 
services identified by the terms of the APM rather than the population 
and services they would have been responsible for under the MIPS cost 
performance category.
    We received the following comments on this proposals.
    Comment: Commenters supported the proposal, noting that as APM 
participants they are already being assessed on cost performance under 
the terms of participation in their APM.
    Response: We thank commenters for their support. We refer readers 
to section IV.A.3.e. of this final rule, for additional discussion 
around the reweighting of the cost performance category for APM 
Entities that choose to report to MIPS outside of the APP.
    After considering public comments, we are finalizing this policy as 
proposed.
(c) Improvement Activities
    We proposed to assign a score for the Improvement Activities 
performance category for each MIPS APM, and that score will be applied 
to participant MIPS eligible clinicians reporting through the APP. In 
an effort to further reduce reporting burden for MIPS eligible 
clinicians in MIPS APMs and to better recognize improvement activities 
work performed through participation in MIPS APMs, we proposed to 
assign a baseline score for each MIPS APM based on the improvement 
activity requirements of the particular MIPS APM. CMS would review the 
MIPS APM's requirements in relationship to activities specified under 
the generally applicable MIPS improvement activities performance 
category and assign for each MIPS APM an improvement activities 
performance category score that is applicable to all MIPS eligible 
clinicians reporting through the APP who are participants in the MIPS 
APM. To develop the improvement activities score for MIPS APMs, we 
would compare requirements of the APM with the list of Improvement 
Activities, described in Sec.  414.1355(a), for the applicable year, 
and score those improvement activities as they would otherwise be 
scored according to Sec.  414.1380(b)(3). Thus, as proposed, points 
assigned to an APM participant MIPS eligible clinician participating in 
MIPS through the APP would be based, at least in part, on the 
documented terms and requirements of participation in the MIPS APM, 
such as under a participation agreement or regulation. In the event a 
MIPS APM participant does not actually perform an activity for which 
Improvement Activities credit would otherwise be assigned under the 
proposal, the MIPS APM participant would not receive credit for the 
associated Improvement Activity.
    We noted that we would publish the assigned improvement activities 
scores for each MIPS APM on the CMS website prior to the beginning of 
the MIPS performance period. In the event that the assigned score for a 
MIPS APM does not represent the maximum improvement activities score, 
we proposed that MIPS eligible clinicians reporting through the APP 
would have the opportunity to report additional improvement activities 
that then would be applied towards their scores.
    We noted that under section 1848(q)(5)(c)(ii) of the Act, a MIPS 
eligible clinician in an APM for a performance period automatically 
earns a minimum score of one half of the highest potential score for 
the improvement activities category for their participation in an APM 
for the performance period. Additionally, under section 
1848(q)(5)(c)(i) of the Act, MIPS eligible clinicians participating in 
a patient-centered medical home model or comparable specialty practice, 
as determined by the Secretary for a performance period, automatically 
earn the highest potential score for the improvement activities 
category. These baseline scores would be automatically applied for all 
MIPS eligible clinicians who participate in an APM in accordance with 
Sec.  414.1380(b)(3)(i) and (ii), respectively.
    We sought comment on the proposal.
    Comment: One commenter expressed confusion about the improvement 
activities reporting requirements for MIPS eligible clinicians 
reporting through the APP. Specifically, how participants of a MIPS APM 
would know when they are required to report additional improvement 
activities for MIPS scoring.
    Response: In past years, and in the 2021 performance year, we have 
identified all MIPS APMs as having met the improvement activity 
threshold score requirement to receive a score of 100 percent for that 
performance category. In the event that in the future an APM does not 
meet this threshold, we would allow participants in that APM to report 
additional quality measures in order to earn a score of up to 100 
percent for that performance category.
    Similarly, should we learn that a MIPS eligible clinician or group 
has reported through the APP, but we discovered that their APM Entity 
has failed to complete the required improvement activities and any CAP 
developed as a result of this discovery, participants in that APM 
Entity may be subject to an audit wherein they would have the 
opportunity to produce evidence that they have completed sufficient 
improvement activities to maintain their performance category score of 
up to 100 percent. If it is determined that participants in such APM 
Entity did not complete enough improvement activities to earn a score 
of 100 percent, their performance category score will be recalculated. 
We note that the statute assigns a minimum improvement activities 
performance category score of 50 percent to all APM participants.
    After considering public comments, we are finalizing the policy as 
proposed.
(d) Promoting Interoperability
    We proposed that the Promoting Interoperability performance 
category score would be reported and calculated in the same manner 
described at Sec.  414.1375. We sought comment on the proposal.
    Comment: One commenter suggested that we enable ACOs to report the 
PI performance category.
    Response: As in past years, it is not currently operationally 
feasible for CMS to accept PI performance category reporting at the APM 
Entity level in cases where an APM Entity is comprised of more than one 
TIN. However, we continue to reassess this issue annually, and we 
welcome stakeholder input on how we might implement changes of this 
sort in future program years.
    After considering public comment, we are finalizing the policy as 
proposed.
(4) APP Performance Category Weights
    We proposed to continue to waive the requirement to weight each 
MIPS performance category as described in

[[Page 84866]]

section 1848(q)(5)(E) of the Act using the waiver authority in sections 
1115A(d)(1) and 1899(f) of the Act for CMS Innovation Center APMs and 
the Medicare Shared Savings Program, respectively. For reasons 
described in the CY 2021 PFS proposed rule (85 FR 50287), we stated 
that we believe it is necessary to waive the cost performance category 
for MIPS eligible clinicians reporting to MIPS through the APP. As a 
result, we stated that it also would be necessary to waive the 
requirement to weight each MIPS performance category as described in 
section 1848(q)(5)(E) of the Act and to redistribute the cost 
performance category weight to the remaining performance categories to 
be scored for APM participants reporting through the APP.
    We proposed to reweight the performance categories for APM 
participants reporting through the APP to:

 Quality: 50 percent
 Cost: 0 percent
 Promoting Interoperability: 30 percent
 Improvement Activities: 20 percent

    We noted that we believe these weights are appropriate as they 
generally align with the relative performance category weights under 
MIPS and MVPs in circumstances where the cost performance category has 
been reweighted to zero percent of the final score, and the cost 
performance category weight has been distributed proportionately among 
the remaining performance categories.
    We proposed to codify these proposals at Sec.  414.1367(d)(1). We 
did not receive any comments on these proposals, and we are finalizing 
them as proposed.
(a) Reweighting a Performance Category
    We recognize that there are certain circumstances when a MIPS 
eligible clinician, group, or APM Entity may be unable to complete 
reporting to MIPS due to, for example, extreme and uncontrollable 
circumstances, hardship, or the unavailability or inapplicability of 
measures due to practice size or other data limitations. Therefore, 
under the authority provided in section 1848(q)(5)(F) of the Act, it 
may become necessary to reweight one or more performance categories.
    In a case where the Promoting Interoperability performance category 
is reweighted to zero percent, we proposed to reweight the quality 
performance category to 75 percent and the Improvement Activities 
performance category to 25 percent.
    In a situation where the quality performance category is reweighted 
to zero percent, we proposed to reweight the Promoting interoperability 
performance category to 75 percent and the improvement activities 
performance category to 25 percent.
    We noted that we believe that the distributions appropriately value 
performance categories that require reporting on measures and measuring 
improvement, without disproportionately emphasizing one performance 
category over another. Furthermore, the performance category weights 
will contribute to a unified performance category reweighting policy 
throughout MIPS in the event of an Extreme and uncontrollable 
circumstance that requires the reweighting of cost and any other MIPS 
performance category.
    We proposed to codify this policy at Sec.  414.1367(d)(2). We did 
not receive any comments on this proposal, and therefore, we are 
finalizing as proposed.
(5) Scoring for APM Participants Reporting Through the APP
    We proposed that final scoring for APM participants reporting to 
MIPS through the APP would follow the same methodology as established 
for MIPS generally at Sec.  414.1380. Specifically, we noted that we 
would continue to score each performance category and multiply each 
performance category score by the applicable performance category 
weight, and then calculate the sum of each weighted performance 
category score and apply any applicable adjustments.
    We proposed to codify this policy at Sec.  414.1367(e). We did not 
receive any comments on this proposal, and therefore, we are finalizing 
as proposed.
(6) Performance Feedback for APM Participants Reporting Through the APP
    We proposed to make performance feedback available to MIPS eligible 
clinicians reporting through the APP according to the methods 
applicable to all MIPS eligible clinicians, as described in the 2017 
QPP final rule (81 FR 77347). We did not receive any comments on this 
proposal, and therefore, we are finalizing as proposed.
c. MIPS Performance Category Measures and Activities
(1) 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.
    In the CY 2021 PFS proposed rule (85 FR 50288), we proposed to:
     Weight the quality performance category at 40 percent for 
the 2023 MIPS payment year and 30 percent for the 2024 MIPS payment 
year, at Sec.  414.1330(b)(4) and (5), respectively.
     Sunset the CMS Web Interface measures as a collection type 
for groups and virtual groups with 25 or more eligible clinicians 
starting with the 2021 performance period.
     Make changes to the MIPS quality measure set as described 
in Appendix 1 of the CY 2021 PFS proposed rule (85 FR 50413 through 
50665), including addition of new measures, updates to specialty sets, 
removal of existing measures, and substantive changes to existing 
measures.
     Establish separate performance periods specific to 
administrative claims measures at Sec.  414.1320(d)(1).
     Make changes to the CAHPS for MIPS Survey to address the 
increased use of telehealth care.
     Expand telehealth codes used in beneficiary assignment for 
the CAHPS for MIPS Survey beginning with the performance year 2021 
survey.
(b) Weight in the Final Score
    Section 1848(q)(5)(E)(i)(I) of the Act, provides that 30 percent of 
the final score shall be based on performance for the quality 
performance category, in which the percentage points attributed to the 
final score for the quality and cost performance categories will both 
be equivalent at 30 percent, totaling 60 percent of the final score. 
The percentage points attributed to both the quality and cost 
performance categories are in tandem. For each year within the first 5 
years of the MIPS program, the quality performance category performance 
percentage can be increased to more than 30 percent of the final score. 
The percentage increase of the quality performance category is 
equivalent to the decrease of the cost performance category.
    As discussed in the CY 2021 PFS proposed rule (85 FR 50293 through 
50294), we proposed to weight the cost performance category at 20 
percent for the 2023 MIPS payment year and 30 percent for the 2024 MIPS 
payment year and each subsequent MIPS payment year. Accordingly, we 
proposed to establish the weight of the quality performance category 
for the 2023 and 2024 MIPS payment years. At Sec.  414.1330(b)(4), the 
percentage points attributed to performance in the quality performance 
category would comprise 40 percent of a MIPS eligible clinician's final 
score for the 2023 MIPS payment year and at Sec.  414.1330(b)(5), the

[[Page 84867]]

percentage points attributed to performance in the quality performance 
category would comprise 30 percent of a MIPS eligible clinician's final 
score for the 2024 MIPS payment year and future years.
    We noted our belief that being transparent in how both the quality 
and cost performance category weights would be modified over the next 2 
years of the program will allow stakeholders to better plan and 
anticipate how the performance category scores would be calculated in 
future for MIPS eligible clinicians, groups, and virtual groups as we 
incrementally adjust the final score weights for the quality and cost 
performance categories.
    We solicited public comment on the proposals to incrementally 
reduce the weight of the quality performance category as we 
incrementally increase the weight of the cost performance category, 
specifically our proposal to adjust the percentage points attributed to 
the final score in the quality performance category to be comprised of 
40 percent for the 2023 MIPS payment year and 30 percent for the 2024 
MIPS payment year and future years. The following is a summary of 
public comments received regarding the proposals.
    Comment: A few commenters supported our proposal to incrementally 
reduce the weight of the quality performance category while increasing 
the weight of the cost performance category in order to achieve the 
weights established by Congress under the Act.
    Response: We appreciate the support from commenters.
    Comment: Many commenters did not support our proposal to 
incrementally reduce the weight of the quality performance category in 
order to increase the weight of the cost performance category during 
the PHE for COVID-19 because clinicians are burdened in new ways and 
trying to navigate through various challenges brought on by the PHE. 
The commenters recommended that CMS maintain the weight of the quality 
performance category at 45 percent until the PHE for COVID-19 has ended 
in order for clinicians to focus on serving patients safely. A few 
commenters recommended that CMS maintain the weight of 45 percent for 
the quality performance category for the 2023 MIPS payment year in 
order for the commenters' concerns regarding the cost measures to be 
addressed. In particular, the commenters noted that there are not many 
cost measures to select, particularly for specialties, which has 
significant implications for not accurately measuring cost performance. 
One commenter requested that CMS work with Congress on an extension for 
the timeframe to increase the weight for the cost performance category.
    Response: Section 1848(q)(5)(E)(i) of the Act provides that by the 
sixth year of the program, 30 percent of the final score shall be based 
on performance for the quality performance category and 30 percent of 
the final score shall be based on the cost performance category. Prior 
to the sixth year, section 1848(q)(5)(E)(II)(bb) of the Act states that 
the cost performance category may be weighted at not less than 10 
percent and not more than 30 percent of the total score. If less than 
30 percent, the percentage by which it is less than 30 percent is to be 
shifted to the quality performance category. Given that the percentage 
points attributed to both the quality and cost performance categories 
are in tandem, and we are required to achieve equal weighting at 30 
percent for each of the two performance categories by payment year 
2024, we believe that it is important to meet the statutory requirement 
while balancing the impact of simultaneously reducing the weight of the 
quality performance category and increasing the weight of the cost 
performance category. We are providing a gradual transition over a 2-
year period subject to the limitations imposed by the statute. In 
section IV.A.3.c.(2)(a) of this final rule, we finalized our proposal 
to increase the weight of the cost performance category to 20 percent 
for the 2023 MIPS payment year and 30 percent for the 2024 MIPS payment 
year and each subsequent MIPS payment year. Thus, the weight of the 
quality performance category will be reduced to 40 percent for the 2023 
MIPS payment year and 30 percent for the 2024 MIPS payment year and 
each subsequent years.
    Regarding concerns that the weight of the quality performance 
category should not be reduced until there are additional cost measures 
applicable to specialties in order to adequately measure cost 
performance for specialties, we note that there are two broad-based 
cost measures (Medicare Spending Per Beneficiary Clinician and Total 
Per Capita Cost) that generally apply to all clinician types, including 
specialties. There are a total of 20 cost measures, including 18 
episode-based cost measures. In the event that there are not any 
applicable cost measures to measure performance, the cost performance 
category would be re-weighted to zero. Also, we previously established 
facility-based measurement. Facility-based measurement provides certain 
clinicians and groups that primarily work within an inpatient setting 
with the opportunity to receive MIPS quality and cost performance 
category scores based on their assigned facility's hospital value-based 
purchasing program score in lieu of receiving scores based on quality 
and cost measures. We do not believe that maintaining the weight of the 
quality performance category at 45 percent until there are additional 
cost measures is necessary to assess cost performance. We will consider 
the inclusion of additional cost measures in future rulemaking, as 
available and appropriate. Regarding the comment requesting that CMS 
work with the Congress to extend the timeframe for increasing the 
weight of the cost performance category, we will take the comment into 
consideration.
    After consideration of the public comments, we are finalizing our 
proposal, which is as follows: At Sec.  414.1330(b)(4), the percentage 
points attributed to performance in the quality performance category 
will comprise 40 percent of a MIPS eligible clinician's final score for 
the 2023 MIPS payment year and at Sec.  414.1330(b)(5), the percentage 
points attributed to performance in the quality performance category 
will comprise 30 percent of a MIPS eligible clinician's final score for 
the 2024 MIPS payment year and each subsequent year.
(c) Groups and Virtual Groups Reporting via the CMS Web Interface
    At Sec.  414.1335(a)(2), the CMS Web Interface measures is a 
collection type in which groups and virtual groups with 25 or more 
eligible clinicians are able to report data on a set of pre-determined 
quality measures. For the 2020 performance periods, the total number of 
CMS Web Interface measures required to complete reporting on is 10 CMS 
Web Interface measures (83 FR 59713 through 79715 and 59756). Each CMS 
Web Interface measure must have complete reporting (no partial 
reporting) on all 10 measures while quality measures in other 
collection types require the reporting of fewer measures. The reporting 
requirements for the CMS Web Interface measures are more stringent than 
other collection types for the quality performance category, which 
include reporting on a larger set of measures and a higher data 
completeness rate. At Sec.  414.1335(a)(1)(i), it is established that 
groups and virtual groups reporting quality measures using non-CMS Web 
Interface measures collection types (such as Qualified Registries, 
Qualified Clinical Data Registries (QCDRs), electronic health records 
(EHRs), and Medicare Part B claims) are required to report on a minimum 
of 6 quality

[[Page 84868]]

measures, including at least one outcome measure. The data completeness 
criteria for reporting quality measures for Qualified Registry 
measures, QCDR measures, EHR measures, and Medicare Part B claims 
measures has a lower threshold compared to the CMS Web Interface 
measures. The data completeness criteria for the CMS Web Interface 
measures requires groups and virtual groups to report on the first 248 
consecutively ranked beneficiaries in the sample for each measure (and 
if the sample of eligible assigned beneficiaries is less than 248, then 
the group or virtual group must report on 100 percent of assigned 
beneficiaries), and at least one measure for which there is Medicare 
patient data (at Sec. Sec.  414.1335(a)(2) and 414.1340(c)). For the 
2020 performance period, the data completeness criteria threshold for 
Qualified Registry measures, QCDR measures, EHR measures, and Medicare 
Part B claims measures is 70 percent of the MIPS eligible clinician, 
group, or virtual group's patients (and applicable Medicare Part B 
patients for Medicare Part B claims measures) that meet the measure's 
denominator criteria (at Sec. Sec.  414.1340(a)(3) and 414.1340(b)(3)). 
Thus, groups and virtual groups submitting quality data through the CMS 
Web Interface measures report on a significantly larger number of 
patients compared to other collection types and such patients are 
identified in a sample by us (at Sec.  414.1340(c)).
    In sections III.G.1.b. and III.G.1.c. of the CY 2021 PFS proposed 
rule (85 FR 50231 and 50234 through 50235), we discussed the proposal 
to revise the quality reporting requirements for the Medicare Shared 
Savings Program to align with the APP framework and make corresponding 
revisions to the quality performance standard that ACOs must meet in 
order to be eligible to share in savings under the program. In 
conjunction with the proposed modifications to the Medicare Shared 
Savings Program quality reporting requirements, which included a 
proposal to transition to an APP for ACOs starting with the 2021 
performance period, we conducted an assessment of the utilization of 
the CMS Web Interface measures as a collection type for groups and 
virtual groups participating in MIPS. As noted above, we recognize that 
the CMS Web Interface reporting requirements, which include reporting 
on a larger set of measures and a higher data completeness rate, are 
more stringent than other collection types available under MIPS.
    In assessing the utilization of the CMS Web Interface by groups and 
virtual groups, there has been a substantial decrease in participation 
each year since the inception of MIPS in the 2017 performance year. 
From the 2017 to 2019 performance years, the number of groups eligible 
to report quality measures via the CMS Web Interface (groups registered 
to utilize the CMS Web Interface) decreased by approximately 45 
percent. Similarly, the number of groups utilizing the CMS Web 
Interface as a collection type has decreased by approximately 40 
percent from the 2017 to 2019 performance years. It is not clear as to 
why groups and virtual groups are not seeking to participate in MIPS by 
submitting quality data for CMS Web Interface Measures. There could be 
various reasons explaining the decrease in CMS Web Interface 
participation such as MIPS offering several collection types that can 
be utilized by any individual MIPS eligible clinician, group, or 
virtual group to meet program requirements; the CMS Web Interface 
measure reporting requirements may be burdensome compared to other 
collection types/submission types; the measure set is limited to 
primary care; groups and virtual groups may have a preference to select 
their own measures to have performance assessed instead of a pre-
determined measure set; or as a result of the CMS Web Interface 
measures being topped out, it may deter groups and virtual groups from 
participating because they would not fiscally benefit to be compared 
and assessed when there is little or no data variation in performance 
across ACOs, groups, and virtual groups.
    Given the above factors, we considered the following two options in 
our assessment: Continue the utilization of the CMS Web Interface 
measures solely for groups and virtual groups while ACOs transition to 
APP participation; or sunset the utilization for the CMS Web Interface 
measures as a collection type for groups and virtual groups. Groups and 
virtual groups account for less than 20 percent of organizations 
utilizing the CMS Web Interface measures while ACOs participating in 
the Medicare Shared Savings Program or Next Generation ACO Model 
account for more than 80 percent. With an expected 80 percent reduction 
if our proposed revisions to the quality performance standard under the 
Shared Savings Program are finalized and a continued decrease in groups 
and virtual groups seeking to report quality data on CMS Web Interface 
measures, we explained that it is not fiscally viable, feasible, or 
sustainable for MIPS to continue to make available the CMS Web 
Interface measures as a collection type/submission type. A reduction in 
the number of organizations submitting quality data on CMS Web 
Interface measures does not equate to the reduction in direct costs 
associated with operating and maintaining the CMS Web Interface 
measures. To operate and maintain the CMS Web Interface measures solely 
for groups and virtual groups, there would be an increase in cost and 
needed resources under MIPS associated with the items such as the 
establishment and maintenance of CMS Web Interface benchmarks, 
assignment and sampling, technical support, and education and outreach; 
thus, there would be proportionally higher costs associated with the 
operationalization and maintenance of the CMS Web Interface with a 
significantly smaller number of groups and virtual groups utilizing the 
CMS Web Interface measures as a collection type/submission type.
    In assessing the second option to sunset the CMS Web Interface 
measures as a collection type starting with the 2021 performance year, 
we would be aligning with the proposal under the Medicare Shared 
Savings Program to no longer utilize the CMS Web Interface as a means 
for assessing and scoring the quality performance of ACOs. For purposes 
of MIPS, groups and virtual groups would transition to meeting 
requirements under the quality performance category using other collect 
and submission types. We recognized that the sunset of the CMS Web 
Interface for groups and virtual groups may be burdensome to current 
groups and virtual groups submitting quality data on CMS Web Interface 
measures. Such groups and virtual groups would need to select a 
different collection type/submission type and redesign their systems to 
be able to interact with the new collection type/submission type. The 
timeframe for groups and virtual groups to select a new collection 
type/submission type and redesign their systems may be perceived as 
burdensome.
    We noted that groups and virtual groups would be able to select a 
different collection type/submission type, including at least six 
quality measures that are similar to previously established CMS Web 
Interface measures and reflect their specialty, and prepare for the 
2021 reporting period in advance of the reporting period starting in 
January of 2022. While there may be an initial increase in burden for 
current groups and virtual groups utilizing the

[[Page 84869]]

CMS Web Interface measures having to transition to the utilization of a 
different collection type/submission type, we recognized that we would 
also be reducing reporting requirements by no longer requiring groups 
and virtual groups to have to completely report on all pre-determined 
10 CMS Web Interface measures; groups and virtual groups would be able 
to select their own measures to report, would be reporting data on at 
least six measures, and data completeness threshold would be 70 percent 
for each measure, which is a reduction in program requirements compared 
to completed reporting required for all CMS Web Interface measures. We 
noted our belief that groups and virtual groups would be able to 
transition to the utilization of an available alternative collection 
type for the 2021 performance period. The type of data collected by 
groups and virtual groups for the 2020 performance period would be able 
to be captured by one of the available collection types such as an eCQM 
or MIPS CQM for the 2021 performance period. The 10 CMS Web Interface 
measures that are required for reporting under the 2020 performance 
period have an eCQM and MIPS CQM equivalent measure. For the 2021 
performance period, there are 10 eCQMs and 9 CQMs that are equivalent 
to the 10 CMS Web Interface measures. Also, we noted our belief that 
groups and virtual groups would be able to identify at least 6 
equivalent eCQMs or MIPS CQMs (or a combination) that capture the same 
type of data collected for the measures used in the CMS Web Interface. 
Also, such transition for groups and virtual groups could potentially 
be more beneficial. For example, if a measure from a different 
collection type (for example, MIPS CQMs) meets data completeness but 
may not meet case minimum, the measure would receive a score of 3; 
whereas, under the CMS Web Interface, any measure that did not meet 
reporting requirements would receive a score of 0.
    The sunset of the CMS Web Interface measures would reduce burden on 
groups and virtual groups while aligning program requirements and 
scoring policies for MIPS and the Medicare Shared Savings Program, and 
removing CMS Web Interface measures that do not provide a meaningful 
means of assessing performance across groups, virtual groups, and ACOs. 
With the CMS Web Interface measures being topped out as noted above, we 
strive to remove measures that are topped out and establish a set of 
robust and meaningful measure sets that are available under the other 
collection types. We noted our belief that the benefits groups and 
virtual groups would reap from transitioning to the utilization of 
other collection types starting with the 2021 performance year outweigh 
the initial disruption that would be experienced when the CMS Web 
Interface measures would be sunset. Based on our assessment, we 
proposed at Sec.  414.1325(c)(1) and (2) to sunset the CMS Web 
Interface measures as a collection type/submission type starting with 
the 2021 performance period. Specifically, at Sec.  414.1305, we 
proposed to modify the definition of the terms collection type and 
submission type to remove the CMS Web Interface measures as an 
available option starting with the 2023 MIPS payment year. We proposed 
to modify the definition of collection type to mean a set of quality 
measures with comparable specifications and data completeness criteria, 
as applicable, including, but not limited to: Electronic clinical 
quality measures (eCQMs); MIPS Clinical Quality Measures (MIPS CQMs); 
QCDR measures; Medicare Part B claims measures; for the 2019 through 
2022 MIPS payment years, CMS Web Interface measures; the CAHPS for MIPS 
Survey; and administrative claims measures. We proposed to revise the 
definition of ``submission type'' to mean the mechanism by which the 
submitter type submits data to CMS, including, but not limited to: 
Direct; log in and upload; log in and attest; Medicare Part B claims; 
and for the 2019 through 2022 MIPS payment years, the CMS Web 
Interface.
    We solicited public comment on the proposal to sunset the CMS Web 
Interface as a collection and submission type under MIPS starting with 
the 2021 performance period. The following is a summary of public 
comments received regarding the proposal.
    Comment: Several commenters generally supported the proposal to 
sunset the CMS Web Interface as a collection and submission type (with 
a few commenters expressing support of the proposal based on the 
condition of having a transition period of at least 1 year) and noted 
that the removal of the CMS Web Interface would reduce the quantity of 
quality measures reported, allow groups and virtual groups to select 
specialty measures, and encourage the use of electronically reported 
measures rather than the manual abstraction of data using a CMS-created 
Excel template for uploading quality data.
    Response: We appreciate the support from commenters and note that 
we are finalizing our proposal to remove the CMS Web Interface as a 
collection and submission type with a 1-year delay. Also, we note that 
the CMS Web Interface not only has the function of providing for a 
manual abstraction of data using a CMS-created Excel template for 
uploading quality data, but allows for the use of an application 
programming interface (API), which encourages the use of enhanced EHR 
technology.
    Comment: Most commenters did not support the proposal to sunset the 
CMS Web Interface as a collection and submission type starting with the 
2021 performance period, indicating that CMS did not provide adequate 
notice of the CMS Web Interface being under consideration for 
elimination and noting that the lack of adequate notice would create a 
burden for users to be able to successfully transition to the use of a 
different collection and submission type, which would require a 
significant amount of time and fiscal resources to build a new health 
IT infrastructure and workflows, and train staff on the new system. A 
few commenters indicated that organizations elect to utilize the CMS 
Web Interface as a cost-effective option for TINs using multiple, 
disparate EHR systems and the removal of the CMS Web Interface would 
make it particularly burdensome for such organization to change 
collection and submission types. One commenter indicated that not all 
organizations have the resources to transition to a different 
collection and submission type and doing so would be difficult for 
small community practices to implement. Most commenters recommended 
that CMS delay the sunset of CMS Web Interface by one or more years, 
particularly as clinicians are responding to the PHE for COVID-19 and 
CMS continues to define the MVP framework, which may necessitate 
program participants to change collection and submission types again in 
a few years.
    Response: We recognize that the general sentiment of most 
commenters was not in opposition to the proposal to remove the CMS Web 
Interface as a collection type and submission, but rather the proposed 
timeframe for removal, which would be burdensome due to insufficient 
time to build and integrate new health IT infrastructures and systems, 
implement workflows, and train staff on new health IT systems while 
mitigating and responding to the PHE for COVID-19 that has further 
strained limited fiscal resources. To reduce the burden of 
transitioning to a new collection and submission type, we are extending 
the availability of the CMS Web Interface as a collection and 
submission type for one additional performance period. Thus, we are

[[Page 84870]]

modifying our proposal to sunset the CMS Web Interface starting with 
the 2022 performance period.
    Comment: Some commenters indicated that the removal of the CMS Web 
Interface as a collection and submission type may limit the ability of 
clinicians to achieve the maximum possible score under the quality 
performance category. One commenter expressed concern that as APMs 
migrate to other collection types, the performance rates for benchmarks 
of other collection types would increase and the performance of non-APM 
participants may be disadvantaged when compared to the increased 
benchmarks.
    Response: We disagree that the removal of the CMS Web Interface as 
a collection type would inhibit APM Entities, groups, or virtual groups 
that formerly utilized the CMS Web Interface from being able to achieve 
the maximum possible score allotted under the quality performance 
category or pose a potential disadvantage for non-APM participants that 
had not previously reported quality data via the CMS Web Interface as 
APMs that migrate from utilizing the CMS Web Interface to other 
collection types. It should be noted that the way in which APM Entities 
(ACOs participating in the Medicare Shared Savings Program or Next 
Generation ACO Model), groups, and virtual groups are scored relative 
to the benchmarks established for the CMS Web Interface measures differ 
from the way in which MIPS eligible clinicians, groups, virtual groups, 
and APM Entities are scored relative to the benchmarks established for 
all other quality measures. The deciles for the CMS Web Interface 
benchmarks are flat (meaning that each decile is stagnant and equally 
distributed increments equating 100 percent; for example, if a CMS Web 
Interface user had a performance score of 92 percent, the points 
achieved would be 9 points) while the deciles for other quality measure 
benchmarks are based on the distribution of performance (meaning that 
each decile reflects a specific range of performance distribution in 
incremental percentages equating to 100; for example, the decile 
representing the 10 percent of highest performance could have a range 
of performance from 98 percent to 100 percent, so in order to achieve 
the maximum points, a MIPS eligible clinician, group, or virtual group 
would need to have a performance within such range). Performance rates 
pertaining to the CMS Web Interface measures are not comparable to 
performance rates pertaining to other quality measures for other 
collection types and do not provide an indication of how performance 
would be distributed across the performance curve outside of the CMS 
Web Interface. In order to achieve the maximum possible score for the 
quality performance category, a MIPS eligible clinician, group, virtual 
group, or APM Entity would need to have better performance compared to 
other clinicians along the distribution curve of performance for a 
particular measure.
    Comment: One commenter suggested that CMS provide CMS Web Interface 
users with an option to file a hardship exception for transitioning to 
a new EHR as a collection type, which would reweight the quality and 
promoting interoperability performance categories to zero to ensure 
that such clinicians would not be penalized while transitioning to new 
collection types.
    Response: We disagree with the commenter's suggestion that a 
hardship exception be established for groups or virtual groups 
utilizing the CMS Web Interface as such users transition to a different 
collection type. The hardship exemption is a policy established 
pertaining to specific circumstances such as using decertified EHR 
technology, insufficient internet connectivity, extreme and 
uncontrollable circumstances, and the lack of control over CEHRT. We do 
not believe that the transition to utilizing a different collection 
type would warrant the establishment of a new hardship exception. The 
CMS Web Interface will remain as a collection type for the 2021 
performance period to provide sufficient time for CMS Web Interface 
users to prepare to utilize a different collection type starting with 
the 2022 performance period as the CMS Web Interface will sunset 
starting with the 2022 performance period.
    Comment: One commenter recommended CMS to provide tools to assist 
with the transition from the CMS Web Interface to other collection 
types by providing a simple tool for aggregating QRDAIII files from 
multiple EHR systems into a single QRDAIII or JSON format file for MIPS 
submission. The commenter acknowledged that CMS has provided open 
source software for such purpose, but requested that CMS embed the file 
aggregation process in the MIPS quality submission workflow in order to 
allow an authorized submitter to choose an upload and submission method 
for the quality performance category that automatically aggregates 
multiple QRDAIII files.
    Response: We note that groups and virtual groups are required to 
aggregate data across the group or virtual group in order to meet 
reporting requirements established at Sec. Sec.  414.1310(e)(3) and 
414.1315(d)(3). We are unable to provide the embedded aggregation tool 
the commenter is requesting, but will take this into consideration for 
future enhancements.
    After consideration of the public comments, we are finalizing our 
proposal to remove the CMS Web Interface as a collection and submission 
type with a 1-year delay. In order to address the potential burden that 
groups and virtual groups would experience by the removal of the CMS 
Web Interface as a collection and submission type during the PHE for 
COVID-19, we believe it is critical to reduce the burden of groups and 
virtual groups at this juncture and postpone the sunset of the CMS Web 
Interface to the 2022 performance period. Thus, we are finalizing at 
Sec.  414.1325(c)(1) and (2) to sunset the CMS Web Interface measures 
as a collection type/submission type starting with the 2022 performance 
period. Specifically, at Sec.  414.1305, we are finalizing our proposal 
with modification to define the terms collection type and submission 
type to remove the CMS Web Interface measures as an available option 
starting with the 2024 MIPS payment year. We are finalizing our 
proposal with modification to revise the definition of collection type 
to mean a set of quality measures with comparable specifications and 
data completeness criteria, as applicable, including, but not limited 
to: Electronic clinical quality measures (eCQMs); MIPS Clinical Quality 
Measures (MIPS CQMs); QCDR measures; Medicare Part B claims measures; 
for the 2019 through 2023 MIPS payment years, CMS Web Interface 
measures; the CAHPS for MIPS Survey; and administrative claims 
measures. We are finalizing our proposal with modification to revise 
the definition of ``submission type'' to mean the mechanism by which 
the submitter type submits data to CMS, including, but not limited to: 
Direct; log in and upload; log in and attest; Medicare Part B claims; 
and for the 2019 through 2023 MIPS payment years, the CMS Web 
Interface.
(d) Selection of MIPS Quality Measures
    Previously finalized MIPS quality measures can be found in the CY 
2020 PFS final rule (84 FR 63205 through 63513); CY 2019 PFS final rule 
(83 FR 60097 through 60285); 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). Proposed changes to the MIPS 
quality

[[Page 84871]]

measure set as described in Appendix 1 of the CY 2021 PFS proposed rule 
(85 FR 50412 through 50663) include the following: Addition of new 
measures; updates to specialty sets; removal of existing measures, and 
substantive changes to existing measures. For the 2021 performance 
period, we proposed a measure set of 206 MIPS quality measures.
    The new MIPS quality measures proposed for inclusion in MIPS for 
the 2021 performance period and future years were found in Table Group 
A of Appendix 1 of the proposed rule (85 FR 50413 through 50414). For 
the 2021 performance year, we proposed 2 new administrative claims 
outcome measures. In addition to the establishment of new individual 
MIPS quality measures, we also develop and maintain specialty measure 
sets to assist MIPS eligible clinicians with selecting quality measures 
that are most relevant to their scope of practice. The proposed 
modifications to existing specialty sets and new specialty sets were 
outlined in Table Group B of Appendix 1 of the proposed rule (85 FR 
50415 through 50580). Specialty sets may include: New measures; 
previously finalized measures with modifications; previously finalized 
measures with no modifications; the removal of certain previously 
finalized quality measures; or the addition of existing MIPS quality 
measures. Note that the specialty and subspecialty sets are not 
inclusive of every specialty or subspecialty.
    On January 6, 2020,\124\ we announced that we would be accepting 
recommendations for potential new specialty measure sets or revisions 
to existing specialty measure sets for year 5 of MIPS under the Quality 
Payment Program. These recommendations were based on the MIPS quality 
measures finalized in the CY 2019 PFS final rule, the 2019 Measures 
Under Consideration list, and provides recommendations to add or remove 
the current MIPS quality measures from existing specialty sets, or 
provides recommendations for the creation of new specialty sets. All 
specialty set recommendations submitted for consideration were assessed 
and vetted, and as a result, the recommendations with which we agreed 
were proposed in the CY 2021 PFS proposed rule.
---------------------------------------------------------------------------

    \124\ Listserv messaging was distributed through the Quality 
Payment Program listserv on January 6, 2020, titled: ``CMS is 
Soliciting Stakeholder Recommendations for Potential Consideration 
of New Specialty Measure and/or Revisions to the Existing Specialty 
Measure Sets for the 2021 Program Year of Merit-based Incentive 
Payment System (MIPS).''
---------------------------------------------------------------------------

    In addition to establishing new individual MIPS quality measures 
and modifying existing specialty sets and new specialty sets as 
outlined in Tables Group A and Group B of Appendix 1 of the CY 2021 PFS 
proposed rule, we refer readers to Table Group C of Appendix 1 of the 
CY 2021 PFS proposed rule for a list of quality measures and rationales 
for removal (85 FR 50580 through 50585). For the 2021 performance 
period, we proposed to remove 14 MIPS quality measures: 2 MIPS quality 
measures that are extremely topped out; 1 MIPS quality measure that is 
duplicative to another current quality measure; 1 MIPS quality measure 
that is duplicative to one of the new proposed MIPS quality measures; 2 
MIPS quality measures that do not align with the Meaningful Measures 
Initiative; 5 MIPS quality measures that are no longer stewarded or 
maintained; 1 MIPS quality measure that does not meet current clinical 
guidelines; and 2 MIPS quality measures that are under the topped out 
lifecycle. We noted that we have continuously communicated to 
stakeholders our desire to reduce the number of process measures within 
the MIPS quality measure set. Also, we noted our belief that the 
proposal to remove the quality measures outlined in Table Group C would 
lead to a more parsimonious inventory of meaningful, robust measures in 
the program, and that our approach to remove measures should occur 
through an iterative process that will include an annual review of the 
quality measures to determine whether they meet our removal criteria.
    Lastly, MIPS quality measures with proposed substantive changes can 
be found in Table Group D of Appendix 1 of the CY 2021 PFS proposed 
rule. We proposed substantive changes to 112 MIPS quality measures. On 
an annual basis, we review the established MIPS quality measure 
inventory to consider updates to the measures. Possible updates to 
measures may be minor or substantive. Section 1848(q)(2)(D)(i)(II)(cc) 
of the Act requires all substantive measure changes to be proposed and 
identified through notice-and-comment rulemaking. In the CY 2017 
Quality Payment Program final rule (81 FR 77137), we determined that 
substantive changes to measures (that is, measure specifications, 
measure title, and domain modifications) would be identified during the 
rulemaking process while maintenance changes that do not substantively 
change the intent of the measure (that is, updated diagnosis and 
procedure codes, definitions, and changes to patient population 
exclusions) would not be included in the rulemaking process.
    We note that changes to measure Q134, Prevention Care and 
Screening: Screening for Depression and Follow-Up Plan (eCQM 
Specifications and CMS Web Interface Measure Specifications collection 
types), specifically the removal of SNOMED codes, were published in the 
eCQI Resource Center and the Value Set Authority Center (in May of 2018 
for the eCQM Specifications) and on the CMS website (in December of 
2018 for the CMS Web Interface Measure Specifications). While the 
current cycle of measure updates to MIPS quality measures is separate 
from the eCQM annual update process, we inadvertently recognized such 
update allowed MIPS eligible clinicians to meet performance of a 
follow-up plan by rescreening the patient who has a positive depression 
screen with an additional standardized depression screening tool. The 
change to the measure was continued for CY 2020. As a result, such 
changes were not identified during the CY 2019 PFS or CY 2020 PFS 
rulemaking cycles. The changes to measure Q134 (eCQM Specifications and 
CMS Web Interface Measure Specifications collection types) impact 
performance periods starting with 2019. For the 2019 and 2020 
performance periods, measure Q134 applicable to the eCQM Specifications 
and CMS Web Interface Measures Specifications will be suppressed from 
scoring. To adequately capture the substantive changes to measure Q134 
(eCQM Specifications and CMS Web Interface Measure Specifications 
collection types) through rulemaking for the 2021 performance period, 
we are identifying the substantive changes for this MIPS quality 
measure as outlined in Table Group D of Appendix 1 of the CY 2021 PFS 
proposed rule (85 FR 50586 through 50663).
    We refer readers to Table Groups A through D of Appendix 1 of this 
final rule for a summary of public comments received regarding the 
proposed changes to the MIPS quality measure set for the 2021 
performance period and our final decisions.
(e) MIPS Performance Period
(i) Establishing Separate Performance Periods for Administrative Claims 
Measures Under the Quality Performance Category Beginning With the 2023 
MIPS Payment Year
    In the CY 2019 PFS final rule (83 FR 59745), we established at 
Sec.  414.1320(d)(1) that beginning with the 2022 MIPS payment year, 
the

[[Page 84872]]

performance period for 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. We noted that we 
established a 1-year performance period for measures in the quality 
performance category because a 1-year performance period would provide 
statistically larger sample sizes and more accurate and actionable 
information. As discussed in Table Group A of Appendix 1 of the CY 2021 
PFS proposed rule, we proposed to add a new administrative claims 
measure of risk-standardized complication rate following elective 
primary total hip arthroplasty and/or total knee arthroplasty. As 
discussed, this measure was developed and tested using a performance 
period that was longer than a full calendar year in order to provide 
larger sample sizes, and more accurate and actionable information. 
Beginning with the 2021 performance year, this measure would have a 3-
year performance period (consecutive 36-month timeframe) that would 
start on October 1 of the calendar year 3 years prior to the applicable 
performance year and conclude on September 30 of the calendar year of 
the applicable performance year, and proceeding with a 3-month 
numerator assessment period (capturing complication outcomes) followed 
by a 2-month claims run-out period. For example, the 3-year (36 
consecutive months) performance period for this measure would span from 
October 1, 2018 to September 30, 2021 with a 90-day numerator 
assessment period followed by a 60-day claims run-out period.
    To account for this measure and other future administrative claims 
measures that may have a performance period differing from 1 full 
calendar year, we proposed to modify the definition of the performance 
period for the quality and cost performance categories at Sec.  
414.1320(d)(1) to be as follows: Beginning with the 2023 MIPS payment 
year, the performance period for 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, except 
as otherwise specified for administrative claims-based measures in the 
MIPS final list of quality measures described in Sec.  414.1330(a)(1). 
We noted that while we have established a single performance period for 
measures and activities within each performance category in the MIPS 
program, we have established measure-specific performance periods in 
other programs, such as in the hospital value-based purchasing program, 
which includes measures of various performance periods (84 FR 42394 
through 42395). We continue to believe that establishing a single 
performance period for measures requiring the submission of data 
optimizes operational efficiency for MIPS eligible clinicians, groups, 
and virtual groups that submit data on such measures. However, 
administrative claims measures (proposal to add 2 new administrative 
claims measures found in Table Group A of Appendix 1 of the CY 2021 PFS 
proposed rule: Hospital-Wide, 30-Day, All-Cause Unplanned Readmission 
(HWR) Rate, and Risk-standardized Complication Rate (RSCR) Following 
Elective Primary Total Hip Arthroplasty (THA) and/or Total Knee 
Arthroplasty (TKA)); and the proposal to remove the All-Cause 
Readmission measure found in Table Group C of Appendix 1 (was the only 
administrative claims-based measure) do not require the submission of 
data and are calculated by CMS based on administrative data. Thus, we 
noted our belief that a different performance period should be 
considered on a measure-by-measure level for administrative claims 
measures.
    We solicited public comment on the proposal to modify the 
definition of performance period for the quality and cost performance 
categories that would establish a separate performance period for 
administrative claims measures under the quality performance category. 
The following is a summary of the public comments received regarding 
the proposal.
    Comment: One commenter supported the incorporation of a 3-year 
timeframe for the RSCR following elective primary THA and/or TKA 
measure because the measure evaluates individuals and groups over a 
longer timeframe for increased reliability and aligns with the HWR 
measure. The commenter recommended that CMS allow for a longer 
performance period for other MIPS measures, where appropriate.
    Response: We appreciate the support from the commenter.
    Comment: Several commenters expressed concern about the proposal to 
establish a separate performance period for administrative claims 
measures under the quality performance category and recommended that 
the performance period for administrative claims measures under the 
quality performance category retain a 1-year performance period. The 
commenters understood the issue surrounding the basis for larger sample 
sizes, and more accurate and actionable information needed for reliable 
measurement, but indicated that a 3-year performance period is too long 
to provide timely, meaningful feedback for MIPS eligible clinicians. 
The commenters expressed concern that the performance is not 
representative of the changes in data over 3 consecutive years. One 
commenter indicated that many small and independent practices would not 
be able to retroactively report quality measures that require a 3-year 
performance window. One commenter stated that differing performance 
periods under the same performance category would cause confusion for 
clinicians.
    Response: We believe that it is important for measures to be 
developed based on larger sample sizes, and more accurate and 
actionable information in order to reliably measure quality 
performance. We disagree with commenters that a 3-year performance 
period for administrative claims measures under the quality performance 
category would inhibit timely and meaningful feedback for MIPS eligible 
clinicians, groups, and virtual groups; MIPS eligible clinicians, 
groups, and virtual groups will continue to receive annual, 
confidential performance feedback reports that reflect prior 
performance. MIPS eligible clinicians, groups, and virtual groups can 
compare their performance provided in performance feedback to better 
understand their performance relative to their peers, identify care 
coordination and quality of care opportunities, and streamline resource 
use for their attributed patients. The performance period for 
administrative claims measures would span a 3-year period, in which 2 
years of the 3-year period would overlap with the prior measurement 
period and 1 year would represent new data. While this approach may not 
capture small improvements in the quality of care, it ensures 
statistical reliability and therefore, a valid measure result. For 
example, the proposed new administrative claims measure of risk-
standardized complication rate following elective primary total hip 
arthroplasty and/or total knee arthroplasty would have a 3-year (36 
consecutive months) performance period, including elective primary 
total hip/knee arthroplasty procedures performed between October 1, 
2018 to September 30, 2021.
    We do not believe that establishing different performance periods 
specific to administrative claims measures under the quality 
performance category would cause confusion within the quality 
performance category while all other quality measures have a full 
calendar year as a performance period given that differing performance 
periods only

[[Page 84873]]

pertain to administrative claims measures and the submission of data is 
not required for such measures due to CMS conducting the calculations 
based on administrative claims data. The introduction of measure-
specific performance periods is a concept established in other CMS 
programs, such as in the hospital value-based purchasing program, which 
includes measures of various performance periods (84 FR 42393 through 
42395). We continue to believe that establishing a single performance 
period for measures requiring the submission of data optimizes 
operational efficiency for MIPS eligible clinicians, groups, and 
virtual groups that submit data on such measures.
    After consideration of the public comments, we are finalizing our 
proposal to define the performance period for the quality and cost 
performance categories at Sec.  414.1320(d)(1) as follows: Beginning 
with the 2023 MIPS payment year, the performance period for 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, except as otherwise specified for administrative claims-
based measures in the MIPS final list of quality measures described in 
Sec.  414.1330(a)(1).
(f) Quality Data Submission Criteria
(i) Performance Criteria for Quality Measures for Groups Electing To 
Report Consumer Assessment of Healthcare Providers and Systems (CAHPS) 
for MIPS Survey
    We refer readers to the CY 2018 Quality Payment Program final rule 
(82 FR 53629 through 53632) for previous finalized policies for the 
CAHPS for MIPS Survey, specifically regarding the Summary Survey 
Measures (SSMs).
    To address the PHE for COVID-19 and the increased use of telehealth 
care, we proposed the following changes to our policies related to the 
CAHPS for MIPS Survey:
     We proposed to integrate one telehealth item into the 
CAHPS for MIPS Survey. Specifically, we proposed to add a survey-based 
measure on telehealth that assesses patient-reported usage of 
telehealth services (for example, phone or video visit) to the PY 2021 
CAHPS for MIPS Survey.
     We also proposed revisions to the CAHPS for MIPS Survey 
cover page to include a reference to care received in telehealth 
settings. This may help to ensure that patients who respond to the 
survey are reflecting on experiences of the care they received via 
telehealth in their responses. We noted that we are considering such 
changes for the PY 2021 CAHPS for MIPS Survey administration.
    To clarify the instructions in the CAHPS for MIPS Survey, we 
proposed revisions to the instructions in the ``Your Care From 
Specialists in the Last 6 Months'' section of the CAHPS for MIPS Survey 
to clarify the inclusion of the provider named in Question 1 of the 
survey. We noted that we are considering such changes for the PY 2021 
CAHPS for MIPS Survey administration.
    We refer readers to section VII of this rule the Collection of 
Information Requirements for additional information.
    We received public comments on the performance criteria for quality 
measures for groups electing to report CAHPS for MIPS Survey proposals. 
The following is a summary of the comments we received and our 
responses.
    Comment: Several commenters supported adding a survey-based measure 
in the CAHPS for MIPS Survey that reflects the increased use of 
telehealth services, and helps clinicians understand utilization 
patterns, consumer satisfaction and outcomes of telehealth. One 
commenter indicated support for a survey question related to the use of 
telehealth services only, but not a question or measure to evaluate a 
clinician's performance during the telehealth visit.
    Response: We clarify that the item on use of telehealth would be a 
single question that collects self-reported information from CAHPS for 
MIPS Survey respondents on the modalities of care they received over 
the prior 6 months (in-person, by phone, or video visit). We clarify 
here that this survey item would be for informational purposes only 
(similar to the existing CAHPS for MIPS Survey item that assesses 
internet use at home), and would not be used for quality scoring or 
payment purposes.
    Comment: One commenter did not support the inclusion of a new 
measure assessing telehealth services until there is clarification on 
the intent of the questions, descriptions of what information will be 
collected, robust testing of the usefulness of the new measure and 
impact on response rates and performance, and NQF endorsement of the 
new CAHPS for MIPS survey question. One commenter wanted clarification 
on whether the purpose of adding a telehealth measure is to assess 
digital literacy of patients or to allow patients to assess the degree 
to which services provided remotely were appropriate and met their 
needs.
    Response: We note that in 85 FR 50292, we proposed to integrate a 
single item into the CAHPS for MIPS Survey to collect respondents' 
self-reported data on use of telehealth services (for example, by phone 
or video visit) during the prior 6 months. We clarify here that this 
survey item would be for informational purposes only (similar to the 
existing CAHPS for MIPS Survey item that assesses internet use at 
home). That is, this item would not be used for quality scoring or 
payment purposes. Rather, the purpose of this question would be to 
provide CMS and participating groups with useful information about 
utilization of telehealth by their assigned patients, specifically, 
self-reported data on mode of telehealth delivery (phone vs. video). 
The item will also capture whether any in-person visits occurred and 
will allow CMS and participating groups to examine the reports and 
ratings of care for patients receiving telehealth visits and will allow 
CMS to examine resulting CAHPS scores for groups whose patients used 
telehealth. It may promote comparison of the experiences of patients 
using telehealth with those who have not used telehealth, which could 
inform quality improvement efforts for individual groups and allow CMS 
to monitor the experiences of assigned patients (both those utilizing 
telehealth and those who do not). The proposed item has not been field 
tested. As with existing CAHPS for MIPS Survey items, the proposed item 
has been tested in one-on-one interviews with patients to assess 
whether patients correctly understand the terms and phrases used in the 
question and are able to recall experiences relevant to the question. 
Testing was conducted in English and Spanish. CAHPS for MIPS Survey 
items are not a candidate for NQF review. We do not anticipate the 
addition of a single telehealth question will affect the survey 
response rate. Given the rapidly evolving use of telehealth services as 
a result of the COVID-19 pandemic, we believe the addition of an item 
to capture the use of telehealth should be added to the performance 
year 2021 CAHPS for MIPS Survey.
    Comment: A few commenters supported the proposed revisions to the 
CAHPS for MIPS Survey cover page to include a reference to care 
received in telehealth settings.
    Response: We appreciate the commenters for their support.
    After consideration of public comments, we are finalizing our 
proposal to integrate one telehealth item and update the cover page to 
reference to care received in telehealth settings

[[Page 84874]]

starting in the PY 2021 CAHPS for MIPS Survey administration. 
Additionally, while no public comments were received, as a result of 
the qualitative testing we are not making any changes regarding the 
instructions in the ``Your Care From Specialists in the Last 6 Months'' 
section of the CAHPS for MIPS Survey in Question 1 of the survey.
(ii) CAHPS for MIPS Patient Assignment
    Section 1834(m) of the Act 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. When furnished under the telehealth 
rules, these specified Medicare telehealth services are reported using 
the same codes used for the ``face-to-face'' services, but are 
furnished using audio/video, real-time, interactive communications 
technology instead of in person. As such, the majority of the codes for 
primary care services included in the additional telehealth services 
added in the March 31st COVID-19 IFC for purposes of the PHE for COVID-
19 are already included in the definition of primary care services for 
purposes of the MIPS assignment methodology for the CAHPS for MIPS 
Survey (82 FR 77168 through 77169; and 82 FR 53646 through 53647). At 
Sec.  414.1305, we proposed to codify the definition of primary care 
services for purposes of MIPS assignment methodology for the CAHPS for 
MIPS Survey as follows:
     CPT codes:
    ++ 99201 through 99215 (codes for office or other outpatient visit 
for the E/M of a patient); 99304 through 99318 (codes for professional 
services furnished in a nursing facility, excluding professional 
services furnished in a SNF for claims identified by place of service 
(POS) modifier 31); 99319 through 99340 (codes for patient domiciliary, 
rest home, or custodial care visit); 99341 through 99350 (codes for E/M 
services furnished in a patient's home for claims identified by POS 
modifier 12); 99487, 99489, and 99490 (codes for chronic care 
management); and 99495 and 99496 (codes for transitional care 
management services); and
    ++ Beginning with the 2023 MIPS payment year, 99421, 99422, and 
99423 (codes for online digital E/M services (e-visit)); 99441, 99442, 
and 99443 (codes for telephone E/M services); and 96160 and 96161 
(codes for Administration of Health Risk Assessment).
     HCPCS codes:
    ++ G0402 (code for the Welcome to Medicare visit); and G0438 and 
G0439 (codes for the annual wellness visits); and
    ++ Beginning with the 2023 MIPS payment year, G2010 (code for 
remote evaluation of patient video/images); and G2012 (code for virtual 
check-in).
    In the March 31st COVID-19 IFC, we also established flexibilities 
for certain services that are furnished virtually using communication 
technologies, but that are not considered Medicare telehealth services 
such as virtual check-ins and e-visits (separate payments for such 
services had previously been established in the CY 2019 PFS final 
rule). We also established separate payment for telephone E/M services 
codes during the PHE. The communications technology-based services 
(CTBS) and the telephone E/M services are not currently included in the 
MIPS assignment methodology for the CAHPS for MIPS survey.
    We believe it is critical to include codes for CTBS and telephone 
E/M services, as identified and discussed later in this section, in the 
definition of primary care services to ensure these services are 
included in our determination of where beneficiaries receive the 
plurality of their primary care for purposes of beneficiary assignment. 
Such inclusion ensures that the assignment methodology appropriately 
reflects the expanded use of technology that is helping people who need 
routine care during the PHE for COVID-19 and allowing vulnerable 
beneficiaries and beneficiaries with mild symptoms to remain in their 
homes, while maintaining access to the care they need. By including 
services provided virtually, either through telehealth or other uses of 
communications technology, we would ensure that this care is 
appropriately reflected in our consideration of the plurality of care 
used to assign beneficiaries to groups and virtual groups.
    We have added new services to the separately billable CTBS under 
the Physician Fee Schedule over the past several years and a result of 
the PHE, we expect that the utilization of communications technology-
based services will substantially increase during the PHE for COVID-19 
and thereafter. We believe that clinicians are increasingly using such 
services as a key component of their ongoing primary care. In an effort 
to address the increased use of telehealth during the PHE and use of 
telehealth, and to maintain alignment with the Shared Savings Program, 
we proposed to integrate the same telehealth CPT and HCPCS codes that 
are used for purposes of assigning beneficiaries to Shared Savings 
Program ACOs into the set of primary care service codes that are used 
for patient assignment to MIPS groups. We proposed to revise the 
definition of primary care services used in the MIPS assignment 
methodology for the 2021 CAHPS for MIPS Survey, and for any subsequent 
performance year, to include the following additions: (1) CPT codes: 
99421, 99422, and 99423 (codes for online digital E/M services (e-
visits)); 99441, 99442, and 99443 (codes for telephone E/M services); 
and 96160 and 96161 (codes for administration of health risk 
assessment); and (2) HCPCS codes: G2010 (code for remote evaluation of 
patient video/images) and G2012 (code for virtual check-in). It should 
be noted that the proposed inclusion of such codes in the MIPS 
assignment methodology for the CAHPS for MIPS Survey would align with 
the definition of primary care services used for purposes of 
beneficiary assignment under the Medicare Shared Savings Program, which 
was amended in the May 8th COVID-19 IFC to ensure that these codes for 
e-visits, telephone E/M services, remote evaluation of patient video/
images, and virtual check-ins would be included in determining 
beneficiary assignment for the 2020 performance year and any subsequent 
performance year that starts during the PHE for COVID-19 (85 FR 27583). 
We referred readers to the May 8th COVID-19 IFC (85 FR 27582 through 
27586) for a detailed description of the codes that were added to the 
definition of primary care services under the Medicare Shared Savings 
Program. We also referred readers to the 2018 PFS final rule (82 FR 
53007 through 53011) for a detailed description of the primary care 
services codes for Administration of Health Risk Assessment.
    The services represented by the codes listed above are being used 
in place of similar E/M services, the codes for which are already 
included in the list of codes used for assignment. We noted that as a 
result, we believe these services are an important component of primary 
care and it is appropriate to include these codes in the definition of 
primary care services used for assignment for the CAHPS for MIPS 
Survey. The only codes that are newly billable during the PHE for 
COVID-19 pertain to the telephone E/M services. It should be noted that 
these services as well as the remote evaluation of patient video/images 
and virtual check-in codes, and the online digital E/M service (e-
visit) codes are not separately billable by a clinician if they are 
related to a visit within the past 7 days or lead

[[Page 84875]]

to a visit within the following 24 hours or next available appointment.
    We believe that clinicians are increasingly using CTBS as a key 
component of their ongoing primary care. We noted that we expect that 
the utilization of such services will substantially increase not only 
during the PHE for COVID-19, but also thereafter. Accordingly, we 
proposed to include virtual primary care visits and telehealth visits 
to determine patient assignment to groups for purposes of the CAHPS for 
MIPS Survey for PY 2021 and subsequent performance years.
    We did not receive public comments on this proposal, and therefore, 
we are finalizing it as proposed.
(g) Quality Performance Category: Expansion of Telehealth Codes Used in 
Beneficiary Assignment for the CMS Web Interface and CAHPS for MIPS 
Survey
(i) Background
    In conjunction with this final rule and the ongoing impact of the 
PHE for COVID-19, we published the ``Medicare and Medicaid Programs, 
Clinical Laboratory Improvement Amendments (CLIA), and Patient 
Protection and Affordable Care Act; Additional Policy and Regulatory 
Revisions in Response to the COVID-19 Public Health Emergency'' IFC in 
the September 2, 2020 Federal Register, (hereinafter referred to as the 
September 2nd COVID-19 IFC), in which we adopted on an interim final 
basis a policy to include codes for CTBS and telephone E/M services in 
the definition of primary care services to ensure these services are 
included in our determination of where beneficiaries receive the 
plurality of their primary care for purposes of beneficiary assignment.
    As discussed in the IFC, on March 17, 2020, we announced (https://www.cms.gov/newsroom/fact-sheets/medicare-telemedicine-health-care-provider-fact-sheet) the expansion of payment for telehealth services 
on a temporary and emergency basis pursuant to waiver authority added 
under section 1135(b)(8) of the Act by the Coronavirus Preparedness and 
Response Supplemental Appropriations Act, 2020 such that Medicare can 
pay for telehealth services, including office, hospital, and other 
visits furnished by physicians and other practitioners to patients 
located anywhere in the country, including in a patient's place of 
residence, starting March 6, 2020. In the context of the PHE for COVID-
19, we recognize that physicians and other health care professionals 
are faced with new challenges regarding potential exposure risks, 
including for Medicare beneficiaries, for health care providers, and 
for members of the community at large. For example, the CDC has 
recommended health care professionals to make every effort to interview 
persons under investigation for infection by telephone, text messaging 
system, or video conference instead of in-person. In the March 31st 
COVID-19 IFC, to facilitate the use of telecommunications technology as 
a safe substitute for in-person services, we added on an interim basis 
many services to the list of eligible Medicare telehealth services, 
eliminating frequency limitations and other requirements associated 
with particular services furnished via telehealth, and clarifying 
several payment rules that apply to other services that are furnished 
using telecommunications technologies that can reduce exposure risks 
(85 FR 19232).
    Section 1834(m) of the Act 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. When furnished under the telehealth 
rules, these specified Medicare telehealth services are reported using 
the same codes used for the ``face-to-face'' services, but are 
furnished using audio/video, real-time, interactive communications 
technology instead of in person. As such, the majority of the codes for 
primary care services included in the additional telehealth services 
added in the March 31st COVID-19 IFC for purposes of the PHE for COVID-
19 are already included in the definition of primary care services for 
purposes of the MIPS beneficiary assignment methodology for the CMS Web 
Interface and CAHPS for MIPS Survey (81 FR 77168 through 77169; and 82 
FR 53646 through 53647).
    In the March 31st COVID-19 IFC, we also established flexibilities 
and separate payment for certain services that are furnished virtually 
using communication technologies, but that are not considered Medicare 
telehealth services such as virtual check-ins, e-visits. Additionally, 
we established separate payment for telephone E/M services codes during 
the PHE. The CTBS and the telephone E/M services are not currently 
included in the MIPS beneficiary assignment methodology for the CMS Web 
Interface and CAHPS for MIPS Survey.
    We believe it is critical to include codes for CTBS and telephone 
E/M services, as identified and discussed later in this section, in the 
definition of primary care services to ensure these services are 
included in our determination of where beneficiaries receive the 
plurality of their primary care for purposes of beneficiary assignment. 
Such inclusion ensures that the assignment methodology appropriately 
reflects the expanded use of technology that is helping people who need 
routine care during the PHE for COVID-19 and allowing vulnerable 
beneficiaries and beneficiaries with mild symptoms to remain in their 
homes, while maintaining access to the care they need. By including 
services provided virtually, either through telehealth, or other uses 
of communications technology, we ensure that this care is appropriately 
reflected in our consideration of the plurality of care used to assign 
beneficiaries to groups and virtual groups.
(ii) Use of Codes for Virtual Check-ins, Remote Evaluations E-Visits, 
and Telephone E/M Services in MIPS Beneficiary Assignment for the CMS 
Web Interface and CAHPS for MIPS Survey
    We added new services to the separately billable CTBS under the PFS 
over the past several years and a result of the PHE for COVID-19, we 
expect that the utilization of CTBS will substantially increase during 
the PHE for the COVID-19 pandemic and thereafter. We believe that 
clinicians are increasingly using such services as a key component of 
their ongoing primary care. In the September 2nd COVID-19 IFC (85 FR 
54820), we codified the definition of primary care services used in the 
MIPS beneficiary assignment methodology for the CMS Web Interface and 
CAHPS for MIPS Survey. The included codes consisted of previously 
finalized codes that were already considered primary care services and 
additional codes that we will be treating as primary care services for 
the duration of the PHE for COVID-19. The previously finalized codes 
were as follows: (1) CPT codes: 99201 through 99215 (codes for office 
or other outpatient visit for the E/M of a patient); 99304 through 
99318 (codes for professional services furnished in a nursing facility, 
excluding professional services furnished in a SNF for claims 
identified by place of service (POS) modifier 31) (81 FR 77168); 99319 
through 99340 (codes for patient domiciliary, rest home, or custodial 
care visit); 99341 through 99350 (codes for E/M services furnished in a 
patients' home for claims identified by POS modifier 12); 99487, 99489, 
and 99490 (codes for

[[Page 84876]]

chronic care management); and 99495 and 99496 (codes for transitional 
care management services); and (2) HCPCS codes: G0402 (code for the 
Welcome to Medicare visit); and G0438 and G0439 (codes for the annual 
wellness visits). The additional codes we added through the September 
2nd COVID-19 IFC are as follows: (1) CPT codes: 99421, 99422, and 99423 
(codes for online digital E/M service (e-visit)), and 99441, 99442, and 
99443 (codes for telephone E/M services); and (2) HCPCS codes: G2010 
(code for remote evaluation of patient video/images) and G2012 (code 
for virtual check-in). It should be noted that the inclusion of such 
codes for the MIPS beneficiary assignment methodology for the CMS Web 
Interface and CAHPS for MIPS Survey aligns with the revision that was 
made to the definition of primary care services used for purposes of 
beneficiary assignment under the Medicare Shared Savings Program to 
include the same codes in determining beneficiary assignment for 
performance year 2020 and any subsequent performance year that starts 
during the PHE for COVID-19 (85 FR 27583 through 27586).
    The services listed above are an important component of primary 
care and as a result, we believe it is appropriate to include these 
codes in the definition of primary care services used for assignment 
for the CMS Web Interface and CAHPS for MIPS Survey because the 
services represented by these codes are being used in place of similar 
E/M services, the codes for which are already included in the list of 
codes used for assignment. It should be noted that the remote 
evaluation of patient video/images and virtual check-in codes, and the 
online digital E/M service (e-visit) codes are not separately billable 
by a clinician if they are related to a visit within the past 7 days or 
lead to a visit within the following 24 hours or next available 
appointment. The only codes that are newly billable during the PHE for 
COVID-19 pertain to the telephone E/M services.
    We included the codes in the definition of primary care services 
for the 2020 performance year and any subsequent performance year that 
starts during the PHE for COVID-19. We recognized that the application 
of this policy for the 2020 MIPS performance period is retroactive. 
Section 1871(e)(1)(A)(ii) of the Act provides for retroactive 
application of a substantive change to an existing policy when the 
Secretary determines that failure to apply the policy change 
retroactively would be contrary to the public interest. Without the 
inclusion of these codes for purposes of the MIPS beneficiary 
assignment methodology for the CMS Web Interface and CAHPS for MIPS 
Survey for the 2020 performance year during the PHE for COVID-19, we 
would not be able to adequately account for the ways in which 
beneficiaries are receiving primary care services during the PHE for 
COVID-19 and as a result, the process to derive assignment and sampling 
of beneficiaries for the CMS Web Interface and CAHPS for MIPS Survey 
would not be able to comprehensively capture how primary care services 
are being furnished to beneficiaries, which may cause many groups and 
virtual groups to have insufficient sample sizes to be able to 
administer the 2020 CAHPS for MIPS Survey or report data for the 
quality performance category using the CMS Web Interface measures. In 
regard to the CMS Web Interface, such groups and virtual groups may not 
have sufficient time to select an alternate collection type and prepare 
their systems to report on measures from a different collection type 
before the submission period begins for the 2020 performance period and 
as a result, they would not be able to meet the quality performance 
category reporting requirements, which could negatively impact their 
MIPS final score and MIPS payment adjustment. We believe it is 
important to include the above codes in our assignment methodology 
because we determine assignment based upon where beneficiaries receive 
the plurality of their primary care services and whether beneficiaries 
have designated a MIPS eligible clinician as their primary clinician, 
responsible for their overall care, and hold groups and virtual groups 
accountable for the resulting assigned beneficiary population. 
Including such codes in the definition of primary care services used in 
MIPS beneficiary assignment during the PHE for COVID-19 will result in 
a more accurate identification of where beneficiaries have received the 
plurality of their primary care services.
    We received the following comments on the codified definition of 
primary care services used in the MIPS beneficiary assignment 
methodology for the CMS Web Interface and CAHPS for MIPS Survey.
    Comment: Several commenters supported the proposal to expand the 
use of telehealth codes to the definition of primary care services that 
is used in the beneficiary assignment for purposes of MIPS for the CMS 
Web Interface and CAHPS for MIPS Survey. The commenters indicated that 
the inclusion of CTBS and telephone E/M services in the primary care 
definition appropriately reflects the reality of the care being 
provided during the PHE for COVID-19 and allows patients with mild 
symptoms to remain in their homes while maintaining access to care. 
Some commenters stated that the expansion of CTBS and telephone E/M 
services codes may incentivize clinical data registry reporting. A few 
commenters recommended that CMS continue this policy on a permanent 
basis.
    Response: We appreciate the support from commenters. In regard to 
the comment about the applicability of including the added CTBS and 
telephone E/M services codes for purposes of the assignment methodology 
on a permanent basis, we note that for purposes of the CMS Web 
Interface, the addition of such codes would be included for the 2020 
performance year and any subsequent performance year that starts during 
the PHE for COVID-19. The CMS Web Interface will be removed as a 
collection and submission type starting with the 2022 performance 
period. For purposes of the CAHPS for MIPS Survey, in section 
IV.A.3.c.(1)(f)(ii) of this final rule, we note that the inclusion of 
the added CBTS and telephone E/M services codes in the assignment 
methodology would be applicable for PY 2021 and subsequent performance 
years.
    Comment: One commenter requested that CMS consider the inclusion of 
audio-only services.
    Response: We will take into consideration the inclusion of other 
additional service codes pertaining to telehealth services for future 
rulemaking.
    After consideration of the public comments, we are finalizing the 
provisions of the September 2nd COVID-19 IFC without any modifications. 
We are finalizing the codified definition of primary care services used 
in the MIPS beneficiary assignment methodology for the CMS Web 
Interface and CAHPS for MIPS Survey for the 2020 performance year due 
to the PHE for COVID-19 as defined in Sec.  400.200, to include the 
following additions: (1) CPT codes: 99201 through 99215 (codes for 
office or other outpatient visit for the E/M of a patient); 99304 
through 99318 (codes for professional services furnished in a nursing 
facility, excluding professional services furnished in a SNF for claims 
identified by place of service (POS) modifier 31) (81 FR 77168); 99319 
through 99340 (codes for patient domiciliary, rest home, or custodial 
care visit); 99341 through 99350 (codes for E/M services furnished in a 
patients' home for claims identified by POS modifier

[[Page 84877]]

12); 99421, 99422, and 99423 (codes for online digital E/M service (e-
visit)), and 99441, 99442, and 99443 (codes for telephone E/M 
services); 99487, 99489, and 99490 (codes for chronic care management); 
and 99495 and 99496 (codes for transitional care management services); 
and (2) HCPCS codes: G0402 (code for the Welcome to Medicare visit); 
G0438 and G0439 (codes for the annual wellness visits); G2010 (code for 
remote evaluation of patient video/images); and G2012 (code for virtual 
check-in).
(2) Cost Performance Category
    We refer readers to the CY 2017 and CY 2018 Quality Payment Program 
final rules, and the CY 2019 and CY 2020 PFS final rules (81 FR 77162 
through 77177, 82 FR 53641 through 53648, 83 FR 59765 through 59776, 
and 84 FR 62959 through 62968, respectively) for a description of the 
statutory basis and existing policies pertaining to the cost 
performance category.
    In the CY 2021 PFS proposed rule (85 FR 50293), we proposed to 
weight the cost performance category at 20 percent for MIPS payment 
year 2023 and 30 percent for MIPS payment year 2024 and all subsequent 
MIPS payment years.
(a) Weight in the Final Score
    Under section 1848(q)(5)(E)(i)(II)(aa) of the Act, in general, 30 
percent of the MIPS final score shall be based on the cost performance 
category. However, section 1848(q)(5)(E)(i)(II)(bb) of the Act gives 
the Secretary discretion with respect to the weight of the cost 
performance category for the first 5 years of MIPS. Specifically, under 
that section, for the first year for which the MIPS applies to payments 
(the 2019 MIPS payment year), not more than 10 percent of the MIPS 
final score shall be based on the cost performance category; and for 
each of the second, third, fourth, and fifth years for which the MIPS 
applies to payments (the 2020, 2021, 2022, and 2023 MIPS payment years, 
respectively), not less than 10 percent and not more than 30 percent of 
the MIPS final score shall be based on the cost performance category. 
Additionally, section 1848(q)(5)(E)(i)(II)(bb) of the Act states that 
it shall not be construed as preventing the Secretary from adopting a 
30 percent weight for the second, third, fourth, or fifth year 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. The weights adopted in prior rulemaking for the 
cost performance category are codified under Sec.  414.1350(d).
    In the CY 2020 PFS proposed rule (84 FR 40752), we proposed to 
incrementally increase the weight of the cost performance category from 
the existing weight of 15 percent for the 2021 MIPS payment year to 30 
percent beginning with the 2024 MIPS payment year as required by 
section 1848(q)(5)(E)(i)(II)(aa) of the Act. We proposed to 
incrementally increase the weight of the cost performance category by 5 
standard increments each year through the 2024 MIPS payment year, 
reflecting a weight of 20 percent for the 2022 MIPS payment year, 25 
percent for the 2023 MIPS payment year, and 30 percent for the 2024 
MIPS payment year and each subsequent MIPS payment year (84 FR 40752 
through 40753).
    As cost measures are still being developed, we recognized that 
clinicians may not have the same level of familiarity or understanding 
of cost measures as they do with the comparable quality measures. To 
implement a gradual and predictable approach of increasing the weight 
of the cost performance category each year would provide clinicians 
with adequate time to prepare for a 30 percent weight and enable 
clinicians to gain experience with the cost measures while they 
represent a smaller portion of the MIPS final score. We recognized that 
there may be greater understanding of the measures in the cost 
performance category as clinicians obtain more experience with the 
measures (84 FR 62959).
    After considering the comments we received, we did not finalize our 
proposals, and instead established at Sec.  414.1350(d)(3) that the 
weight of the cost performance category will remain at 15 percent of 
the MIPS final score for MIPS payment years 2021 and 2022 (84 FR 
62961). We stated that we expected to propose a weight for the cost 
performance category for the 2023 MIPS payment year in the CY 2021 PFS 
proposed rule.
    In developing the proposals in the CY 2021 PFS proposed rule, we 
considered a range of numerical options for the weight of the cost 
performance category for the 2023 MIPS payment year, with the intention 
of reaching a weight of 30 percent no later than the 2024 MIPS payment 
year as required by the statute. The first option we considered was to 
maintain the cost performance category weight at the status quo for an 
additional year, in which it would remain at 15 percent for the 2023 
MIPS payment year and then increase to 30 percent beginning with the 
2024 MIPS payment year, which would be a 100 percent increase (an 
increase of 15 percentage points) in the weight from 2023 to 2024. We 
considered such option as a result of the PHE for COVID-19 in order to 
not increase the weight of the cost performance category during an 
unprecedented time. However, by maintaining the weight at 15 percent 
for the 2023 MIPS payment year, the weight would increase two-fold to 
30 percent beginning with the 2024 MIPS payment year, which we believe 
would pose a significant burden to stakeholders and would eliminate any 
transition of an incremental increase in the cost performance category 
weight. We believe that the first option would be more burdensome than 
beneficial to clinicians as they continue to gain more experience with 
the cost measures and confront the PHE for COVID-19.
    The second option we considered was to increase the weight from 15 
percent for MIPS payment years 2021 and 2022 to 20 percent for the 2023 
MIPS payment year in order to provide a minimal transition that would 
enable clinicians to continue to become familiar with the cost measures 
and be prepared for the final increase in the weight of the cost 
performance category from 20 percent to 30 percent beginning with the 
2024 MIPS payment year. We believe that such approach would allow us to 
reach the statutorily required weight of 30 percent by the 2024 MIPS 
payment year while providing clinicians with an eased incremental 
transition starting with the 2023 MIPS payment year and accounting for 
the consequential impact of the increased clinical costs associated 
with the PHE for COVID-19. For the 2023 MIPS payment year, we sought to 
identify a smaller increase in weight while enabling clinicians to gain 
more experience and familiarity with the cost measures amidst the 
mitigation of the PHE for COVID-19.
    After considering these options, we proposed to establish at Sec.  
414.1350(d)(4) the weight of the cost performance category to be 20 
percent of the MIPS final score for the 2023 MIPS payment year and at 
Sec.  414.1350(d)(5) the weight of the cost performance category to be 
30 percent for the 2024 MIPS payment year and each subsequent MIPS 
payment year.
    We solicited public comment on the proposal, the other options we 
considered, and any additional options for the weight of the cost 
performance category that commenters believe we should consider, such 
as a 22.5 percent weight for the 2023 MIPS payment year and a 30 
percent weight beginning with the 2024 MIPS payment year (a 7.5 percent 
increase for each year). In

[[Page 84878]]

general, we noted that we prefer to consider whole numbers for 
performance category weights, but were interested in obtaining feedback 
from commenters on the weighing of the cost performance category to 
have an increase of 7.5 percent for 2 consecutive years for the 2023 
and 2024 MIPS payment years.
    The following is a summary of the public comments received 
regarding the proposal to establish the weight of the cost performance 
category to be 20 percent of the MIPS final score for the 2023 MIPS 
payment year and 30 percent of the MIPS final score for the 2024 MIPS 
payment year and each subsequent MIPS payment year and other options 
for weighting the cost performance category.
    Comment: Several commenters supported the proposal to reduce the 
weight of the quality performance category while simultaneously 
increasing the weight of the cost performance category. Some commenters 
supported a gradual and incremental weight increase of the cost 
performance category from 20 percent for the 2023 MIPS payment year to 
30 percent for the 2024 MIPS payment year as a means to balance short-
term scoring changes with long-term statutory requirements, which would 
enable MIPS eligible clinicians, groups, and virtual groups to continue 
to become familiar with cost measures and be prepared for the final 
weight increase to 30 percent for the 2024 MIPS payment year. One 
commenter indicated that such increases to the weight of the cost 
performance category have been anticipated and is statutorily mandated. 
Another commenter indicated that the changes to the weight of the cost 
performance category would heighten the importance of efficiency and 
cost control for clinicians remaining in FFS and encourage more 
clinicians to consider migrating to APMs. Another commenter stated that 
the gradual and incremental increase in weighting for the cost 
performance category would help compensate for the impact of increased 
clinical costs associated with the PHE for COVID-19.
    Response: We appreciate the support from commenters and agree that 
providing a 2-year timeframe for the cost performance category to 
gradually increase would allow us to meet the statutory requirement for 
weighing the cost performance category at 30 percent by the 2024 MIPS 
payment year. We also agree that this approach of gradually and 
incrementally increasing the weight of cost enables MIPS eligible 
clinicians, groups, and virtual groups to continue to become familiar 
with the cost measures during the PHE for COVID-19.
    Comment: In regard to other options for weighing the cost 
performance category, one commenter indicated that a 7.5 percent 
increase in weight each year over a 2-year period (22.5 percent for the 
2023 MIPS payment year and 30 percent for 2024 MIPS payment year) may 
be the most equal option, but that a 5-percentage point weight increase 
from 15 percent to 20 percent for the 2023 MIPS payment year and a 10-
percentage point weight increase from 20 percent to 30 percent for the 
2024 MIPS payment year would not be any more of a burden. Another 
commenter recommended that the weight of the cost performance category 
be weighted in whole numbers.
    Response: We recognize that any increase in weight for the cost 
performance category could potentially pose varying levels of burden; 
however, we sought to decrease burden by establishing a gradual and 
incremental transition over a 2-year period while allowing clinicians 
to gain more experience with the cost measures and confront the 
challenges brought forth by the PHE for COVID-19. We believe that 
increasing the weight of the cost performance category from 15 percent 
to 20 percent for the 2023 MIPS payment year in order to provide a 
minimal transition would enable clinicians to continue to become 
familiar with the cost measures and be prepared for the final increase 
in the weight of the cost performance category from 20 percent to 30 
percent beginning with the 2024 MIPS payment year, which allows 
clinicians to become familiar with cost measures and accounts for the 
consequential impact of the increased clinical costs associated with 
the PHE for COVID-19. In regard to the comment pertaining to the weight 
of the cost performance category to be in whole numbers, we agree with 
the commenter that weighting the cost performance category in whole 
numbers may reduce added confusion and complexity within our scoring 
system.
    Comment: A few commenters suggested that as the weight of the cost 
category increases, CMS should help clinicians understand their 
performance throughout the performance period by creating an 
application programming interface (API) or another mechanism to provide 
MIPS eligible clinicians, groups, and virtual groups with real-time 
information about their cost score in order for them to understand 
their performance during the performance year and identify areas for 
improvement.
    Response: We appreciate the recommendation from the commenters. We 
strive to provide performance feedback reports on the MIPS performance 
categories as soon as we are able to technically and feasibly do so. In 
order to further assist MIPS eligible clinicians, groups, and virtual 
groups in understanding their performance under the cost performance 
category, we provide additional feedback on cost measures that is at 
the patient level. With the submission and analysis of all data, 
including the assessment and calculation of cost data occurring after 
the conclusion of the applicable performance year, it would be 
impossible to provide real-time scores and feedback reports when the 
cost performance category has a performance period of a full calendar 
year, in which performance is based on 12 months of data. We believe 
that MIPS eligible clinicians, groups, and virtual groups are able to 
benefit and effectively utilize the performance feedback reports that 
are typically available around July 1 after the close of the submission 
period for an applicable performance period. Information provided in 
the feedback reports are applicable and can be used by MIPS eligible 
clinicians, groups, and virtual groups to identify areas for 
improvement for the cost performance category.
    Comment: Many commenters did not support the proposal to reduce the 
weight of the quality performance category to increase the weight of 
the cost performance category during the PHE for COVID-19 given 
clinicians are burdened in new ways and trying to navigate through 
various challenges brought on by the PHE. Several commenters indicated 
that the PHE for COVID-19 has caused major disruptions in practice, 
prompting the need to adjust to unusual and unpredictable patient 
volumes, and indicated that the PHE would impact performance data and 
therefore, the ability of CMS to accurately assess quality and cost. 
One commenter indicated that practices in COVID-19 hotspots that are 
testing for and treating patients with the virus, and fighting the 
pandemic would be unfairly penalized. Several commenters urged CMS to 
defer changes to the weight of the cost performance category and 
maintain the weight at 15 percent of the final MIPS score for the 2023 
MIPS payment year while a few commenters recommended that the cost 
performance category be reweighted to zero percent for the 2023 MIPS 
payment year to provide clinicians with more time to care for patients 
through the pandemic, as well as familiarize themselves with

[[Page 84879]]

their resource use, including telehealth visits.
    Other commenters expressed concern regarding the appropriateness of 
the cost measures, specifically indicating that there are not many cost 
measures available to assess cost performance, particularly for 
specialties. These commenters indicated that a limited number of cost 
measures would have significant implications for not accurately 
measuring cost performance and requested that we add new cost episodic-
based measures for specialties. One commenter expressed concern that 
the outcome measures for many specialties are still in the testing 
phase and indicated that there continues to be confusion surrounding 
their use and reliability. These commenters did not support any 
increases to the weight of the cost performance category until more 
cost measures are available and concerns regarding the validity and 
accuracy of existing cost measures are addressed (for example, 
attributing costs at the group level (not attributing the same costs to 
both individual clinicians and groups), adjusting for risk of social 
determinants of health, publishing detailed testing results, and 
holding all measures to strict standards for reliability, statistical 
significance, actionability, and impact on health outcomes).
    Response: Under section 1848(q)(5)(E)(i)(I) and (II) of the Act, 
for each of the first 5 years of MIPS, the weight of the quality 
performance category in the final score is determined based on the 
weight of the cost performance category. The statute requires that by 
the sixth year of MIPS, the quality performance category and the cost 
performance category each will make up 30 percent of the final score. 
Given that the percentage points attributed to the quality and cost 
performance categories are in tandem, we believe that it is important 
to meet the statutory requirements while balancing the impact of 
simultaneously reducing the weight of the quality performance category 
and increasing the weight of the cost performance category. We believe 
that increasing the weight of the cost performance category to 20 
percent for the 2023 MIPS payment year and 30 percent for the 2024 MIPS 
payment year and each subsequent MIPS payment year provides a 
transition that eases the impact of experiencing an increase in the 
weight of the cost performance category by enabling a gradual and 
incremental transition over a 2-year period while clinicians confront 
the challenges brought forth by the PHE for COVID-19 and become 
familiar with cost measures and feedback reports.
    In regard to concerns regarding an insufficient number of cost 
measures for specialties, and the appropriateness, actionability, 
validity, and accuracy of available cost measures, we recognize that 
measures focusing on specific clinical areas and specialties allow for 
clinicians to receive more actionable and meaningful feedback. To date, 
we have developed and implemented 18 episode-based cost measures, which 
are intended to capture the nuances of costs associated with procedures 
and conditions spanning different types of specialties and clinical 
areas. We revised the total per capita cost measure to focus on 
specialties that provide primary care and the Medicare spending per 
beneficiary clinician measure to focus on costs associated with an 
inpatient hospitalization. We anticipate that future measures may apply 
to a greater range of specialties and clinical areas, including areas 
suggested by stakeholders. We believe that we are able to continue to 
accurately assess performance for the cost performance category with 
the available cost measures; in the event that we cannot calculate a 
score for a given cost measure (for example, if we cannot calculate a 
benchmark for the measure, or a clinician does not meet the minimum 
case volume), the measure will not be scored and thus will not affect a 
clinician's overall cost performance category score. It should be noted 
that we are not able to address concerns with the existing cost 
measures during this rulemaking cycle for 2021 performance year given 
that any new cost measure or modifications to the existing cost 
measures for the 2021 performance period would have had to be proposed 
in the CY 2021 PFS proposed rule. The next opportunity for us to 
introduce new cost measures or modify existing measures would be for 
the 2022 performance year rulemaking cycle. We do not believe that 
maintaining the weight of the cost performance category at 15 percent 
until there are additional cost measures or modifications made to cost 
measures would be appropriate as we are statutorily required to 
increase the weight of the cost performance category to 30 percent by 
the 2024 MIPS payment year and want to ease the impact of experiencing 
the increase in the weight of the cost performance category by 
providing a gradual and incremental transition over a 2-year period. We 
believe it would be significantly more burdensome for MIPS eligible 
clinicians, groups, and virtual groups to experience a two-fold 
increase from 15 percent to 30 percent beginning with the 2024 MIPS 
payment year.
    In regard to the concerns about inaccurately assessing cost 
performance amidst the PHE for COVID-19 and unfairly penalizing 
practices in COVID-19 hotspots that are testing for and treating 
patients with the virus, and fighting the pandemic, we note that 
service assignment allows the episode-based cost measures to capture 
only the cost of services that are clinically related to the triggering 
event for the episode (for example, a knee replacement procedure or a 
hospitalization for stroke). This means that costs resulting from high 
volumes of COVID-19 treatment services are less likely to be captured 
in the episode-based costs measures. In addition, all cost measures, 
including total per capita cost measure and Medicare spending per 
beneficiary clinician measure are adjusted for clinical risk to account 
for different levels of care beneficiaries may require due to 
comorbidities, disability, age, and other risk factors. The risk 
adjustment model includes variables for clinical factors based on the 
patient's recent medical history that are outside the influence of the 
attributed condition to ensure that clinicians who treat higher risk 
populations, are not penalized. Also, cost measures use standardized 
claims payments to account for differences in Medicare payments for the 
same services across health care providers, removing the effect of 
regional differences in health care provider costs measured by the 
hospital wage indexes and geographic price cost indexes (GPCIs) or 
other payment adjustments such as those for teaching hospitals. The 
payment standardization process also removes the 20 percent increase in 
the IPPS relative weight under the CARES Act for individuals diagnosed 
with COVID-19. Furthermore, we have policies in place to account for 
scenarios when we cannot calculate a score for a given cost measure 
that does not meet our reliability and benchmark requirements. We 
believe that the measures in place will allow us to continue to 
accurately assess cost performance.
    In regard to the comment expressing concern about outcome measures 
for specialties, we note that we have not adopted any such measures in 
the cost performance category, as these are quality measures. The 
episode-based cost measures pertaining to specialties that we have 
adopted are procedural and acute inpatient medical condition measures. 
These measures focus on the clinicians performing particular procedures 
or managing particular acute

[[Page 84880]]

inpatient medical conditions. These clinicians may often come from one 
specialty, but not necessarily.
    After consideration of the public comments, we are finalizing our 
proposal to establish at Sec.  414.1350(d)(4) the weight of the cost 
performance category to be 20 percent of the MIPS final score for the 
2023 MIPS payment year and at Sec.  414.1350(d)(5) the weight of the 
cost performance category to be 30 percent of the MIPS final score for 
the 2024 MIPS payment year and each subsequent MIPS payment year. We 
believe that such approach allows us to reach the statutorily required 
weight of 30 percent by the 2024 MIPS payment year while reducing the 
impact of experiencing an increase in the weight of the cost 
performance category too much in any one year, and providing clinicians 
with an eased gradual and incremental transition starting with the 2023 
MIPS payment year.
(b) Addition of New Codes for Telehealth Services to Previously 
Established Measures for the Cost Performance Category Beginning With 
the 2021 Performance Period
    For the 2021 performance period and future performance periods, we 
proposed to add costs associated with certain telehealth services to 
the previously established cost measures. For each cost measure, the 
telehealth services we proposed to add are directly relevant to the 
intent of the measure. We referred readers to Table 47 in the CY 2020 
PFS final rule (84 FR 62979) for a summary list of the cost measures 
that have been established for the 2021 performance period and future 
performance periods, as well as the related discussions in the CY 2019 
PFS final rule (83 FR 59767 through 83 FR 59774) and the CY 2020 PFS 
final rule (84 FR 62962 through 62979). Many services included on the 
Medicare telehealth service list are billed as telehealth services 
through the use of a modifier appended to the same code that is used 
when the service is furnished in person. These codes are already 
included in the cost measures; however, the additional codes we 
proposed to add are not currently included for a few reasons. First, 
some of the codes we proposed to add to the cost measures were newly 
included on the Medicare telehealth services list through the March 
31st COVID-19 IFC (85 FR 19230) and subsequent subregulatory process 
established in the May 8th COVID-19 IFC (85 FR 27550). Second, some of 
the codes we proposed to add were not previously considered for 
inclusion because they were not billed widely enough to be found in 
empirical claims-based data. This is because our approach for 
determining clinically related services to include in cost measures, 
which we established in the CY 2019 PFS final rule (83 PFS 59767 
through 59771), relies on empirical data to examine existing practice 
patterns, in addition to clinical expertise. Having observed an 
increase in the use of these codes, including those that existed before 
the PHE for COVID-19, we proposed to add them to adapt the measures to 
this change in practice patterns. The codes we proposed to add to the 
cost measures represent service categories already captured in the 
measures (for example, E/M, follow up consultation following hospital 
discharge); thus, we do not consider their addition to alter the intent 
of the measures or capture a new category of costs. Updated measure 
specifications with the added telehealth codes are available on the CMS 
website at http://www.cms.gov/Medicare/Quality-Payment-Program/Quality-Payment-Program/Give-Feedback.
    We solicited public comment on the proposal. The following is a 
summary of the comments we received and our responses.
    Comment: Several commenters supported our proposal to add costs 
associated with certain telehealth services to the previously 
established cost measures beginning with the 2021 performance period. 
Other commenters requested that CMS release updated measure 
specifications that include the additional telehealth services as soon 
as possible.
    Response: We appreciate the support of our proposal to add costs 
associated with certain telehealth services to the cost measures. We 
posted the measure codes list files, which include the telehealth codes 
that we proposed to add for each cost measure, at the link specified in 
the proposed rule (http://www.cms.gov/Medicare/Quality-Payment-Program/Quality-Payment-Program/Give-Feedback) (85 FR 50294) for the duration 
of the public comment period.
    Comment: One commenter suggested that CMS explore options for 
separately identifying telehealth services on episode cost performance 
feedback reports provided to clinicians to help guide clinicians' 
assessment of optimal telehealth use from the cost perspective.
    Response: We thank the commenter for their suggestion. We will 
explore the possibility of including information on telehealth use when 
producing future performance feedback reports.
    Comment: A few commenters suggested that CMS conduct and publicly 
share testing on the inclusion of telehealth services in the existing 
cost measures so that clinicians can become more familiar with how 
these services will affect the measures and to allow CMS to implement 
any necessary changes based on input from physician specialty societies 
regarding the impact of the addition of these services. One commenter 
indicated that the codes CMS proposed to add within the cost measures 
represent service categories already captured in the measures and 
requested that CMS clarify whether they plan to alter the intent of the 
cost measures. Another commenter requested more information on how 
telehealth services would be identified, whether the inclusion of these 
services could penalize physicians practicing in areas with COVID-19 
outbreaks, and whether there will be downstream effects from adding 
codes that are only temporarily covered by Medicare during the PHE.
    Response: The addition of the proposed telehealth services and 
corresponding codes to the measures beginning with the 2021 performance 
period will ensure that the cost measures adapt to the changes in care 
provision and service utilization caused by the PHE. As we explained in 
the proposed rule (85 FR 50294), we do not consider the addition of the 
proposed codes for telehealth services to be a substantive change as 
they do not represent a new category of costs or change the intent of 
the measure and so we do not believe it is necessary to conduct 
specific testing on their inclusion for public feedback. Our intent is 
only to update the list of codes in the service categories already 
captured in the measures. For this reason, we do not anticipate that 
these services will have an impact on the measures' ability to 
accurately capture cost of care or clinician performance on measures in 
a way that is different from other similarly appropriate services that 
are currently included in the measures.
    Furthermore, not all telehealth services billed by a clinician will 
be automatically included in all of the cost measures. Specific 
telehealth services will be included in a given measure if they are 
clinically relevant (for example, contain a relevant diagnosis code) to 
the trigger event of the measure (for example, a knee arthroplasty). 
For this reason, clinicians in areas with COVID-19 outbreaks would not 
be adversely affected by the addition of these services to the cost 
measures; only telehealth services they bill in relation to the care 
provided for the trigger event would be included in the cost measure. 
The service assignment logic and the specific telehealth codes that we

[[Page 84881]]

proposed to include for each cost measure are available in the measure 
codes list files on the CMS website (http://www.cms.gov/Medicare/Quality-Payment-Program/Quality-Payment-Program/Give-Feedback).
    Upon the expiration of the PHE, Medicare will no longer include on 
the Medicare telehealth list the services that were added on an interim 
basis during the PHE for COVID-19, which we expect will result in the 
reduction of telehealth utilization in place of the corresponding in-
person services already included in the cost measures. As the cost 
measures include the costs of services found empirically in the 
Medicare claims data, only services actually billed by clinicians, 
whether furnished in-person or via telehealth, would be included in 
service assignment for the measure. For this reason, we do not 
anticipate any downstream effects of adding to the cost measures codes 
that may be temporarily billed as telehealth services. As we anticipate 
that telehealth will continue to occupy an important role in care 
delivery, we do not plan to remove the proposed telehealth codes from 
the cost measures unless they are no longer applicable or payable by 
Medicare. We will continue to monitor the telehealth services for 
potential updates, if necessary, as part of ongoing measure maintenance 
for the cost measures.
    Comment: One commenter indicated that the rationale for including 
telehealth costs within the cost performance category measures was 
understood, but urged CMS to consider developing hardship exemptions 
from such telehealth cost attribution and/or providing bonus points for 
cost measures that include telehealth services to help adjust for the 
upfront investments that solo practitioners and small practices would 
need to put forth to upstand and scale telehealth platforms during the 
PHE for COVID-19.
    Response: We appreciate the commenter's feedback. The proposed 
telehealth codes would be added to the cost measures to capture costs 
of services clinicians have continued to provide via telehealth and not 
in person during the PHE and that are related to the trigger event for 
a given measure. There is no separate telehealth cost attribution for 
which these codes would be used. Performance under the cost measures 
will be assessed according to existing MIPS scoring policies and any 
new policies we are finalizing in this rule. With regard to hardship 
exemptions, we provide the option for clinicians to submit applications 
requesting reweighting for one or more MIPS performance categories 
based on extreme and uncontrollable circumstance.
    After consideration of the public comments, we are finalizing our 
proposal to add costs associated with certain telehealth services and 
their corresponding codes to the previously established cost measures 
as proposed, beginning with the 2021 performance period.
(3) Improvement Activities Performance Category
(a) Background
    For previous discussions on the background of the improvement 
activities performance category, we refer readers to the CY 2017 
Quality Payment Program final rule (81 FR 77177 through 77178), the CY 
2018 Quality Payment Program final rule (82 FR 53648 through 53661), 
the CY 2019 PFS final rule (83 FR 59776 through 59777), and the CY 2020 
PFS final rule (84 FR 62980 through 62990). We also refer readers to 
Sec.  414.1305 for the definition of improvement activities and 
attestation, Sec.  414.1320 for the performance period, Sec.  414.1325 
for the data submission requirements, Sec.  414.1355 for the 
improvement activity performance category generally, Sec.  414.1360 for 
data submission criteria, and Sec.  414.1380(b)(3) for improvement 
activities performance category scoring.
    In the CY 2021 PFS proposed rule (85 FR 50294), beginning with the 
CY 2021 performance period and future years, we proposed: (1) Changes 
to the Annual Call for Activities: An exception to the nomination 
period timeframe during a PHE; and a new criterion for nominating new 
improvement activities; (2) a process for HHS-nominated improvement 
activities; and (3) to modify two existing improvement activities. In 
addition, in the March 31st COVID-19 IFC (85 FR 19276 through 19277), 
we adopted, on an interim final basis, a policy to add one new 
improvement activity to the Inventory for the CY 2020 performance 
period in response to the PHE titled ``COVID-19 Clinical Trials.'' The 
activity required that a clinician must attest to participation in a 
COVID-19 clinical trial utilizing a drug or biological product to treat 
a patient with a COVID-19 infection and report their findings through a 
clinical data repository or clinical data registry. Following the 
publication of March 31st COVID-19 IFC, we received several inquiries 
from stakeholders requesting further information on whether a clinician 
working with COVID-19 patients who provides their data to a clinical 
data registry, without participating in a clinical trial, may get 
credit for this activity. In our efforts to provide clarification we 
realized that we needed to codify changes in the regulation for this 
improvement activity to apply in the manner that was intended. 
Therefore, in the September 2nd COVID-19 IFC (85 FR 54848 through 
52851), we issued an IFC in which we adopted a modification, on an 
interim final basis, to the COVID-19 improvement activity that for CY 
2020 continuing into CY 2021, the improvement activity IA_ERP_3 titled 
``COVID-19 Clinical Data Reporting with or without Clinical Trial'' 
would include: (1) Clinicians participating in a COVID-19 clinical 
trial utilizing a drug or biological product to treat a patient with a 
COVID-19 infection who report their findings through a clinical data 
registry for the duration of their study; or (2) clinicians 
participating in the care of a patient diagnosed with COVID-19 who 
simultaneously submit their clinical patient data to a clinical data 
registry for research.
(b) Improvement Activities Inventory
(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

[[Page 84882]]

form available at www.qpp.cms.gov during the Annual Call for 
Activities.
(A) Timeframe for the Annual Call for Activities
(aa) Currently Adopted Timeframe
    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 available at www.qpp.cms.gov during the Annual 
Call for Activities.
    In the CY 2019 PFS final rule (83 FR 59781 through 59782), we 
finalized to change the performance year for which nominations of 
prospective new and modified improvement activities would apply, such 
that beginning with the CY 2019 performance period and for future 
years, 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. In addition, we finalized to 
change the submission timeframe for the Annual 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 beginning with the CY 2019 performance period.
(bb) Exception During Public Health Emergencies
    The unprecedented PHE \125\ for COVID-19 has brought to our 
attention the necessity of having the flexibility to consider 
nominations of new improvement activities to the Inventory outside the 
established Annual Call for Activities nomination period. We believe 
having the flexibility to consider nominations during a PHE is 
important because of the nature of a PHE; we want the ability to 
consider relevant improvement activities while the emergency is 
ongoing. We refer readers to the CY 2019 PFS final rule (83 FR 59779) 
for a complete definition of PHE and its application to inclusion 
criteria for new improvement activities.
---------------------------------------------------------------------------

    \125\ https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
---------------------------------------------------------------------------

    As a result, beginning with the CY 2021 performance period, we 
proposed to make an exception to the established timeframe, such that 
during a PHE, stakeholders can nominate improvement activities outside 
of the established Annual Call for Activities timeframe. Instead of 
only accepting nominations and modifications submitted February 1st 
through June 30th each year, we would accept nominations for the 
duration of the PHE as long as the improvement activity is still 
relevant. No other aspects of the Annual Call for Activities process 
would be affected (for example, criteria for nominating improvement 
activities, considerations for selection of improvement activities, or 
weighting policies would all still apply). We noted that we continue to 
believe it is important for stakeholders to be able to comment on 
improvement activities. Therefore, any improvement activity considered 
for inclusion in the Inventory would be finalized through a future 
rulemaking. We invited public comments on the proposal.
    We received public comments on the proposal to make an exception to 
the established Annual Call for Activities timeframe, such that during 
a PHE, stakeholders can nominate improvement activities outside of the 
established Annual Call for Activities timeframe. The following is a 
summary of the comments we received and our responses.
    Comment: Several commenters supported adding flexibility to 
consider nominations of new improvement activities outside the 
established Annual Call for Activities nomination period during a PHE, 
noting that it will allow new improvement activities to reflect real-
world events, spur innovation, and allow for timely responses to a PHE.
    Response: We appreciate the support for establishing the 
flexibility to consider nominations of new improvement activities 
outside the established Annual Call for Activities nomination period 
during a PHE. We believe that this flexibility will allow us to be 
responsive to the needs of clinicians during PHEs.
    Comment: A few commenters supported adding this flexibility, but 
recommended that data validation and other guidance for how to receive 
credit be provided when activities were introduced, that new additions 
allow for a 90-day performance period with a ``ramp-up'' period, and 
that feedback be provided on why certain submitted improvement 
activities were not accepted.
    Response: We appreciate the additional comments related to data 
validation, a ``ramp-up'' period, and feedback for submitted activities 
that are not accepted. No other aspects of the Annual Call for 
Activities process would be affected (for example, criteria for 
nominating improvement activities, considerations for selection of 
improvement activities, or weighting policies would all still apply). 
We noted that we continue to believe it is important for stakeholders 
to be able to comment on improvement activities. Therefore, any 
improvement activity considered for inclusion in the Inventory would be 
finalized through a future rulemaking. For improvement activities 
related to a PHE, we plan to issue subregulatory guidance as soon as 
feasible following adoption of the new improvement activity. 
Improvement activities added during a PHE will be subject to the same 
90-day performance period requirement as all improvement activities and 
will be available for reporting as stated in the regulation that the 
new activity is finalized. There will not be an added ``ramp-up'' or 
trial period as the goal of this added flexibility is to encourage 
clinicians to begin addressing the PHE as soon as possible and get 
credit for early efforts.
    Comment: We received a few comments stating that the improvement 
activity submission and acceptance process through the Annual Call for 
Activities is unclear. Commenters stated that they are uncertain what 
types of improvement activities we are looking for, and the reasons 
improvement activities are not accepted are not explicitly provided. A 
few commenters recommended that we should better incorporate the 
suggestions of physicians and specialty societies and allow more time 
for providers to adjust

[[Page 84883]]

to changes to improvement activities before they take effect.
    Response: We understand the need for feedback on why certain 
submitted improvement activities were not accepted during the Call for 
Activities and will do our best to provide clear responses when not 
accepting suggested activities in the future. In the CY 2018 Quality 
Payment Program final rule (85 FR 53656 through 53660), we provide 
details regarding adding new activities through the Annual Call for 
Activities, the criteria for nominating new improvement activities, and 
the submission timeline for nominating new improvement activities. In 
addition, each year we provide subregulatory guidance that contains 
comprehensive information regarding the Annual Call for Activities. We 
refer readers to these documents on the Quality Payment Program website 
in the resource library at https://qpp.cms.gov/about/resource-library. 
After consideration of the public comments, we are finalizing this 
policy as proposed.
(B) Criteria for Nominating New Improvement Activities
    In the CY 2019 PFS final rule (83 FR 59778 through 59779), we 
adopted one new criterion and removed a criterion from the improvement 
activities nomination criteria. We also clarified our considerations in 
selecting improvement activities.
(aa) Currently Adopted Criteria
    In the CY 2017 Quality Payment Program final rule (81 FR 77190 
through 77195), 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 should 
apply one or more of the below criteria when submitting nominations for 
improvement activities (82 FR 53660). In addition, in the CY 2019 PFS 
final rule (83 FR 59779) we finalized to add a ``public health 
emergency as determined by the Secretary'' to the criterion below.
     Relevance to an existing improvement activities 
subcategory (or a proposed new subcategory);
     Importance of an activity toward achieving improved 
beneficiary health outcomes;
     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.
(bb) New Criteria
    In addition to the aforementioned considerations, when considering 
improvement activities for possible inclusion in MIPS, we proposed that 
beginning with the 2021 Call for Activities, MIPS improvement 
activities submitted should be linked to existing and related quality 
and cost measures, as applicable and feasible. Stakeholders that select 
this criteria would be required to provide a rationale describing how 
they believe their improvement activity correlates to other performance 
category measures as a part of the Call for Activities. We noted that 
we believe that when possible, it is important to establish a strong 
linkage between quality, cost, and improvement activities.
    Therefore, we proposed to adopt an additional criterion entitled 
``Include activities which can be linked to existing and related MIPS 
quality and cost measures, as applicable and feasible'' to the criteria 
for nominating new improvement activities beginning with the CY 2021 
performance period and future years. We noted that if the proposal to 
add one criterion is adopted as proposed, stakeholders should apply one 
or more of the below criteria when submitting nominations for 
improvement activities beginning with the CY 2021 performance period 
and future years:
     Relevance to an existing improvement activities 
subcategory (or a proposed new subcategory);
     Importance of an activity toward achieving improved 
beneficiary health outcomes;
     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;
     Include activities which can be linked to existing and 
related MIPS quality and cost measures, as applicable and feasible; or
     CMS is able to validate the activity.
    We received public comments on the proposal to adopt an additional 
criterion entitled ``Include activities which can be linked to existing 
and related MIPS quality and cost measures, as applicable and 
feasible'' to the criteria for nominating new improvement activities. 
The following is a summary of the comments we received and our 
responses.
    Comment: Several commenters supported the proposal for improvement 
activities to be linked to existing and related MIPS quality and cost 
measures, noting that it could offer more visibility for cost measures, 
synchronize cost and quality measures, and help reduce reporting 
burden.
    Response: We appreciate commenters' support for this policy. We 
believe these policies will also facilitate cohesive MVPs in the 
future.
    Comment: A few commenters supported linking improvement activities 
to MIPS quality and cost measures but recommended deferring the 
requirement until the MIPS MVPs have been implemented and assessed. 
Commenters also recommended linking new improvement activities to 
existing MIPS QCDR measures, adding more improvement activities that 
are focused on specific specialties and clinician types and can be more 
easily linked to quality and cost measures, and allowing new 
improvement activities to be added even when they cannot be linked to 
existing quality and cost measures.
    Response: We appreciate the support for linking improvement 
activities to MIPS quality and cost measures. To clarify, linking 
nominated improvement activities to existing and related MIPS quality 
and cost measures is not a stand-alone requirement. In the proposed 
rule, we proposed that beginning with the 2021 Call for Activities, 
MIPS improvement activities submitted should be linked to existing and 
related MIPS quality and cost measures, as

[[Page 84884]]

applicable and feasible. Stakeholders should apply one or more of the 
listed criteria when submitting nominations for improvement activities. 
The quality and cost performance categories are two of the four 
performance categories required by statute in MIPS. We believe that the 
improvement activities should be linked to existing and related quality 
and cost measures rooted in statute. We applied a similar criterion for 
the quality measures as finalized in the CY 2020 PFS final rule (84 FR 
62954) such that beginning with the 2020 Call for Measures process, 
MIPS quality measure stewards will be required to link their MIPS 
quality measures to existing and related cost measures and improvement 
activities, as applicable and feasible. MIPS quality measure stewards 
will be required to provide a rationale as to how they believe their 
measure correlates to other performance category measures and 
activities as a part of the Call for Measures process. In addition, we 
have finalized in the CY 2020 PFS final rule (84 FR 63063 through 
63065) that QCDRs will be required to link their QCDR measures to 
existing and related cost measures and improvement activities, as 
applicable and feasible.
    Comment: Several commenters supported making changes to how MIPS 
improvement activities are developed and added to the Improvement 
Activity Inventory, including selecting improvement activities that 
promote modern connected technologies, incent clinicians who 
participate in COVID-19 efforts, encourage clinicians who serve as 
preceptors for students, promote integration of registered dietitians 
on population management care teams, incent bone health, and expand the 
list of health equity-related improvement activities.
    Response: We encourage stakeholders to submit nominations for 
activities through the Call for Activities period where nominations may 
include promoting modern connected technologies, incenting clinicians 
who participate in COVID-19 efforts, encouraging clinicians who serve 
as preceptors for students, promoting integration of registered 
dietitians on care teams, incenting bone health, and increasing the 
number of health equity-related improvement activities. Regarding the 
latter, we currently have an improvement activity in the Inventory, 
IA_AHE_6, titled ``Provide Education Opportunities for New Clinicians'' 
that is weighted high for participation as a preceptor for clinicians 
in-training that encourage clinical rotation in community practices in 
small underserved, or rural areas. If the commenter believes an 
additional improvement activity for preceptors should be included in 
the Inventory, we encourage them to submit a nomination through the 
Call for Activities. In addition, in the September 2nd COVID-19 IFC (85 
FR 54848 through 52851), we adopted, on an interim final basis, a 
policy to add an additional improvement activity to the Inventory for 
CY 2020 and CY 2021. We also refer readers to Appendix 2 of the CY 2021 
PFS proposed rule (85 FR 50664 through 50665) for further details and 
Appendix 2 of this final rule for responses to comments received and 
finalization of the COVID-19 improvement activity, IA_ERP_3, titled 
``COVID-19 Clinical Data Reporting with or without Clinical Trial.'' 
Furthermore, in section IV.A.3.c.(3)(b)(i) of this final rule, we are 
finalizing an exception to the established Annual Call for Activities 
timeframe, such that during a PHE, stakeholders can nominate 
improvement activities outside of the established Annual Call for 
Activities timeframe. In section IV.A.3.c.(3)(b)(ii) of this final 
rule, we are also finalizing a process for HHS-nominated improvement 
activities. Combined, we believe these two new policies will help 
streamline efforts to create MIPS policies in a timely manner in 
response to PHEs.
    After consideration of the public comments, we are finalizing this 
policy as proposed.
(ii) HHS-Nominated Improvement Activities
(A) Background
    As stated in the CY 2021 PFS proposed rule (85 FR 50295), this 
unprecedented PHE for COVID-19 has brought to our attention the 
necessity of having the flexibility to consider nominations of new 
improvement activities to the Inventory outside the Annual Call for 
Activities nomination period and process.'' We noted that we believe 
that we should have the flexibility to nominate activities from within 
HHS. We noted that the federal government is uniquely positioned to 
quickly address administration goals versus the public sector in 
pertinent areas that may have national impact to improve the health 
care system. For example, CMS has established the CMS Strategic 
Initiatives which provides 16 distinct focus areas including Patients 
over Paperwork. The CMS Strategic Initiatives focus areas aim to 
empower patients and unleash innovation while transforming the health 
care system. We also noted that we believe that goals such as the CMS 
Strategic Initiatives deliver better value and results for patients 
through competition and innovation. To accomplish goals included in 
agency-wide plans, such as the CMS Strategic Initiatives, there are 
instances when it is necessary to accept HHS-nominated improvement 
activities outside of the Call to advance these type of goals in an 
expedited manner. We referred readers to https://www.cms.gov/About-CMS/Story-Page/our-16-strategic-initiatives for more information about CMS 
strategic initiatives and to https://www.cms.gov/About-CMS/story-page/patients-over-paperwork for more information about Patients over 
Paperwork.
(B) HHS-Nominated Improvement Activities Process
    Beginning with the CY 2021 performance period and future years, we 
proposed that we would consider HHS-nominated improvement activities 
all year long in order to address HHS initiatives in an expedited 
manner. These HHS-nominated improvement activities would be subject to 
the same criteria for nominating new improvement activities as 
discussed in the CY 2021 PFS proposed rule (85 FR 50295 through 50296) 
titled ``Criteria for Nominating New Improvement Activities.'' In 
addition, the HHS-nominated activity would need to apply the criteria 
of: ``aligned with at least one of the HHS goals, when feasible and 
appropriate'' to the nominated activity. Further, the HHS-nominated 
improvement activity would be assessed for the most appropriate 
subcategory; we refer readers to Sec.  414.1355(c).
    We noted that we continue to believe it is important for 
stakeholders to be able to comment on these HHS-nominated improvement 
activities. Thus, we would propose any HHS-nominated improvement 
activities through rulemaking. In such proposal, we would specifically 
request comment on whether stakeholders agree the activities improve 
clinical practice or care delivery.
    We received public comments on the proposal that we would consider 
HHS-nominated improvement activities all year long to address HHS 
initiatives in an expedited manner. The following is a summary of the 
comments we received and our responses.
    Comment: A few commenters supported the proposal to allow for HHS-
nominated improvement activities all year long.
    Response: We appreciated the support for allowing HHS-nominated 
improvement activities all year long. This will allow us to be 
responsive to HHS initiatives.

[[Page 84885]]

    After consideration of the public comments, we are finalizing this 
policy as proposed.
(iii) Changes to the Improvement Activities Inventory
    In the CY 2018 Quality Payment Program final rule (82 FR 53660), we 
finalized that we would establish improvement activities 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), Tables F and G in the Appendix of the CY 2018 Quality 
Payment Program final rule (82 FR 54175 through 54229), Tables A and B 
in the Appendix 2 of the CY 2019 PFS final rule (83 FR 60286 through 
60303), and Tables A, B, and C in the Appendix 2 of the CY 2020 PFS 
final rule (84 FR 63514 through 63538) for our previously finalized 
improvement activities Inventory. We also refer readers to the Quality 
Payment Program website under Explore Measures and Activities at 
https://qpp.cms.gov/mips/explore-measures?tab=improvementActivities&py=2020 for a complete list of the 
most current list of improvement activities. In the CY 2021 PFS 
proposed rule, we did not propose to remove any previously adopted 
improvement activities. We also proposed to modify two existing 
improvement activities for the CY 2021 performance period and future 
years. In this final rule, we are finalizing the modification of two 
existing improvement activities, removal of one obsolete improvement 
activity, and adoption of the COVID-19 improvement activity added via 
IFC. We refer readers to the below and Appendix 2 of this final rule 
for more details.
(A) Removal of IA_CC_5
    Subsequent to publication of the proposed rule, we became aware 
that one underlying program, which forms the basis for one improvement 
activity, has expired. The improvement activity is: IA_CC_5, titled 
``Partner in Patients Hospital Engagement Network.'' The Partner in 
Patients Hospital Engagement Network activity description requires 
membership and participation in a CMS Partnership for Patients Hospital 
Engagement Network which ended March 31, 2020, and may be found at 
https://innovation.cms.gov/innovation-models/partnership-for-patients. 
Because the Partnership for Patients Hospital Engagement Network has 
ended and performance of this activity will no longer be possible 
starting with the CY 2021 performance year, this improvement activity 
is obsolete; therefore, we are finalizing removal of this improvement 
activity beginning with the CY 2021 performance year/2023 MIPS payment 
year to avoid any potential confusion. We refer readers to Appendix 2 
of this final rule for more details.
(B) Finalization of COVID-19 Improvement Activity Added via IFC
    The COVID-19 pandemic was deemed a PHEby the Secretary of the 
Department of HHS. In response, in the March 31st COVID-19 IFC (85 FR 
19276 through 19277), we added one new improvement activity to the 
Improvement Activities Inventory for the CY 2020 performance period in 
response to the PHE titled ``COVID-19 Clinical Trials.'' As described 
in the March 31st COVID-19 IFC, this improvement activity promotes 
clinician participation in a COVID-19 clinical trial utilizing a drug 
or biological product to treat a patient with a COVID-19 infection. We 
stated that to receive credit for this improvement activity, a 
clinician must attest to participation in a COVID-19 clinical trial 
utilizing a drug or biological product to treat a patient with a COVID-
19 infection and report their findings through a clinical data 
repository or clinical data registry (85 FR 19276). In that IFC, we 
also stated that we believe that participation in this activity would 
likely result in improved outcomes by improving the collection of data 
clinicians use for the care of their patients as they monitor and 
manage COVID-19 and drive care improvements (85 FR 19277). We stated 
that we believe that encouraging clinicians to utilize an open source 
clinical data repository or clinical data registry for data reporting 
will bring the results of their research to the forefront of healthcare 
far quicker than if it goes through the cycle of peer review and 
publishing (85 FR 19277). In addition, we stated that we believe that 
centralized data could improve clinical practice and care delivery (85 
FR 19277). As stated in the September 2nd COVID-19 IFC (85 FR 54848 
through 52851), following the publication of the March 31st COVID-19 
IFC, we received several inquiries through meetings, email 
correspondence, and Quality Payment Program help desk requesting 
further information on whether a clinician working with COVID-19 
patients who provides their data to a clinical data registry, without 
participating in a clinical trial, may get credit for this activity. 
The Quality Payment Program help desk tracks, documents, and resolves 
inquiries submitted by MIPS eligible clinicians and groups. 
Stakeholders may submit inquiries to the help desk via 1-866-288-8292 
(Monday-Friday 8 a.m.-8 p.m. ET) or email [email protected]. Some 
stakeholders believed that clinicians providing care to patients with 
COVID-19 outside of a clinical trial that report those data through a 
clinical data registry should receive credit for this activity. It came 
to our attention that clinical data registries not only collect data as 
part of clinical trials, but also collect data from clinicians not 
participating in clinical trials. The improvement activity as written 
was causing confusion for clinicians and groups attempting to meet the 
needs of patients and address gaps in research. Since IA_ERP_3 titled 
``COVID-19 Clinical Trials'' was established, this improvement activity 
has been the subject of approximately 30 percent of the inquiries to 
the Quality Payment Program help desk, demonstrating the desire for 
clinicians to improve clinical care and overall outcomes for patients 
diagnosed with COVID-19 by conducting this improvement activity, but 
also indicating the need for further clarity in its activity 
description.
    As a result, we expanded the improvement activity to include 
clinicians participating in the care of a patient diagnosed with COVID-
19 who simultaneously submit their clinical patient data to a clinical 
data registry for research. Thus, in order to receive credit for this 
improvement activity, a MIPS eligible clinician or group must: (1) 
Participate in a COVID-19 clinical trial utilizing a drug or biological 
product to treat a patient with a COVID-19 infection and report their 
findings through a clinical data repository or clinical data registry 
for the duration of their study; or (2) participate in the care of 
patients diagnosed with COVID-19 and simultaneously submit relevant 
clinical data to a clinical data registry for ongoing or future COVID-
19 research. Data would be submitted to the extent permitted by 
applicable privacy and security laws. We also modified the improvement 
activity title to reflect this change.
    For purposes of this improvement activity, clinical data registries 
must meet the following requirements: (1) The receiving entity must 
declare that they are ready to accept data as a clinical registry; and 
(2) be using the data to improve population health outcomes.
    Most public health agencies and clinical data registries declare 
readiness to accept data from clinicians via a public online posting. 
Clinical data registries should make publicly available specific 
information on what data the registry gathers, technical

[[Page 84886]]

requirements or specifications for how the registry can receive the 
data, and how the registry may use, re-use, or disclose individually 
identifiable data it receives. For purposes of credit toward this 
improvement activity, any data should be sent to the clinical data 
registry in a structured format, which the registry is capable of 
receiving. A MIPS eligible clinician may submit the data using any 
standard or format that is supported by the clinician's health IT 
systems, including but not limited to, certified functions within those 
systems. Such methods may include, but are not limited to, a secure 
upload function on a web portal, or submission via an intermediary, 
such as a health information exchange. To ensure interoperability and 
versatility of the data submitted, any electronic data should be 
submitted to the clinical data registry using appropriate vocabulary 
standards for the specific data elements, such as those identified in 
the United States Core Data for Interoperability (USCDI) standard 
adopted in 45 CFR 170.213.
    As stated in the March 31st COVID-19 IFC, we continue to believe 
that participation in this activity is likely to result in improved 
outcomes by improving the collection of data clinicians use for the 
care of their patients. We believe that all clinical data gathered in 
the treatment of patients diagnosed with COVID-19 may be helpful in 
finding a solution to end this pandemic. We believe encouraging 
clinicians collectively to utilize a clinical data registry for data 
reporting could facilitate sharing of data for use in additional 
clinical studies with larger sample sizes. These additional and larger 
clinical studies are likely to identify efficacy of certain treatments, 
which in turn could result in wider improvements in health outcomes, 
including reduced severity and mortality due to COVID-19 across the 
nation. This could benefit patients nationwide as well as improve 
clinical practice and care delivery for the patients of the clinician 
attesting to this improvement activity. We would like to encourage all 
clinicians to provide data through an open source clinical data 
repository or clinical data registry, meaning that the results of 
research are made public, including via publications and scientific 
data sources, which enables reuse, increases transparency, and 
facilitates reproducibility of research results. Furthermore, a 
clinical data registry may allow such data to be publicly available 
which may be used for research.
    As stated above, we previously added the improvement activity to 
the Inventory for the CY 2020 performance period only in response to 
the PHE for COVID-19. In the IFC, we extended the newly modified COVID-
19 Clinical Data Reporting with or without Clinical Trial improvement 
activity through the CY 2021 performance period due to the increased 
rate of COVID-19 infection we were experiencing nationwide. We 
anticipated the need for COVID-19 clinical trials and data collection/
sharing through registries to continue through CY 2021 at which time we 
would reassess whether there remains a need for additional data sharing 
or if preventive measures and clinical treatments have advanced to the 
point where these type of data are not needed. We wanted eligible 
clinicians to be able to attest to this improvement activity if it is 
still pertinent. We believed that participation in this improvement 
activity was likely to result in improved outcomes by improving the 
collection of data clinicians use for the care of their patients as 
they monitor and manage COVID-19.
    In this final rule, we are providing summary of public comments and 
our responses as well as finalizing the addition of this COVID-19 
improvement activity and its subsequent modification and continuation. 
We refer readers to Appendix 2 of this final rule for more details.
(4) Promoting Interoperability
(a) Background
    Section 1848(q)(2)(A) of the Act includes the meaningful use of 
certified electronic health record technology (CEHRT) as a performance 
category under the MIPS. 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 Promoting 
Interoperability performance category.
(b) Promoting Interoperability Performance Category Performance Period
    As finalized in the CY 2020 PFS final rule at Sec.  414.1320(f)(1) 
(84 FR 62992), for purposes of the 2023 MIPS payment year, the 
performance period for 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. Thus, for the 2023 MIPS 
payment year, the performance period for the Promoting Interoperability 
performance category is 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).
    For the 2024 MIPS payment year and each subsequent MIPS payment 
year, we proposed to add Sec.  414.1320(g)(1), which would establish a 
performance period for the Promoting Interoperability performance 
category of 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. As discussed in the CY 2021 
PFS proposed rule (85 FR 50297), the proposal aligns with what we 
proposed (and subsequently finalized) for the EHR reporting period in 
CY 2022 for the Medicare Promoting Interoperability Program for 
eligible hospitals and critical access hospitals (CAHs) (85 FR 58966 
through 58967). We stated that we believe this would be an appropriate 
performance period because it would offer stability and consistency for 
eligible clinicians reporting for the Promoting Interoperability 
performance category.
    We requested comments on the proposal and the following is a 
summary of the comments we received and our responses.
    Comment: Many commenters appreciated the continuation of the 
flexibility of being able to choose a 90-day performance period, which 
allows more eligible clinicians to successfully participate in the 
Promoting Interoperability performance category. A few commenters 
believe that 90 days is a sufficient amount of time to capture the 
necessary information required for the Promoting Interoperability 
performance category and allows the opportunity to update or implement 
new and innovative technology through the course of the CY without fear 
of negatively impacting performance data. Several commenters supported 
our proposal because it aligns with the EHR reporting period for 
eligible hospitals and CAHs adopted for the Medicare Promoting 
Interoperability Program.
    Response: We agree that keeping the performance period to a minimum 
of 90 consecutive days affords MIPS eligible clinicians the flexibility 
they may need to develop and update their evolving EHRs. We believe 
aligning the length of the Promoting Interoperability Performance 
category performance period with the EHR reporting period for the 
Medicare Promoting Interoperability Program for eligible hospitals and 
CAHs will reduce health IT burden across EHR systems in the clinician 
and hospital settings.

[[Page 84887]]

    Comment: Several commenters suggested that we make the Promoting 
Interoperability Performance category performance period any continuous 
90-day period for the remainder of the Quality Payment Program. One 
stated that by providing continued program stability, CMS allows 
clinicians and groups to focus more on caring for patients and 
improving interoperability and less on prescriptive reporting 
requirements.
    Response: We agree and proposed that the performance period for the 
2024 MIPS payment year and each subsequent MIPS payment year would be a 
minimum of a continuous 90-day period within the calendar year.
    After consideration of the comments we received, we are finalizing 
the proposal for the 2024 MIPS payment year and each subsequent MIPS 
payment year to establish a performance period for the Promoting 
Interoperability performance category of 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. We codified this policy at Sec.  414.1320(g)(1).
(c) Promoting Interoperability Performance Category Measures for MIPS 
Eligible Clinicians
(i) Changes to the Query of Prescription Drug Monitoring Program (PDMP) 
Measure Under the Electronic Prescribing Objective
    As discussed in the CY 2021 PFS proposed rule (85 FR 50297 through 
50298), stakeholders have continued to express concern that it is still 
too premature to require the Query of PDMP measure because PDMPs are 
still maturing in their development, use and integration with EHRs. We 
proposed to make the Query of PDMP measure under the Electronic 
Prescribing objective optional and eligible for 10 bonus points in CY 
2021. This would represent an increase in the amount of the bonus 
points for the Query of PDMP measure from 5 points to 10 points to 
reflect the importance of this measure and to further incentivize 
clinicians to perform queries of PDMPs.
    We solicited comments on these proposals.
    The following is a summary of the comments we received and our 
responses.
    Comment: Many commenters stated that CMS should maintain the Query 
of the Prescription Drug Monitoring Program (PDMP) measure as optional. 
One commenter stated that many clinicians will not be able to fulfill 
this measure because not all clinicians prescribe controlled 
substances.
    Response: We appreciate commenters for their support for 
maintaining the Query of PDMP measure as optional for the performance 
period in CY 2021 and allowing time for further progress around EHR-
PDMP integration efforts minimizing the burden on MIPS eligible 
clinicians. We believe this will provide an opportunity for capable 
implementers to report on and earn bonus points for fulfilling the 
optional measure. Additionally, eligible clinicians who choose not to 
report on the Query of PDMP measure or are unable to report on this 
optional measure may still earn a full score for the Promoting 
Interoperability performance category.
    Comment: Commenters indicated that clinicians have made great 
strides in their adoption of PDMPs despite a continuing lack of 
interoperability across many systems; therefore, they supported the 
measure remaining optional. Some commenters stated that it should not 
be required because it is challenging to electronically report due to 
the additional documentation and verification requirements with an 
external system, which creates unnecessary burden for clinicians. 
Another commenter expressed concern that until the information found 
within PDMPs is easily and seamlessly integrated into health IT systems 
that this type of EHR functional-use measure will be burdensome and 
require multiple actions outside of the clinical workflow. One 
commenter noted concerns that separate sign-in to a non-integrated PDMP 
requires hand entry of demographic data elements to search for a 
specific patient, which may increase the probability of erroneously 
matching a patient to another individual's health information, which in 
turn raises patient safety concerns. For those reasons, the commenters 
support CMS' proposal to maintain the Query of PDMP measure as optional 
for the performance period in CY 2021.
    Response: We agree with the commenters' concerns and the importance 
of working towards improved EHR-PDMP integration. Keeping the Query of 
PDMP measure as optional for CY 2021 would allow states and other 
stakeholders an additional year to make further progress on developing 
functionality to support better integration of PDMPs within clinical 
workflows.
    Comment: One commenter stated that the use of PDMPs is a proven 
means to increase accountability in opioid prescribing practices by 
providing information directly to the clinician that facilitates the 
coordination of multiple medications. Also, it has been proven to help 
prevent adverse drug interactions. The commenter concurred that PDMPs 
increase patient safety by assisting prescribers in the identification 
of patients who have multiple prescriptions for controlled substances 
or may be misusing or overusing them. Expanding the use of PDMPs is a 
component of a broader strategy to prevent opioid abuse and ensure the 
safe, legal, and responsible prescribing of opioids for those who need 
them. The commenter also agreed that improving prescribing practices by 
use of PDMPs should reduce hospitalizations, emergency room visits, and 
the social challenges associated with the opioid epidemic. They believe 
that this not only demonstrates the importance of the measure, but also 
signals it will likely become a required Promoting Interoperability 
performance category measure in the future.
    Response: We agree that PDMPs are an important tool to support 
clinicians' efforts to coordinate multiple medications, and increase 
patient safety by ensuring safe, legal and responsible prescribing. 
With the many benefits of clinicians querying PDMPs, we are finalizing 
the policy as proposed for the 2021 performance period. We plan on 
reevaluating this measure in future years to determine whether 
integration efforts have enabled improvements in PDMP querying.
    Comment: A commenter stated that while they understand that CMS 
wants to limit burden regarding the implementation and integration of 
PDMP queries, the commenter is concerned about the potentially negative 
effect on patient outcomes occurring due to insufficient querying of 
PDMPs amid the current opioid epidemic. Thus, the commenter suggested 
CMS move this measure from optional to required as soon as possible.
    Response: We understand the importance of implementation and 
integration of PDMP queries and effects on patient outcomes for the 
opioid crisis and during the PHE. We also recognize that various state 
programs are still maturing toward the development of robust EHR-PDMP 
integration. We will continue to collaborate with our partners in ONC 
on how to advance standards surrounding PDMP functionality and 
integration. Keeping the Query of PDMP measure as optional for the 
performance period in 2021 would allow states and other stakeholders an 
additional year to make further progress on developing functionality to 
support better integration of PDMP use within clinical

[[Page 84888]]

workflows, which is necessary before we will propose to require this 
measure.
    Comment: Many commenters appreciated and supported increasing the 
bonus from 5 to 10 points for this measure to reflect the importance of 
this measure and to further incentivize clinicians to perform queries 
of PDMPs. A commenter agreed with the proposed increase because it 
emphasizes the importance of the measure as it relates to improved 
patient safety and incentivizes clinicians to expand the use of PDMPs. 
Another commenter stated that the increase of the bonus points for the 
Query of PDMP measure from 5 to 10 points, not only demonstrates the 
importance of the measure, but also signals it will likely become a 
required Promoting Interoperability measure in the future.
    Response: We appreciate the overwhelming support and agree that our 
proposed approach emphasizes the importance of the measure as it 
relates to improved patient safety and incentivizes clinicians to 
expand the use of PDMPs.
    Comment: One commenter did not support increasing the value of this 
measure from 5 points to 10 points. Instead, they suggested that CMS 
keep the bonus at the current 5 points, because they believe most 
vendors who plan on implementing functionality for this measure have 
done it, and that groups are currently attesting for it.
    Response: We disagree and believe that increasing the points from 5 
to 10 points emphasizes the importance of conducting PDMP queries and 
the importance of this activity for patient outcomes during the PHE and 
for the opioid crisis. Solo and small practices may have more 
difficulties incorporating PDMP into practice than larger groups; 
therefore, we want to incentivize all clinicians to adopt this measure.
    After consideration of the comments received, we are finalizing the 
proposal to maintain the Electronic Prescribing objective's Query of 
PDMP measure as optional for the performance period in CY 2021. We are 
also finalizing the proposal to increase the amount of the bonus points 
for the Query of PDMP measure from 5 points to 10 points for 
performance periods in CY 2021.
2. Health Information Exchange Objective
a. Support Electronic Referral Loops by Receiving and Incorporating 
Health Information Measure
    In the CY 2019 PFS final rule (83 FR 59807 through 59812), we 
established a new Support Electronic Referral Loops by Receiving and 
Incorporating Health Information measure by combining the Request/
Accept Summary of Care measure and the Clinical Information 
Reconciliation measure. To better reflect specific actions required by 
the measure's numerator and denominator, we proposed to replace the 
word ``incorporating'' with the word ``reconciling'' in the name of the 
measure (85 FR 50299). The new name would read: Support Electronic 
Referral Loops by Receiving and Reconciling Health Information measure.
    We requested comments on the proposal and the following is a 
summary of the comments we received and our responses.
    Comment: Several commenters agreed that the use of the word 
``incorporating'' was confusing to clinicians and supported our 
proposal. Some stated that the new name better reflects the workflow 
associated with the measure.
    Response: We appreciate the commenters support and agree that 
modifying the name to Support Electronic Referral Loops by Receiving 
and Reconciling Health Information measure reduces confusion for 
clinicians and is a more accurate representation of the measures.
    Comment: Several commenters opposed the nomenclature change because 
it is confusing for clinicians when measure names are changed.
    Response: We received significant stakeholder feedback that the 
proposed name change would more clearly reflect the existing policy. 
The measure is not requiring clinicians to input redundant information, 
but rather to review and reconcile what is received with what is 
already in the patient record.
    Comment: A commenter supported the change to the name, but noted 
that ``reconciling'' may be impossible with certain patient data, so 
``attempting to reconcile'' would be preferable.
    Response: While we understand the commenter concern, the measure 
only requires reconciling the available data. Thus, we believe the new 
name accurately reflects the measure.
    Comment: A commenter suggested CMS to maintain this name in future 
years, as this is the third change in 5 years.
    Response: We believe that we are adopting a name that is reflective 
of the intent of the measure, which should result in no need to revise 
it in the near future.
    After consideration of the comments received, we are finalizing the 
proposed change to the name of the measure as proposed. The new name 
is: Support Electronic Referral Loops by Receiving and Reconciling 
Health Information measure.
b. Engagement in Bi-Directional Exchange Through Health Information 
Exchange (HIE)
    As discussed in the CY 2021 PFS proposed rule (85 FR 50299 through 
50302), we proposed an alternative measure for bi-directional exchange 
through an HIE under the Health Information Exchange objective.
    We proposed to add the following new measure under the HIE 
objective beginning with the performance period in 2021: Health 
Information Exchange (HIE) Bi-Directional Exchange measure. We proposed 
to add this new HIE Bi-Directional Exchange measure to the HIE 
objective as an optional alternative to the two existing measures: The 
Support Electronic Referral Loops by Sending Health Information measure 
and the Support Electronic Referral Loops by Receiving and 
Incorporating Health Information measure. We proposed that clinicians 
either may report the two existing measures and associated exclusions 
OR may choose to report the new measure. We proposed that the HIE Bi-
Directional Exchange measure would be worth 40 points. We also proposed 
the HIE Bi-Directional Exchange measure would be reported by 
attestation and would require a yes/no response. We proposed that 
clinicians would attest to the following:
    ++ I participate in an HIE in order to enable secure, bi-
directional exchange to occur for every patient encounter, transition 
or referral, and record stored or maintained in the EHR during the 
performance period.
    ++ The HIE that I participate in is capable of exchanging 
information across a broad network of unaffiliated exchange partners 
including those using disparate EHRs, and does not engage in 
exclusionary behavior when determining exchange partners.
    ++ I use the functions of CEHRT for this measure, which may include 
technology certified to criteria at 45 CFR 170.315(b)(1), (b)(2), 
(g)(8), or (g)(10).
    We requested comments on our proposals and the following is a 
summary of the comments we received and our responses.
    Comment: The overwhelming majority of commenters supported the 
addition of the HIE Bi-Directional Exchange measure. Several stated 
that incentivizing participation in HIEs that support bi-directional 
exchange would contribute to a longitudinal care record for the patient 
and facilitate enhanced care coordination across settings. Several 
commenters supported the increased use and integration of HIEs

[[Page 84889]]

into the clinical workflow and applauded CMS for taking steps to 
incentivize bi-directional exchange with these systems. One commenter 
supported the measure because it removes the barrier of not having 
access to another clinician's ``Direct address'' to send transition of 
care information manually. The commenter stated that this is not only a 
step in the right direction both to promote increased HIE adoption and 
use, but also to move away from the existing Send/Receive Transitions 
of Care measures, which can be convoluted and onerous to optimize 
within EHR documentation and reporting workflows.
    Response: We appreciate all the support for this new measure as we 
agree that there are many benefits to HIE participation.
    Comment: Some commenters appreciated that the attestation 
statements require information exchange for all patients and all 
patient records without exclusion, or allowances for partial credit to 
ensure all patients will benefit from bi-directional exchange.
    Response: We appreciate commenters' support and agree that an 
important feature of this measure is that it emphasizes enabling bi-
directional exchange for all of an eligible clinician's patients.
    Comment: A commenter worries the proposed new HIE Bi-Directional 
Exchange measure is unworkable in real-world practice settings and is 
likely to be cumbersome. The commenter stated that the proposed 
attestations assume clinicians know what HIEs their hospital uses, and 
its particular usage. The commenter noted that this generally is not 
the case and puts the clinician in a position of having to defer to 
others with this knowledge--an unnecessary and onerous task that 
increases burden.
    Response: We understand that not all eligible clinicians are 
currently aware of the HIE arrangements utilized by the hospitals and 
other institutions in which they practice. However, we believe that in 
many cases eligible clinicians' institutions may be submitting data for 
MIPS on behalf of clinicians and will be able to assist clinicians with 
further information about the HIEs in which they participate. 
Furthermore, we encourage the HIEs whose services qualify to support 
clinicians in meeting this measure to reach out to participants in 
order to make them aware of how they can satisfy the measure.
    Comment: Another commenter stated that the inclusion of this 
measure is premature because there are numerous ways that HIEs connect 
to EHRs. The commenter recommended that CMS partner with ONC to develop 
certification criteria as there is great variability among HIE 
connection requirements currently.
    Response: We recognize that there is significant variation in the 
technology arrangements used by HIEs currently. Accordingly, in the 
third proposed attestation statement, we sought to allow for use of 
different CEHRT functions, which may support robust HIE connections. 
Moreover, we believe that HIEs are likely to continue to leverage 
different technology capabilities to connect to EHRs in accordance with 
local variations in technology implementation. While we believe it is 
important to move forward now with incentivizing eligible clinicians to 
establish robust connections with HIEs, we will continue to work with 
ONC to explore how the ONC Health IT certification program can further 
support integration between HIEs and EHRs.
    As we stated in the proposed rule, we believe there are numerous 
certified health IT capabilities which can support bi-directional 
exchange with a qualifying HIE. For instance, participants may interact 
with an HIE by using technology certified to the criterion at Sec.  
170.315(b)(1) to transmit patient summary care records in the form of a 
C-CDA to the HIE, or using the technology certified to the criterion at 
Sec.  170.315(b)(2) to receive and reconcile information received from 
the HIE into an EHR. Participants could also utilize API technology 
certified to either the criterion at Sec. Sec.  170.315(g)(8) or (10) 
as finalized in the 21st Century Cures Act final rule (85 FR 25742), to 
enable an HIE to obtain data from a participant's EHR. We note that 
certified health IT modules meeting certification criteria beyond those 
mentioned in the proposed rule may also support exchange of information 
with an HIE for transitions of care, including: Certification criteria 
at Sec.  170.315(g)(7), ``Design and performance--Application access--
patient selection,'' and (g)(9), ``Design and performance--Application 
access--all data request,'' which support information exchange via API; 
the certification criterion at Sec.  170.315(e)(1) ``View, download, 
and transmit to 3rd party'' which supports patient access to their 
information; and the certification criterion at Sec.  170.315(g)(6) 
``Consolidated CDA creation performance'' which supports creation of a 
summary of care record.
    However, we believe that we can provide more clarity in the third 
attestation statement regarding our intent to allow flexibility for 
clinicians to use different functions of CEHRT as appropriate to enable 
bi-directional exchange with an HIE that meets the requirements of the 
measure. While there are many certified technology capabilities which 
may support connections with HIEs, as described above, we wish to 
emphasize that clinicians are only required to use the certified 
functionality appropriate to their connection with an HIE necessary to 
support the measure actions. Accordingly, we are finalizing 
modifications to the third attestation statement, to read: ``I use the 
functions of CEHRT to support bi-directional exchange with an HIE.'' We 
believe that this revised statement will provide more clarity to 
stakeholders regarding the requirements of the measure.
    Comment: Several commenters requested that this measure be added to 
the Medicare Promoting Interoperability Program for eligible hospitals 
and CAHs. CMS should maintain program alignment by including the HIE 
Bi-Directional Exchange measure starting in the 2022 reporting year, 
only after the measure is finalized for inclusion in the program for 
eligible hospitals and CAHs.
    Response: We appreciate the commenters' suggestion to include the 
HIE Bi-Directional Exchange measure in the Medicare Promoting 
Interoperability Program for eligible hospitals and CAHs. We may 
consider adding this measure in future rulemaking. We believe that the 
benefits that could be reaped by implementing the measure for the 2021 
performance period for MIPS eligible clinicians do not warrant a delay 
of a year for alignment. We disagree that CMS should maintain program 
alignment with the Promoting Interoperability Program and delay 
implementing this measure by starting in the 2022 performance period. 
Due to the PHE and the importance of HIE's enabling enhanced use of 
telehealth and telemedicine for obtaining and aggregating patient 
information it is important to implement for the 2021 performance 
period.
    Comment: A commenter stated that the measure fails to account for 
the significant expense to clinicians who wish to report this new 
measure. HIEs are expensive, often requiring monthly or yearly 
subscription fees. Many operational hurdles exist for bi-directional 
exchange for ``every patient encounter, transition or referral, and 
record stored or maintained in the EHR'' (section IV.A.3.c.(4)(c)(ii)). 
These hurdles include but are not limited to: The cost of HIE 
agreements and implementation, the ability of an HIE to implement 
interfaces capable of meeting

[[Page 84890]]

the standards of the measure, and the difficulty of logistics for 
healthcare organizations that exist across the jurisdictions of 
multiple HIE agencies. A commenter recommended that the measure 
requirements be relaxed for the first year in order to implement the 
processes through the EHRs and to educate clinicians on utilization and 
workflows. A suggestion would be to treat this like the measures of the 
Public Health and Clinical Data Exchange objective thus allowing 
``credit'' for being in the process of implementation and/or testing to 
be compliant with the new measure.
    Response: We recognize that there may be additional costs related 
to establishing a connection with an HIE. Accordingly, we proposed to 
make this measure optional, and understand that many eligible 
clinicians may wish to use the capabilities of their CEHRT which 
represent investments which eligible clinicians have already made. 
However, we understand that many eligible clinicians are also seeking 
to take advantage of robust HIE connections which can enable 
information exchange in an advanced fashion, and we are seeking to 
incentivize these investments as part of the Promoting Interoperability 
performance category.
    As this measure is optional and attestation-based, we also do not 
believe it is necessary to provide a ``phase-in'' period for this 
measure, or to provide credit for eligible clinicians that are in the 
process of establishing these connections. These clinicians may 
continue to report on the existing numerator-denominator measures for 
the HIE objective and switch to reporting on the optional HIE Bi-
Directional exchange measure at a future date when they are prepared to 
do so.
    Comment: Several commenters stated that the attestation statements 
for this measure appropriately reflect the expectations for information 
exchange capabilities. The commenters believed that the attestation 
statements are sufficiently broad and allow for the different ways 
health care providers connect with HIEs.
    Response: We appreciate the commenters support.
    Comment: A commenter encourages CMS to expand the measure to 
include ``HIEs, exchange frameworks, or other organizations focused on 
bi-directional health information exchange'' since participation in a 
single HIE might not meet the measure's requirement to support HIE for 
``every patient encounter, transition or referral.''
    Response: We appreciate the commenters' concerns. The term ``HIE'' 
is intended to broadly refer to arrangements that facilitate the 
exchange of health information, and may include arrangements commonly 
denoted as exchange ``frameworks,'' ``networks,'' or using other terms. 
To qualify for the measure, an HIE or other exchange network may 
qualify to support clinicians in meeting the measure provided it 
qualifies under the attestation statements including providing the 
capabilities specified under attestation statement 1 to allow a 
clinician to enable bi-directional exchange for all of an eligible 
clinician's patient records and meeting the standard specified under 
attestation statement 2 related to facilitating non-exclusionary 
exchange.
    Comment: A commenter suggested the first attestation statement be 
modified by replacing ``enable'' with ``attempt''. Another commenter 
stated that the second part of the first attestation is confusing: 
``and record stored or maintained in the EHR during the performance 
period.'' EHRs interact with HIEs in different ways and clarification 
is requested.
    Response: We appreciate the commenters' concerns. As we are 
offering a significant amount of points for this measure, we believe 
that ``enable'' more accurately reflects the high level of performance 
and the specific action we are expecting clinicians to take. Also, we 
understand that there is wide variation in HIE arrangements which may 
result in different modes of information exchange. The description of 
services in the first attestation statement would only require enabling 
of bi-directional functionality for the specified patient population 
and information. Eligible clinicians would not be required to adhere to 
specific guidance regarding what data is stored locally by the eligible 
clinicians EHR and what data is stored within the HIE, if any.
    Comment: A commenter suggested that until there is more widespread 
connectivity and available information in the HIE space that CMS should 
remove the second attestation statement. Another commenter requested 
that to minimize burden, CMS remove the second attestation statement.
    Response: We disagree that we should remove the second attestation 
statement, and believe that removing the attestation statement would 
not be consistent with the exchange behavior we are seeking to 
encourage through this measure, which is focused on the use of an HIE 
to exchange with any other clinician who may be involved in the care of 
any of an eligible clinician's patients. The second attestation 
statement is intended to ensure that an HIE which supports a clinician 
in attesting to this measure has the capacity to enable widespread 
exchange across a given health care market. We also believe that 
prioritizing those HIEs capable of exchanging information across a 
broad network of unaffiliated exchange partners including those using 
disparate EHRs, and which do not engage in exclusionary behavior when 
determining exchange partners, will encourage HIE networks to adopt 
wider connectivity.
    Comment: A commenter stated that the requirement that ``bi-
directional engagement occurs for all patients and all records'' is 
na[iuml]ve. Newborn babies, for example, do not have information in an 
HIE, and it is a waste of resources for the system to send a query 
regarding them.
    Response: The first attestation statement as proposed would require 
clinicians to attest that they have enabled bi-directional exchange for 
every patient record in their EHR. Enabling bi-directional exchange 
does not mean that an eligible clinician would be required to conduct 
information transactions that are not clinically necessary. Rather, it 
means that an eligible clinician has established the capabilities 
necessary to complete exchanges of information for their patients at 
the appropriate time.
    Comment: One commenter was encouraged by CMS' proposal and 
supported CMS relying on yes/no measure attestations for this category 
as much as possible, which would minimize clinician reporting burden 
and aligns with how clinicians attest to the improvement activity 
performance category.
    Response: We agree that this measure will provide an optional path 
for qualifying clinicians to earn credit under the HIE objective while 
reducing administrative burden associated with reporting on the current 
measures.
    Comment: The definition of an HIE is broad and could apply to many 
existing entities across the country. A commenter requested that CMS 
provide some examples of HIEs that they consider to meet the definition 
of the measure. They added that it would be helpful if CMS could 
provide examples of the types of evidence that an organization might 
preserve and provide in case of an audit due to the broad nature of the 
attestation measure, and multiple sub-statements in which an 
organization must attest.
    Response: We decline to provide a list of HIEs that meet the 
attributes specified

[[Page 84891]]

in the measure. We believe there are a wide number of organizations 
providing HIE services around the country which could effectively 
support clinicians who wish to attest to the measure, and we do not 
want to appear to endorse particular HIEs over others. We also 
recognize that the HIE space is rapidly changing, and additional 
organizations may emerge or evolve to meet the attributes described in 
the attestation statements following the publication of this final 
rule. In regards to audit documentation, eligible clinicians who choose 
to attest to this optional measure could support their attestation 
statements using a variety of materials, including: Agreements with the 
organization providing them with health information exchange services; 
materials from the organization that provides their HIE services 
describing their services in a manner consistent with the attestation 
statements; or systems documentation from their EHR vendor describing 
their connection to the HIE.
    Comment: Several commenters suggested that CMS implement this new 
`bi-directional engagement' replacement option immediately. However, 
the commenters stated that the threshold should not be every patient 
encounter. Instead, to make the measure reasonable, the threshold 
should be set at 50 percent of all eligible encounters. Another 
commenter suggested that CMS impose a lower threshold for performance. 
A commenter stated that, as this measure is new and robust connections 
with HIEs are still rare, they contend that this is an unreasonable 
requirement and recommend for the CY 2021 reporting year that it be 
modified to be ``a minimum of 10 percent of patient encounters and for 
a minimum of 10 percent of patient records transmitted during the 
performance period.'' Another commenter recommended that CMS consider 
partial credit for eligible clinicians and new sites being on-boarded 
to an HIE during the performance period.
    Response: We appreciate the commenter's support. However, we 
disagree with the recommendation to set a threshold for the measure. 
The goal of this measure is to incentivize connections with HIEs that 
enable bi-directional functionality for all of the patient records in 
an eligible clinician's EHR. For clinicians with a robust connection 
available to an HIE, we do not believe that it would make sense to only 
enable this functionality for a subset of patients. Therefore, we 
decline to apply a threshold percentage to this measure. We understand 
that all eligible clinicians may not have a connection with an HIE that 
is capable of enabling bi-directional exchange for all of the patient 
records in an eligible clinician's EHR. However, in recognizing that 
this functionality is not available for all eligible clinicians, we 
have proposed that this measure would be optional. We also decline to 
provide partial credit for this measure as partial performance would 
not meet the goals of the measure. Our goal in proposing this measure 
is to incentivize the high standard of performance on health 
information exchange which can be achieved by establishing robust, bi-
directional exchange capabilities facilitated by an HIE. We do not 
believe that allowing eligible clinicians to satisfy the measure based 
on a partial threshold would be consistent with incentivizing a high 
performance standard for the exchange of health information.
    Comment: A commenter applauded CMS' desire to incentivize eligible 
clinicians to participate in HIEs while establishing a high performance 
standard for sharing information with other clinicians. Like many other 
practices, the commenter struggles with the ``Sending Health 
Information'' measure because many receiving health care providers and 
facilities have not implemented the technology necessary to receive and 
acknowledge the summary of care.
    Response: We appreciate the commenter for their support.
    Comment: Commenters suggested that CMS ensure that clinicians 
continue to have multiple options to meet the Health Information 
Exchange objective, as not all clinicians will have access to an HIE. 
The other issue facing practices is the cost of connecting with their 
local exchanges. High connectivity fees imposed by the HIE and/or the 
practice's EHR vendor can act as a significant deterrent to 
connectivity.
    Response: We are only finalizing this measure as optional at this 
time, and recognize that many clinicians may prefer to continue to 
report using the existing HIE objective measures. We also agree and 
understand that there are costs associated with utilizing the 
capabilities of an HIE, and that all clinicians may not choose to 
assume these costs in addition to existing EHR investments.
    Comment: A commenter recommended that CMS limit its HIE Bi-
Directional measure conditions to that of exchange between unaffiliated 
health care provider entities regardless of whether they are using the 
same EHR product or participating in the same EHR-run HIE. Another 
commenter stated that more should be done to promote bi-directional 
exchange between unaffiliated entities and between disparate EHRs.
    Response: While we believe that HIE arrangements which only permit 
exchange between the clinicians using the same EHR product may be 
useful for increasing interoperability among specific groups of 
clinicians, our goal with this measure is to incentivize exchange 
arrangements that allow for advanced interoperability across users of 
different vendor products. We agree that it is important to continue to 
encourage HIE arrangements that are capable of supporting exchange 
between different EHR systems. We note that there are a number of 
promising initiatives currently seeking to address this issue, and 
believe that incorporation of the HIE Bi-Directional Exchange measure 
will contribute to furthering these initiatives and making such 
services more widely available.
    Comment: A commenter stated that while they support incentivizing 
interoperability of EHRs and the bi-directional flow of health 
information, the commenter did not believe it is appropriate or timely 
to introduce this new measure. Clinicians and EHR vendors, in 
particular, need additional time to comply with 21st Century Cures and 
subsequent rulemaking requirements regarding interoperability before 
this measure is added.
    Response: We recognize that eligible clinicians participating in 
the Promoting Interoperability performance category are also impacted 
by the recently finalized provisions in the 21st Century Cures Act 
final rule. Our goal in finalizing this measure is to provide eligible 
clinicians with additional options to earn credit under the Promoting 
Interoperability performance category. We believe that the flexibility 
associated with this attestation-based measure can contribute to 
reducing administrative burden for eligible clinicians.
    Comment: A commenter required clarification from CMS of whether an 
attestation response of ``yes'' could mean that the eligible clinician 
is prepared to implement the measure but their vendor is not yet 
capable of supporting the measure. Analogous to the public health 
measure with a similar attestation, the commenter suggested 
confirmation that an eligible clinician can attest ``yes'' to the 
proposed new measure when the clinician is ready and able to 
participate in the bi-directional exchange but for a limitation of the 
vendor.
    Response: No. To earn the 40 points, the clinician must be 
connected to an HIE. If their vendor does not support

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that connection, they do not fulfill the measure and would earn zero 
points.
    Comment: A commenter stated that given that greater use of HIEs for 
bi-directional exchange will immediately contribute to enhanced care 
coordination across settings, this measure should not be optional for 
2021, it should be required. Additionally, the commenter recommended 
that CMS continue to include this as a required measure in the MVPs.
    Response: We appreciate commenters' support for this measure. 
However, at this time we do not believe it is appropriate to require 
clinicians to report this measure. For instance, we understand that 
some clinicians may not yet have access to an HIE that is capable of 
the functions reflected in the attestation statements. As the Promoting 
Interoperability performance category measures are considered 
foundational under the MVP framework, all Promoting Interoperability 
performance category measures would be available to those clinicians 
choosing to participate in MVPs.
    Comment: A commenter requested CMS clarify the HIE being measured 
through the Promoting Interoperability performance category relates to 
any exchange of health information between HIE entities, meaning the 
measure does not restrict the exchange to only information sent and 
received from state HIEs or local health authority HIEs. Another 
commenter inquired as to whether national HIE networks would qualify.
    Response: Nothing in the proposed requirements for this measure 
would limit qualifying HIE services to those entities managed by states 
or local health authorities. Moreover, we note that networks providing 
HIE services which are national in scope could also support eligible 
clinicians' successful attestation, provided they satisfy the finalized 
attestation statements.
    Comment: A commenter questioned if there are requirements that 
dictate which HIE clinicians are expected to connect to. The commenter 
also noted that CMS should clarify whether clinicians are expected to 
connect to more than one (one in each state) HIE if they practice near 
a state border. The commenter also requested clarification surrounding 
a clinician's ability to fulfill this measure if there are no HIEs 
available for them to connect to.
    Response: We did not propose any requirements for HIEs beyond those 
specified in the attestation statements for eligible clinicians, 
specifically, that the HIE permits a clinician to enable bi-directional 
exchange for all of the patient records within their EHR, and that the 
HIE meets the attributes described around exchanging information across 
unaffiliated health care providers and disparate EHR systems. We 
recognize that an organization providing HIE services could meet the 
conditions in the attestation statements while not facilitating a 
connection to every clinician or maintaining information on every 
patient in a given health care market, for instance, in cases where a 
health care market crosses a state line and the HIEs in each state do 
not yet share records. However, an eligible clinician may successfully 
attest to the measure statements as long as they are connected to at 
least one HIE in a manner consistent with the statements. We also 
understand that there may be some eligible clinicians who do not have 
access to any organizations providing HIE services at this time. While 
clinicians who do not participate in an HIE would not be able to attest 
for this measure, they would continue to be able to attest to the 
existing HIE objective measures.
    Comment: Other commenters expressed concerns with the attestation 
statements as proposed. One commenter interprets the statements as 
meaning that clinicians are attesting that they have the functional 
capability to conduct bi-directional exchange for all patients during 
the performance period, not that physicians must conduct bi-directional 
exchange for all patients during the performance period. Another 
commenter recommended that CMS revise the attestation language proposed 
to ensure that the attesting clinician is not being held accountable 
for some features of his/her HIE that she might not know about or have 
control over.
    Response: The first attestation statement for this measure requires 
eligible clinicians to attest that they participate in an HIE to enable 
bi-directional exchange for transactions for all of their patients. 
Enabling this functionality to occur for all of the patient records in 
an eligible clinician's HIE does not mean that clinicians would be 
required to share or request information when it is not clinically 
appropriate.
    Comment: A commenter appreciated CMS' reference to CEHRT in the 
third attestation statement and suggested that CMS clarify that the 
minimum set of data needed to meet this measure's requirement for bi-
directional exchange align with the Common Clinical Data Set (CCDS) 
soon to be the US Core Data for Interoperability (USCDI). The CCDS/
USCDI serves as the baseline set of data required for interoperability 
and is what EHRs are commonly exchanging with HIEs today.
    Response: The third attestation statement requires clinicians to 
attest that they use the functions of CEHRT to engage in bi-directional 
exchange. Similar to the guidance for the existing measures under the 
HIE objective, we are not defining a data set as part of the measure, 
but note that functions of CEHRT include technology certified to 
criteria which ensure a health IT module is capable of exchanging data 
contained in the CCDS, and subsequently the USCDI. As finalized in the 
21st Century Cures Act final rule, existing references to the CCDS in 
these criteria will be updated to refer to USCDI consistent with the 
certification criteria in 45 CFR part 170.
    Comment: A commenter requested clarification from CMS regarding the 
points a clinician is eligible for under this alternative measure. The 
proposed rule states that a clinician cannot earn more than 40 points, 
yet under the redistribution policy for exclusions, if a clinician can 
exclude the eRx measure, the 10 points for that measure are 
redistributed to the HIE measure, which would make it worth 50 points. 
The commenter requested that CMS clarify if this is still true if 
eligible clinicians choose this measure.
    Response: The 40 points reflects the number of points available for 
the new HIE measure. It does not reflect the redistribution of points 
for the E-prescribing measure. If an exclusion is claimed for the E-
Prescribing measure, the 10 points associated with that measure would 
be redistributed to the HIE objective resulting in 50 points available 
for the two existing HIE measures or the new HIE Bi-Directional 
exchange measure.
    Comment: A commenter stated that clinicians should not have to 
attest to the capabilities of their HIE. There are great variances 
within HIE capabilities, and clinicians have no way of knowing all of 
them when selecting an HIE. Several commenters requested that HHS 
publish a list of common, widely known entities that would meet the 
definition of an HIE for the purposes of this measure.
    Response: As discussed above, we decline to name specific entities 
who represent the attributes described in the second attestation 
statement, as we do not want to endorse specific organizations. 
Specifically, the second attestation statement specifies that 
clinicians attesting to the measure must participate in an HIE that is 
capable of exchanging information across a broad network of 
unaffiliated exchange partners including those using disparate

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EHRs, and does not engage in exclusionary behavior when determining 
exchange partners.
    However, we believe that qualifying HIEs that can support eligible 
clinicians in attesting to this measure will have an interest in 
clearly communicating this fact to participants and potential 
participants. We encourage those HIEs that meet the description in the 
second attestation statement to publicly announce their availability to 
support this measure, both on their public website and through other 
communications methods. While a public announcement of availability to 
support this measure would not be required for an eligible clinician to 
leverage an HIE in order to attest to the measure, we believe that such 
activities will help to address commenters' concerns regarding how to 
determine whether an HIE meets the attributes described in the second 
attestation statement.
    Comment: One commenter suggested CMS to allow for exclusions based 
on an individual patient's privacy request and potential state laws 
that would restrict information from being sent through an HIE.
    Response: The first attestation statement requires eligible 
clinicians to attest that they participate in an HIE to enable bi-
directional exchange for all of the patient records in their EHR. This 
is not intended to conflict with or supersede any applicable law 
including state, federal or tribal law governing access, exchange or 
use of electronic health information, the information blocking rules 
finalized at 45 CFR part 171, or any other patient privacy rules 
adopted by a specific HIE implementation such as policies permitting 
patients to opt out of sharing their health information through the 
HIE. Since attesting to this statement would not requiring sharing of 
information that is prohibited under existing laws, regulations and 
other policies, we do not believe it is necessary to specify additional 
exclusions. However, for additional clarity, we are revising the first 
attestation statement to specify that the bi-directional exchange is 
conducted ``in accordance with applicable law and policy.''
    Comment: A commenter suggested phasing in language for every 
patient encounter beginning with transitions or referrals for new 
patients only. This is more reflective of where clinicians currently 
are with HIE integration and will encourage more robust future 
participation. In developing this new requirement, CMS should clarify 
that none of the language in the attestation statements conflict with 
applicable state law and guidance.
    Response: We decline to phase in the measure requirement to enable 
bi-directional exchange based on subsets of patients as suggested by 
the commenter. We do not believe that there would be an appropriate 
reason to limit bi-directional exchange capabilities via an HIE to a 
subset of patients, such as new patients. Moreover, our goal in 
establishing this optional measure is to incentivize eligible 
clinicians to engage in HIE arrangements which enable bi-directional 
exchange for all of an eligible clinician's patient records, providing 
robust support for coordinated patient care. None of the requirements 
for this measure are intended to conflict with applicable federal, 
state, or tribal law or guidance. While eligible clinicians attesting 
to the first attestation statement attest that they have enabled bi-
directional exchange for all of their patient records, enabling this 
functionality would not require clinicians to share information when 
sharing that information is prohibited by law or policy. We have 
revised the first attestation statement accordingly.
    Comment: A commenter requested clarification on the content of 
information included in bi-directional exchange. It is unclear if, for 
example, portal messages must be included in the information exchanged 
with the HIE. The commenter requested guidance on how this can be 
implemented for practices on a portal that does not connect to an HIE.
    Response: To successfully attest to this measure, the eligible 
clinician must use the capabilities defined for CEHRT to engage in bi-
directional exchange via the HIE, which includes exchanging clinical 
data represented by the CCDS or included in the USCDI. Portal messages 
that are outside the CEHRT would not be included.
    After consideration of the comments we received, we are adopting 
our proposals with the following modifications. Attestation statement 1 
is as follows: ``I participate in an HIE in order to enable secure, bi-
directional exchange to occur for every patient encounter, transition, 
or referral, and record stored or maintained in the EHR during the 
performance period in accordance with applicable law and policy.''
    Attestation statement 3 is as follows: ``I use the functions of 
CEHRT to support bi-directional exchange with an HIE.''
(d) Scoring Methodology
(1) Changes to the Scoring Methodology for the 2021 Performance Period
    Table 48 summarizes the Promoting Interoperability performance 
category objectives and measures for CY 2021, including the changes 
adopted as final in the preceding sections of this final rule.

[[Page 84894]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.094

    Comment: A commenter supported the modified scoring methodology for 
the Promoting Interoperability performance category, which was 
initially finalized beginning with the 2019 performance year. The 
scoring methodology is less cumbersome and easier to understand, and is 
effective in highlighting important objectives of the category. We are 
pleased that the scoring methodology will continue in 2021.
    Response: We appreciate the commenter for their support of the 
modified scoring methodology and agree that the approach is less 
cumbersome and easy to understand.
(e) Additional Considerations
(1) Nurse Practitioners, Physician Assistants, Clinical Nurse 
Specialists, and Certified Registered Nurse Anesthetists
    We established a policy at Sec.  414.1380(c)(2)(i)(A)(5) for the 
performance periods in 2017 through 2020 under section 1848(q)(5)(F) of 
the Act to assign a weight of zero to the Promoting Interoperability 
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 Promoting Interoperability performance category, but if they 
choose to report, they will be scored on the Promoting Interoperability 
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.
    As in past years, we intend to use data from prior performance 
periods to further evaluate the participation of NPs, PAs, CRNAs, and 
CNSs in the Promoting Interoperability performance category and 
consider for subsequent years whether the measures specified for this 
category are applicable and available to these MIPS eligible 
clinicians. We have analyzed the data submitted for the 2017 
performance period for the Promoting Interoperability performance 
category and have discovered that the vast majority of MIPS eligible 
clinicians submitted data as part of a group. Although we are pleased 
that MIPS eligible clinicians utilized the option to submit data as a 
group, it does limit our ability to analyze data at the individual NPI 
level. For the 2017 performance period, approximately 4 percent of MIPS 
eligible clinicians who are NPs, PAs, CRNAs, or CNSs submitted data 
individually for MIPS, and more than two-thirds of them did not submit 
data for the Promoting Interoperability performance category. For the 
2018 performance period, approximately 34 percent of MIPS eligible 
clinicians who are NPs, PAs, CRNAs, or CNSs submitted data individually 
for the Promoting Interoperability performance category. In addition, 
the majority of MIPS eligible clinicians reported data for the 
Promoting Interoperability performance category for the 2017 and 2018 
performance periods using the transition measure set. This set is 
unavailable for the 2019 performance period, which could have 
contributed to the decrease of MIPS eligible clinicians reporting data 
for Promoting Interoperability performance category. For the 2019 
performance period, approximately 30 percent of MIPS eligible 
clinicians who are NPs, PAs, CRNAs, or CNSs submitted data individually 
for the Promoting Interoperability performance category, a reduction of 
4 percent from the previous year.
    For these reasons, we proposed at 85 FR 50302 through 50303 to 
continue the existing policy of reweighting the Promoting 
Interoperability performance category for NPs, PAs, CRNAs, and CNSs for 
the performance period in 2021, and to revise Sec.  
414.1380(c)(2)(i)(A)(5) to reflect the proposal.
    The following is a summary of the comments we received and our 
responses.
    Comment: A commenter supports this proposal until CMS can obtain 
more robust data. We continue to encourage the agency to provide 
technical assistance to clinicians with the goal of increasing EHR 
adoption and familiarity with the Promoting Interoperability 
performance category reporting requirements for all clinicians.
    Response: We appreciate the commenter for their support in 
continuing the existing reweighting policy for NPs, PAs, CRNAs, and 
CNSs for the performance period in 2021 until we can obtain more robust 
data and

[[Page 84895]]

plan on continuing our support of stakeholders to increase EHR adoption 
and familiarity with the Promoting Interoperability performance 
category reporting requirements for all clinicians.
    Comment: Another commenter appreciated the continued flexibility 
provided as CMS works to further assess the use of CEHRT by PAs and 
NPs. The commenter stated PAs are fully ready and capable to 
participate under the Promoting Interoperability performance category, 
with possible exception of small PA-owned practices that are unable to 
afford CEHRT systems that are fully compliant with current 
requirements. PAs in most practice settings have been using EHR systems 
for a number of years, often being the health profession who leads a 
practice's EHR system implementation and should be held to the same 
standards as physicians.
    Response: We are pleased to hear that many PAs have the ability to 
participate in the Promoting Interoperability performance category and 
we hope those that are ready will submit data. For those who cannot, we 
will reweight the Promoting Interoperability performance category.
    After consideration of the comments we received, we are finalizing 
our policy as proposed: We are continuing the existing policy of 
reweighting the Promoting Interoperability performance category for 
NPs, PAs, CRNAs, and CNSs for the performance period in 2021, and 
revising Sec.  414.1380(c)(2)(i)(A)(5) to reflect this policy.
(2) Physical Therapists, Occupational Therapists, Qualified Speech-
Language Pathologists, Qualified Audiologists, Clinical Psychologists, 
and Registered Dieticians or Nutrition Professionals
    In the CY 2020 PFS final rule (84 FR 63003 through 63004), we 
adopted a policy at Sec.  414.1380(c)(2)(i)(A)(4) to apply the same 
policy we adopted for NPs, PAs, CNSs, and CRNAs to other types of MIPS 
eligible clinicians who are NPPs (physical therapists, occupational 
therapists, qualified speech-language pathologist, qualified 
audiologists, clinical psychologists, and registered dieticians or 
nutrition professionals) for the performance period in 2020. We stated 
that 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.
    For the reasons discussed in the proposed rule (85 FR 50302-50303), 
we proposed to continue the existing policy of reweighting the 
Promoting Interoperability performance category for physical 
therapists, occupational therapists, qualified speech-language 
pathologist, qualified audiologists, clinical psychologists, and 
registered dieticians or nutrition professionals for the performance 
period in 2021, and to revise Sec.  414.1380(c)(2)(i)(A)(4) to reflect 
the proposal. We invited comments on the proposal.
    We received public comments on this proposal. The following is a 
summary of the comments we received and our responses.
    Comment: One commenter thanked CMS for continuing to reweight the 
Promoting Interoperability performance category for therapists as they 
have not received any financial incentives or support for implementing 
EHRs.
    Response: We appreciate the commenter for their support.
    Comment: One commenter supports the proposal to continue 
reweighting the Promoting Interoperability performance category to zero 
for certain NPPs and psychologists reporting under MIPS. The commenter 
stated that psychologists have never been eligible for the financial 
incentives offered to physicians to promote the use of CEHRT and 
because many do not utilize CEHRT in their private practices, most 
psychologists would not have enough Promoting Interoperability 
performance category measures to successfully report. The commenter 
supports the proposal to continue to reweight the Promoting 
Interoperability performance category to zero as it will protect 
psychologist and certain other NPPs from being unfairly penalized.
    Response: We appreciate the commenter's support and are finalizing 
our proposal to continue the existing policy of reweighting the 
Promoting Interoperability performance category for physical 
therapists, occupational therapists, qualified speech-language 
pathologist, qualified audiologists, clinical psychologists, and 
registered dieticians or nutrition professionals.
    After consideration of the comments, we are finalizing our 
proposals for the 2021 performance period to continue the existing 
policy of reweighting the Promoting Interoperability performance 
category for physical therapists, occupational therapists, qualified 
speech-language pathologist, qualified audiologists, clinical 
psychologists, and registered dieticians or nutrition professionals, 
and are revising Sec.  414.1380(c)(2)(i)(A)(4) to reflect our policy.
(5) APM Entity Groups and APM Scoring Standard for MIPS Eligible 
Clinicians Participating in MIPS APMs
(a) Overview
    The APM scoring standard, codified at Sec.  414.1370, is the MIPS 
scoring methodology applicable for MIPS eligible clinicians 
participating in a MIPS APM for the applicable MIPS performance period. 
As discussed in the CY 2017 Quality Payment Program final rule (81 FR 
77246), the APM scoring standard was designed to reduce reporting 
burden for participants in MIPS APMs by eliminating the need for such 
MIPS eligible clinicians to submit data for both MIPS and their 
respective APMs, and to ensure that these eligible clinicians were not 
assessed in multiple ways on the same performance activities. We also 
believed that the APM scoring standard would encourage APM 
participation and support the goal of encouraging APM participants to 
better manage care for patients within their respective APM Entities by 
tying their MIPS performance scores together.
    As we have gained experience in implementing the APM scoring 
standard, we have learned that it is infeasible to fully implement it 
as it was originally designed, as was discussed in the CY 2020 PFS 
final rule (84 FR 63007). Public comments on the CY 2020 revised APM 
scoring standard finalized in the CY 2020 PFS final rule (84 FR 63010), 
and most comments in response to the request for comments on APM 
scoring beyond 2020, made clear that the complexity of the APM scoring 
standard and its inflexibility in adapting to changes in APM 
participation and design have resulted in confusion and unintended 
additional burden for APM Entities and their participant MIPS eligible 
clinicians.
    With this insight in mind, and with the goal of better aligning 
MIPS reporting rules for all MIPS eligible clinicians, including those 
in MIPS APMs, we proposed to terminate the APM scoring standard as 
described at Sec.  414.1370, effective January 1 of the 2021 
performance year, by amending that regulation accordingly.
    We further proposed in the CY 2021 PFS proposed rule (85 FR 50285), 
effective January 1, 2021, to establish an APM Performance Pathway and 
scoring rules that would be available for MIPS reporting for MIPS 
eligible clinicians in MIPS APMs.
(b) APM Entity Groups
    We proposed to terminate the APM scoring standard effective January 
1, 2021, however, beginning with the 2021 performance period, we 
proposed to

[[Page 84896]]

retain certain APM Entity group reporting policies that were 
established and finalized for reporting and scoring under MIPS 
beginning with the 2021 performance period (85 FR 50303 through 50304). 
Therefore, we proposed to redesignate in part the regulation that 
describes APM Entity group determinations, from Sec.  414.1370(e) to 
Sec.  414.1317, and to title that section ``APM Entity Groups.''
    We received the following comments on these proposals.
    Comment: A few commenters stated support for allowing MIPS quality 
reporting at an individual or group level as well as the APM Entity 
level. Commenters believe that this approach would reward high 
performers within APM Entities and enable specialists to be scored on 
quality measures that reflect their area of practice.
    Response: We thank commenters for their support and will continue 
to consider additional ways in which we can continue to support and 
encourage APM participation.
    Comment: A few commenters supported the proposal but requested that 
we extend the waiver of the cost performance category to all APM 
participants in MIPS, as the cost-containment requirements of the APMs 
are equally applicable to all APM Entities, regardless of how they 
chose to participate in MIPS.
    Response: In the CY 2017 Quality Payment Program final rule (81 FR 
77256, 77265), for the APM scoring standard, we finalized at Sec.  
414.1370(g)(2) a policy to waive the cost performance category uner the 
waiver authority at section 1115A(d)(1) of the Act for CMS Innovation 
Center APMs, and at section 1899(f) of the Act for the Medicare Shared 
Savings Program. In the CY 2021 PFS proposed rule (85 FR 50287), for 
the APP, we proposed to continue to waive the cost performance category 
under the same authorities, and we are finalizing this proposal in 
section IV.A.3.b. of this final rule. Upon further consideration, we 
recognize that the policy rationale for waiving the cost performance 
category is equally applicable to all APM Entities in MIPS APMs, 
regardless of whether an APM Entity chooses to participate in MIPS 
through the APP or through traditional MIPS reporting options. As we 
described in the CY 2017 Quality Payment Program final rule (81 FR 
77256, 77265), and reiterated in the CY 2021 PFS proposed rule (85 FR 
50287), we believe this use of waiver authority is justified for three 
reasons. First, APM Entities in MIPS APMs already are subject to cost 
performance assessment under their APMs, as the MIPS APM criteria would 
continue to include the assessment of participants based on cost. 
Second, MIPS APMs may measure cost performance in different ways than 
MIPS, for example, by basing cost on total cost of care, which measures 
a broader scope of cost or resource use than would necessarily be 
reflected in the narrower claims-based accountability standard under 
MIPS. Finally, MIPS APMs may attribute beneficiaries differently from 
MIPS for purposes of measuring cost, leading to an unpredictable degree 
of overlap between the sets of beneficiaries for whom the MIPS eligible 
clinicians would be responsible under their APM and under MIPS. We 
continue to believe that with an APM Entity's finite resources for 
engaging in efforts to improve quality and lower costs for a specified 
beneficiary population under the APM, it is necessary to give the APM 
Entity the ability to identify a single beneficiary population to 
prioritize in its cost-saving efforts so that the goals and evaluation 
associated with the APM are as clear and free of confounding factors as 
possible. With this flexibility, MIPS eligible clinicians who are 
attempting to strategically transform their respective practices would 
not jeopardize their ability to succeed in either MIPS or under the 
terms of their APM.
    We believe the potentially conflicting or confounding incentives 
between the MIPS APMs and the MIPS cost performance category would 
still exist for APM Entities in MIPS APMs, regardless of which MIPS 
participation option an APM Entity chooses. Therefore, we will continue 
to waive the cost performance category for APM Entities in MIPS APMs 
under the waiver authority at section 1115A(d)(1) of the Act for CMS 
Innovation Center APMs, and at section 1899(f) of the Act for the 
Medicare Shared Savings Program, and weight the cost performance 
category at zero percent of an APM Entity's final score.
    In addition, because we proposed to no longer rely on quality 
measures reported to an APM, as is required under the existing APM 
scoring standard, we no longer believe that there is substantial risk 
of the MIPS final scores being inappropriately influenced by MIPS 
eligible clinicians moving into or out of APM Entities late in the 
performance year, which was the impetus for the full-TIN APM policy. 
Therefore, we proposed to end the full-TIN APM policy currently 
codified at Sec.  414.1370(e)(1), which allows for an APM Entity group 
to include eligible clinicians on the Participation List in a full-TIN 
APM on December 31 of the MIPS Performance Period only if the APM is a 
full-TIN APM as defined at Sec.  414.1305. We also proposed that MIPS 
eligible clinicians identified on the Participation List or Affiliated 
Practitioner List of any APM Entity participating in any MIPS APM on 
any of the three snapshot dates (March 31, June 30, August 31), as well 
as December 31 during a performance period, beginning in the 2021 MIPS 
performance period, would be considered participants in an APM Entity 
group. As the proposals would eliminate the need for the term ``full 
TIN APM,'' we also proposed to delete the defined term ``full TIN APM'' 
from Sec.  414.1305.
    We did not receive any comments on this proposal.
    After consideration of the comments we received, we are finalizing 
the proposed policy as proposed. In addition, for the reasons discussed 
in our response to comments above, we are adoptiong a final policy at 
Sec.  414.1317(b)(2) to weight the cost performance category at zero 
percent for APM Entities in MIPS APMs.
(c) APM Entity Group Eligibility
    In the absence of the APM scoring standard and mandatory reporting 
to MIPS through the APM Entity group, it would no longer be necessary 
to conduct low-volume threshold determinations at the APM Entity group 
level. Therefore, along with the termination of the APM scoring 
standard under Sec.  414.1370, we also proposed to terminate, effective 
January 1, 2021, the use of APM Entity level low-volume threshold 
determinations and remove the term APM Entity group from the definition 
of the low-volume threshold at Sec.  414.1305, with corresponding 
changes to applicability at Sec.  414.1310(b)(1).
    Going forward, we would apply the same rules for MIPS eligibility 
to APM participants as to other MIPS eligible clinicians. For example, 
if an eligible clinician who is a participant in a MIPS APM is below 
the low-volume threshold he or she would not be required to report to 
MIPS as an individual; however, if the group TIN of which that eligible 
clinician is a part is MIPS eligible and does report to MIPS, that 
eligible clinician would be treated as a MIPS eligible clinician for 
purposes of MIPS scoring and payment adjustments, and would receive the 
higher of the group score and any available APM Entity group score. 
Being a participant in an APM Entity that reports to MIPS would not 
confer MIPS eligibility to an eligible clinician who would otherwise be 
excluded from MIPS.

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    We did not receive public comments on this propsal and we are 
finalzing it as proposed.
(d) APM Entity Group Scoring
    Consistent with our past approach under the APM scoring standard at 
Sec.  414.1370(f), we proposed at Sec.  414.1317(b) that the MIPS final 
score calculated for the APM Entity would be applied to each MIPS 
eligible clinician in the APM Entity group. The MIPS payment adjustment 
would be applied at the TIN/NPI level for each of the MIPS eligible 
clinicians in the APM Entity group.
    Similar to our past approach under the APM scoring standard at 
Sec.  414.1370(g)(4)(ii) and (iii), as originally discussed and 
finalized in the CY 2017 Quality Payment Program final rule (81 FR 
77268), we proposed at Sec.  414.1317(b)(1) that in all cases where an 
APM Entity reports to MIPS, but a performance category's data 
submission cannot be made at the APM Entity level, each MIPS eligible 
clinician in the APM Entity group would be assigned the highest 
available score for that performance category (either the individual or 
TIN-level score), and the scores for all MIPS eligible clinicians in 
the APM Entity group would be averaged in order to calculate the APM 
Entity level performance category score. In the event that a MIPS 
eligible clinician in an APM Entity receives an exception from the 
reporting requirements, such eligible clinician would be assigned a 
null score when we calculate the APM Entity's performance category 
score.
    Similar to our past approach under the APM scoring standard at 
Sec.  414.1370(g)(1)(iv), we proposed at Sec.  414.1317(b)(2) that for 
an APM Entity for which we calculated a total performance category 
score for one or more participants in the APM Entity for the preceding 
MIPS performance period, we would calculate an improvement score for 
each performance category for which a previous year's total performance 
category score is available as specified in Sec.  414.1380(b). Note 
that unlike Sec.  414.1370(g)(1)(iv), proposed Sec.  414.1317(b)(2) 
would not be limited to the quality performance category, but will 
apply to any performance category.
    We did not receive public comments on these proposals and are 
finalzing as proposed.
(e) Reweighting Based on Extreme and Uncontrollable Circumstances for 
APM Entity Groups
    Section 414.1380(c)(2)(i) allows for the submission of an 
application to CMS to request reweighting of one or more MIPS 
performance categories due to extreme and uncontrollable circumstances. 
We proposed that an APM Entity may submit such an application beginning 
with the 2020 performance period/2022 MIPS payment year, at Sec.  
414.1317(b)(3). The request for reweighting in the application would 
apply for all four MIPS performance categories and all MIPS eligible 
clinicians in the APM Entity group. If the request for reweighting is 
approved by CMS, this would result in MIPS eligible clinicians 
participating in the APM Entity being excepted from MIPS reporting 
requirements for the applicable performance period, and the APM Entity 
would receive a final score equal to the performance threshold. Such 
request for reweighting would be approved or denied in its entirety.
    We considered allowing an APM Entity to submit an application to 
request reweighting for individual performance categories, but rejected 
this approach. As discussed in the CY 2021 PFS proposed rule (85 FR 
50304, we believe the amount of complexity at the intersection of the 
various performance category submission and scoring requirements, 
submitter types, and exception applications for MIPS eligible 
clinicians could place a burden on these clinicians and their 
representatives to continually invest in understanding their shifting 
obligations under such an approach. Furthermore, operationalizing a 
policy where an APM Entity would have the ability to request and 
receive reweighting for one or more, but not all, performance 
categories would be prone to error. In addition, such a piecemeal 
approach to addressing extreme and uncontrollable circumstances likely 
would cause scoring delays that could result in CMS being unable to 
timely provide performance feedback and payment adjustment information 
to all MIPS eligible clinicians.
    We also proposed at Sec.  414.1317(b)(3)(i) that an APM Entity must 
demonstrate in its application to CMS that greater than 75 percent of 
its participant MIPS eligible clinicians would be eligible for 
reweighting the Promoting Interoperability performance category for the 
applicable performance period.
    Due to the unique and complex relationship between an APM Entity 
and its individual participant MIPS eligible clinicians, we noted that 
we believe it is appropriate to offer an APM Entity the opportunity to 
apply for reweighting based on extreme and uncontrollable circumstances 
for all performance categories, including the Promoting 
Interoperability performance category, rather than collecting Promoting 
Interoperability hardship exception applications from each MIPS 
eligible clinician in the APM Entity group as is currently required. 
However, we believe that setting a 75 percent threshold for the 
Promoting Interoperability performance category is appropriate as a 
means of assuring that the request for reweighting is only granted in 
cases where absent the reweighting, it would be impossible to calculate 
a score for that performance category that is truly representative of 
the APM Entity group's performance. We proposed a 75 percent threshold 
because such threshold is consistent with the Promoting 
Interoperability performance category reweighting policy for groups of 
hospital-based MIPS eligible clinicians and non-patient facing MIPS 
eligible clinicians, which similarly could face an administrative 
burden in attempting to secure approvals for individual reweighting 
requests for each MIPS eligible clinician in such groups. We noted that 
we recognize that as a result of the variety of participation 
requirements of different APMs, APM Entity groups may be composed of a 
wide range of health care provider types and sites of service. We 
stated that we believe scoring an entire APM Entity as the result of a 
single MIPS eligible clinician's submission of data for the Promoting 
Interoperability performance category could place an extreme 
administrative burden on APM Entity groups, and could potentially 
create unintended consequences for APM participation decisions among 
MIPS eligible clinicians.
    In addition, we proposed at Sec.  414.1317(b)(3)(ii) that if CMS 
approves the request for reweighting based on an APM Entity's 
application, and if MIPS data are submitted for the APM Entity for the 
applicable performance period, all four of the MIPS performance 
categories still would be reweighted for the APM Entity group 
notwithstanding the data submission. The data submission would not 
effectively void the request for reweighting and its approval. We 
proposed this policy because we do not believe it would be appropriate 
or desirable for an individual MIPS eligible clinician or for a group 
TIN with no direct affiliation with an APM Entity to accidentally 
override an APM Entity's application. This could happen if the MIPS 
eligible clinician or group TIN reports to MIPS either out of an 
abundance of caution or on behalf of a MIPS eligible clinician who is 
not in the APM Entity, but happens to share a billing TIN with an

[[Page 84898]]

eligible clinician who is in the APM Entity. We also recognized that 
there may be circumstances where an APM may require some form of 
quality reporting for purposes of the APM itself, such as is required 
for Shared Savings Program ACOs as described in the CY 2021 PFS 
proposed rule (85 FR 50233), but that in complying with such 
requirement an APM Entity may also be submitting quality performance 
category data that would result in scoring for purposes of MIPS when 
that APM Entity group would otherwise have been excepted from MIPS 
reporting.
    We noted that under the proposal and the proposed changes to the 
MIPS scoring hierarchy, described in the CY 2021 PFS proposed rule (85 
FR 50315), reporting done by a MIPS eligible clinician or group would 
result in a MIPS final score for only that MIPS eligible clinician or 
group, which may be used to determine a MIPS eligible clinician's 
payment adjustment.
    To the extent that the proposed policies would constitute a change 
to the MIPS scoring or payment methodology for the 2022 MIPS payment 
adjustment after the start of the 2020 performance period, we noted 
that we believe that, consistent with section 1871(e)(1)(A)(ii) of the 
Act, it would be contrary to the public interest not to establish these 
policies because of the PHE for COVID-19. We noted that we believe that 
the intersection of the 2020 APM scoring standard rules and the extreme 
and uncontrollable circumstances policies being put in place by APMs 
themselves in response to the PHE for COVID-19, such as the changes 
being proposed for participants in the Shared Savings Program, would 
make obtaining reweighting under MIPS based on extreme and 
uncontrollable circumstances unusually burdensome absent these proposed 
changes. For instance, the Shared Savings Program (85 FR 50239) will 
continue to require the submission of quality performance data by 
participating ACOs, and that data would be eligible to be used for MIPS 
quality scoring absent the proposal, which would have the result of not 
allowing Shared Savings Participants the option to take advantage of 
extreme and uncontrollable circumstances policies that are available to 
other MIPS eligible clinicians. This policy change is necessary to give 
participants in the Shared Savings Program the opportunity to request 
reweighting of the MIPS performance categories in the event that they 
believe the data reported for purposes of the Shared Savings Program do 
not adequately reflect the performance of the ACO Entity for purposes 
of MIPS quality performance category scoring.
    The following is a summary of the comments we received and our 
responses.
    Comment: Several commenters support our proposal to introduce APM 
Entity level requests for reweighting due to extreme and uncontrollable 
circumstances in light of the PHE for COVID-19.
    Response: We appreciate the commenters for their support.
    After consideration of the comments we received, we are finalzing 
this policy as proposed.
d. MIPS Final Score Methodology
(1) Performance Category Scores
(a) Background
    For the 2023 MIPS payment year, we intend to continue to build on 
the scoring methodology we finalized for prior years. The scoring 
methodology allows for accountability and alignment across the 
performance categories and minimizes burden on MIPS eligible 
clinicians. We are maintaining many of our scoring policies, focusing 
on only making proposals to maintain stability. Specifically, in the CY 
2021 PFS proposed rule (85 FR 50305 through 50310), we proposed the 
following:
     To implement scoring flexibility for quality measures with 
specification or coding changes during the performance year.
     To implement benchmark and topped out scoring policies 
that are responsive to potential low reporting rates for the 2019 
performance year due to the national PHE for COVID-19.
     To implement scoring for all administrative claims-based 
measures.
     To continue policies for scoring quality measures based on 
achievement as well as policies for measures that do not meet case 
minimum, data completeness requirements, or have a benchmark.
     To continue bonuses in the quality performance category.
     To continue improvement scoring of the quality performance 
category comparing clinicians to a 30 percent baseline score if 
clinicians scored 30 percent or less.
    We did not propose changes to scoring policies for the cost, 
improvement activities and Promoting Interoperability performance 
categories.
    We have maintained our approach that MIPS eligible clinicians are 
scored against performance standards for each performance category and 
receive a final score, comprised of their performance category scores, 
and calculated according to the final score methodology. We refer 
readers to Sec.  414.1380 for general policies on scoring. We refer 
readers to section IV. A.3.c.(5) of this rule for the discussion to 
remove the APM scoring standard and to section IV.A.3.b. of this rule 
for information on the APM Performance Pathway scoring.
(b) Scoring the Quality Performance Category for the Following 
Collection Types: Medicare Part B Claims Measures, eCQMs, MIPS CQMs, 
QCDR Measures, CMS Web Interface Measures, the CAHPS for MIPS Survey 
Measure and Administrative Claims Measures
    We referred readers to Sec.  414.1380(b)(1) for our policies 
regarding quality measure benchmarks, calculating total measure 
achievement and measure bonus points, calculating the quality 
performance category percent score, including achievement and 
improvement points, and the small practice bonus (81 FR 77276 through 
77308, 82 FR 53716 through 53748, 83 FR 59841 through 59855, and 84 FR 
63011 through 63018). We proposed to maintain many policies finalized 
in prior years to retain stable scoring in MIPS with minimal new 
proposals as we transition to MVPs.
    Please refer to section IV.A.3.c.(1)(c) of this rule for more 
information about our proposal to sunset the CMS Web Interface measures 
as a collection type for groups and virtual groups with 25 or more 
eligible clinicians, which we are finalizing with implementation 
delayed until the 2022 performance period. Scoring policies applicable 
to CMS Web Interface as a collection type will be in effect in the 2021 
performance period. In the 2022 performance period CMS Web Interface 
will be removed as a collection type.
(i) Scoring Flexibility for Changes That Impact Quality Measures During 
the Performance Period
    We proposed to expand the list of reasons that a quality measure 
may be impacted during the performance period in addition to revising 
when we would allow scoring of the measure with a performance period 
truncation (to 9 months of data) or the complete suppression of the 
measure if 9 months of data are not available. We noted that we 
previously established policies to provide scoring flexibilities in 
instances in which changes to measures during the performance period 
have impacted clinicians' ability to submit the quality measures for 
the entire 12-month performance period because of an ICD-10 coding 
change or when there are clinical guideline changes when we believe 
continued adherence to the

[[Page 84899]]

guideline in the existing measure could result in patient harm, or 
otherwise provide misleading results and render the measure no longer 
comparable to the historic benchmark. Specifically, 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 coding changes during the performance period based only on 
the first 9 months of the 12-month performance period. We noted that we 
believe that 9 months of data is sufficient to assess performance when 
12 months of data is not available. We finalized that we would publish 
a list of measures requiring a 9 months of data on the CMS website by 
October 1st of the performance period if technically feasible, but no 
later than the beginning of the data submission period (for example, 
January 2, 2021 for the 2020 performance period). We refer readers to 
Sec.  414.1380(b)(1)(viii) for more on our policy for scoring 
flexibility for ICD-10 changes.
    In the CY 2019 Quality Payment final rule (83 FR 59845 through 
59847), we finalized policies beginning with the 2021 MIPS payment year 
to reduce the total available measure achievement points from the 
quality performance category by 10 points for MIPS eligible clinicians 
for each measure submitted that is significantly impacted by clinical 
guideline changes or other changes when we believe adherence to the 
guidelines in the existing measures could result in patient harm or 
otherwise no longer be comparable to a historic benchmark. We refer 
readers to Sec.  414.1380(b)(1)(vii)(A) for more information on the 
scoring flexibility policy.
    We proposed, beginning with the 2021 performance period, a policy 
to truncate the performance period or suppress a quality measure if CMS 
determines that revised clinical guidelines, measure specifications or 
codes impact clinician's ability to submit information on the measure 
or may lead to potentially misleading results. Based on the timing of 
the changes to clinical guidelines, measure specifications or codes, we 
would assess the measure on 9 months of data, and if 9 consecutive 
months of data are not available, we would suppress the measure by 
reducing the total available measure achievement points from the 
quality performance category by 10 points for each measure submitted 
that is impacted.
    In addition to ICD-10 and clinical guideline changes, we noted that 
we believe that there may be instances when there are changes after the 
final approval of quality measures including changes to the measure 
specification, or updates to coding that may lead to misleading 
results. If there are no concerns with potential patient harm, we would 
like the ability to assess performance on the quality measure (not 
including the change) if we have sufficient data. Depending on the 
timing of the change during the performance period we would like to 
assess performance on the quality measure; we believe we can assess 
performance if we have 9 months of data and should suppress the measure 
if we have less than 9 months of data.
    We will examine quality measures that are impacted by changes 
during the performance period to determine how the change may impact 
our ability to assess performance on the measure. Potential changes 
that may impact quality measures during the performance period include 
updates to clinical guidelines or measure specifications, such as 
revisions to medication lists, codes and clinical actions. For example, 
the introduction of a new drug class after the performance period 
began, would not be captured as numerator compliant by an existing 
measure specification but may meet the intent of the measure and its 
associated clinical actions. Assessment of clinician's performance on 
the measure would be hampered by the fact that the measure 
specification would not be able to be updated to collect information 
and assess performance related to use of the medication from the new 
drug class. As reflected at sections 1848(q)(2)(D)(1) and 
1848(q)(2)(D)(1)(II)(cc) of the Act, quality measures adopted under 
MIPS, including substantive updates must be made through notice and 
comment rulemaking.
    Additionally, we may examine a quality measure to determine if the 
change impacts the ability of clinicians to submit the measure, 
including the number of encounters a clinician may be able to submit, 
the number of clinicians who may be able to submit the measure, and the 
proportion of clinicians from a specialty who may be able to submit the 
measure. We would also assess if the change to a code would potentially 
lead to misleading results. For example, changes that impact the 
clinicians' ability to report a measure include changes to Common 
Procedural Technology (CPT) codes and the Healthcare Common Procedure 
Coding System (HCPCS) codes during the performance period, which may 
potentially produce misleading results. We believe that code changes 
that impact a clinician's ability to report a measure will be rare 
events, however, mid-year changes to CPT and HCPCS codes can be 
unanticipated when a clinician selects a quality measure and may 
introduce an additional burden if the clinician is unable to submit the 
quality measure.
    When possible, we want an approach that allows us to score a 
quality measure even when there has been a change to the measure 
outside of the clinician's control during the performance period. We 
have finalized a policy that allows scoring on the first 9 months of 
data for a 12-month performance period data when there are ICD-10 code 
changes (82 FR 53714 through 53716). We assess performance on the first 
9 months of data in the case of ICD-10 changes, which happen 
predictably in October on an annual basis, allowing us to truncate and 
remove the last quarter of the performance period from our assessment. 
However, as discussed in the CY 2021 PFS proposed rule (85 FR 50306 
through 50307), we cannot anticipate when there will be a change to 
clinical guidelines, measure specifications, an inadvertent deletion, 
or revision of a code. These types of changes do not occur on an annual 
basis, and do not follow a predictable, consistent timeline. We become 
aware of changes to measures from feedback from clinicians, third 
parties and measure stewards. Updates to codes, which may not happen at 
a predictable time, may significantly impact how many cases a clinician 
can report and how a clinician performs on a measure. We want to 
account for instances such as coding changes during the performance 
period, in which scoring should be applied to the first 9 months of 
data from the performance period. If 9 consecutive months of data from 
the performance period is not available, we would have the ability to 
suppress the measure by reducing the total available measure 
achievement points from the quality performance category by 10 points 
for MIPS eligible clinicians for each measure submitted that is 
significantly impacted.
    Therefore, as noted in the CY 2021 PFS proposed rule (85 FR 50307 
through 50308), we proposed beginning with the 2021 performance period, 
a policy to truncate the performance period or suppress a quality 
measure if CMS determines revised clinical guidelines, measure 
specifications or codes impact the clinician's ability to submit the 
measure or may lead to potentially misleading results. As proposed, we 
would maintain the flexibility to assess the measure on 9

[[Page 84900]]

consecutive months of data when available and would suppress the 
measure if 9 consecutive months of data are not available. We proposed 
that we would publish a list of measures requiring 9 months of data on 
the CMS website as soon as technically feasible, but no later than the 
beginning of the data submission period (for example, January 2, 2021 
for the 2020 performance period).
    Accordingly, we proposed to consolidate Sec.  
414.1380(b)(1)(vii)(A) and (b)(1)(viii) at Sec.  
414.1380(b)(1)(vii)(A). The consolidated paragraph would provide that 
for each submitted measure that is impacted by significant changes that 
CMS determines may result in patient harm or misleading results, 
performance on the measure is assessed based on data for 9 consecutive 
months of the applicable CY performance period. If such data are not 
available, the total available measure achievement points are reduced 
by 10 points. For purposes of this paragraph (b)(1)(vii)(A), 
``significant changes'' means changes to codes (including ICD-10, CPT, 
and HCPCS), clinical guidelines, or measure specifications. We noted 
that we will publish a list of all measures scored under this paragraph 
(b)(1)(vii)(A) on the CMS website as soon as technically feasible, but 
by no later than the beginning of the data submission period at Sec.  
414.1325(e)(1).
    We invited public comments on our proposal to truncate the 
performance period or suppress a quality measures if CMS determines 
that there are significant changes that occurred during the performance 
period. The following is a summary of the comments we received and our 
responses.
    Comment: A few commenters supported expanding policies for scoring 
measures with significant changes during the performance period that 
did not allow comparison to historical benchmarks.
    Response: We thank commenters for their support.
    Comment: One commenter recommended that CMS consider extending the 
scoring policies for measures with significant changes to include 
instances in which clinicians have difficulty obtaining 12 months of 
data, because a contract with a facility is modified during the 
performance period.
    Response: The policies address instances in which there are 
significant changes to measures specifications or coding that do not 
permit any clinicians that selected the measure to submit data or other 
circumstances where a measure may result in patient harm or misleading 
results. It is not intended to address instances in which individual 
clinicians have difficulty obtaining and submitting data, while other 
clinicians are able to be measured accurately on the measure. The 
policy relates to changes to the measure, measure specifications or 
other changes that are outside of the clinicians' control and is 
applied to all clinicians. For individual clinicians, we have other 
scoring flexibilities for individuals unable to submit data, such as 
the ability to apply for reweighting of the quality performance 
category based on extreme and uncontrollable circumstances as described 
in section IV.A.3.d.(2)(b)(iv) of this final rule.
    Comment: One commenter expressed concerns that depending on how CMS 
identifies substantive changes, the policy may result in the lack of 
scorable measures for some clinicians for a performance period and 
recommended working with measure stewards to determine the most 
appropriate course of action in each case to ensure the most accurate 
data is used. The commenter asked for clarification on the expected 
scale of the impact of this change, including how many measures are 
expected to be impacted, and how performance may shift for clinicians.
    Response: The proposal was built on previously established policies 
in which CMS identifies the rare instances in which measures had 
significant changes during the performance period where adherence to 
the guideline of the existing measure or calculating the measure could 
result in patient harm or misleading results. The policy allows us to 
identify changes to measures that are outside of the control of 
clinicians. We often become aware of the changes from feedback from 
clinicians, third parties and measure stewards. We will continue to 
work with measure stewards on how the changes during the performance 
period impact measures. For example, we are concerned that due to 
changes in health care processes and use of hospital services during 
the PHE for COVID-19, there are significant changes to administrative 
claims data used to calculate measures, which may lead to misleading 
results. For purposes of Sec.  414.1380(b)(1)(vii)(A), we would like to 
expand our definition so that ``significant changes'' means changes to 
a measure that are outside the control of the clinician and its agents 
and that CMS determines may result in patient harm or misleading 
results. Significant changes include, but are not limited to, changes 
to codes (such as ICD-10, CPT, or HCPCS codes), clinical guidelines, or 
measure specifications. We do not anticipate that the proposed policy 
to identify mid-year changes to measures that require special scoring 
will result in no available and applicable measures for some 
clinicians.
    Comment: One commenter did not support the suppression of scores 
for quality measures with significant changes during the performance 
period because they believed the policy added complexity to the program 
and recommended removing the quality measure and informing clinicians 
that they should select another measure. One commenter cautioned that 
allowing measures to be suppressed may inflate quality performance 
category scores and permit gaming because there was an incentive to 
submit measures that would be suppressed.
    Response: We are concerned about program complexity but also 
realize that often clinicians select their measures in advance and 
establish workflows for the collection and reporting of data. We 
believe that expanding a previously finalized policy that truncates 
measures considered significantly impacted by ICD-10 coding changes 
during the performance period (82 FR 53714 through 53716) to include 
additional, significant changes to the measure outside of a clinician's 
control, will allow us to continue to use data that clinicians 
collected and reported. If data is available and does not cause patient 
harm or misleading results, our first priority is to utilize 9 months 
of data for scoring. We will attempt to make information available on a 
rolling basis about measures with significant changes; however, 
depending upon the timing, this might not allow sufficient time for 
clinicians to select another measure. When significant changes occur 
during the performance period, we believe that suppression of the 
measure or use of a truncated 9 months of data is appropriate, because 
clinicians are unaware of which measures will require the special 
scoring policies until after the performance period begins and all 
other submitted measures will be scored, we do not believe this will 
result in gaming or inflation of quality performance category scores.
    Comment: A few commenters requested additional information about 
the approach to truncating the performance period of measures to 9 
months of data. One commenter recommended that for measures that could 
only be scored on 9 months of data, that clinicians have the 
flexibility to select their 9-month reporting period. A few commenters 
asked if clinicians were able to submit 12 months of data for measures 
using a truncated 9 months of data, to be consistent with their 
reporting of other measures.

[[Page 84901]]

Commenters indicated that third party vendors would need to restructure 
reporting systems to limit reporting to 9 months of data.
    Response: The policy to truncate the performance period to 9 months 
has been used when there are changes to measure coding, such as ICD-10 
updates, in the final quarter of the performance period that are 
substantial enough to significantly impact the measure. We believe it 
is important to use data in these instances if there are no concerns 
that the 9 months of data could result in patient harm or misleading 
results. We would not allow clinicians to elect which 9 months of data 
to report because the truncation of the performance period occurs only 
if there is a change during the performance period that allows for 9 
months of consecutive data; if there is a change during the performance 
period that does not allow for 9 months of data the measure will be 
suppressed. We believe that it is appropriate for clinicians to submit 
9 months of data and recommend that clinicians work with third party 
intermediaries to allow submission of data.
    Comment: One commenter indicated that the policy to truncate the 
performance period to 9 months of data would not be appropriate for 
quality measures affected by the increases of telehealth visits from 
March to August of 2020 because of the national PHE for COVID-19 and 
recommended greater flexibility in adjusting benchmarks for quality 
measures impacted by changes in patient access due to the national PHE 
in the 2020 performance year.
    Response: We agree with the commenter that the policy to truncate 
the performance period can only be used if we have 9 consecutive months 
of data to assess performance. We will continue to monitor the impact 
of the use of telehealth and changes to clinical processes because of 
the national PHE for COVID-19, and work with measure stewards if they 
believe changes to clinical processes are significant enough to update 
clinical guidelines or trigger our scoring policies to suppress a 
measure. We continue to believe we should suppress a measure if the 
measure is impacted by significant changes that we determine may result 
in patient harm or misleading results. In section IV.A.3.d.(1)(b)(ii) 
of this final rule, we discuss our preference to use historical 
benchmarks when they are complete and reliable. If clinicians believe 
they are unable to submit quality measures for the 2020 performance 
period because of the national PHE for COVID-19, clinicians are allowed 
to submit an application for the reweighting of the quality performance 
category based on extreme and uncontrollable circumstances as described 
in section IV.A.3.d.(2)(b)(iv) of this final rule.
    Comment: A few commenters urged caution in using less than a full 
year of measurement data. One commenter believes using only 9 months of 
data could potentially skew results. One commenter urged CMS to offer a 
review period and to work with measure stewards to determine the most 
appropriate course of action in each case to yield the most accurate 
data.
    Response: We will continue to monitor how many measures are 
impacted by the scoring flexibility policies. Changes to measures 
specifications and coding often do not allow time for a public review 
period, however, we will continue to work with measure stewards when we 
believe that scoring flexibility polices are needed. As stated 
previously, we believe it is important to use data in these instances 
if there are no concerns that the 9 months of data could result in 
patient harm or misleading results.
    Comment: One commenter requested clarification if policies to 
suppress or truncate data would be applied to all measures for the 2021 
performance period.
    Response: The policy will be applied to the 2021 performance period 
and beyond for each measure impacted by significant changes that CMS 
determines may result in patient harm or misleading results. To ensure 
that this includes all collection types, including administrative 
claims measures as well as all measures submitted by clinicians, we are 
modifying the proposal to update the finalized regulation text and 
consolidate Sec.  414.1380(b)(1)(vii)(A) and (b)(1)(viii) at Sec.  
414.1380(b)(1)(vii)(A) to provide that for each measure that is 
submitted, if applicable, and impacted by significant changes that CMS 
determines may result in patient harm or misleading results, 
performance on the measure is assessed based on data for 9 consecutive 
months of the applicable CY performance period. If 9 months of data is 
not available, the measure will be suppressed.
    After consideration of the public comments, we are finalizing our 
proposal with modification: We are finalizing the consolidation of 
Sec.  414.1380(b)(1)(vii)(A) and (b)(1)(viii) at Sec.  
414.1380(b)(1)(vii)(A) to provide that for each measure that is 
submitted, if applicable, and impacted by significant changes, 
performance is based on data for 9 consecutive months of the applicable 
CY performance period. If such data are not available or may result in 
patient harm or misleading results, the measure is excluded from a MIPS 
eligible clinician's total measure achievement points and total 
available measure achievement points. For purposes of this paragraph 
(b)(1)(vii)(A), ``significant changes'' means changes to a measure that 
are outside the control of the clinician and its agents and that CMS 
determines may result in patient harm or misleading results. 
Significant changes include, but are not limited to, changes to codes 
(such as ICD-10, CPT, or HCPCS codes), clinical guidelines, or measure 
specifications. CMS will publish on the CMS website a list of all 
measures scored under this paragraph (b)(1)(vii)(A) as soon as 
technically feasible, but by no later than the beginning of the data 
submission period at Sec.  414.1325(e)(1).
(ii) Quality Measure Benchmarks
    We refer readers to the CY 2017, CY 2018, CY 2019, and CY 2020 
Quality Payment Program final rules (81 FR 77277 through 77282, 82 FR 
53699 through 53718, 83 FR 59841 through 59842, and 84 FR 63014 through 
63016, respectively) for our previously established benchmarking 
policies.
    In the CY 2017 QPP final rule (81 FR 77277 through 77282), we 
finalized that we would use performance in the baseline period to set 
benchmarks for the quality performance category, with the exception of 
new quality measures, quality measures that lack historical data, or 
where we do not have comparable data from the baseline period, for 
which we would set the benchmarks using performance in the performance 
period. We defined the baseline period to be the 12-month CY that is 2 
years prior to the performance period for the MIPS payment year. For 
example, for CY 2021 performance period, the baseline period would be 
CY 2019 which is 2 years prior to the CY 2021 performance period (81 FR 
77277). Additionally, we further clarified that CMS can establish 
benchmarks either by the applicable baseline or performance period in 
the CY 2019 PFS final rule (83 FR 59842), where we finalized the 
terminology change amending 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.
    Because of the flexibility provided to MIPS eligible clinicians to 
allow for no data submission for the 2019

[[Page 84902]]

performance period (see 85 FR 19277 through 19278), we may not have had 
as representative of a sample of data as we would have had without the 
national PHE for COVID-19. Therefore, we revisited our benchmarking 
policy for the 2021 performance period. We anticipated that we may have 
a gap in our data due to potentially receiving fewer submissions for CY 
2019 which could skew the benchmarking results, as the triggering of 
this policy no longer requires clinicians to submit data. We believed 
this gap in data could result in different distributions of scores from 
what we normally see, thus skewing the benchmarks when using CY 2019 
baseline period for the CY 2021 performance period. As a result, we 
considered two benchmarking options for CY 2021 performance period.
    We intended to use performance period benchmarks for the CY 2021 
performance period in accordance with Sec.  414.1380(b)(1)(ii). As 
discussed in the CY 2021 PFS proposed rule (85 FR 50307), this would 
mean that benchmarks for the CY 2021 performance period are based on 
the actual data submitted during the CY 2021 performance period. We 
noted that we believed that using performance period benchmarks for the 
year where we are facing gaps in baseline data will allow us to ensure 
that we continue to have reliable and accurate data. We recognized that 
this methodology would not allow clinicians to know the benchmarks 
ahead of the performance period, but we believe that using the most 
current information has the potential to provide more accurate results 
for benchmarking purposes for CY 2021 performance period and could 
capture any changes in care that have occurred as a result of the 
national PHE for COVID-19.
    We sought feedback on the criteria for using data from the 2019 
MIPS performance period to calculate CY 2021 benchmarks. As an 
alternative to performance period benchmarks we considered and 
requested stakeholder comments and feedback on utilizing the historic 
benchmarks from the 2020 MIPS performance period (which are based on 
submissions for CY 2018 MIPS performance period) for the CY 2021 
performance period. We noted that we believe that this option would 
allow clinicians to continue to receive advance notice for quality 
performance category measures so that MIPS eligible clinicians can set 
a clear performance goal for these measures for CY 2021 performance 
period. However, we remained concerned that utilizing outdated data 
could also potentially result in distributions of scores used for 
benchmarks that no longer reflect the standard of care.
    We invited public comments on our intent to use performance period 
benchmarks for the CY 2021 performance period. The following is a 
summary of the comments we received and our responses.
    Comment: Several commenters recommended that CMS monitor and 
analyze to determine if the 2019 data is a representative sample based 
on the number of submissions for 2019 before deciding and finalizing 
which benchmarks should be used. A few commenters suggested that we see 
if there are statistically significant fewer submissions for CY 2019 
than were received in previous performance periods that constitutes the 
need to use performance period benchmarks.
    Response: Based on our analysis of 2019 submissions, we believe 
that we have sufficient data to calculate historical benchmarks and do 
not believe it is necessary to use performance period benchmarks. The 
analysis showed minimal to no impact due to the national PHE for COVID-
19 policies for the eCQM and Part B claims collection types. Overall, 
we generally saw an increase in eCQM submissions. In addition, we know 
we have complete data from Part B claims collection types because that 
submission ended before the PHE. For the other collection types for 
2021, the MIPS CQM and QCDR measures, we generally saw decreases in 
submissions, but the decreased submissions appear to have a modest 
distributional effect for most measures and is likely due to an 
increase in group reporting and the increase in eCQM submissions. The 
national PHE for COVID-19 E/U circumstances policy led to only a slight 
increase in the number of clinicians not engaged with MIPS in 2019 
compared to 2018 submission data.
    Comment: Several commenters opposed the use of 2021 performance 
period benchmarks as this would not allow clinicians to have 
referenceable benchmarks as a guide to predict their scores or set 
performance goals or priorities, making it difficult to determine 
performance improvement opportunities and preferred the use of 
historical benchmarks from 2019 data. Several commenters did not 
support holding clinicians accountable for performance against a 
benchmark that would not be set until after the performance period is 
closed as the use of performance period benchmarks would burden 
clinicians by not providing time to understand how performance compares 
to benchmarks and could lead to lower performance and MIPS scores. 
Several commenters encouraged CMS to publish a benchmark file to 
provide guidance to evaluate and strategize reporting. A few clinicians 
stated that the use of performance period benchmarks would burden 
clinicians by not providing time to understand how performance compares 
to benchmarks and could lead to a decrease in performance and MIPS 
scores. A few commenters specifically supported using historical 
benchmarks from the 2019 MIPS performance period data over utilizing 
2018 data for benchmarks because the 2019 performance period provides 
more recent data.
    Additionally, one commenter stated that using performance period 
benchmarks would limit EHR vendors' ability to provide timely scoring 
feedback and insight into performance. One commenter suggested that CMS 
use 2019 benchmarks for 2021 performance and to limit the performance 
period to the months at the end of 2021 not impacted by the national 
PHE for COVID-19 to allow for comparison of data not influenced by the 
national PHE for COVID-19 in 2019 to 2021.
    Response: We agree that providing a historical benchmark for the 
quality performance category allows MIPS eligible clinicians to know 
quality performance category benchmarks in advance. We believe there is 
value in the advance notice for quality performance measures so that 
MIPS eligible clinicians can benchmark themselves for quality measures 
when historical data is available. We agree with commenters that 
quality benchmarks should be made public and should be known in advance 
when possible so that MIPS eligible clinicians can understand how they 
will be measured and to not limit vendors from providing timely 
feedback and insight into performance. We will continue to rely on 
historical benchmarks for CY 2021 since data from CY 2019 has become 
available and is representative and comparable. We will continue to 
monitor the impact of the national PHE for COVID-19 on data in CY 2020 
and CY 2021. The historical benchmarks based on CY 2019 data will be 
available prior to the CY 2021 performance period at qpp.cms.gov.
    Comment: Many commenters supported the use of 2021 performance 
period benchmarks since they are based on current information that can 
provide accurate benchmarks from data that are reliable, accurate, 
complete, and representative of performance in 2021. The commenters 
expressed support given that performance period benchmarks capture any 
changes in care

[[Page 84903]]

due to the national PHE for COVID-19 and avoid unfairly penalizing 
practices for variations in performance compared to data from prior to 
the national PHE for COVID-19.
    Response: Based on our analysis of the 2019 data, we believe that 
the data is reliable, complete, or representative and no longer believe 
we need to rely on performance period benchmarks. We realize there may 
be a risk for some measures that performance in CY 2021 might differ 
from CY 2019 given the automatic extreme and uncontrollable 
circumstances policy for CY 2019 quality performance category in 
response to the national PHE for COVID-19 (85 FR 19277 through 19278). 
We are continuing to evaluate the effects of the national PHE for 
COVID-19 on clinicians and will take this comment into consideration 
for the future, but we also understand and have previously stated, that 
there are benefits to knowing the benchmark target in advance and 
believe there is value to clinicians in having historical benchmarks. 
We believe there is more value in providing advance notice for quality 
performance category measures so that MIPS eligible clinicians can set 
a clear performance goal for these measures, provided that historical 
data is available.
    Comment: Several commenters opposed the use of performance period 
benchmarks and supported the alternative to use historical benchmarks 
based on 2018 MIPS performance data to continue to receive advance 
notice of benchmarking targets, allow clinicians to understand how they 
are performing in real-time compared to the 2018 benchmarks, provide a 
degree of certainty, and help clinicians prepare in advance for 
selecting measures based on data that is not impacted by the national 
PHE for COVID-19. A few commenters recommended using historical 
benchmarks from 2018 data for the 2021 performance year if the 
participation rate dropped significantly from 2018 to 2019. A few 
commenters stated that CEHRT vendors rely on benchmarks to set 
dashboards and reports and having benchmarks from 2018 would allow 
developers to provide accurate information to clinicians. A few 
commenters stated that the data from 2019 might not be inclusive 
because of the extreme and uncontrollable circumstance policy for the 
national PHE for COVID-19 and performance period benchmarks will make 
it difficult for clinicians to predict how they will score. One 
commenter suggested the use of CY 2020 quality data as a baseline for 
benchmarking for CY 2021. One commenter suggested calculating 
benchmarks by combining 2017, 2018, and 2019 data to provide a larger 
sample to address concerns around skewed data while still providing 
target information.
    Response: Based on our 2019 data analysis, we believe we have 
sufficient data to reliably generate historical benchmarks for CY 2021 
and we will not need to rely on 2018 benchmarks to provide a known 
target for benchmarking. Using historical benchmarks based on the 
reliable and complete data from 2019 will allow us to provide 
benchmarks based on more recent data in advance for clinicians to 
prepare and since the data from 2019 is usable, representative, and 
more recent, we do not believe it necessary to use data from 2018 to 
create benchmarks for CY 2021, as it would be more out of data than 
data from 2019. Using the data from 2019, CEHRT vendors remain able to 
rely on the benchmarks for CY 2021 to set dashboards and reports to 
provide accurate information to clinicians. Additionally, we do not 
believe we need to combine benchmarks across years to create a reliable 
benchmark.
    Comment: Several commenters suggested that we calculate two 
benchmarks, one historical and one performance period, and then have 
CMS use the more favorable of the two benchmarks for each measure. The 
commenters suggested this approach to provide baseline information to 
guide measure selection and advance notice to clinicians on possible 
benchmarks while considering the impact of the national PHE for COVID-
19 and having complete, reliable data. One commenter suggested 
calculating both 2019 and 2020 performance year measure benchmarks and 
using the lower benchmark for each quality measure since CMS already 
calculated this data and will allow for comparing scores given the 
impact of the national PHE for COVID-19. One commenter recommended that 
CMS use CY 2019 data to publish a benchmark file and then score 
measures based on the average of 2021 and 2019 data. One commenter 
suggested setting a threshold to assess change in benchmarks and if the 
change threshold is not exceeded, a performance period benchmark would 
be appropriate. If change above the set threshold occurred, the 
historical benchmark would be used.
    Response: Based on our 2019 data analysis, we can use historical 
benchmarks for CY 2021 that are complete and reliable and do not 
believe that we need to create two benchmarks or use an average of 2 
years of data to create a benchmark. The data we received for CY 2019 
is robust as we only saw a slight increase in the number of clinicians 
not engaged with MIPS in CY 2019 compared to CY 2018 submission data. 
This allows us to provide benchmarks in advance for clinicians to have 
baseline information to guide measure selection and gives advance 
notice to clinicians on benchmarks. The benchmarks based on CY 2019 
data will be available prior to the CY 2021 performance period at 
qpp.cms.gov.
    Comment: Several commenters recommended that CMS consider the 
impacts that the PHE for COVID-19 will have on participation and data 
from 2019, 2020, and potentially 2021 when setting future benchmarks. 
Commenters stated that the national PHE for COVID-19 will continue to 
disrupt patient volume, case mix, and patient outcomes, making data 
incomparable when comparing years impacted by the national PHE for 
COVID-19 to prior years without impact. A few commenters requested CMS 
to take major changes in care, including disruptions in the delivery of 
medical services, into account when comparing data from year to year. A 
few commenters suggested that CMS compute benchmarks with 2018, 2019, 
and 2020 data separately to understand the impact of the PHE on quality 
measures. One commenter stated that due to the removal of telehealth 
exclusion language from select measure specifications, data will not be 
comparable and will no longer be reliable for measures in the future.
    Response: For performance year 2020, we continue to offer the 
extreme and uncontrollable circumstances policy in response to the 
national PHE for COVID-19, allowing clinicians to submit an application 
for the reweighting of the quality performance category based as 
described in section IV.A.3.d.(2)(b)(iv) of this final rule. We will 
continue to monitor the impacts of the national PHE for COVID-19 on 
data comparability, including due to the removal of telehealth 
exclusion language from select measure specifications, and will 
incorporate changes and offer flexibilities through future rulemaking 
cycles, as necessary, to account for changes in care delivery. 
Benchmarks from CY 2018 data have already been released publicly and 
benchmarks from CY 2019 data will be released prior to the start of CY 
2021. Benchmarks from CY 2020 data will be released once the data is 
available. Those benchmarks will be available at qpp.cms.gov.
    After consideration of the public comments, we are not finalizing 
our intent to use performance period benchmarks for the CY 2021

[[Page 84904]]

performance period and will use historical benchmarks for CY 2021 based 
on the 2019 data.
(iii) Minimum Case Requirements
    In the CY 2017 Quality Payment program final rule (81 FR 77287 to 
77289), we finalized that we will use 20 cases as the case minimum for 
all quality measures, with the exception of the hospital-wide 
readmission measure which has a minimum of 200 cases. As proposed in 
Table Group A within Appendix 1, the hospital-wide readmission measure 
is replacing the all-cause readmission measure and an additional 
administrative claims-based measure for hip/knee complications is being 
added to the program. In the case of the hospital-wide readmission 
measure, the case minimum will remain the same at 200 cases and will 
only apply to groups. For the new hip/knee complications measure, a 
case minimum of 25 is proposed and is applicable for individuals and 
groups. As noted in the CY 2021 PFS proposed rule (85 FR 50308), we 
proposed to amend Sec.  414.1380(b)(1)(i) to clarify how administrative 
claims measures are scored. We proposed to amend Sec.  
414.1380(b)(1)(iii) to reflect that, except for administrative claims 
measures, the minimum case requirement is 20 cases. For each 
administrative claims-based measure, the minimum case requirement is 
specified in the annual list of MIPS measures.
    We invited public comments on our proposal to amend Sec.  
414.1380(b)(1)(i) to clarify how administrative claims measures are 
scored and amend Sec.  414.1380(b)(1)(iii) to reflect that, except for 
administrative claims measures, the minimum case requirement is 20 
cases. The following is a summary of the comments we received and our 
responses.
    Comment: One commenter did not support the proposal to define the 
minimum case requirement for administrative claims measures in the 
annual list of MIPS measures. One commenter recommends that CMS 
maintain the current regulatory process of limiting such requirements 
to amounts specifically listed in regulation (for example, for non-
administrative claims measures, the minimum case requirement is 20 
cases) to minimize negative impact in program compliance and to limit 
additional changes in an already nuanced quality reporting program.
    Response: While we understand the commenter's concern regarding 
additional annual updates, we believe providing the specific minimum 
case requirements for administrative claims measures in the annual list 
of MIPS measures allows these measures to be reliably scored based on 
the case minimum specific to each measure. Based on the specifications, 
administrative claims measures may require a case minimum that is an 
exception to the 20 cases otherwise required. Any further changes in 
the case minimum requirement would be considered substantial and would 
go through rule making. Additionally, this exception is for 
administrative claims measures, which do not require reporting and are 
based on claims data we receive.
    Comment: One commenter stated that a sample of 25 cases is 
insufficient to provide meaningful data for the newly added hip/knee 
complications measure.
    Response: While we understand the commenter's concern about the 
proposed case minimum for the new hip/knee complications measure, we 
selected a minimum case count of 25 to ensure a measure result is 
available for most eligible clinicians and eligible clinician groups 
while maintaining measure reliability. We believe that for this 
measure, a minimum case count of 25 cases demonstrates reliability 
results consistent with standards of other measures within MIPS. We 
refer readers to Table Group A of Appendix 1 of this rule for 
discussion on new individual MIPS quality measures proposed for the 
2023 MIPS payment year and future years.
    After consideration of the public comments, we are finalizing our 
proposal as proposed.
(iv) Assigning Quality Measure Achievement Points
    We refer readers to Sec.  414.1380(b)(1)(i) for more details on our 
policies for scoring performance on quality measures (81 FR 77276 
through 77307, 82 FR 53694 through 53701, 83 FR 59841 through 59856, 
and 84 FR 63011 through 63019).
(A) Scoring Measures Based on Achievement
    We previously established 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) for the 2019 through 2022 
MIPS payment years. MIPS eligible clinicians 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. In the CY 2017 Quality 
Payment Program final rule (81 FR 77282), we established that measures 
with a benchmark based on the performance period (rather than on the 
baseline period) would continue to receive between 3 and 10 measure 
achievement points for performance periods after the first transition 
year. For measures with benchmarks based on the baseline period, we 
stated that we would revisit the 3-point floor in future years.
    For the 2023 MIPS payment year, we proposed to again apply a 3-
point floor for each measure that can be reliably scored against the 
benchmark. As we move towards the MVP framework discussed the CY 2021 
PFS proposed rule (85 FR 50308), we anticipated we will be able to 
score quality measures from 1 to 10 for measures in MVPs and as such 
will revisit and possibly remove the 3-point floor for traditional MIPS 
in future years. As a result, we discussed that we would wait until 
there is further policy development under the MVP framework before 
proposing to remove the 3-point floor. Accordingly, in the CY 2021 PFS 
proposed rule (85 FR 50308), we proposed to revise Sec.  
414.1380(b)(1)(i) to remove the years 2019 through 2022 and adding in 
its place the years 2019 through 2023 to provide that for the 2019 
through 2023 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.
    We invited public comments on our proposal to again apply a 3-point 
floor for each measure that can be reliably scored against a benchmark 
for the MIPS 2023 payment year. The following is a summary of the 
comments we received and our responses.
    Comment: Several commenters supported the proposal to continue the 
3-point floor for each measure that can be reliably scored against a 
benchmark.
    Response: We thank the commenters for their support.
    Comment: One commenter recommended adopting a 5-point floor for 
each measure that can be reliably scored against a benchmark to help 
mitigate the disruptive effects of the PHE and to provide incentives 
for clinicians to report measures. A few commenters recommended 
adopting a universal scoring floor of 5 points to mitigate the 
disruptive effects of the national PHE for COVID-19 on benchmarks while 
incentivizing clinicians to report measures that

[[Page 84905]]

historically lack a benchmark and would increase use of under-reported 
measures and incentivize clinicians to report instead of opting out.
    Response: We appreciate the commenter's concern. We do not want to 
mask performance with a floor above 3 points. Clinicians will know in 
advance what the benchmarks are, and we believe that the 3-point floor 
provides protection for clinicians.
    After consideration of the public comments, we are finalizing our 
proposal as proposed.
(B) Scoring Measures That Do Not Meet Case Minimum, Data Completeness, 
and Benchmark Requirements
    We refer readers to Sec.  414.1380(b)(1)(i)(A) and (B) for more on 
our 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 
(84 FR 63012).
    In the 2017 QPP final rule (81 FR 77288) and the 2018 QPP final 
rule (82 FR 53727), we identified ``classes of measures'' which were 
intended to characterize measures for the ease of discussion. Class 1 
measures are measures that can be scored based on performance because 
they have a benchmark, meet the case minimum and data completeness 
requirements. Class 2 measures are measures that cannot be scored based 
on performance because they do not have a benchmark or do not meet the 
case minimum which is generally 20 cases. Class 3 measures are measures 
that do not meet the data completeness requirement. We also noted that 
policies for Class 2 and Class 3 measures would not apply to measures 
submitted with the CMS Web Interface or administrative claims-based 
measures.
    We did not propose to modify how we score these measures within 
MIPS, as we consider policies for transitioning to MVPs. For class 2 
measures, for the 2023 MIPS payment year, we proposed to again apply 
the special scoring policies for measures that meet the data 
completeness requirement but do not have a benchmark, due to fewer than 
20 individual clinicians or groups adequately reporting the measure, or 
meet the case minimum requirement. Accordingly, in the CY 2021 PFS 
proposed rule (85 FR 50308 through 50309), we proposed to revise Sec.  
414.1380(b)(1)(i)(A)(1) to remove the years 2019 through 2022 and add 
in its place the years 2019 through 2023 to provide that except as 
provided in paragraph (b)(1)(i)(A)(2) (which relates to CMS Web 
Interface measures and administrative claims-based measures), for the 
2019 through 2023 MIPS payment years, MIPS eligible clinicians would 
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.
    We invited public comments on our proposal to again apply the 
special scoring policies for measures that meet the data completeness 
requirement but do not have a benchmark or meet the case minimum 
requirement for the MIPS 2023 payment year. The following is a summary 
of the comments we received and our responses.
    Comment: One commenter supported the continuation of the policies 
as proposed.
    Response: We appreciate the commenter for their support.
    Comment: A few commenters did not support the proposal to continue 
the 3 measure achievement points for measures without a benchmark 
because the commenters believed that the policy provides a disincentive 
to submit more specialized measures and recommended that CMS provide 
bonus points for submitting measures without a benchmark.
    Response: We recognize the commenters' concerns regarding the 
assignment of 3 points to measures without a benchmark. We are 
continuing to evaluate our approach to scoring measures without a 
benchmark and will take these comments into consideration for the 
future.
    After consideration of the public comments, we are finalizing our 
proposal as proposed.
    A summary of the policies for the CY 2021 MIPS performance period 
is provided in Table 49.

[[Page 84906]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.095

(v) Assigning Measure Achievement Points for Topped Out Measures
    We refer readers to Sec.  414.1380(b)(1)(iv) for our previously 
finalized policies regarding the identification of topped out measures 
and Sec.  414.1380(b)(1)(iv)(B) for our finalized policies regarding 
the scoring of topped out measures. Under Sec.  414.1380(b)(1)(iv), we 
will identify topped out measures in the benchmarks published for each 
Quality Payment Program year. Under Sec.  414.1380(b)(1)(iv)(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).
    We noted in the CY 2021 PFS proposed rule (85 FR 50307) that we 
intended to use performance period benchmarks for the 2021 MIPS 
performance period, which would mean we would not be able to publish 
measures that are topped out prior to the 2021 MIPS performance period. 
As discussed in that proposed rule (85 FR 50309), this also means we 
would not be able to identify those that have been topped-out for 2 or 
more consecutive years for purposes of the topped out scoring of 7 
measure achievement points. We noted that we believe it is still 
important to retain a topped-out scoring cap of 7 measure achievement 
points so that clinicians have incentives to pick alternate measures 
that are not topped out. We also noted that a measure may not always be 
topped out and we believe that if a measure is not topped out in the 
2021 performance period benchmark, then it should have the ability to 
achieve up to 10 measure achievement points.
    Therefore, for the 2021 MIPS performance period, as an exception 
from the general rule at Sec.  414.1380(b)(1)(iv)(B), we proposed at 
Sec.  414.1380(b)(1)(iv)(B)(1) to apply the 7 measures achievement 
point cap to measures that meet the following two criteria. The first 
criterion would be that the measures have been topped out for 2 or more 
periods based on the published 2020 MIPS performance period historical 
benchmarks (which are based on submissions for the 2018 MIPS 
performance period). The second criterion would be the measures remain 
topped out after the 2021 MIPS performance period benchmarks have been 
calculated. We noted that we believe these two criteria collectively 
would provide clinicians the information to know prior to the 2021 MIPS 
performance period which measures would have the topped-out scoring 
applied but would also account for the scenario where a measure is no 
longer topped out. We would not limit the number of measure achievement 
points for measures that have not been topped out for at least 2 years 
as published in the 2020 MIPS performance period historical benchmarks.
    We invited public comments on our proposal to apply the 7 measures 
achievement point cap to measures that meet the two criteria. The 
following is a summary of the comments we received and our responses.
    Comment: Several commenters do not support the proposal to apply 
the scoring cap of 7 achievement points for the 2021 performance period 
for measures that are found to be topped out and based this rationale 
on the thinking that the cap would apply to topped out measures for 2 
or more consecutive years, including the 2021 MIPS performance period 
benchmarks. A few commenters discussed concerns over not knowing which 
measures will have the cap prior to the 2021 performance period and 
could put clinicians at risk of inadvertently reporting on measures 
with topped out

[[Page 84907]]

benchmarks, resulting in a capped score for the measure.
    Response: We appreciate the commenters' responses for this 
proposal. As discussed in section IV.A.3.d.(1)(b)(ii) of this rule, we 
no longer intend to use performance period benchmarks and will use 
historical benchmarks for CY 2021. This allows us to provide benchmarks 
in advance for clinicians to have baseline information to guide measure 
selection. Because we are using historical benchmarks, we no longer 
need an exception to identify topped out measures, instead we will 
follow our normal topped out lifecycle process.
    Comment: A few commenters requested that CMS suspend the topped-out 
measure scoring cap for the 2021 MIPS performance period due to the 
national PHE for COVID-19 and since many topped-out measures remain the 
most meaningful measures on which certain clinicians can report.
    Response: We appreciate the commenters' concern about the scoring 
cap for topped out measures. As MIPS is a performance-based program, we 
do not believe that MIPS eligible clinicians electing to report topped 
out measures should be able to receive the same maximum score as other 
measures that demonstrate variations in performance and room for 
improvement. We therefore continue to believe it necessary to maintain 
the 7-point cap for measures identified as topped out. Additionally, 
please refer to qpp.cms.gov/about/covid19 for our national PHE for 
COVID-19 response and flexibilities provided within QPP.
    Comment: Several commenters supported the proposed criteria for 
determining which measures should have the 7-point cap applied in 2021 
performance year based on the use of performance period benchmarks as 
it provides important protections for clinicians given the impact of 
the national PHE for COVID-19.
    Response: We appreciated the commenters for their support for this 
policy based on the intended use of the performance period benchmarks, 
but note that we are not finalizing the use of performance period 
benchmarks policy as discussed in section IV.A.3.d.(1)(b)(ii) of this 
rule.
    After consideration of public comments, we are not finalizing our 
proposal to create an exception from the general rule at Sec.  
414.1380(b)(1)(iv)(B) that we had proposed at Sec.  
414.1380(b)(1)(iv)(B)(1). Instead, we will continue our policy that the 
7-point cap will be applied to measures (except for measures in the CMS 
Web Interface) that are identified as topped out for 2 or more 
consecutive years, beginning in the second year the measure is 
identified to be topped out.
(vi) Incentives To Report High-Priority Measures
    We refer readers to Sec.  414.1380(b)(1)(v)(A) for our previously 
finalized policies regarding incentives to report high priority 
measures. In the CY 2017 Quality Payment Program final rule (81 FR 
77293), we established the scoring policies for high priority measure 
bonus points to encourage the selection of additional high-priority and 
outcome measures that impact beneficiaries and were closely aligned to 
our measurement goals. In the CY 2019 PFS final rule (83 FR 59850), we 
discontinued awarding measure bonus points to CMS Web Interface 
reporters for reporting high priority measures since CMS Web Interface 
reporters have no choice in measures.
    We stated in the CY 2019 PFS proposed and final rules (83 FR 35950, 
59851) that as part of our move towards fully implementing high value 
measures, we believe that bonus points for high priority measures for 
all collection types may no longer be needed, and as a result, we 
intended 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. We noted in the CY 2019 PFS final rule (83 FR 59851) 
that measure bonus points were created as transition policies which 
were not meant to continue through the life of the program. We believe 
with the finalized framework for transforming MIPS through MVPs (84 FR 
62948), we will find ways in the future to emphasize high priority 
measures without needing to incentivize with bonus points. As a result, 
we noted that we would wait until there is further policy development 
under the MVP framework before proposing to remove our policy of 
assigning bonus points for high priority measures.
    As noted in the CY 2021 PFS proposed rule (85 FR 50309 through 
50310), we proposed to maintain the cap on measure points for reporting 
high priority measures for the 2023 MIPS payment year. Accordingly, we 
proposed to revise Sec.  414.1380(b)(1)(v)(A)(1)(ii) to remove the 
years 2019 through 2022 and adding in its place the years 2019 through 
2023 to provide that through the 2023 MIPS payment year, the total 
measure bonus points for high priority measures cannot exceed 10 
percent of the total available measure achievement points.
    We invited public comments on our proposal to maintain the cap on 
measure points for reporting high priority measures for the 2023 MIPS 
payment year. The following is a summary of the comments we received 
and our responses.
    Comment: A few commenters supported our proposal to continue the 
high priority bonus. Commenters expressed the belief that these bonuses 
can help clinicians meet the performance threshold.
    Response: We thank the commenters for their support.
    Comment: One commenter did not support our stated intention to 
phase out high priority measure bonus points in the future because 
commenter believes these bonuses are important to ensure benchmarks are 
established for these high priority measures through incentivizing 
reporting.
    Response: We appreciate the commenter's concerns and will take 
their recommendations into consideration for the future. We envision 
that the progression of the MIPS program under the MVP framework will 
allow us to remove some of the scoring complexity associated with the 
MIPS program. We anticipate that removing bonuses would be part of this 
framework. We also understand the interest in being as flexible as 
possible in awarding clinicians for supporting the goals of the program 
such as reporting high priority measures and creating benchmarks. While 
bonuses do not directly affect the calculation of benchmarks, we will 
continue to consider the best ways to support our goals in future 
rulemaking.
    After consideration of the public comments, we are finalizing our 
proposal as proposed.
(vii) 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. In the CY 2017 Quality Payment 
Program final rule (81 FR 77297), we established the measure bonus 
point and bonus cap for using CEHRT for end-to-end reporting. We refer 
readers to Sec.  414.1380(b)(1)(v)(B) for our previously finalized 
policies regarding measure bonus points for end-to-end electronic 
reporting. We believe that with the framework for transforming MIPS 
through MVPs discussed in the CY 2020 PFS proposed rule (84 FR 40739) 
and the CY 2021 PFS proposed rule (85 FR 50279 through 50285), we will 
find ways to incorporate digital measures without needing to 
incentivize end-to-end reporting with

[[Page 84908]]

bonus points. In the CY 2018 Quality Payment Program final rule (82 FR 
53636), we encouraged stakeholders to consider electronically 
specifying their quality measures as eCQMs, to encourage clinicians and 
groups to move towards the utilization of electronic reporting. As 
noted in the CY 2019 PFS final rule (83 FR 59851), bonus points were 
created as transition policies which were not meant to continue through 
the life of the program. As a result, we noted that we would wait until 
there is further policy development under the finalized MVP framework 
(84 FR 62948) before proposing to remove our policy of assigning bonus 
points for end-to-end electronic reporting.
    As noted in the CY 2021 PFS proposed rule (85 FR 50310), we 
proposed to continue to assign and maintain the cap on measure bonus 
points for end-to-end electronic reporting for the 2023 MIPS payment 
year. Accordingly, we proposed to revise Sec.  
414.1380(b)(1)(v)(B)(1)(i) to remove the years 2019 through 2022 and 
add in its place the years 2019 through 2023 to provide that for the 
2019 through 2023 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.
    We invited public comments on our proposal to maintain the cap on 
measure bonus points for end-to-end electronic reporting for the 2023 
MIPS payment year. The following is a summary of the comments we 
received and our responses.
    Comment: A few commenters supported and urged CMS to continue the 
bonus for end-to-end reporting using CEHRT because it would drive 
electronic reporting and maintain stability in the program.
    Response: We thank the commenters for their support.
    After consideration of the public comments, we are finalizing our 
proposal as proposed.
(viii) Improvement Scoring for the MIPS Quality Performance Category 
Percent Score
    We refer readers to Sec.  414.1380(b)(1)(vi)(C)(4) for more on our 
policy stating that for the 2020 through 2022 payment years, for the 
purpose of improvement scoring, we will assume a quality performance 
category achievement percent score of 30 percent in the previous year 
if a MIPS eligible clinician earned a quality performance category 
score less than or equal to 30 percent in the previous year.
    As noted in the CY 2021 PFS proposed rule (85 FR 50310), we 
proposed to continue our previously established policy for improvement 
scoring for the 2023 MIPS payment years and to revise Sec.  
414.1380(b)(1)(vi)(C)(4) to remove the phrase ``2020 through 2022 MIPS 
payment year'' and adding in its place the phrase ``2020 through 2023 
MIPS payment years'' to indicate that for each MIPS payment year 
through 2023, we will assume a quality performance category achievement 
percent score of 30 percent in the previous year if a MIPS eligible 
clinician earned a quality performance category score less than or 
equal to 30 percent in the previous year. Specifically, for the 2023 
MIPS payment year, we would compare the MIPS eligible clinician's 
quality performance category achievement percent score for the 2021 
MIPS performance period to an assumed quality performance category 
achievement percent score of 30 percent if the MIPS eligible clinician 
earned a quality performance score less than or equal to 30 percent for 
the 2020 MIPS performance period.
    We invited public comments on our proposal to assume a quality 
performance category achievement percent score of 30 percent in the 
previous year if a MIPS eligible clinician earned a quality performance 
category score less than or equal to 30 percent in the previous year 
for the 2023 MIPS payment year. The following is a summary of the 
comments we received and our responses.
    Comment: A few commenters expressed support for improvement scoring 
for the quality performance category because it better rewards high 
quality performers and promotes strategic priorities of CMS.
    Response: We thank the commenters for their support.
    After consideration of the public comments, we are finalizing our 
proposal as proposed.
(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) and the discussion in the CY 2017 and CY 
2018 Quality Payment Program final rules, and the CY 2019 and CY 2020 
PFS final rules (81 FR 77319 through 77329, 82 FR 53769 through 53785, 
83 FR 59868 through 59878, 84 FR 63020 through 63031, respectively). In 
the CY 2021 PFS proposed rule (85 FR 50310 through 50315), we proposed 
to continue the complex patient bonus for the 2023 MIPS payment year, 
and we also proposed to modify the complex patient bonus for the 2022 
MIPS payment year as established in prior rulemaking due to the PHE for 
COVID-19. In addition, we proposed performance category redistribution 
policies for the 2023, 2024, and future MIPS payment years.
(a) Complex Patient Bonus
(i) Background
    Section 1848(q)(1)(G) of the Act requires us to consider risk 
factors in our MIPS scoring methodology. Specifically, it provides that 
the Secretary, on an ongoing basis, shall, as the Secretary determines 
appropriate and based on an individual's 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)) (Pub. L. 113-
185, enacted on October 6, 2014) and, as appropriate, other 
information, including information collected before completion of such 
studies and recommendations. In the CY 2018 Quality Payment Program 
final rule, under the authority in section 1848(q)(1)(G) of the Act, we 
established 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). In subsequent rulemaking, we continued the 
complex patient bonus at Sec.  414.1380(c)(3) for the 2021 and 2022 
MIPS payment years (83 FR 59870 and 84 FR 63023). We refer readers to 
these final rules for additional details on the background, statutory 
authority, policy rationale, and calculation of the complex patient 
bonus.
    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. The overall goal, when considering a bonus for complex 
patients, is 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 used

[[Page 84909]]

the term ``patient complexity'' to take into account a multitude of 
factors that describe and have an impact on patient health outcomes; 
such factors include the health status and medical conditions of 
patients, as well as social risk factors. We believe that as the number 
and intensity of these factors increase for a single patient, the 
patient may require more services, more clinician focus, and more 
resources in order to achieve health outcomes that are similar to those 
who have fewer factors. In developing the policy for the complex 
patient bonus, we assessed whether there was a MIPS performance 
discrepancy by patient complexity using two well-established indicators 
in the Medicare program: Medical complexity as measured through 
Hierarchical Condition Category (HCC) risk scores, and social risk as 
measured through the proportion of patients that are dually eligible 
for Medicare and Medicaid (82 FR 53771 through 53776).
(ii) Complex Patient Bonus for the 2023 MIPS Payment Year
    As discussed in the CY 2021 PFS proposed rule (85 FR 50310), we 
intended the complex patient bonus as a short-term solution to address 
the impact patient complexity may have on MIPS scoring. However, we 
noted that we currently do not believe we have sufficient information 
available to develop a long-term solution to account for patient risk 
factors in MIPS that we could include as a proposal for the 2023 MIPS 
payment year. In the CY 2020 PFS proposed and final rules, we 
considered whether newly available data from the Quality Payment 
Program still supported the complex patient bonus at the final score 
level. More specifically, within the data analysis, we did not observe 
a consistent linear relationship for any reporting type or complexity 
measure, HCC risk score or dual eligible status (84 FR 40793 through 
40795 and 84 FR 63021 through 63023). However, we only have a few years 
of data and believe that more recent data may bring different results 
than the findings we explained in detail in the CY 2020 PFS final rule. 
We refer readers to the CY 2020 PFS final rule for further details on 
the methodology and findings (84 FR 63021 through 63023).
    As stated previously in this final rule, section 1848(q)(1)(G) of 
the Act requires us to take into account the relevant studies conducted 
under section 2(d) of the IMPACT Act and, as appropriate, other 
information, including information collected before completion of such 
studies and recommendations. ASPE completed its first report in 
December 2016, which examined the effect of individuals' socioeconomic 
status on quality, resource use, and other measures under the Medicare 
program, and included analyses of the effects of Medicare's current 
value-based payment programs on clinicians serving socially at-risk 
beneficiaries and simulations of potential policy options to address 
these issues. We also noted, in the CY 2020 PFS final rule, that a 
second ASPE report on social risk factors within CMS value-based 
purchasing programs was expected. This second report, Social Risk and 
Performance in Medicare's Value-Based Purchasing Programs, was publicly 
released in June 2020, which builds on the analyses included in the 
initial report and provides additional insight for addressing risk 
factors in MIPS and other value-based payment programs.\126\ More 
specifically, the report has a 3-pronged strategy approach to measure 
and report quality; to set high, fair quality standards; and to reward 
and support better outcomes for beneficiaries with social risk. As a 
part of this 3-pronged strategy, the report supports the use of the 
complex patient bonus in MIPS, explaining that it is well supported 
because this policy gives additional points to clinicians who treat 
patients with high social risk factors and does not lower the standard 
of care. Further, the report suggested that CMS should not include the 
complex patient bonus within the final score that is publicly reported 
to ensure that patients can see the true clinician performance. As we 
continue to review the findings from the report, we intend to consider 
its recommendations, along with any updated data that would become 
available, for future rulemaking. Hence, based on our data analysis 
from the CY 2020 PFS final rule (84 FR 63022) and the lack of currently 
available additional data sources, for the 2021 MIPS performance 
period/2023 MIPS payment year, we proposed to continue the complex 
patient bonus without any modifications (as finalized for the 2020 MIPS 
performance period/2022 MIPS payment year) and to revise Sec.  
414.1380(c)(3) accordingly. We noted that we plan to continue working 
with ASPE, the public, and other key stakeholders on this important 
issue to identify longer term policy solutions that achieve the goals 
of attaining health equity for all beneficiaries, minimizing unintended 
consequences, and would propose modifications to the complex patient 
bonus in future rulemaking as appropriate.
---------------------------------------------------------------------------

    \126\ ASPE. Second Report to Congress on Social Risk and 
Medicare's Value-Based Purchasing Programs. June 29 2020. https://aspe.hhs.gov/pdf-report/second-impact-report-to-congress.
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    We invited public comments on our proposal to continue the complex 
patient bonus for the 2021 MIPS performance period/2023 MIPS payment 
year. The following is a summary of the comments we received and our 
responses.
    Comment: A few commenters supported our proposal to continue the 
complex patient bonus of up to 5 points for the 2021 MIPS performance 
period/2023 MIPS payment year. Another commenter supported the complex 
patient bonus but requested that we increase the complex patient bonus.
    Response: We thank the commenters for their support to maintain the 
complex patient bonus for the 2021 MIPS performance period/2023 MIPS 
payment year. We plan to review available information, including any 
updated data, in future years to determine if it is appropriate to 
modify our approach to adjusting for social risk factors.
    Comment: Many commenters encouraged CMS to finalize the proposed 
policy, discussed in the CY 2021 PFS proposed rule (85 FR 50311), of 
doubling the complex patient bonus for the CY 2020 performance period, 
and to continue doubling the complex patient bonus into the CY 2021 
performance period, because the impact of the national PHE for COVID-19 
will likely continue, as well as the associated increased complexity 
due to COVID-19.
    Response: We understand that both direct and indirect impacts of 
the PHE for COVID-19 will likely continue into CY 2021. We will 
continue to assess and better understand the implications of the 
national PHE of COVID-19 on care delivery and complex patient care 
during 2021 and will consider whether to make any policy changes in 
future rulemaking. At this time, we continue to offer the application-
based extreme and uncontrollable circumstances policy for CY 2021, as 
referenced in section IV.A.3.d.(2)(b)(iv)(B) of this final rule, and we 
believe we do not need to continue to double the complex patient bonus 
for the 2021 performance period/2023 MIPS payment year, although we 
intend to reevaluate after we gather more data and learn more about 
both the direct and indirect impacts of the PHE for COVID-19. We will 
continue to assess our complex patient bonus policy regarding both the 
value of the points and the calculation methodology and ensure that we 
do not risk artificially increasing MIPS final scores while providing 
enough flexibility to clinicians to account for increased patient 
complexity.

[[Page 84910]]

    Comment: A few commenters pointed out perceived limitations in the 
use of the HCC risk score in calculating the complex patient bonus. 
More specifically, they believed that the existing methodology does not 
fully and appropriately capture the clinical and social complexity of 
patients and encouraged CMS to find more appropriate and long-term 
solutions. A few commenters suggested that CMS consider other medical 
and social risk factors outside of what is already captured in the HCC 
and dual-eligible status, when determining patient complexity. Another 
commenter requested that CMS develop an alternative applicable to all 
clinician types. One commenter suggested that CMS include ICD-10 Z 
codes, such as Z590.0 homelessness, Z65.0 unemployed, or Z59.5 extreme 
poverty to capture additional social risk factors.
    Response: We thank the commenters for their suggestions and will 
take them into consideration as we consider options for updating the 
complex patient bonus in future years. Further, while the ASPE's second 
report is supportive of the complex patient bonus, they have specific 
recommendations as to how to further incorporate risk adjustment at the 
MIPS program level which we plan to address in future rulemaking. 
Additionally, although the ASPE report found dual eligibility to be a 
reliable indicator of social risk, we understand there may be some 
limitations. However, we are not aware of data sources and/or 
methodologies to account for other social indicators such as income and 
education that are readily available for all Medicare beneficiaries 
that would be more complete indices of a patient's complexity. Further, 
we continue to believe that average HCC risk scores are a valid proxy 
for medical complexity that are also used by other CMS programs. 
Therefore, we have decided to continue to pair the HCC risk score with 
the proportion of dually eligible patients to create a more complete 
complex patient indicator than can be captured using HCC risk scores 
alone. We will evaluate additional, more comprehensive options, such as 
the utilization of ICD-10 Z codes, in future years based on any updated 
data or additional information, including to better account for social 
risk factors while minimizing unintended consequences and consider 
these as we move forward.
    Comment: One commenter expressed concerns with calculating the 
complex patient bonus points given the substantial disruptions to 
patient care due to the national PHE for COVID-19, which could cause 
data, used for the lookback period, to be either compromised or 
unreliable.
    Response: When we calculate the complex patient bonus points, we 
rely on dual eligibility status and the HCC risk score, which should 
not be impacted by potential coding modifications or disruptions for 
the CY 2020 performance period. Pursuant to Sec.  414.1380(c)(3)(i), in 
order to calculate an average HCC risk score, CMS uses the model 
adopted under section 1853 of the Act for Medicare Advantage risk 
adjustment purposes, for each MIPS eligible clinician or group; that 
average HCC risk score is used as a part of the complex patient bonus 
calculation. We refer readers to the CY 2018 QPP final rule (82 FR 
53771) for more details on how we calculate the average HCC risk score 
for a MIPS eligible clinician or group. Specifically, we average HCC 
risk scores for beneficiaries cared for by the MIPS eligible clinician 
or clinicians in the group during the second 12-month segment of the 
eligibility period during the prior performance period. HCC risk scores 
for beneficiaries would be calculated based on the calendar year 
immediately prior to the performance period. For example, for the 2020 
MIPS performance period, the HCC risk scores would be calculated based 
on beneficiary services from CY 2019, which is prior to the year in 
which the PHE occurred. Additionally, as the claims coding for the HCC 
occurred prior to this proposal, we believe this approach mitigates the 
risk of potential coding modifications or disruptions to get higher 
expected costs, which could happen if concurrent risk adjustments were 
incorporated. However, we acknowledge some of the policy flexibilities 
we established for the national PHE for COVID-19 potentially could have 
an effect on data for CY 2020. Given that this is the primary source of 
data available to us to calculate the complex patient bonus for CY 
2021, for now, we plan to utilize this data, and we will monitor and 
consider making additional adjustments, as necessary.
    After consideration of the public comments, we are finalizing the 
proposal to continue the complex patient bonus for the 2021 performance 
period/2023 MIPS payment year as proposed and to revise Sec.  
414.1380(c)(3) accordingly.
(iii) Complex Patient Bonus for the 2022 MIPS Payment Year
    In this section of the final rule, we discuss the proposed policy 
to modify the complex patient bonus for the 2022 MIPS payment year in 
response to the PHE for COVID-19 (85 FR 50311). In the CY 2020 PFS 
final rule, we continued the complex patient bonus for the 2020 
performance period/2022 MIPS payment year (84 FR 63021 through 63023). 
More specifically, we continued to utilize our two established 
complexity indicators, HCC risk scores and dual eligible status, 
because we believed that they continued to account for the multitude of 
factors that describe and have an impact on patient health outcomes. 
Further, risk scores are based on a beneficiary's age and sex; whether 
the beneficiary is eligible for Medicaid, first qualified for Medicare 
on the basis of disability, or lives in an institution (usually a 
nursing home); and the beneficiary's diagnoses from the previous 
year.\127\ Additionally, the HCC model also accounts for the number of 
conditions a beneficiary has, making an adjustment as the number of 
diseases or conditions increases, and includes additional diagnosis 
codes related to mental health and substance use disorders, and chronic 
kidney disease.\128\ However, due to the national PHE for COVID-19 
during performance period 2020, we noted that we need to re-evaluate 
the previously established policy for the complex patient bonus for the 
2022 MIPS payment year. We acknowledged that there are direct effects 
of COVID-19 for those patients who have the disease and indirect 
effects of COVID-19 for other patients, including increased complexity 
and barriers such as postponing care, accessing care in a different way 
(for example, via telecommunications), and disruptions to lab results 
and medications, which are not accounted for in our existing final 
score calculations using these complexity indicators. We noted that we 
realize that the first year of the novel virus may add complexity that 
we have not already captured via the complex patient bonus. This 
complexity includes patients who have gotten sick, as well as patients 
who may now have complications or other factors because of delayed care 
or disruptions to lab services or medications due to COVID-19. 
Government guidelines, such as the Centers for Disease Control and 
Prevention (CDC) guidance on ``Groups

[[Page 84911]]

at Higher Risk for Severe Illness'', indicate that COVID-19 patients 
who are already high-risk due to pre-existing medical conditions are at 
further risks of increased COVID-19 related hospitalizations and 
mortality.\129\ Further, literature also indicates that those patients 
who are already high-risk due to social factors are also at further 
risk of serious illness related to COVID-19.\130\
---------------------------------------------------------------------------

    \127\ CMS, Medicare Fee-For-Service Provider Utilization & 
Payment Data Physician and Other Supplier Public Use File: A 
Methodological Overview'': https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/Downloads/Medicare-Physician-and-Other-Supplier-PUF-Methodology.pdf.
    \128\ CMS, ``Report to Congress: Risk Adjustment in Medicare 
Advantage'': https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads/RTC-Dec2018.pdf.
    \129\ CDC, ``Groups at Higher Risk for Severe Illness'': https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/groups-at-higher-risk.html.
    \130\ Kaiser Family Foundation, ``Low-Income and Communities of 
Color at Higher Risk of Serious Illness if Infected with 
Coronavirus'': https://www.kff.org/coronavirus-covid-19/issue-brief/low-income-and-communities-of-color-at-higher-risk-of-serious-illness-if-infected-with-coronavirus/.
---------------------------------------------------------------------------

    Further, during this time, hospitals reported that medical systems 
delayed and canceled care, resulting in reduced utilization of 
healthcare services and a changing care delivery system.\131\ Although 
access to Medicare telehealth services was expanded so that 
beneficiaries could receive a wider range of services from clinicians 
without having to travel to a healthcare facility,\132\ this only 
partially filled the gap in services from the reduction in delivery of 
care, as not all specialties can utilize telehealth. We recognized the 
increased challenges of providing care to complex patients in the 
context of the national PHE for COVID-19. Patients with comorbidities 
(as measured by HCC risk score) and social risk (measured by dual 
eligible status) are disproportionately likely to be severely affected 
by COVID-19.133 134 135 More specifically, findings from our 
recently released data reinforces previous findings by the CDC that 
older Americans and those with chronic health conditions are at the 
highest risk for COVID-19. The data also show that COVID-19 has 
disproportionately impacted lower income adults, further confirming 
longstanding healthcare disparities in dually eligible 
populations.\136\ Additionally, in light of the care delivery changes, 
we noted that clinicians may see patients in 2020, with medical or 
social risk factors, whose health conditions may have been exacerbated 
due to delayed care. Patients with comorbidities and social risk are 
likely to suffer adverse outcomes due to delaying or not receiving 
care.137 138 139 Given that the limited available literature 
and data on COVID-19 suggests that patients with social risk factors or 
underlying conditions have increased complexity, we believe that our 
existing complexity indicators, HCC risk score and dual eligibility, 
could serve as a proxy for capturing increased complexity due to the 
PHE for COVID-19.
---------------------------------------------------------------------------

    \131\ American Hospital Association, ``Hospitals and Health 
Systems Face Unprecedented Financial Pressures Due to COVID-19'': 
https://www.aha.org/guidesreports/2020-05-05-hospitals-and-health-systems-face-unprecedented-financial-pressures-due.
    \132\ CMS, ``Medicare Telemedicine Healthcare Provider Fact 
Sheet'': https://www.cms.gov/newsroom/fact-sheets/medicare-telemedicine-health-care-provider-fact-sheet.
    \133\ The Journal of the American Medical Association Network, 
``Presenting Characteristics, Comorbidities, and Outcomes Among 5700 
Patients Hospitalized with COVID-19 in the New York City Area'': 
https://jamanetwork.com/journals/jama/fullarticle/2765184.
    \134\ Morbidity and Mortality Weekly Report/CDC COVID-19 
Response Team, ``Preliminary Estimates of the Prevalence of Selected 
Underlying Health Conditions Among Patients with Coronavirus Disease 
2019--United States, February 12-March 28, 2020'': https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7119513/pdf/mm6913e2.pdf.
    \135\ The Commonwealth Fund, ``Assessing Underlying State 
Conditions and Ramp-Up Challenges for the COVID-19 Response'': 
https://www.commonwealthfund.org/publications/issue-briefs/2020/mar/assessing-underlying-state-conditions-and-ramp-challenges-covid.
    \136\ CMS, ``Medicare COVID-19'' Data Release Blog'': https://www.cms.gov/blog/medicare-covid-19-data-release-blog.
    \137\ Kaiser Health News, ``Nearly Half of American Delayed 
Medical Care Due to Pandemic'': https://khn.org/news/nearly-half-of-americans-delayed-medical-care-due-to-pandemic/.
    \138\ The British Medical Journal, ``Delayed presentation of 
acute ischemic strokes during the COVID-19 crisis'': https://jnis.bmj.com/content/early/2020/05/27/neurintsurg-2020-016299.
    \139\ US National Library of Medicine National Institutes of 
Health, ``Hospitalization for Ambulatory-care-sensitive Conditions 
in Taiwan Following the SARS Outbreak: A Population-based 
Interrupted Time Series Study'': https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7135451/.
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    Currently, the complex patient bonus is worth up to 5 points. 
However, given the anticipated increase in complexity due to the 
national PHE for COVID-19, we proposed at Sec.  414.1380(c)(3)(iv) that 
for the CY 2020 performance period/2022 MIPS payment year, the complex 
patient bonus would be calculated pursuant to the existing formulas in 
Sec.  414.1380(c)(3)(i) and (ii), and the resulting numerical value 
would then be multiplied by 2, but the complex patient bonus cannot 
exceed 10. The doubled numerical value (subject to the 10-point cap) 
would be added to the final score. Additionally, we proposed to revise 
Sec.  414.1380(c)(3)(iii) to state that the complex patient bonus 
cannot exceed 5.0 except as provided in Sec.  414.1380(c)(3)(iv). As 
proposed, clinicians could receive up to 10 complex patient bonus 
points added to their final score. For example, if a MIPS eligible 
clinician were to receive 4 complex patient bonus points under the 
existing formulas, the MIPS eligible clinician would receive 8 complex 
patient bonus points (doubling the bonus points) under our proposal for 
the CY 2020 performance period/2022 MIPS payment year. In instances 
where clinicians would have received the maximum of 5 complex patient 
bonus points, they would receive the maximum of 10 complex patient 
bonus points under our proposal for the CY 2020 performance period/2022 
MIPS payment year. To the extent that the proposed change constitutes a 
change to the MIPS scoring or payment methodology for the 2022 MIPS 
payment adjustment after the start of the 2020 performance period, we 
noted that we believe that, consistent with section 1871(e)(1)(A)(ii) 
of the Act, it would be contrary to the public interest not to account 
for increased patient complexity due to the national PHE for COVID-19. 
We believe it would be contrary to the public interest if MIPS scores 
do not adequately recognize this increased patient complexity that 
could not have been accounted for during the CY 2020 rulemaking. More 
specifically, as discussed in the CY 2021 PFS proposed rule, we are 
unable to measure the magnitude of the direct and indirect effects of 
the PHE for COVID-19 on MIPS scores, and we remain concerned about 
potentially misidentifying poor performance with regard to the care 
delivered in CY 2020 due to the PHE for COVID-19 (85 FR 50312). Hence, 
we believe this approach of doubling the complex patient bonus 
recognizes the difficulty of managing complex patients during the PHE 
for COVID-19 and lowers the risk of inaccurately identifying a 
clinician as a ``poor performer'' when the underlying issue is caring 
for increasingly complex patients due to both direct and indirect 
effects of COVID-19.
    Due to limited data available related to the PHE for COVID-19, we 
noted that it is difficult to gauge whether the proposal would be 
artificially increasing MIPS final scores or not providing enough 
flexibility to clinicians to account for increased patient complexity 
during the CY 2020 performance period. Given the challenges we assumed 
clinicians may be facing, we noted that doubling the complex patient 
bonus would be a reasonable and operationally feasible approach. In 
developing our proposal, we considered several alternatives, including 
maintaining the complex patient bonus as it currently is (up to 5 
points), as well as whether it would be appropriate to triple (up to 15 
points) the complex patient bonus. However, due to the limited data 
available, we did not propose those options as we were concerned that 
an approach of tripling

[[Page 84912]]

the bonus could artificially increase final scores and maintaining the 
current bonus (up to 5 points) may not be sufficient to account for the 
increased patient complexity during the CY 2020 performance period. 
Additionally, we noted that we believe that by doubling the complex 
patient bonus, clinicians whose MIPS performance may be negatively 
affected by the challenges of caring for a complex patient population 
during a PHE will be less likely to have the maximum negative 
adjustment due to circumstance beyond their control.
    We also considered whether we should add a new indicator of patient 
complexity, such as establishing a threshold for the percentage of 
patients with COVID-19. We expressed concern about this alternative 
approach for two reasons. First, we did not believe the effects of 
COVID-19 are limited to those patients who are experiencing the 
illness. Second, there was uncertainty of the consistency of diagnosis 
coding for both patients who are experiencing the illness or who are 
being treated for the sequelae of the illness.
    We requested comments on our proposal, the alternatives we 
considered, and any other approaches to account for patient complexity 
during the PHE for COVID-19 that commenters believe we should consider, 
as well as alternative data sources for patient complexity. We invited 
public comments on our proposal to double the complex patient bonus for 
the CY 2020 performance period/2022 MIPS payment year. The following is 
a summary of the comments we received and our responses.
    Comment: Many commenters supported our proposal to double the 
complex patient bonus for the CY 2020 performance period/2022 MIPS 
payment year. One commenter appreciated CMS' proposal to double the 
complex patient bonus points but suggested that CMS provide additional 
flexibility, including further modifying the complex patient bonus 
policy to create accountability for achieving equity for all Medicare 
beneficiaries, both within and outside the context of the PHE for 
COVID-19.
    Response: We will continue to assess and expand our understanding 
of both the direct and indirect impact of the PHE for COVID-19 and will 
incorporate additional data and findings in future rulemaking. We want 
to note that in addition to the complex patient bonus proposal, we also 
announced that clinicians and practices affected by the PHE for COVID-
19 could apply for reweighting of the MIPS performance categories due 
to extreme and uncontrollable circumstances. We refer readers to 
https://qpp.cms.gov/about/covid19 for the flexibilities provided during 
the PHE for COVID-19.
    Comment: A few commenters agreed that the complex patient bonus for 
the CY 2020 performance period should be increased but recommended CMS 
to consider alternatives. One commenter suggested that CMS consider 
providing more than 10 complex patient bonus points in areas of the 
country that are most impacted by COVID-19. For example, the commenter 
suggested that CMS look at areas that are among the top ranking in 
positive cases. Another commenter suggested that doubling the complex 
patient bonus is fair but suggested CMS to consider increasing the 
complex patient bonus points by more than double. A few commenters 
encouraged CMS to make this increase permanent and one specifically 
recommended a permanent increase until more clinically appropriate 
quality measures are developed. Another commenter suggested that CMS 
increase the complex patient bonus points for CY 2020 to 15 points and 
then 10 points for CY 2021 to recognize the ongoing effects of the 
national PHE.
    Response: We thank the commenters for their support and their 
suggestions to further revise the complex patient bonus policy. With 
regard to assessing which areas of the country are more impacted by 
COVID-19, we believe it is difficult to assess the true impact in 
certain areas. More specifically, it could be possible that the 
impacted areas may change throughout the year, making it difficult to 
assess which areas are treating more complex patients. For example, 
back in spring of 2020, New York faced an initial surge of COVID-19 
cases.\140\ However, overtime, data is indicating that certain areas in 
the Midwest region are now seeing an influx of COVID-19 cases as cases 
in New York are decreasing.\141\ Furthermore, we have identified the 
PHE for COVID-19 as a national event, and therefore, we believe it is 
appropriate to apply one policy for the national event as opposed to 
establishing different policies for varying geographic areas. However, 
we will continue to assess the impact of the PHE and consider whether 
to further modify the policy in future rulemaking. Additionally, as 
indicated in the comment summary above, a few commenters suggested that 
we consider further increasing the complex patient bonus points beyond 
10 points. As noted in the CY 2021 PFS proposed rule (85 FR 50312), we 
considered several alternatives, including maintaining the complex 
patient bonus as it currently is (up to 5 points), as well as whether 
it would be appropriate to triple (up to 15 points) the complex patient 
bonus. However, due to the limited data available, we decided not to 
propose those options because we were concerned that tripling the bonus 
could artificially increase final scores and maintaining the current 
bonus (up to 5 points) may be insufficient to account for the increased 
patient complexity during the CY 2020 performance period. We 
acknowledge that the impact of the national PHE for COVID-19 may affect 
CY 2021 and intend to continue to offer the application-based extreme 
and uncontrollable circumstances policy for CY 2021, as referenced in 
section IV.A.3.d.(2)(b)(iv)(B) of this final rule, while we continue to 
assess the impact and our established related policies. Hence, we 
continue to believe this one-time adjustment of doubling the complex 
patient bonus is important and believe that an increase of up to 10 
points is appropriate.
---------------------------------------------------------------------------

    \140\ John Hopkins University & Medicine, ``Coronavirus Resource 
Center'' https://coronavirus.jhu.edu/data/state-timeline/new-confirmed-cases/new-york.
    \141\ Modern Healthcare, ``Hospitals feel squeeze as coronavirus 
spikes in Midwest'': https://www.modernhealthcare.com/hospitals/hospitals-feel-squeeze-coronavirus-spikes-midwest.
---------------------------------------------------------------------------

    Comment: A few commenters stated concerns with doubling the complex 
patient bonus points for the CY 2020 performance period/CY 2022 MIPS 
payment year. One commenter stated that offering up to 10 complex 
patient bonus points could potentially mask poor performance and reward 
clinicians who did not treat significant numbers of complex COVID-19 
patients. The commenter also stated concerns with clinicians 
potentially upcoding due to this policy change. Another commenter 
stated concerns with potentially diluting the overall MIPS score for 
groups and potentially skewing the national average. Another commenter 
said it would be inappropriate to have complex patient bonus points 
tied to the number of COVID-19 cases a particular clinician sees.
    Response: We thank the commenters for their responses. We 
acknowledge that doubling the complex patient bonus could potentially 
mask poor performance or skew the national average, but we are weighing 
these potential effects against the unforeseen complexity of caring for 
complex patients during the national PHE for COVID-19. We disagree that 
doubling the complex patient bonus would dilute the overall score. As 
discussed above, we considered a complex patient bonus of up to 15 
points but believe that a bonus of up to 10 appropriately

[[Page 84913]]

balances our desire to account for the PHE without artificially 
increasing scores. Additionally, we rely on dual eligibility status and 
the HCC risk score, in order to calculate the complex patient bonus for 
the performance period. We believe this methodology would continue to 
appropriately account for the increased complexity we are seeing in 
light of the PHE while balancing the impact of caring for patients with 
both medical and social risks. We also acknowledge that doubling the 
complex patient bonus could potentially reward clinicians who did not 
treat significant number of complex COVID-19 patients. We intend to 
provide this one-time adjustment of doubling the complex patient bonus 
because we recognize that there are both direct and indirect effects of 
the national PHE for COVID-19. For example, clinicians who have not 
cared for COVID-19 patients are, nevertheless, dealing with the 
indirect impact of delayed care for complex patients. Alternatively, 
for clinicians who have cared for COVID-19 patients, we believe this 
adjustment would account for the medical complexity the clinician 
directly faces in treating these patients. Hence, we continue to 
believe that an adjustment of up to 10 points is appropriate to account 
for both direct and indirect potential impacts on clinicians and care 
delivery due to the PHE. Finally, we disagree that this policy proposal 
could encourage upcoding. As we explained in a previous response to 
comments, when we calculate the complex patient bonus points, we rely 
on dual eligibility status and the HCC risk score, which should not be 
impacted by potential coding modifications or disruptions for the CY 
2020 performance period. The HCC risk score for CY 2020 is calculated 
based on data from CY 2019, the year prior to the national PHE for 
COVID-19.
    Finally, the proposed policy would be calculated pursuant to the 
existing formulas in Sec.  414.1380(c)(3)(i) and (ii), and we do not 
intend to alter the formula based on the number of COVID-19 cases a 
clinician sees. As we noted in the CY 2021 PFS proposed rule (85 FR 
50313), we considered whether we should add a new indicator of patient 
complexity, such as establishing a threshold for the percentage of 
patients with COVID-19, and we continue to be concerned about this 
alternative approach for two reasons including: (1) The effects of 
COVID-19 are not limited to those patients who are experiencing the 
illness; and (2) we are still uncertain of the consistency of diagnosis 
coding for both patients who are experiencing the illness or who are 
being treated for the sequelae of the illness.
    Comment: One commenter stated concerns with doubling the complex 
patient bonus points given that the additional resources utilized to 
treat COVID-19 patients are already being accounted for through Part A 
and Part B reimbursement, such as lab tests and medically necessary 
hospitalizations, and should not be additionally funded by the Quality 
Payment Program.
    Response: We disagree that doubling the complex patient bonus 
points would be redundant of Part A and Part B reimbursement. The 
purpose of the complex patient bonus is to account for risk factors 
through appropriate adjustments to MIPS scoring. The policy is not 
intended to reimburse clinicians for costs associated with treating 
more complex patients.
    After consideration of the public comments, we are finalizing our 
proposal for the complex patient bonus for the CY 2020 performance 
period/2022 MIPS payment year as proposed. We are finalizing Sec.  
414.1380(c)(3)(iv), under which the complex patient bonus will be 
calculated pursuant to the existing formulas in paragraphs (c)(3)(i) 
and (ii), and the resulting numerical value will then be multiplied by 
2, but cannot exceed 10.0. The doubled numerical value (subject to the 
10-point cap) will be added to the final score. Additionally, we 
finalize our proposal to revise paragraph (c)(3)(iii) to state that the 
complex patient bonus cannot exceed 5.0 except as provided in paragraph 
(c)(3)(iv).
(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; 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 
through CY 2018 Quality Payment Program final rules, and CY 2019 
through CY 2020 PFS final rules (81 FR 77320 through 77329, 82 FR 53779 
through 53785, 83 FR 59870 through 59878, and 84 FR 62950 through 84 FR 
62959, respectively). In section IV.A.3.c.(2)(a) of the CY 2021 PFS 
proposed rule, we proposed that the cost performance category would 
make up 20 percent of a MIPS eligible clinician's final score for the 
2023 MIPS payment year and 30 percent for the 2024 MIPS payment year 
and each subsequent MIPS payment year. In section IV.A.3.c.(1) of that 
proposed rule, we proposed the quality performance category would thus 
make up 40 percent of a MIPS eligible clinician's final score for the 
2023 MIPS payment year and 30 percent for the 2024 MIPS payment year 
and each subsequent MIPS payment year. In sections III.K.3.c.(1)(b) and 
III.K.3.c.(2)(a) of this final rule, we finalized these proposed 
weights for the quality and cost performance categories for the 2023, 
2024, and subsequent MIPS payment years as proposed. Table 50 
summarizes the weights for each performance category.
[GRAPHIC] [TIFF OMITTED] TR28DE20.096


[[Page 84914]]


(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 generally would receive a score of zero for the measure or 
activity, which would contribute to the final score for that MIPS 
eligible clinician. Under certain circumstances, however, a MIPS 
eligible clinician who fails to report could be eligible for an 
assigned scoring weight of zero percent and a redistribution of the 
performance category weights. For a description of our existing 
policies for reweighting performance categories, please refer to Sec.  
414.1380(c)(2) and the CY 2020 PFS final rule (84 FR 63023 through 
63027).
(iii) Redistributing Performance Category Weights
    In the CY 2017 through CY 2018 Quality Payment Program final rules, 
and CY 2019 through CY 2020 PFS final rules (81 FR 77325 through 77329, 
82 FR 53783 through 53785, 83 FR 59876 through 59878, and 84 FR 63027 
through 63031), and at Sec.  414.1380(c)(2)(ii), we established 
policies for redistributing the weights of performance categories in 
the event that a scoring weight different from the generally applicable 
weight is assigned to a category or categories. Under these policies, 
we generally redistribute the weight of a performance category or 
categories to the quality performance category because of the 
experience MIPS eligible clinicians have had reporting on quality 
measures under other CMS programs. For the 2020 MIPS performance period 
and 2022 MIPS payment year, we did not redistribute performance 
category weights to improvement activities, except for the scenario 
where the only two performance categories being scored are improvement 
activities and cost (84 FR 63028). Also for that year in scenarios when 
the cost performance category weight is redistributed while the 
Promoting Interoperability performance category weight is not, we 
redistributed a portion of the cost performance category weight to the 
Promoting Interoperability performance category, as well as to the 
quality performance category (84 FR 63027). As stated in CY 2020 PFS 
final rule, we continue to believe this redistribution policy is 
appropriate given our focus on working with the Office of the National 
Coordinator for Health IT (ONC) on implementation of the 
interoperability provisions of the 21st Century Cures Act (the Cures 
Act) (Pub. L. 114-255, enacted on December 13, 2016) to ensure seamless 
but secure exchange of health information for clinicians and patients 
and emphasize the importance of interoperability without overwhelming 
the contribution of the quality performance category to the final score 
(84 FR 63027).
    In the CY 2021 PFS proposed rule (85 FR 50293), we proposed a 
weight for the cost performance category of 20 percent for the 2023 
MIPS payment year. For the 2023 MIPS payment year, we proposed similar 
redistribution policies as finalized for the 2022 MIPS payment year, 
with minor modifications to account for the cost performance category 
being 20 percent. As proposed, we would once again only redistribute 
weight to the cost performance category in cases when the cost and 
improvement activities performance categories are the only categories 
scored (each of these performance categories would be 50 percent in 
this scenario). We noted that we do not believe it is appropriate to 
redistribute more weight to the cost performance category, because cost 
would not yet be at the maximum weight specified by the statute (30 
percent), and because clinicians still have relatively limited 
experience being scored on and receiving feedback on cost measures 
compared with quality measures. Our proposed redistribution policies 
for the 2023 MIPS payment year, which we proposed to codify at Sec.  
414.1380(c)(2)(ii)(E), are included in Table 45 of CY 2021 PFS proposed 
rule (85 FR 50314).
    In the CY 2021 PFS proposed rule (85 FR 50294), we proposed to 
weight the cost performance category at 30 percent for the 2024 MIPS 
payment year and each subsequent MIPS payment year, as required by 
section 1848(q)(5)(E)(i)(II)(aa) of the Act. Given that 2024 would be 
the first year that cost would be set at the maximum weight prescribed 
by the statute, we noted that we did not believe it would be prudent to 
begin redistributing more weight to cost for the 2024 MIPS payment 
year, except in cases when only the cost and improvement activities 
performance categories are scored. For the improvement activities 
performance category, we are only assessing whether a MIPS eligible 
clinician completed certain activities (83 FR 59876 through 59878). 
Because MIPS eligible clinicians will have had several years of 
experience reporting under MIPS, we noted that it is important to 
prioritize performance on measures that show a variation in 
performance, rather than the activities under the improvement 
activities performance category, which are based on attestation of 
completion. We also noted that we believe this helps to reduce 
incentives to not report measures for the quality performance category 
in circumstances when a clinician may be able to report but chooses not 
to do so. For example, when a clinician may be able to report on 
quality measures, but chooses not to report because they are located in 
an area affected by extreme and uncontrollable circumstances as 
identified by CMS and qualify for reweighting under Sec.  
414.1380(c)(2)(i)(A)(8). Therefore, we noted that we continue to 
believe that weighting the cost and improvement activities performance 
categories each at 50 percent would be an appropriate balance (84 FR 
63027). As for the other reweighting scenarios, we plan to revisit our 
redistribution policies in future rulemaking and may consider 
redistributing more weight to the cost performance category after 
clinicians have more experience with cost being weighted at 30 percent. 
Our proposed redistribution policies for the 2024 MIPS payment year, 
which we proposed to codify at Sec.  414.1380(c)(2)(ii)(F), are 
included in Table 46 of CY 2021 PFS proposed rule (85 FR 50315).
    We invited public comments on our proposed redistribution policies 
for the 2023 and 2024 MIPS payment years. The following is a summary of 
the comments we received and our responses.
    Comment: A few commenters were supportive of CMS' proposal to 
redistribute the category weights. One commenter specifically agreed 
with CMS' reweighting proposals in instances when only the quality 
performance category and the improvement activities performance 
category are scored. A few commenters specifically supported CMS' 
proposal to not redistribute weight to the cost

[[Page 84915]]

performance category except in cases when only cost and improvement 
activities performance categories are scored. One commenter stated that 
the reweighting polices builds confidence in the program and 
demonstrates transparency.
    Response: We thank the commenters for their support. We agree that 
our reweighting policies allow for flexibility, leading to confidence 
and transparency within the program. We also appreciate commenters' 
support in our policy rationale for not redistributing weight to the 
cost performance category except in cases when only cost and 
improvement performance categories are scored.
    Comment: One commenter requested that CMS should not redistribute 
weights to the cost performance category until that performance 
category has more relevant and applicable cost measures available 
across all specialties.
    Response: We agree with the commenter that there is currently a 
limited set of cost measures within the cost performance category. 
However, we do have concerns with redistributing a substantial portion 
of the performance category weights to the improvement activities 
performance category for several reasons. Specifically, through our 
redistribution policies, we aim to prioritize interoperability, 
performance on measures that show a variation in performance, and 
performance categories that have some or all measures that focus on 
performance, as compared to the activities under the improvement 
activities performance category, which are solely based on attestation 
of completion. We continue to believe that we should not redistribute 
weight to the improvement activities performance category. We also note 
that, given that 2024 would be the first year that cost would be set at 
the maximum weight prescribed by the statute, we continue to believe it 
would not be prudent to begin redistributing more weight to cost for 
the 2024 MIPS payment year, except in cases when only the cost and 
improvement activities performance categories are scored. We should 
give clinicians more time to adjust to new and revised cost measures 
before redistributing more weight to the cost performance category. 
However, similar to all performance categories of MIPS, there are 
continued opportunities to improve the measures and activities used to 
assess performance. We also continue to provide detailed performance 
feedback on the cost measures to clinicians and expect to provide 
detailed feedback on any new and revised cost measures in the future, 
providing clinicians a further opportunity to improve their performance 
within cost measures. Hence, we continue to believe that reweighting 
the cost and improvement activities performance categories each at 50 
percent would appropriately continue to balance our concerns with 
redistributing weight to the improvement activities performance 
category.
    Comment: One commenter requested that if CMS finalizes the proposal 
to increase the cost performance category weight, then CMS take the 
Promoting Interoperability and improvement activities performance 
category weights and further redistribute them within the cost 
performance category due to a concern that these two performance 
categories do not reward the actual results on improvement in quality 
of care.
    Response: As is reflected in our proposals, we do not intend to 
redistribute a substantial portion of the performance category weight 
to the improvement activities performance category given that we intend 
to prioritize performance on measures that show a variation in 
performance, rather than the activities under the improvement 
activities performance category, which are based on attestation of 
completion. However, we believe that both the Promoting 
Interoperability and improvement activities performance categories 
reflect important aspects of quality improvement performance. More 
specifically, over time, we want to redistribute more weight to the 
cost and Promoting Interoperability performance categories, and less to 
the quality performance category, to have better alignment between the 
cost and quality performance categories and due to our focus on 
interoperability. We also disagree that we should redistribute more 
weight within the cost performance category than we have proposed, as 
clinicians are still adjusting to newly developed cost measures. As 
noted in our previous response, we do not believe that the cost 
performance category weight should be minimized but should also remain 
at the proposed 50 percent weight in instances of where only the cost 
and improvement activities performance categories are scored.
    After consideration of the public comments, we are finalizing our 
proposed redistribution policies for the 2023 and 2024 MIPS payment 
years as proposed, and the codification of those policies at Sec.  
414.1380(c)(2)(ii)(E) and (F). Our finalized redistribution policies 
for both the 2023 and 2024 MIPS payment years are included in Table 51 
and 52.

[[Page 84916]]

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[GRAPHIC] [TIFF OMITTED] TR28DE20.098

(iv) MIPS Applications for Reweighting for the 2021 and 2023 MIPS 
Payment Years Based on Extreme and Uncontrollable Circumstances
(A) MIPS Applications for Reweighting for the 2021 MIPS Payment Year 
Based on Extreme and Uncontrollable Circumstances
    Recognizing the urgency of the PHE for COVID-19, we published the 
March 31st COVID-19 IFC modifying Medicare rules, including the PFS, so 
that physicians and other practitioners and clinicians are allowed 
added flexibilities due to the PHE for COVID-19. To provide relief to 
individual clinicians, groups, and virtual groups for whom sufficient 
MIPS measures and activities may not be available for the 2019 MIPS 
performance period due to the PHE for the COVID-19, we extended the 
deadline to submit an application for reweighting the quality, cost, 
and improvement activities performance categories (Sec.  
414.1380(c)(2)(i)(A)(6)), as well as the Promoting Interoperability 
performance category (Sec.  414.1380(c)(2)(i)(C)(2)) based on extreme 
and uncontrollable circumstances from December 31, 2019 to April 30, 
2020, or a later date that we may specify (85 FR 19278). The extended 
deadline is available only for applications that demonstrate the 
clinician has been adversely affected by the PHE for the COVID-19. We 
also modified the policy at Sec.  414.1380(c)(2)(i)(A)(6) to create an 
exception for the 2019 performance period/2021 MIPS payment year only, 
such that if a MIPS eligible clinician demonstrates through an 
application submitted to CMS that they have been adversely affected by 
the PHE for the COVID-19, but also submits data for the quality, cost, 
or improvement activities performance categories, the performance 
categories for which data are submitted would still be reweighted 
(subject to CMS' approval of the application), and the data submission 
would not effectively void the application for reweighting (85 FR 
19278). We also modified the policy at

[[Page 84917]]

Sec.  414.1380(c)(2)(i)(C) to create a similar exception for the 
Promoting Interoperability performance category for the 2019 
performance period/2021 MIPS payment year only (85 FR 19278).
    We invited public comments on these interim final policies. The 
following is a summary of the comments we received and our responses.
    Comment: Several commenters expressed support for CMS' efforts to 
reduce administrative burden for physicians through increased 
availability of the extreme and uncontrollable circumstances policies. 
Commenters expressed their belief that these changes are necessary 
because it may be difficult for clinicians to meet data submission 
requirements for the Quality Payment Program due to circumstances 
beyond their control.
    Response: We thank commenters for their support of our policies.
    Comment: A few commenters requested that we modify our extreme and 
uncontrollable circumstances policies so that if clinicians do not 
submit an application for extreme and uncontrollable circumstances and 
submit data and achieve a score above the performance threshold, we use 
that score for payment purposes. However, in cases where clinicians 
achieve a score below the performance threshold, we will not use that 
score for payment purposes.
    Response: We do not believe the approach requested by the 
commenters would be consistent with the statute. We do not believe the 
statute gives us discretion to disregard scores below the performance 
threshold and only apply the MIPS payment adjustments based on scores 
above the performance threshold.
    Comment: One commenter stated that we should not require clinicians 
to demonstrate that they are impacted by the PHE for COVID-19 in order 
to receive reweighting under our extreme and uncontrollable 
circumstances policies.
    Response: We note that we assume most clinicians are impacted by 
the PHE for COVID-19. However, we recognize that not all clinicians and 
practices have been impacted to the same extent, and therefore, may not 
all need reweighting. We requested that clinicians select COVID-19 as 
the reason for requesting reweighting and provide a brief narrative 
describing how they have been impacted. More information is available 
at https://qpp.cms.gov/about/covid19?py=2020.
    Comment: One commenter expressed the belief that we should provide 
reweighting automatically under our extreme and uncontrollable 
circumstances policies unless clinicians opt in for participation in 
the Quality Payment Program.
    Response: We believe that requiring clinicians to opt in to be 
scored within the Quality Payment Program would place undue burden on 
clinicians who submitted information intending to participate in the 
program.
    After consideration of the public comments, we are adopting these 
interim final policies as final without any modifications. We are 
finalizing the regulation text at Sec.  414.1380(c)(2)(i)(A)(6) and 
(c)(2)(i)(C).
(B) MIPS Applications for Reweighting for the 2023 MIPS Payment Year 
Based on Extreme and Uncontrollable Circumstances
    We anticipate that the national PHE for COVID-19 will continue into 
and through CY2021. Therefore, we remind clinicians that the 
application-based extreme and uncontrollable circumstances policy, as 
described in Sec.  414.1380(c)(2)(i)(A)(6) and (c)(2)(i)(C)(2), will be 
available for the 2021 performance period/2023 MIPS payment year 
(please refer to https://qpp.cms.gov/about/covid19?py=2020 for 
details). The application allows clinicians, groups, and virtual groups 
significantly impacted by the PHE for COVID-19 to request reweighting 
for any or all MIPS performance categories. Under this policy, however, 
if a clinician, group, or virtual group decides to submit data for the 
2021 performance period, the data submission will override the 
application, and the clinician, group, or virtual group will be scored 
on the data submitted. We believe this approach maintains a balance of 
encouraging participation in the Quality Payment Program while still 
providing for flexibility in weighting the performance categories for 
those who have been affected by the COVID-19 pandemic. Please refer to 
https://qpp.cms.gov/about/covid19?py=2021 for more information.
e. MIPS Payment Adjustments
(1) Background
    For our previously established policies regarding the final score 
hierarchy used to determine MIPS payment adjustments, we refer readers 
to the CY 2020 PFS final rule (84 FR 63031 through 63045), CY 2019 PFS 
final rule (83 FR 59878 through 59894), CY 2018 Quality Payment Program 
final rule (82 FR 53785 through 53799) and CY 2017 Quality Payment 
Program final rule (81 FR 77329 through 77343). In the CY 2021 PFS 
proposed rule (85 FR 50315 through 50321), we proposed to modify these 
policies: (1) To reflect the discontinuation of the APM scoring 
standard and the addition of the APM Performance Pathway (APP), both as 
proposed in the CY 2021 PFS proposed rule (85 FR 50303); (2) to set the 
performance threshold at 50 points for the 2023 MIPS payment year, 
instead of 60 points as previously finalized; and (3) to potentially 
revisit and revise the prior estimate of the performance threshold for 
the 2024 MIPS payment year.
(2) Final Score Hierarchy Used in Payment Adjustment Calculation
    In some cases, a TIN/NPI could have more than one final score 
associated with it from a performance period, if the MIPS eligible 
clinician submitted multiple data sets. In the CY 2018 Quality Payment 
Program final rule (82 FR 53785 through 53787), we established the 
following final score hierarchy that applies as displayed in Table 53 
when more than one final score is associated with a TIN/NPI.

[[Page 84918]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.099

    With the proposed discontinuation of the APM scoring standard and 
addition of the APP in section IV.A.2.b.(5) of the CY 2021 PFS proposed 
rule, we proposed to modify the existing final score hierarchy 
beginning with the 2021 performance period/2023 MIPS payment year. In 
the CY 2018 Quality Payment Program final rule (82 FR 53785 through 
53787), we finalized prioritizing the APM Entity final score over any 
other score for a TIN/NPI by using the waiver authority for Innovation 
Center models under section 1115A(d)(1) of the Act and the Shared 
Savings Program waiver authority under section 1899(f) of the Act to 
waive section 1848(q)(5)(I)(i)(I) and (II) of the Act so that we could 
use the APM Entity final score instead of the virtual group final score 
for a TIN/NPI. This hierarchy was intended to incentivize APM 
participation; however, we proposed to terminate the APM scoring 
standard in section IV.A.2.b.(5) of the CY 2021 PFS proposed rule, and 
while we believe it is important to still encourage movement to APMs, 
we stated that we do not believe that prioritizing an APM Entity score 
over other reported MIPS data would necessarily further our goal of 
increasing APM participation. The proposed modifications to the final 
score hierarchy would include MIPS eligible clinicians who are 
reporting through the APP, which is designed to provide a predictable 
and consistent MIPS reporting standard to reduce reporting burden and 
encourage continued APM participation. MIPS eligible clinicians who are 
already participating in APMs, and therefore, have different reporting 
obligations than MIPS eligible clinicians, who have not already taken 
that step, can opt to report through the APP and receive an APP final 
score that may be used in the MIPS payment adjustment calculation. 
Beginning with the 2021 performance period/2023 MIPS payment year, if a 
TIN/NPI has a virtual group final score associated with it, we proposed 
to use the virtual group final score to determine the MIPS payment 
adjustment. If a TIN/NPI does not have a virtual group final score 
associated with it, we proposed to use the highest available final 
score associated with the TIN/NPI to determine the MIPS payment 
adjustment. We stated that the proposal was consistent with section 
1848(q)(5)(I)(i) of the Act, which requires us to prioritize a virtual 
group final score over other final scores such as individual and group 
scores (82 FR 53786). We stated that we believe that using the highest 
final score available regardless of how the clinician chose to submit 
data to MIPS would benefit all MIPS eligible clinicians. For example, 
we have noticed some instances where prioritizing the APM Entity final 
score over other final scores has resulted in some clinicians not 
receiving the highest final score associated with their TIN/NPI, which 
may have the unintended consequence of moving clinicians away from APM 
participation. As we seek to move more clinicians into APMs, we believe 
using their highest score regardless of participation method would 
benefit all MIPS eligible clinicians. With the establishment of MVPs, 
we intend to revisit policies regarding the final score hierarchy used 
for payment adjustment determinations in future rulemaking.
    Table 54 illustrates the proposed modified final score hierarchy.
    [GRAPHIC] [TIFF OMITTED] TR28DE20.100
    

[[Page 84919]]


    The following is a summary of the comments we received on the 
proposal regarding the final score hierarchy used in payment adjustment 
calculation.
    Comment: A few commenters did not support CMS's proposal to modify 
the scoring hierarchy because of their belief that it may de-emphasize 
the role of ACOs and may create additional complexity and confusion, 
urging CMS to minimize the year-to-year changes to scoring policies. 
One commenter believed that the previous scoring hierarchy, where ACO 
entities scores took precedent over all other scores, worked well for 
ACOs and also urged CMS to not make year-to-year changes.
    Response: We disagree that the modified scoring hierarchy would de-
emphasize the role of ACOs, as we believe it is still important to 
encourage movement to APMs as we have demonstrated through our policies 
for the APP and MVPs. As described further in section II.E.1. of this 
final rule, ACOs participating in the Medicare Shared Savings Program 
would be required to report through the APP for purposes of determining 
shared savings under that program; but MIPS eligible clinicians 
participating in these ACOs also would have the option of reporting 
outside the APP for purposes of being scored under MIPS, like all other 
MIPS APM participants, if they should choose to do so. As the APP is 
optional for purposes of MIPS scoring, MIPS APM participants may report 
through the APP or through any other available MIPS reporting mechanism 
they choose. We do not intend to create additional confusion or 
complexity with our annual policy modifications, but rather provide a 
predictable and consistent MIPS reporting standard to reduce reporting 
burden and encourage continued APM participation.
    Comment: A few commenters supported CMS's proposal to modify the 
final score hierarchy because of their belief that the final score 
hierarchy allows for flexibility that rewards high performing 
clinicians, encourages clinicians to continue to participate in the 
program, simplifies the MIPS final score determination, and benefits 
all MIPS eligible clinicians. One commenter stated that the modified 
final score hierarchy may also prevent MIPS APM participants from 
getting a lower payment adjustment that is based on their APM Entity 
final score.
    Response: We agree that the modified final score hierarchy 
incentivizes MIPS program participation, simplifies final score 
determinations and provides beneficial flexibilities for all MIPS 
eligible clinicians. Although it is not our intent to shield clinicians 
from payment consequences through our policy changes, it is our intent 
to encourage continued participation in MIPS, to include APM 
participants, as well as to provide pathways for participating 
clinicians to be successful in the program.
    Comment: Commenters supported the proposal to modify the existing 
final score hierarchy and understand that there is a statutory 
requirement to prioritize the virtual group score, if applicable. The 
commenters appreciate, that otherwise, CMS would allow use of the best 
score attributable through individual, group, or APM entity scoring.
    Response: We agree that using the highest final score available, 
regardless of how a MIPS eligible clinician submits data to CMS, would 
benefit all MIPS eligible clinicians.
    After consideration of the public comments received, we are 
finalizing our proposal, as proposed, to modify the existing final 
score hierarchy beginning with the 2021 performance period/2023 MIPS 
payment year.
(3) 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 (Pub. L. 115-123, February 9, 
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.
    In the CY 2020 PFS final rule (84 FR 63031 through 63037) at Sec.  
414.1405(b)(7) and (8), we finalized the performance thresholds for the 
2022 and 2023 MIPS payment years at 45 and 60 points, respectively, an 
increase of 15 points each year until the 2024 MIPS payment year, where 
we estimated the performance threshold would be 74.01 points (based on 
actual year 1 performance data and estimates for the third and fourth 
years) as depicted in Table 55. However, we also stated that we may 
revisit the performance threshold for the 2023 MIPS payment year in 
future rulemaking, if we receive additional data that changes our 
estimate of the performance threshold for the 2024 MIPS payment year.

[[Page 84920]]

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    In the CY 2021 PFS proposed rule (85 FR 50317), we stated that we 
believe that we should reexamine the performance threshold for year 5 
(2021 performance period/2023 MIPS payment year) due to the disruptions 
caused by the PHE for COVID-19. We anticipated some clinicians not 
having sufficient measures and activities available to participate for 
the fourth year (2020 performance period/2022 MIPS payment year) and 
opting to use flexibilities provided for MIPS participation through the 
extreme and uncontrollable circumstances and hardship exception 
policies. Furthermore, in considering the effect of the PHE for COVID-
19 on clinicians, we stated that we believe that this is enough of a 
disruption to revisit the performance threshold for year 5, especially 
for clinicians who are unable to participate in year 4 due to the PHE 
for COVID-19.
    We stated that clinicians who are unable to participate in the 
fourth year of MIPS due to the PHE for COVID-19, would face an abrupt 
and large increase in the performance threshold if they return to full 
participation in the fifth year, lacking the opportunity to work to 
improve performance. We considered a range of performance threshold 
values for the fifth year, from 50 to 60 points, and believe that a 
performance threshold above 50 could be challenging for clinicians 
affected by the PHE for COVID-19, especially those with small 
practices. We stated that preliminary analysis has shown that when 
applying a performance threshold of 50 points to the data we received 
from the 2021 regulatory impact analysis as summarized in the CY 2021 
PFS proposed rule (85 FR 50383), around 31,376 TIN/NPIs (or 5.6 percent 
of MIPS eligible clinicians) would have payments adjustments that go 
from negative to positive with a performance threshold of 50 points 
compared to 60 points. For example, the analysis showed with the 
previously finalized performance threshold of 60 points, 24.4 percent 
of engaged small practices would receive a negative payment adjustment, 
whereas with a performance threshold of 50 points, 18.8 percent of 
engaged small practices would receive a negative payment adjustment. In 
analyzing the range of performance threshold values and the impact on 
high performers as detailed in the CY 2021 PFS proposed rule (85 FR 
50383), we saw that in setting the performance threshold at 50 points, 
the maximum payment adjustment is 6.89 percent whereas when setting the 
performance threshold at 60 points, the maximum payment adjustment is 
7.36 percent, a decrease in percentage by 0.47. To continue to 
incentivize high performers, we did not revisit the additional 
performance threshold in the proposed rule, which is set at 85 points 
for year 5. We proposed to set the performance threshold at 50 points 
for the 2023 MIPS payment year, instead of 60 points as previously 
finalized at Sec.  414.1405(b)(8). The performance threshold would 
remain at 30 points in the third year, increase to 45 points in the 
fourth year, and increase to 50 points in the fifth year. The increase 
between the third and fifth year would total 20 points. Additionally, 
and as discussed in more detail below in our discussion of revising the 
prior estimate of the performance threshold for the 2024 MIPS payment 
year, we stated that we are open to considering alternatives for the 
performance threshold for the 2023 MIPS payment year. We solicited 
comments on the proposed performance threshold of 50 points, the range 
of values we considered, and any alternatives that commenters believe 
we should consider for the performance threshold for the 2023 MIPS 
payment year.
    Table 56 depicts the performance threshold for the 2019 MIPS 
payment year through 2024 MIPS payment year, including the potential 
change to the performance threshold for the fifth year.

[[Page 84921]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.102

    At the time of publication of the CY 2021 PFS proposed rule, we did 
not have actual performance scores and other data for year 3 (2019 
performance period/2021 MIPS payment year). Since the publication of 
the CY 2021 PFS proposed rule, we now have the CY 2019 performance year 
data, where the mean final score is 79.8 and the median final score is 
85.27. We note these values are estimates and that the mean and median 
may change as we finish the targeted review process for the 2021 MIPS 
payment year. We stated that in the event this information becomes 
available with sufficient time to inform our policy decisions for the 
final rule, we proposed to revisit and potentially revise in the final 
rule our prior estimate of 74.01 points for the performance threshold 
for the 2024 MIPS payment year. We stated that we anticipated that the 
actual performance scores for the 2019 performance period/2021 MIPS 
payment year may be different than the estimates that we published in 
our regulatory impact analysis estimate (84 FR 63033) because the PHE 
for COVID-19 occurred during the data submission period. We also 
expected that the 2019 performance period data may be unusual due to 
the PHE for COVID-19 occurring during the submission period. We 
requested comments on our proposal to revisit and potentially revise 
our prior estimate of the performance threshold for year 6. In 
particular, we sought comment on what indicators (for example, if the 
distribution of scores is skewed due to the PHE for COVID-19), if any, 
should be used to evaluate whether or not the 2019 performance period 
data are appropriate to use to revise our prior estimate.
    Lastly, in the event that we decide to revise our prior estimate of 
the performance threshold for the 2024 MIPS payment year (either higher 
or lower) in the final rule, we proposed to consider the revised 
estimate when we decide on an appropriate numerical value for the 
performance threshold for the 2023 MIPS payment year. We gave the 
example that, if we believe that the estimate for the 2024 MIPS payment 
year performance threshold should be higher than 74.01 (say 80 or 85 
points), then we anticipate the performance threshold for the 2023 MIPS 
payment year would be higher than 50 (likely 55 points, 60 points) to 
reflect the change in the estimate. We seek to ensure a gradual and 
incremental transition to the estimated performance threshold for the 
2024 MIPS payment year, and thus, we stated that we believe that we 
should take into account the revised estimate when determining the 
performance threshold for the 2023 MIPS payment year. We solicited 
comments on the proposal to consider the revised estimate for the 2024 
MIPS payment year when we select a performance threshold for the 2023 
MIPS payment year.
    The following is a summary of the comments we received on the 
proposal to set the performance threshold at 50 points for the 2023 
MIPS payment year, instead of 60 points as previously finalized.
    Comment: One commenter did not support lowering the performance 
threshold to 50 points from the previously finalized performance 
threshold of 60 points for the CY 2023 MIPS payment year, and asked CMS 
to maintain the performance threshold at 60 points. They referenced the 
statutory requirement to set the performance threshold to the mean or 
median of the final scores for a prior period by the CY 2024 MIPS 
payment year, sharing their concern that lowering the performance 
threshold for the CY 2023 MIPS payment year may result in a drastic 
increase when the performance threshold is established for the CY 2024 
MIPS payment year. They indicated that this may put undue stress on 
clinicians who participate in MIPS. A few commenters did not support 
the change in the performance threshold because MIPS is budget neutral, 
and thus, decreasing the performance threshold provides little 
incentive to participate in the program, especially for practices which 
have made efforts to implement technology, workflows, and improve 
patient care. One commenter also believed that because of the increase 
in the complex patient bonus, practices will already be provided relief 
from the PHE for COVID-19.
    Response: We acknowledge the commenter's concern. We agree and 
believe that maintaining the previously finalized performance threshold 
of 60 points for the CY 2023 payment year could help to ensure a more 
consistent increase in the performance threshold from year to year and 
avoid a potentially

[[Page 84922]]

drastic increase between the 2023 and 2024 MIPS payment years. Although 
we acknowledge that a performance threshold above 50 points could be 
challenging for clinicians affected by the PHE for COVID-19, we believe 
it still necessary to incentivize clinicians who are able to 
participate in MIPS and perform highly despite the PHE. We agree that 
because the statute includes a budget neutrality requirement for MIPS, 
decreasing the performance threshold could discourage high performance 
by decreasing the magnitude of the positive payment adjustments. We 
want to ensure that there are appropriate incentives for clinicians to 
continue their participation in MIPS for the 2021 performance period 
despite the PHE for COVID-19, hence our proposed increase in the 
complex patient bonus for the 2020 performance period. While we remain 
concerned with the impact of the PHE for COVID-19 on clinicians, we 
also want to continue to motivate clinicians to participate in MIPS and 
strive for high performance on the measures and activities.
    Comment: A few commenters supported setting the performance 
threshold at 50 points for the CY 2021 MIPS performance period/2023 
MIPS payment year instead of 60 points as was previously finalized. 
They believe reducing the performance threshold by 10 points is an 
appropriate reduction, allows for a small but gradual increase in the 
performance threshold from year-to-year, and addresses the difficult 
circumstances practices are facing during the PHE for COVID-19. One 
commenter also expressed that given uncertainties with the quality 
benchmarks, they believed a 10-point reduction would be prudent. A few 
commenters believed that the 10-point reduction in the performance 
threshold may help small practices in particular, viewing this policy 
change as consistent with the statute, as well as helping to maintain 
programmatic stability within MIPS.
    Response: We thank the commenters for their recommendations and 
acknowledge concerns regarding potential challenges for clinicians 
associated with the PHE for COVID-19. While there are continued 
uncertainties regarding the impact of the PHE on MIPS eligible 
clinicians' ability to report for 2020 and 2021 performance period, we 
cannot ignore that the vast majority of clinicians have been able to 
successfully report for the 2019 performance period despite the PHE. 
Data analysis for the 2019 performance period showed fewer requests for 
reqeighting the MIPS performance categories based on extreme and 
uncontrollable circumstances than previously expected; however, 
clinicians impacted by the PHE for COVID-19 may submit an application 
for reweighting for the 2021 performance period, as discussed in 
section IV.A.3.d.(2)(b)(iv)(B) of this final rule. We want to ensure 
that there are appropriate incentives for clinicians, including those 
with small practices, to continue their participation in MIPS for the 
2021 performance period even if the PHE for COVID-19 continues. It is 
also our intent to prepare clinicians for participation in the MIPS 
program beyond the PHE for COVID-19 and believe maintaining the 
performance threshold at 60 points for the 2023 MIPS payment year would 
align with increasing standards for performance necessary for 
successfully participating in MIPS in future years.
    Comment: One commenter did not support lowering the performance 
threshold to 50 points from the previously finalized performance 
threshold of 60 points for the CY 2023 MIPS payment year because of 
their concerns around performance category weights and reweighting 
policies. They stated the performance threshold for the CY 2023 MIPS 
payment year should be lowered to 45 points because they believe it 
would be hard for some clinicians to meet the performance threshold if 
the cost and Promoting Interoperability performance categories are 
reweighted to zero percent due to clinician type, as well as a lack of 
applicable measures.
    Response: We acknowledge the commenters concerns and recommendation 
to set the performance threshold at 45 points for the CY 2023 MIPS 
payment year. However, we believe that setting the performance 
threshold at 45 points for the CY 2023 MIPS payment year would create a 
larger and more abrupt increase in the performance threshold for 
clinicians who are unable to participate for the 2021 performance 
period due to the PHE for COVID-19 but choose to participate for the 
2022 performance period. Those clinicians would be subject to a minimum 
of a 29.01 point increase in the performance threshold for the 2022 
performance period/2024 MIPS payment year, based on our estimated 
performance threshold for the 2024 MIPS payment year. Under the policy 
we are adopting in section XXX of this final rule, if the cost and 
Promoting Interoperability performance categories are reweighted to 
zero percent, the quality and improvement activities performance 
categories will be reweighted to 85% and 15%, respectively. This could 
provide a scenario that creates greater ease of reaching the 
performance threshold for clinicians participating in MIPS.
    Comment: Several commenters did not support lowering the 
performance threshold to 50 points from the previously finalized 
performance threshold of 60 points for the CY 2023 MIPS payment year 
because they believed the performance threshold should be further 
reduced due to the PHE for COVID-19, limiting regulatory burden for 
clinicians during that time. Several commenters suggested lowering the 
performance threshold to 45 points, the same threshold as the CY 2022 
MIPS payment year, while one commenter suggested lowering the 
performance threshold to 30 points, which is the same as the 2021 MIPS 
payment year. One commenter expressed their belief that further 
decreasing the performance threshold to 45 points may especially help 
small and rural practices. Some commenters stated that clinicians who 
received reweighting of the MIPS performance categories based on 
extreme and uncontrollable circumstances for the CY 2019 and CY 2020 
MIPS performance periods would experience a significant increase in the 
performance threshold. Another commenter stated that since the final 
rule may not be published until December 1, 2020, CMS should set the 
performance threshold to 45 points for the CY 2022 MIPS payment year to 
provide clinicians with more time to familiarize themselves with the 
policy changes and decrease the risk of receiving a negative 
adjustment.
    Response: We thank the commenters for their recommendations and 
acknowledge concerns regarding potential challenges for clinicians due 
to the PHE for COVID-19. Although small and rural practices may benefit 
from a lower performance threshold, we believe that it is important to 
ensure that there are appropriate incentives for clinicians, including 
small and rural practices, to continue their participation in MIPS for 
the 2021 performance period and future years, even if the PHE for 
COVID-19 continues. As discussed in section IV.A.3.d.(2)(b)(iv)(B) of 
this final rule, the extreme and uncontrollable circumstances 
application is an available flexibility for clinicians impacted by the 
PHE for COVID-19. Clinicians who receive reweighting based on extreme 
and uncontrollable circumstances for the CY 2019, CY 2020, and CY 2021 
MIPS performance periods would experience a larger jump in the 
performance threshold for the CY 2022 MIPS performance period than 
those who

[[Page 84923]]

participated in MIPS for the CY 2019, CY 2020, and CY 2021 MIPS 
performance periods. However, we believe that maintaining the 
previously finalized performance threshold of 60 points for the CY 2023 
MIPS payment year lends consistency to the program, which may be 
especially important during this challenging time.
    The following is a summary of the comments we received on the 
proposal to revisit and potentially revise in the final rule our prior 
estimate of 74.01 points for the performance threshold for the 2024 
MIPS payment year.
    Comment: One commenter expressed their appreciation and belief that 
CMS has worked to create a smooth transition in increasing the 
performance threshold in accordance with the statute for the CY 2024 
MIPS payment year.
    Response: We appreciate the support and acknowledgement of our 
efforts to provide an ease of transition to the performance threshold 
for the CY 2024 MIPS payment year.
    Comment: One commenter urged CMS to work with Congress on 
developing a legislative fix to change the statutory requirements for 
the CY 2024 MIPS payment year performance threshold, believing that 
because of the PHE for COVID-19, a change may be needed to ease the 
transition of increasing the performance threshold over time.
    Response: We acknowledge the commenter's concern and 
recommendation. Given that we do not know the magnitude of impact that 
the PHE for COVID-19 will have on clinician participation in MIPS for 
the CY 2023 payment year, we believe it would be premature to seek a 
legislative change at this time. However, we intend to consider these 
concerns and potentially address them in the future.
    Comment: A few commenters expressed their concern with the 
estimated performance threshold of 74.01 points for the CY 2024 MIPS 
payment year. One commenter recommended that the performance threshold 
increase no more than 10 percent year-over-year beginning with the CY 
2024 payment year, while another commenter recommended setting the year 
6 performance threshold at 75 points, since it is a round number. 
Commenters stated that the PHE for COVID-19 will continue into the CY 
2021 performance period and may cause unforeseen consequences. They 
urged CMS to use any flexibilities available in setting the performance 
threshold for the CY 2024 MIPS payment year.
    Response: We understand the commenters concern. We understand that 
both direct and indirect impacts of the PHE for COVID-19 will likely 
continue into CY 2021. We stated in the CY 2021 PFS proposed rule (85 
FR 50318) that in the event that the CY 2019 MIPS performance year data 
becomes available, with sufficient time to inform our policy decisions 
for the final rule, we proposed to revisit and potentially revise our 
prior estimate of 74.01 points for the performance threshold for the 
2024 MIPS payment year. However, after analyzing the data for the CY 
2019 performance period, we have decided not to revise our prior 
estimate of the performance threshold for the 2024 MIPS payment year. 
The statute requires that, beginning with the 2024 MIPS payment 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. The data for the CY 2019 MIPS 
performance period estimates the mean final score as 79.8 and the 
median final score as 85.27, which are significantly higher than our 
prior estimate of 74.01 points for the 2024 MIPS payment year 
performance threshold. We plan to continue utilizing performance data, 
as it becomes available, to inform policy decisions in future 
rulemaking.
    After consideration of the public comments received, we are not 
finalizing our proposal to set the performance threshold at 50 points 
for the 2023 MIPS payment year, instead of 60 points as previously 
finalized at Sec.  414.1405(b)(8). We are maintaining the performance 
threshold at 60 points, as previously finalized, at Sec.  
414.1405(b)(8). We are also not finalizing our proposal to revisit and 
potentially revise our prior estimate of 74.01 points for the 
performance threshold for the 2024 MIPS payment year.
(4) Example of Adjustment Factors
    Figure A provides an illustrative 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 our policies for the 2023 MIPS payment 
year. In Figure A, the performance threshold is set at 60 points. The 
applicable percentage is 9 percent for the 2023 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 9 percent for the 
2023 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 15 points based on 
the finalized performance threshold of 60 points for the 2023 MIPS 
payment year). All MIPS eligible clinicians with a final score in this 
range would receive the lowest negative applicable percentage (negative 
9 percent for the 2023 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 9 percent. If the scaling factor is 
above 1.0 but is less than or equal to 3.0, then the MIPS payment 
adjustment factor for a final score of 100 would be greater than 9 
percent.
    Only those MIPS eligible clinicians with a final score equal to 60 
points (which is the finalized performance threshold) would receive a 
neutral MIPS payment adjustment. Because the performance threshold is 
60 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 
9 percent.
BILLING CODE 4120-01-P

[[Page 84924]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.103

    Table 57 illustrates the changes in payment adjustment based on the 
final policies from the CY 2020 PFS final rule (84 FR 63031 through 
63045) for the 2022 and 2023 MIPS payment year, as well as the 
applicable percent reqired by section 1848(q)(6)(B) of the Act.

[[Page 84925]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.104

BILLING CODE 4120-01-C
f. Review and Correction of MIPS Final Score
(1) Feedback and Information To Improve Performance
    Under section 1848(q)(12)(A)(i) of the Act, we are at a minimum 
required to provide MIPS eligible clinicians with timely (such as 
quarterly) confidential feedback on their performance under the quality 
and cost performance categories beginning July 1, 2017, and we have 
discretion to provide such feedback regarding the improvement 
activities and Promoting Interoperability performance categories. In 
the CY 2018 Quality Payment Program final rule (82 FR 53799 through 
53801), we finalized that on an annual basis, beginning July 1, 2018, 
performance feedback will be provided to MIPS eligible clinicians and 
groups for the quality and cost performance categories, and if 
technically feasible, for the improvement activities and advancing care 
information (now called the Promoting Interoperability) performance 
categories.
    On July 1, 2018, we provided the first performance feedback for the 
Quality Payment Program. The second performance feedback was provided 
on July 1, 2019. However, for this year due to the PHE for COVID-19, we 
stated in the proposed rule (85 FR 50321) that we may provide 
performance feedback after July 1, 2020 (that is, performance feedback 
based on data submitted for the performance period in 2019). We stated 
that although we aim to provide performance feedback on or around July 
1 of each year, it is possible that the release date could be later 
than July 1 depending on the circumstances. We estimated that we would 
provide performance feedback in late July or early August, although we 
noted this timeframe could be subject to change. We directed readers to 
qpp.cms.gov for more information.
    On August 5, 2020, we released the third performance feedback for 
the Quality Payment Program, which was for the 2019 performance period. 
Additional information is available at https://qpp.cms.gov/about/deadlines?py=2019. We received public comments on our expected 
timeframe for providing performance feedback.
    Comment: One commenter noted their appreciation for the updates on 
the PHE delaying the release of performance year

[[Page 84926]]

2019 feedback reports but expressed concern that the online portal for 
QPP feedback reports is confusing and difficult to navigate. The 
commenter recommended sharing additional scoring information with MIPS 
eligible clinicians.
    Response: We appreciated the commenters for their feedback and 
support. We refer readers to qpp.cms.gov Resource Library where the 
2019 MIPS Performance Feedback Resources user guide details how to 
access and how CMS scores these reports.
g. Third Party Intermediaries
    We refer readers to Sec. Sec.  414.1305 and 414.1400, the CY 2017 
Quality Payment Program final rule (81 FR 77362 through 77390), the CY 
2018 Quality Payment Program final rule (82 FR 53806 through 53819), 
the CY 2019 PFS final rule (83 FR 59894 through 59910), the CY 2020 PFS 
final rule (84 FR 63049 through 63080), and the May 8th COVID-19 IFC 
(85 FR 27594 through 27595) for our previously established policies 
regarding third party intermediaries.
    In the CY 2021 PFS proposed rule (85 FR 50321 through 50331), we 
proposed to make several changes to requirements for (1) third party 
intermediaries generally, (2) QCDRs, (3) qualified registries, and (4) 
remedial action.
(1) Generally
(a) Requirements for MIPS Performance Categories That Must Be Supported 
by Third Party Intermediaries
    We refer readers to Sec.  414.1400(a)(2) and the CY 2017 Quality 
Payment Program final rule (81 FR 77363 through 77364), and as further 
revised in the CY 2019 PFS final rule (83 FR 60088) and CY 2020 PFS 
final rule (84 FR 63049 through 63052) at Sec.  414.1400(a)(2) for our 
current policy regarding the types of MIPS data that third party 
intermediaries may submit. Through the CY 2021 PFS proposed rule (85 FR 
50321 through 50322), we intended to clarify our requirements of QCDRs, 
qualified registries, and health IT vendors with regards to submitting 
data for purposes of the MIPS program through revisions to our 
regulation codified at Sec.  414.1400(a)(2), particularly for those 
third party intermediaries who are interested in supporting MVPs in the 
future. Therefore, we proposed to revise Sec.  414.1400(a)(2) as 
follows:
    Except as provided under Sec.  414.1400(a)(2)(ii), QCDRs, qualified 
registries, and health IT vendors must be able to submit data for all 
of the following MIPS performance categories:
     Quality, except:
    ++ The CAHPS for MIPS survey; and
    ++ For qualified registries and health IT vendors, QCDR measures;
     Improvement activities; and
     Promoting Interoperability, if the eligible clinician, 
group, or virtual group is using CEHRT; however, a third party 
intermediary may be excepted from this requirement if its MIPS eligible 
clinicians, groups or virtual groups fall under the reweighting 
policies at Sec.  414.1380(c)(2)(i)(A)(4) or (5) or (c)(2)(i)(C)(1) 
through (7) or (c)(2)(i)(C)(9)).
    Health IT vendors that do not support MVPs, must be able to submit 
data for at least one of the MIPS performance categories described 
above. We requested comments on the proposals.
    We received public comments on the proposed requirements for MIPS 
performance categories that must be supported by third party 
intermediaries. The following is a summary of the comments we received 
and our responses.
    Comment: One commenter agreed with the requirement that health IT 
vendors who do not support MVPs must submit data for at least one of 
the MIPS performance categories. The commenter stated submitting data 
is necessary for at least the quality category as all vendors need to 
be certified for submitting the QRDA file.
    Response: We thank commenters for their support.
    Comment: One commenter supported the reporting exception for QCDRs 
and qualified registries whose clinicians fall under reweighting 
policies.
    Response: We thank the commenter for their support. For the 
Promoting Interoperability performance category, we currently reweight 
clinicians that are non-patient facing, hospital-based or who are one 
of the NPP types eligible for reweighting. We refer readers to review 
our reweighting policies at Sec.  414.1380(c)(2).
    After consideration of public comments, we are finalizing our 
policy as proposed at Sec.  414.1400(a)(2).
(i) Reporting MVPs Through Third Party Intermediaries
    We refer readers to section IV.A.3.a. of this final rule where we 
discuss reporting MVPs through third party intermediaries and 
summarized our proposal that QCDRs, qualified registries, and health IT 
vendors who support the Quality, Promoting Interoperability, and 
Improvement Activities performance categories may also support the 
reporting of MVPs.
(ii) Reporting APM Performance Pathway (APP) Through Third Party 
Intermediaries
    We refer readers to section IV.A.3.b. of this final rule where we 
reiterate our proposal and include responses to public comments that 
beginning with the CY MIPS 2023 payment year, MIPS eligible clinicians 
scored under the APP would be scored on the quality measure set 
finalized for that MIPS performance period. Three quality measures 
(Quality ID# 001: Diabetes: Hemoglobin A1c (HbA1c) Poor Control (>9%), 
Quality ID#: 134: Preventive Care and Screening: Screening for 
Depression and Follow-Up Plan, and Quality ID# 236: Controlling High 
Blood Pressure) were proposed to be reported using the MIPS CQM and 
eCQM collection types.
(b) Approval Criteria for Third Party Intermediaries
(i) Background
    We refer readers to Sec.  414.1400(a)(4), the CY 2019 PFS final 
rule (83 FR 59894 through 59895, 60088), the CY 2020 PFS final rule (84 
FR 63052 through 63053), and the May 8th COVID-19 IFC (85 FR 27594 
through 27595) for previously finalized policies related to the 
approval criteria for third party intermediaries.
(ii) New Approval Considerations--Past Performance and Conduct
    During past years of the MIPS program we have encountered third 
party intermediaries failing to meet program requirements and engaging 
in other conduct that could harm the integrity of the MIPS program. 
Some examples of third party intermediaries failing to meet program 
requirements include, but are not limited to: Failing to meet 
requirements to submit data for a performance category; failing to 
provide services throughout the entire performance period and 
applicable data submission period; and providing data that is not true, 
accurate, or complete. Additionally, we have also encountered third 
party intermediaries who have provided inaccurate information to the 
clinicians and groups they support regarding the obligation to submit 
data to CMS that are true, accurate and complete. For example, we are 
aware of third party intermediaries offering services and tools to 
eligible clinicians that encouraged the selection of misrepresentative 
data to maximize scores, commonly referred to as ``cherry-picking,'' 
that would result in the submission of data that did not accurately 
represent of the clinician's or group's performance.
    In preparation for future years of the program, we believe it is 
important to

[[Page 84927]]

disapprove third party intermediaries that have demonstrated their 
failure to comply with program requirements or have provided inaccurate 
information regarding MIPS program requirements to clinicians. In the 
CY 2021 PFS proposed rule (85 FR 50322), we discussed that we are 
concerned with the potential adverse program effect of this conduct, 
such as delayed and erratic reporting if third party intermediaries 
fail to support MIPS reporting for the entire performance period and 
reporting period, and the possibility of inaccurate data submissions. 
As a result, we noted that we believe it is important to consider these 
factors when making determination regarding whether to approve a third 
party intermediary for future participation in the MIPS program.
    Therefore, we proposed to amend the current Sec.  414.1400(a)(4) to 
add paragraph (a)(4)(ii):
    The determination of whether to approve an entity as a third party 
intermediary for a MIPS performance period may take into account: (1) 
Whether the entity failed to comply with the requirements of this 
section for any prior MIPS payment year for which it was approved as 
third party intermediary; and (2) whether the entity provided 
inaccurate information regarding the requirements of this subpart to 
any eligible clinician. We noted that we intend on utilizing all 
available information to make these approval determinations, including 
without limitation, information collected through compliance audits 
under our existing audit authority as described in Sec.  414.1400(g). 
Third party intermediaries may be selected during the performance 
period to be audited for a given requirement. As a part of our outreach 
to a selected third party intermediary, we intend on providing 
additional direction with regard to the timeline and information needed 
for the audit. The results of the audit will be reviewed to inform 
future approval of a third party intermediary, and if remedial action 
is warranted, we noted that we will utilize our existing authority as 
described in Sec.  414.1400(f). We believe use of this information in 
approval determinations will help reduce the risk of third party 
intermediaries that are unreliable, thereby avoiding a possible 
increase in burden to clinicians who may inadvertently select an 
unreliable third party intermediary for purposes of reporting for the 
MIPS program. We requested comments on the proposals; specifically, on 
whether there are other factors that should inform our considerations 
when approving third party intermediaries.
    The following is a summary of the comments we received and our 
responses.
    Comment: A few commenters agreed with the proposal to take into 
account past performance and conduct when determining whether to 
approve an entity as a third party intermediary for a MIPS performance 
period. However, commenters requested that CMS clarify that an entity 
which may have failed to comply with a requirement of the MIPS program 
will not result in automatic disqualification as a third party 
intermediary for a future MIPS performance period if that entity has 
entered into an CMS approved Corrective Action Plan.
    Response: We thank commenters for their support.
    We also clarify that this policy does not establish that particular 
conduct or the existence of a Corrective Action Plan would 
automatically disqualify a third party intermediary from approval in a 
future performance year. Rather, this policy establishes that failure 
to comply with the requirements of this section for any prior MIPS 
payment year is a factor the agency may take into account when making a 
determination of whether to approve an entity as a third party 
intermediary for a MIPS performance period. We generally do not 
anticipate that conduct for which CMS has approved a Corrective Action 
Plan standing alone would be the basis for CMS not approving the TPI 
for participation in a future MIPS Performance period.
    After consideration of public comments, we are finalizing our 
policy as proposed at Sec.  414.1400(a)(4).
(iii) Third Party Intermediary Training and Support
    In the CY 2017 Quality Payment Program final rule (81 FR 77367 
through 77374) and (81 FR 77384 through 77386), we established our 
expectation that QCDRs and qualified registries perform certain 
functions related to data submission. One of those expectations is 
participation in ongoing support conference calls hosted by CMS 
(approximately one call per month) and an in-person kick-off meeting 
(if held) at our headquarters in Baltimore, MD. (81 FR 77368) and (81 
FR 77384). The purpose of these meetings is to provide approved QCDRs 
and qualified registries program updates from subject matter experts 
who work across the Quality Payment Program. At these meetings, CMS 
subject matter experts and our contractors provide approved QCDRs and 
qualified registries with updates, answer questions, and provide 
technological demonstrations. In light of the PHE for COVID-19 and 
consistent with the goal of infection control, we reevaluated our 
expectations and have decided to adopt a policy allowing for 
flexibility moving forward. With the health and safety of our 
stakeholders in mind, we noted that we believe virtual meetings would 
be sufficient when in-person meetings are not possible. We proposed to 
codify these expectations in a proposed requirement at Sec.  
414.1400(a)(4)(iii) that third parties intermediaries participate in an 
annual meeting and training calls as deemed necessary by CMS.
    In the CY 2017 Quality Payment Program final rule (81 FR 77377 
through 77382), we stated our expectations for health IT vendors that 
serve as third party intermediaries by obtaining data from the CEHRT of 
a MIPS eligible clinician and submitting such data to CMS for 
participation in MIPS. For further discussion of CEHRT, we refer 
readers to sections III.M.3 and IV.A.3.g.(1)(iv) of this final rule. 
Because the submission requirements and policies that may be added or 
modified from year to year have the potential to alter expectations for 
all third party intermediaries, we believe that mandatory meetings and 
training calls would also be appropriate for health IT vendors that 
will serve as third party intermediaries. Hosting training calls for 
health IT vendors would give us an opportunity to provide a review of 
requirements, answer questions, and explain updates to the annual 
submission process and other policies as applicable. Thus, we proposed 
the requirement that third party intermediaries participate in an 
annual meeting and training calls as deemed necessary by CMS including 
those third party intermediaries that are health IT vendors. We 
solicited comments on the best method to reach health IT vendors so 
that we can invite them to required meetings and share additional 
information. We noted that we are considering listserv communications 
through the QPP listserv but would welcome suggestions for other 
communication mechanisms.
    We previously finalized the CMS-approved survey vendor approval 
criteria in Sec.  414.1400(e) as discussed in the CY 2018 PFS final 
rule (83 FR 59907 through 59908). Among the approval criteria, Sec.  
414.1400(e)(3) established the requirement that the entity has 
successfully completed, and has required its subcontractors to 
successfully complete, vendor training(s) administered by CMS or its 
contractors. In the CY 2021 PFS

[[Page 84928]]

proposed rule, (85 FR 50323), we noted that we continue to believe 
these previously finalized requirements are of importance to CMS-
approved survey vendors, such as CAHPS for MIPS vendors. In addition, 
because the submission requirements and policies that may be added or 
modified from year to year have the potential to alter expectations for 
all third party intermediaries, we noted that we believe that the 
proposed requirement that third parties intermediaries participate in 
an annual meeting and training calls as deemed necessary by CMS should 
also be applicable to CMS-approved survey vendors.
    In summary, we believe making support calls and trainings mandatory 
for all third-party intermediaries will provide an abundance of value 
to all approved third party intermediaries themselves, as well as to 
the MIPS program and the clinicians who rely on third party 
intermediaries to make complete, accurate, usable and timely data on 
their behalf. We believe uniformly codifying this language is 
appropriate to hold all third party intermediaries accountable for the 
training and support. Therefore, we proposed to codify at Sec.  
414.1400(a)(4)(iii) that beginning with the 2023 MIPS payment year, 
third party intermediaries must attend and complete training and 
support sessions in the form and manner, and at the times, specified by 
CMS. We affirmed that, in addition to the obligations under this 
policy, CMS-approved survey vendors must also continue to meet the 
requirements at Sec.  414.1400(e)(3).
    The following is a summary of the comments we received and our 
responses.
    Comment: One commenter supported the proposal for health IT vendors 
to be required to attend monthly training and support calls and 
requested additional opportunities to attend trainings and ask 
questions.
    Response: We thank the commenter for their support for Health IT 
vendor training. We believe participation in training and support 
sessions will be very beneficial and educational for health IT vendors. 
CMS agrees that regular dialogue is an important element to help 
vendors receive the latest information and reminders and to give third 
party intermediaries the best opportunity for success of the vendor and 
their clinician participants. For clarification, the requirement, which 
applies beginning with the 2021 MIPS performance year/2023 MIPS payment 
year does not specifically establish mandatory monthly calls for health 
IT vendors but rather establishes that attendance and completion of 
training and support sessions will be ``in the form and manner, and at 
the times, specified by CMS''. We will take into account the 
commenter's suggestion that training opportunities for health IT 
vendors should be more frequent than monthly when developing these 
training and support sessions.
    Additionally, we did not receive comments on our proposal to 
message health IT vendors the same way that that we message to other 
third party intermediaries by utilizing our listserv communications 
through the QPP listserv. We are adopting this approach to 
communication with health IT vendors and encourage health IT vendors, 
if they have not already, to sign up for listserv messages at https://qpp.cms.gov/.
    Comment: One commenter supported the proposal to require QCDRs and 
qualified registries to attend training and support calls.
    Response: We thank the commenter for their support.
    After consideration of public comments, we are finalizing our 
proposals as proposed.
(iv) Future Safeguards for All Third Party Intermediaries
    We understand our obligation to ensure the integrity of the MIPS 
program and will continue to assess opportunities to strengthen program 
safeguards. Certain safeguards apply to all third party intermediaries, 
including those described in Sec.  414.1400(a), (f), and (g). In 
sections IV.A.3.g.(2)(a) and IV.A.3.g.(3) of the CY 2021 PFS proposed 
rule, we proposed additional program safeguards in regard to data 
validation audit and targeted audit requirements that would apply 
specifically to QCDRs and qualified registries. As discussed there, the 
proposals would require QCDRs and qualified registries to conduct 
validation on data prior to the data being submitted to CMS for 
purposes of the MIPS program. We limited those proposals to QCDRs and 
qualified registries, but we solicited feedback on expanding the 
proposed requirements to all third party intermediaries through future 
rulemaking. We refer readers to sections IV.A.3.g.(2)(a) and 
IV.A.3.g.(3) in this final rule for a discussion of our finalized 
policies.
    The Office of the National Coordinator for Health Information 
Technology's (ONC) Health IT Certification Program provides for the 
certification of certain health IT. The requirements for ONC 
certification are based on standards, implementation specifications, 
and certification criteria adopted by the Secretary. The Quality 
Payment Program adopted a definition of certified electronic health 
record technology (CEHRT) at Sec.  414.1305.
    For a discussion of the updates to 2015 Edition certification 
criteria referenced in the CEHRT definition adopted for the Quality 
Payment Program, we refer readers to section III.M. of the CY 2021 PFS 
proposed rule (85 FR 50323) and section IV.A.3.c.(4) of this final 
rule.
    It is important to note that a health IT vendor which acts as a 
third party intermediary for purposes of the MIPS program may or may 
not be the same entity as a health IT developer which certifies health 
IT products as part of the certification program. While health IT 
developers may act as third party intermediaries for their customers, 
other service providers who do not develop health IT products may also 
assist MIPS eligible clinicians by submitting data obtained from CEHRT 
on their behalf and thereby function as a health IT vendor for purposes 
of the MIPS program. Furthermore, the entities that are not health IT 
developers must only submit data on behalf of eligible clinicians that 
has already been captured and calculated using the functions of CEHRT. 
Unlike QCDRs and qualified registries, third party intermediaries that 
are health IT vendors may or may not also possess expertise related to 
quality improvement and analysis/validation of clinical quality data, 
and we do not currently require these organizations to attest that they 
possess these capabilities.
    We are increasingly aware of data integrity issues that have 
impacted data submitted by health IT vendors that obtain data from MIPS 
eligible clinician's CEHRT and serve as third party intermediaries to 
submit this data on behalf of MIPS eligible clinicians. We are aware of 
instances in which health IT vendors have submitted data that are 
inaccurate and unusable. These data issues may result in improper 
payments or otherwise undercut the integrity of the MIPS program. In 
some instances, data issues caused by health IT vendors may have 
downstream negative impacts to the clinicians whose data the health IT 
vendor is submitting, such as negative payment adjustments and 
inaccurate data publically posted on the Physician Compare internet 
website of the Centers for Medicare & Medicaid Services (or a successor 
website).
    Although we did not propose to add data validation requirements for 
health IT vendors in the proposed rule, we noted that we were 
considering ways to

[[Page 84929]]

impose such requirements in the future. We solicited comment on whether 
we should impose data validation requirements on health IT vendors as 
part of the third party intermediary approval process and if so, how 
the data validation requirements for health IT vendors should differ, 
if at all, from those we proposed for QCDRs and qualified registries. 
We noted that we believe that potentially requiring health IT vendors 
to validate the data they submit to us for purposes of the MIPS program 
will lead to the submission of data that can be considered more 
reliable and accurate. Therefore, we sought comment on the future 
application of such requirements on health IT vendors and if there are 
factors unique to health IT vendors that should be considered when 
developing such a policy. We also sought comments on: Whether health IT 
vendors currently submitting data on behalf of MIPS eligible clinicians 
possess the capabilities to engage in the data validation processes we 
proposed for QCDRs and Qualified Registries; the burden on health IT 
vendors of adopting the data validation requirements as proposed for 
QCDRs and qualified registries and whether the imposition of these 
requirements on health IT vendors would discourage health IT vendors 
from serving as third party intermediaries; whether alternative 
requirements for health IT vendors would impose less burden on these 
third parties' intermediaries while still ensuring that the data 
submitted is accurate and complete; and how any future data validation 
processes should impact certification under the ONC Health IT 
Certification Program for health IT developers who also serve as a 
health IT vendor third party intermediary for the purposes of MIPS.
    For CMS-approved survey vendors, such as CAHPS for MIPS vendors, we 
did also not propose any new data validation requirements. In the CY 
2018 PFS final rule (83 FR 59907 through 59908) we previously finalized 
requirements at Sec.  414.1400(e) that address the validity of data 
submitted to CMS for CMS-approved survey vendors. Specifically, we 
previously finalized at Sec.  414.1400(e)(4) that as a condition of 
approval 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. We 
noted that we believe this previously finalized requirement at Sec.  
414.1400(e) is sufficient to address potential concerns about the 
accuracy of data submitted by survey vendors; however, we solicited 
feedback on whether the audit requirements in the proposal should be 
expanded to include survey vendors.
    The following is a summary of the comments we received on potential 
future notice-and-comment to impose new data validation requirements on 
health IT vendors and CMS-approved survey vendors and our responses to 
those comments. We refer readers to sections IV.A.3.g.(2)(a) and 
IV.A.3.g.(3) in this final rule for a discussion of comments and 
responses to our current proposed policies for data validation by QCDRs 
and qualified registries, respectively.
    Comment: Several commenters supported future requirements for 
health IT vendors to perform data validation. One commenter believes 
that it is the responsibility of the health IT developer to ensure the 
validity of the data their CEHRT is producing, and that a health IT 
developer's certification should be tied to its ability to capture and 
calculate data accurately. Another commenter believes that any entity 
that is submitting data on behalf of a clinician to CMS (for example, 
QCDR or health IT vendor) should be held to the same data validation 
requirements of a QCDR and without these requirements, the two 
different standards for registries and health IT vendors would 
undermine the goal of standard data integrity and place increased 
financial burden on non-profit QCDRs above that of health IT vendors.
    Response: We appreciate the support and believe additional data 
validation could help to promote health IT vendor accountability for 
the accuracy of the data they submit to CMS. We have shared with ONC 
the commenter's support for any future data validation process 
impacting certification under the ONC Health IT Certification Program 
for health IT developers who also serve as a health IT vendor third 
party intermediary for the purposes of MIPS.
    Comment: Several commenters did not support health IT vendors being 
required to perform data validation. These commenters believe CMS 
requirements for data validation by health IT vendor third party 
intermediary for the purposes of MIPS would be costly and burdensome 
and duplicative and unnecessary in light of the oversight these health 
IT vendors receive under the ONC regulatory framework, including the 
recently adopted Real World Testing requirement under the 21st Century 
Cures Act. One commenter requested that CMS monitor results of the 
Condition and Maintenance of Certification Real World Testing 
requirement prior to proposing requirements in MIPS. Another commenter 
requested that if CMS undertakes imposes additional requirements in 
MIPS for health IT vendors to validate data submitted on quality 
measures, the CMS requirements should replace work already required by 
ONC through the ONC certification program and real world testing, to 
avoid duplicative efforts.
    One commenter stated that health IT developers already have to 
certify to each measure they offer as an eCQM and will soon be required 
to meet real-world testing requirements under the new Conditions and 
Maintenance of Certification provisions which should include testing 
based on current year measure specifications for the eCQM criteria. The 
commenter further believes that centrally validating eCQM data can be 
difficult because eCQM data collection can vary between each health IT 
developer and potentially between every provider organization depending 
on how a system is implemented by the provider organization. The 
commenter also expressed its concern with who would need to meet the 
eCQM data validation requirements, when they would need to meet the 
requirements, and for what measures the validation would need to be 
performed. The commenter requested that CMS work with the Electronic 
Health Record Association (EHRA) and its members to outline potential 
options for validation of measures as it relates to HIT Developers and 
encouraged CMS to consider means by which these requirements may be met 
by other activities the health IT developer is engaged in for meeting 
the Conditions and Maintenance of Certification such as by real-world 
testing. Another commenter requested CMS differentiate between 
developers of certified health IT and other health IT vendors due to 
their belief that that developers of certified health IT inherently 
already performs data validation.
    Response: We appreciate the commenters' concerns regarding 
potential overlap between potential CMS data validation requirements 
for a health IT vendor third party intermediary for the purposes of 
MIPS and existing policies for oversight of health IT developers. We 
agree that any new data validation requirements for health IT vendors 
that submit data to CMS as third party intermediaries should take into 
account existing requirements designed to ensure these entities enable 
accurate reporting of data. As part of this effort, we plan to consider 
the real world testing Condition of Certification finalized

[[Page 84930]]

under ONC's 21st Century Cures Act final rule (85 FR 25765), which 
focuses on how certified health IT functionality is deployed in real-
world settings and could potentially include activities related to 
validation of data reported using certified health IT. We understand 
that ONC's requirement does not necessarily require validation of data 
reported to CMS using certified health IT. Rather, we understand that 
the ONC condition of certification allows developers the flexibility to 
select measures to demonstrate how their certified health IT products 
function in real world environments. While data validation of eCQMs 
could conceivably be used as part of those real-world testing measures, 
we do not believe it is not a requirement to meet the Condition of 
Certification. We also appreciate the suggestion that CMS work with 
stakeholders, and plan to reach out to both health IT vendors and other 
interested parties prior to further action on new requirements to 
identify ways to minimize burden and align with existing programs.
    As noted above, we will continue to work with ONC going forward as 
we consider any future rulemaking in this area.
    Comment: One commenter did not support future requirements for 
CAHPS survey vendors to conduct data audits due to its belief that it 
would be burdensome and potentially duplicative given that CAHPS 
vendors are currently required to adhere to established quality control 
processes as outlined in the Quality Assurance Guidelines (QAGs) for 
each survey administration which include the requirement to maintain 
and submit a Quality Assurance Plan to CMS' subcontractor on an annual 
basis; keep records of CAHPS for MIPS quality assurance activities; and 
participate in other CAHPS Survey oversight activities, which can 
include auditing of submitted data, on-site visits and/or conference 
calls, and other activities as instructed by CMS.
    Response: We agree with the commenter. We believe our previously 
finalized requirement at Sec.  414.1400(e) is sufficient to address 
potential concerns about the accuracy of data submitted by survey 
vendors, and do not anticipate adding any new data validation 
requirements for CAHPS for MIPS vendors.
(2) Qualified Clinical Data Registries (QCDRs)
    We generally refer readers to section 1848(m)(3)(E) of the Act, as 
added by section 601(b)(1)(B) of the American Taxpayer Relief Act of 
2012 (ATRA) (Pub. L. 112-240, enacted January 2, 2013), which requires 
the Secretary to establish requirements for an entity to be considered 
a QCDR and a process to determine whether or not an entity meets such 
requirements. We refer readers to section 1848(m)(3)(E)(i)(v) of the 
Act, the CY 2019 PFS final rule (83 FR 60088), the CY 2020 PFS final 
rule (84 FR 63053 through 63058), May 8th COVID-19 IFC (85 FR 27594 
through 27595) and Sec.  414.1400(a)(4) through (b) for previously 
finalized policies about third party intermediaries generally and QCDRs 
specifically. In the CY 2021 PFS proposed rule (85 FR 50324), we 
proposed a technical update to Sec.  414.1400(b) title to rename it 
from ``QCDR approval criteria'' to ``QCDRs'', to better align the title 
with the content of the regulation. In addition, we proposed policies 
related to QCDR: (1) Data validation audits and targeted audits; and 
(2) measure requirements.
(a) Data Validation Audit and Targeted Audit Requirements
    In the CY 2017 Quality Payment Program final rule, we discussed our 
expectation that QCDRs and qualified registries would conduct 
validation on the data they intend on submitting for the MIPS 
performance period (81 FR 77366 through 77367) and provide the results 
of the data validation to CMS in the form of a data validation 
execution report by May 31st of the year following the performance 
period. Our intention was to establish our expectation that QCDRs would 
establish a process to assess whether the data are true, accurate, and 
complete prior to submitting them to CMS for purposes of the MIPS 
program. We noted that we believe it is important to establish a 
requirement that QCDRs conduct data validation to ensure they are 
actively monitoring the data they submit to CMS for purposes of a pay-
for-performance program. In instances where a QCDR discovers data are 
inaccurate or incomplete, the entity must correct the issue prior to 
submitting the data to CMS in order to provide accurate certification 
in accordance with Sec.  414.1400(a)(5). A QCDR that submits a false 
certification submits data that is inaccurate, unusable or otherwise 
compromised to CMS for purposes of the MIPS program may be subject to 
remedial action or termination under Sec.  414.1400(f). We also noted 
that we believe requiring QCDRs to validate the accuracy of the data 
they are submitting is an important safeguard to promote accurate 
payments under the MIPS program. Therefore, we proposed to codify at 
Sec.  414.1400(b)(2)(iv) and (v) requirements beginning with the 2023 
MIPS payment year as condition of approval each QCDR must conduct 
annual data validation audits and if one or more deficiencies or data 
errors are identified the QCDR must also conduct targeted audits. We 
also proposed specific obligations for those audits as discussed below.
     We proposed to codify at Sec.  414.1400(b)(2)(iv)(A), that 
the QCDR must conduct data validation for the payment year prior to 
submitting any data for that payment year to CMS for purposes of the 
MIPS program. We believe it is important for QCDRs to conduct 
validation audits to identify and fix concerns regarding data accuracy 
prior to submitting data to us, including potential issues related to 
data aggregation and calculation. Conducting the data validation prior 
to data submission will lead to data being more reliable and promote 
compliance with the requirement of data being true, accurate, and 
complete. In the CY 2017 Quality Payment Program final rule, we 
described this auditing using the term randomized audit (81 FR 77366). 
We proposed instead to refer to this audit as the data validation audit 
in an effort to be abundantly clear regarding our expectations that the 
QCDR will purposefully construct a sample and conduct an audit that 
complies with specific regulatory requirements and also to distinguish 
these audits from the targeted audits discussed below and proposed at 
Sec.  414.1400(b)(2)(v).
     We proposed to codify at Sec.  414.1400(b)(2)(iv)(B), the 
QCDR must conduct data validation on data for each performance category 
for which it will submit data, including if applicable the Quality, 
Improvement Activities, and Promoting Interoperability performance 
categories. We believe that it is important that data validation is 
performed across all performance categories for which the QCDR submits 
data since QCDRs must attest that data submitted to CMS is true, 
accurate, and complete and data for each of these performance 
categories can influence score calculation and payment adjustments.
     We proposed to codify at Sec.  414.1400(b)(2)(iv)(C), that 
the QCDR must conduct data validation on data for each submitter type 
for which it will submit data, including if applicable MIPS eligible 
clinicians, groups, virtual groups, voluntary participants, and opt-in 
participants. We believe it is important for the data submitted to CMS 
be accurate for all clinicians and groups for which the QCDR intends on 
submitting data to the MIPS program, regardless of whether they are 
required to participate, have opted in, or have chosen to voluntarily 
participate.

[[Page 84931]]

Therefore, we proposed to require that the data validation audits 
should account for all types of submitters that are utilizing the QCDR 
to submit data to CMS for purposes of the MIPS program. We noted the 
importance of validating data for all submitter types regardless of its 
use for payment or public reporting. Even clinicians who voluntarily 
report to MIPS and whose data are not used for payment purposes could 
have their data publically posted on the Physician Compare website. We 
noted that we believe all data the QCDR submits, regardless of its use 
for payment or public reporting, should be true, accurate, and 
complete.
     We proposed to codify at Sec.  414.1400(b)(2)(iv)(D) that 
the QCDR must use clinical documentation (provided by the clinicians 
they are submitting data for) to validate that the action or outcome 
measured actually occurred or was performed. If the data a QCDR intends 
to submit to CMS for purposes with the MIPS program are to demonstrate 
that a clinician did a particular clinical activity or achieved a 
particular clinical outcome, we noted that we believe meaningful 
validation of such data requires the QCDR to use clinical documentation 
to confirm that the activity occurred or was performed.
     We proposed to codify at Sec.  414.1400(b)(2)(iv)(E) that 
the QCDR shall conduct each data validation audit using a sampling 
methodology that meets the following requirements:
    ++ Uses a sample size of at least 3 percent of the TIN/NPIs for 
which the QCDR will submit data to CMS, except that if a 3 percent 
sample size would result in fewer than 10 TIN/NPIs, the QCDR must use a 
sample size of at least 10 TIN/NPIs, and if a 3 percent sample size 
would result in more than 50 TIN/NPIs, the QCDR may use a sample size 
of 50 TIN/NPIs.
    ++ Uses a sample that includes at least 25 percent of the patients 
of each TIN/NPI in the sample, except that the sample for each TIN/NPI 
must include a minimum of 5 patients and does not need to include more 
than 50 patients.
    We believe the aforementioned sampling methodology is appropriate 
for multiple reasons. First, the sampling methodology criteria are 
consistent with the methodology established under the legacy Physician 
Quality Reporting System (PQRS) program and as described in the CY 2017 
Quality Payment Program final rule (81 FR 77366 through 77367). As this 
methodology has been used for many years under the legacy program, we 
believe stakeholders are well versed in executing data validation 
audits using this sampling methodology. Second, the proposed 
methodology accounts for QCDRs and qualified registries of varying 
sizes. Data validation requires a level of effort on the part of the 
QCDR to execute a data validation plan, identify a sample, and collect 
information for purposes of chart review; therefore, we are cognizant 
that requiring a larger sample size would create additional burden on 
QCDRs and clinicians to account for a larger volume in TIN/NPIs and 
medical records for review.
     We proposed to codify at Sec.  414.1400(b)(2)(iv)(F) that 
each QCDR data validation audit must include the following:
    ++ Verification of the eligibility status of each eligible 
clinician, group, virtual group, opt-in participant, and voluntary 
participant. We believe that it is important for the QCDR to track the 
eligibility status of each clinician and group that wishes to use a 
third party intermediary to report, because accurate information 
regarding eligibility is important to ensuring payment adjustments are 
properly applied. Furthermore, verification of eligibility status is 
consistent with the requirement for QCDRs to track opt-in participants, 
as described at Sec.  414.1400(a)(4)(iv) and in the context of 
clinicians who voluntarily report to MIPS helps ensure the accuracy of 
data publically posted on the Physician Compare internet website of the 
Centers for Medicare & Medicaid Services (or a successor website).
    ++ Verification of the accuracy of Tax Identification Numbers 
(TINs) or National Provider Identifiers (NPIs). Correct TINs and NPIs 
are critical to ensure data submitted by the QCDR are attributed to the 
correct clinicians and groups. Inaccurate NPIs or TINs may lead to 
inadvertent downstream impacts to the way clinicians and groups are 
scored, and assigned a payment adjustment.
    ++ Calculation of reporting and performance rates (for example, 
formulas included in the quality measure specifications). QCDRs must 
follow the measure specifications when calculating reporting and 
performance rates. Calculations that deviate the formulas included in 
the quality measure specifications undercut efforts to ensure data are 
consistent, reliable, and have been calculated in a uniform manner.
    ++ Verification that only MIPS quality measures and QCDR measures 
that are relevant to the performance period will be utilized for MIPS 
submission. Measure specifications for the MIPS quality measures and 
QCDR measures go through maintenance on an annual basis. Use of 
outdated measure specifications would likely result in the QCDR 
submitting inaccurate or compromised data for the clinicians and groups 
they support. While not all measures go through substantive changes on 
an annual basis, there are changes to codes that do occur annually that 
should be accounted for when programing measures. Therefore, we noted 
that we believe it is important that QCDRs are utilizing the most 
current version of the measure specification, relevant to the 
performance period in which they are participating.
     We proposed to codify at Sec.  414.1400(b)(2)(iv)(G), that 
in a form and manner and by a deadline specified by CMS, the QCDR must 
report the results of each data validation audit, including the overall 
deficiency or data error rate, the types of deficiencies or data errors 
discovered, the percentage of clinicians impacted by any deficiency or 
data error, and how and when each deficiency or data error type was 
corrected. We noted that we believe it is important that the results of 
the data validation be shared with us in order for us to understand the 
types of issues the QCDRs have encountered and what resolutions were 
executed to fix the issues. The information provided will help us track 
frequently occurring issues which may be identified as an area to 
provide further education. It is our belief that the report will be 
largely comprised of issues that were identified and resolved. However, 
if an issue has been identified and could not be resolved, we would 
want to understand what the issue is and why it could not be resolved. 
We emphasized that all data submitted to CMS by a QCDR 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 as described in Sec.  414.1400(a)(5). If a QCDR 
submits a false certification or data that are data that are 
inaccurate, unusable, or otherwise compromised, the QCDR may be subject 
to remedial action or termination as described at Sec.  414.1400(f).
     We proposed to codify at Sec.  414.1400(b)(2)(v)(A), that 
if a data validation audit under Sec.  414.1400(b)(2)(iv) identifies 
one or more deficiency or data error, the QCDR must conduct a targeted 
audit into the impact and root cause of each such deficiency or data 
error for that MIPS payment year. We noted that we believe targeted 
audits are important to further evaluate the impact of deficiencies or 
data errors to the cohort of clinicians

[[Page 84932]]

and groups that the QCDR intends to submit data for, and for QCDRs to 
determine the reason the deficiency or data error occurred.
     We proposed to codify at Sec.  414.1400(b)(2)(v)(B), that 
the QCDR must conduct any required targeted audits for the MIPS payment 
year and correct any deficiencies or data errors identified through 
such audit prior to the submission of data for that MIPS payment year. 
To promote the accuracy of the data submitted to the MIPS program for 
the payment year and to reduce the risk that the agency initiates 
payment calculations in reliance on inaccurate data, it is important 
for the QCDR to conduct required targeted audits and correct any 
deficiencies and data errors identified through those audits prior to 
submitting the data to CMS.
     We proposed to codify at Sec.  414.1400(b)(2)(v)(C), the 
QCDR must conduct the targeted audit using the sampling methodology 
that meets the requirements described in paragraph (b)(2)(iv)(E). The 
sample for the targeted audit must not include data from the sample 
used for the data validation audit in which the deficiency or data 
error was identified.
    We noted that we believe the sampling methodology we proposed for 
data validation audits is equally appropriate for the conduct of 
targeted audits. We believe that adopting the same methodology for both 
audit types would be less burdensome on QCDRs than requiring these 
entities to apply a separate sampling methodology for their targeted 
audits. Provided that data in the sample for the targeted audit does 
not overlap with the data that was reviewed in the data validation 
audit, we believe the targeted audit would provide the QCDR with a 
reasonable perspective into impact and root cause of deficiencies and 
data errors across the data to be submitted without imposing the burden 
that would result from maintaining a separate sampling methodology for 
targeted audits.
     We proposed to codify at Sec.  414.1400(b)(2)(v)(D), in a 
form and manner and by a deadline specified by CMS, the QCDR must 
report the results of each targeted audit, including the overall 
deficiency or data error rate, the types of deficiencies or data errors 
discovered, the percentage of clinicians impacted by each deficiency or 
data error, and how and when each deficiency or data error type was 
corrected. As is the case with the results of data validation audits, 
we noted that we believe it is important that the results of the 
targeted audits be shared with us in order for us to understand the 
types of issues the QCDRs have encountered and what resolutions were 
executed to fix the issues. The information provided will help us track 
frequently occurring issues which may be identified as an area to 
provide further education.
    We requested comments on the aforementioned proposals, including 
whether stakeholders are concerned with implementing the policies for 
the 2023 MIPS payment year, and if so, what barriers do they believe 
they would face in implementing these requirements.
    The following is a summary of the comments we received and our 
responses.
    Comment: Several commenters agreed with the proposal to require 
data validation audits and targeted audits.
    Response: We thank the commenters for their support.
    Comment: A few commenters supported the proposal to require QCDRs 
to be held accountable to report on and correct QCDR measure logic 
issues or other errors generated by the QCDR.
    Response: We clarify that the proposed data validation requirements 
for QCDRs is not targeted specifically to errors generated by the QCDR 
but rather to more broadly help ensure the data submitted to CMS by 
QCDRs is true, accurate and complete.
    Comment: Some commenters stated that while they can advise the 
eligible clinician or group to correct their documentation practices or 
workflow errors, they cannot hold them accountable to act and at the 
point in the performance year at which this audit occurs, the QCDR will 
already be contractually bound to report for the eligible clinician or 
group based on CMS required agreements. Other commenters believe that 
CMS should take responsibility for disciplining eligible clinicians 
that refuse to make data corrections or participate in focused reviews 
and implement a proposal regarding such clinicians which would allow 
registries to submit their data, along with notification of their 
refusal(s).
    Response: We disagree with the commenter's suggestion that CMS 
requires third party intermediaries to enter into agreements that would 
contractually bind the third party intermediary to submit data to CMS 
for the eligible clinician or group that the third party intermediary 
knows the data are not true, accurate and complete. 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. Therefore, in instances where a QCDR determines there is no 
documentation to support that a given quality action or activity was 
completed, the QCDR should advise the eligible clinician or group to 
correct their documentation practices and workflows, and the QCDR must 
also refrain from submitting inaccurate data to CMS. If a third party 
intermediary determines that the data it received for a clinician is 
not true, accurate or complete, and the clinicians refuse to correct 
the error, then the a third party intermediary should not submit the 
inaccurate data on their behalf. We emphasize that we do not want 
inaccurate data submitted to us, and we do not want a third party 
intermediary to submit incorrect data on behalf of non-compliant 
clinicians. Furthermore, as described in the CY 2020 PFS final rule (84 
FR 63023 through 63027), if we determine a MIPS eligible clinician has 
knowingly submitted compromised data for a performance category the 
clinician's performance category score would be zero and the scoring 
weight for the category will not be redistributed. A third party 
intermediary that submits inaccurate data to CMS, may be subjected to 
the remedial action and termination under Sec.  414.1400(f) even in 
instances where clinicians refuse to correct the data.
    Comment: One commenter requested CMS provide a standardized process 
for third party intermediaries to disclose of issues prior to and after 
data submission.
    Response: While we appreciate the commenter's request for a 
standardized process for third party intermediaries to disclose data 
issues, we believe some flexibility is needed to accommodate the range 
of scenarios that arise. We will issue guidance on how QCDRs and 
qualified registries should operationalize the required reporting on 
the results of each data validation audit and targeted audit in which 
identified data issues that have arisen prior to submission and have 
been corrected should be described. To disclose data issues identified 
in other contexts, a third party intermediary should submit a ticket to 
the Quality Payment Program Service Center by phone: 1-866-288-8292 
(TRS: 711) from Monday-Friday, 8 a.m.-8 p.m. eastern standard time, or 
may contact the QPP Service Center by email: [email protected].
    QCDRs must disclose of data issues as a part of their data 
validation execution report. Furthermore, QCDRs are required to conduct 
this validation prior to submitting the data to CMS, so that

[[Page 84933]]

data issues may be identified and corrected. As a reminder, all QCDRs 
must follow the data validation audit and targeted audit requirements 
at Sec.  414.1400(b)(2)(iv) and (v).
    Comment: Several commenters believe that CMS should not require 
collection of more protected health information (PHI) than is necessary 
to achieve its purpose due to their concern that the codification of 
multiple auditing requirements related to clinical documentation and 
patient information could jeopardize their business models and trust 
with clinicians. The commenters also expressed their belief that CMS 
should narrowly define what should be collected via an audit, with such 
criteria preserving the confidentiality of patient information and not 
subjecting QCDRs to additional risks that they would not otherwise 
assume. One commenter believes that many QCDRs do not receive PHI from 
their participants; rather, the participants submit PHI to vendors 
engaged by the registry and vendors subsequently submit de-identified 
data to the QCDR for MIPS reporting.
    Response: We do not believe that the requirement proposed at Sec.  
414.1400(b)(2)(iv)(D) would improperly increase risk to the 
confidentiality of patient information. Collection standards 
established for QCDRs are consistent with program audit requirements 
already established and there is no indication that this creates 
additional risks. CMS respects patient privacy and will not use or 
disclose PHI except as permitted by applicable privacy and security 
laws, including, but not limited to, the HIPAA Privacy Rule. Third 
party intermediaries are generally required to have HIPAA compliant 
business associate agreements with any HIPAA covered entities for which 
they create, receive, maintain, or transmit PHI. This should help 
mitigate concerns regarding receiving or viewing provider's patient's 
PHI during an audit.
    Comment: A few commenters believe that the requirement to audit a 3 
percent sample, and, if an error is found, the requirement to audit an 
additional 3 percent sample that excludes any TINs/NPIs from the 
original sample to ensure the error is corrected creates undue burden 
and the sample size of NPIs and TINs and number of patients per measure 
required for an audit should be reduced. One commenter believes that 
since the nature of an error can vary widely and not all types of 
errors require such an intensive and resource-heavy re-sampling in 
order to ensure that data is error free, QCDRs should be allowed to 
determine the most effective and efficient manner through which they 
can determine the scope and root cause of any errors found in the data 
validation audit. Another commenter believes that either the random 
sample/percentage of overall users methodology or the proposal to 
require data validation for each submitter type be included in the data 
validation and audit requirements, but not both.
    Response: While we understand the level of effort associated with 
data validation, we disagree that this causes undue burden. We believe 
that it is critically important that all data submitted is true, 
accurate and complete and 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 (Sec.  
414.1400(a)(5)). To help ensure that the data is true, accurate and 
complete we believe it is important to have data validation and as 
appropriate audits. Ensuring data integrity and accuracy is critical 
for the QPP feedback, payments and public display of the data. The 
sampling requirements reflect our effort to minimize the burden while 
ensuring a meaningful assessment of the data. We believe it is 
appropriate for the sampling requirements for the targeted audit to 
include data from the sample used for the data validation audit in 
order to determine the scope of the impact of the data errors on those 
that are choosing to use the QCDR to report. Despite the commenter's 
suggestion that the size of the targeted audit sample be left to the 
discretion of the QCDR based on the nature of the error identified in 
data validation, we do not believe the sample size for the targeted 
audit should be different from the sample size for the data validation 
audit. Furthermore, we do not believe it should be at the QCDR's 
discretion which performance categories of the data submission should 
be audited. If a clinician is selected for auditing through the 
sampling methodology, they should be audited in a manner that is 
objective and considerate to all performance categories in which they 
have submitted data. As described in the CY 2021 PFS proposed rule (85 
FR 50325), the aforementioned sampling methodology has been used for 
many years under the legacy program, and in the first few years of the 
MIPS program. We do not believe a smaller sample size for the targeted 
audit would provide us with an understanding of the impact of the 
error. In addition, we disagree with the commenter who suggested that 
the samples used for data validation and targeting audits should not 
include both a minimum number of users and users of each submitter 
type. We believe that the samples should account for both of volume and 
user type in order to promote data accuracy across both these factors. 
We note, however, that the sample size requirements do include 
flexibility to reduce burden, including for example establishing that 
the sample size for each data validation and targeted audit does not 
need to include more than 50 TIN/NPIs. Therefore, we believe these 
sampling thresholds strike the right balance of being reliable for both 
large and small QCDRs and do not impose an undue burden on QCDRs.
    Comment: A few commenters requested clarification regarding the 
calculation of sample sizes for the data validation audits and targeted 
data audits including: Whether ``TIN/NPI'' is referencing TIN-NPI 
combinations or is meant to be read as ``TIN or NPI''. Commenters also 
requested clarification on whether separate sample universes are 
required for the total number of NPIs and the total number of TINs that 
the QCDR submits data for; whether the sample universe can simply be 
based on 3 percent of the total number of TINs that a QCDR submits data 
for, or is the intention that the 3 percent sample size should be 
calculated based on the total number of unique TIN/NPI combinations, 
while also taking into account the minimum and maximum range 
requirements (for example, a minimum of 10 TIN/NPIs and a maximum of 50 
TIN/NPIs); and whether the sample size of 25 percent of patients 
audited must be based on the total patient population for each TIN 
selected in the 3 percent sample or is the intention that the 25 
percent of patients should be calculated based on the total number of 
unique TIN/NPI combinations, while also taking into account the minimum 
and maximum range requirements (for example, a minimum of 5 patients 
and a maximum of 50 patients). One commenter requested clarification 
and guidance on the requirement to use a 3 percent sample for targeted 
data audits separate from the original 3 percent sample used for data 
validation when an error is found.
    Response: To clarify our sample sizes for data validation, the 
sampling methodology described in our proposal and above requires the 
use of at least 3 percent of the TIN/NPIs for which the QCDR will 
submit data to CMS, unless that 3 percent sample would result in fewer 
than 10 TIN/NPIs, which would require the QCDR to use at least 10 TIN/
NPIs. The three percent sample size requirements is based on the QCDR's

[[Page 84934]]

total number of unique TIN/NPI combinations; we are not requiring two 
separate samples based on the number of TINs or NPIs separately. If the 
3 percent sample would result in more than 50 TIN/NPIs, the QCDR may 
limit their sample size to 50 TIN/NPIs. For each TIN/NPI selected as a 
part of the auditing sample, the QCDR must audit 25 percent of the 
patients, with a minimum of 5 patients and a maximum of 50 patients. 
For example, if under a unique TIN/NPI combination a clinician has 1000 
patients for a particular measure, the QCDR will only need to audit a 
maximum of 50 charts for this TIN/NPI for this measure. If they only 
have 10 patients for the given measure, the QCDR would need to review 
the minimum of 5 charts. In the case of 100 patients reported for a 
specific measure, the QCDR would need to review 25 charts.
    To address what we mean by unique TIN/NPI combinations, unique 
combinations are how we refer the combination of identifiers used when 
a specific clinician (that is, NPI) is in a specific practice (that is, 
TIN). For example, a clinician could work under Group X for 2 days in a 
week and for Group Y for the remaining days in the week, this would 
likely result in 2 different unique TIN/NPI combinations, due to the 
NPI being unique to the clinician and the TIN being unique to the 
respective group.
    The sampling methodology must be used to derive a sample for data 
validation. If an error was identified through the data validation 
audit, it would trigger the third party intermediary to conduct a 
targeted audit. The third party intermediary must use a sample for the 
targeted audit that does not include data that was used for the data 
validation process audit in which the error was identified. The third 
party intermediary must use the sampling methodology to ensure their 
sample size meets the requirements for the targeted audit.
    Comment: One commenter stated that the proposals regarding data 
validation audits would be especially cumbersome and burdensome with 
regard to the data of anesthesiologists due to the nature of how the 
specialty is practiced. The commenter stated that quality measures for 
anesthesiologists may be derived from data from multiple sources and 
some practices may collect quality data on paper or practice in 
numerous locations. Several commenters expressed their concerns with 
the proposal to require auditing of the Improvement Activities and 
Promoting Interoperability performance categories and that meaningful 
validation of what constitutes compliance may vary from one group to 
another. The commenters suggested that CMS provide additional guidance, 
as well as allow flexibility to account for the difficulty in 
validating information often tracked outside of a clinician's EHR, 
varying practice conditions and constraints that may be present when 
completing an audit, and the large percent of clinicians who manually 
enter data late in the fourth quarter.
    Response: We thank commenters for their feedback. We understand 
that data to support the performance of a quality action within a 
measure may rely on multiple data sources, and the need to for 
clinicians, such as anesthesiologists, to consistently document the 
clinical action during each patient encounter, to demonstrate the 
quality action has been completed. However, we believe that data 
validation is important to ensure that the quality actions have been 
truly completed by the clinicians. In light of this, we plan to devote 
one of the upcoming support conference calls to data validation for the 
Promoting Interoperability and Improvement Activities performance 
categories. We will provide guidelines and give participants the 
opportunity to ask questions.
    While recognizing that underlying data submission for performance 
categories may differ among the clinicians and groups for whom the 
QCDRs and qualified registries submit data, compliance by a QCDR or 
qualified registry with its obligation to validate the data should not 
vary significantly from one group to another. As it relates to the 
validation of information potentially tracked outside of a clinician's 
EHR, practice conditions, or systemic constraints due to manual data 
entry, we believe the required parameters for data validation and 
targeted audits allow sufficient flexibility to account for this data 
variation.
    Comment: One commenter expressed concern regarding the validation 
of electronic measures citing its belief that the process for 
calculating and auditing these measures is different from manually 
abstracted measures because electronic measures do not consider 
clinician notes, audio, images, videos, and other non-computable 
aspects of the chart in their calculation and therefore, could fail an 
audit if the chart review included areas of the chart not included in 
the eCQM specification. The commenter also requested additional clarity 
regarding the term ``chart review.'' The commenter stated that chart 
review should be defined as a review of the chart data which applies to 
the measure specification and is available in the manner necessary for 
the measure calculation process (electronic or human abstraction). The 
commenter also cited examples of errors (such as a clinician 
incorrectly documenting a case by entering conflicting information in 
the clinical note from the discrete, electronic data fields which make 
up the measure specification, or the EHR storing data in an 
incomprehensible manner) as areas of a chart that the commenter stated 
should not be considered in the chart review.
    Response: We agree that the measure specification and associated 
data source are useful guides for implementing audits that meet the 
data validation requirements. The QCDR must use clinical documentation 
(provided by the clinicians they are submitting data for) to validate 
that the action or outcome measured actually occurred or was performed. 
The eCQM specifications define the data elements in the measure logic 
and ``calculations that deviate the formulas included in the quality 
measure specifications undercut efforts to ensure data are consistent, 
reliable, and have been calculated in a uniform manner.'' We remind the 
commenter that QCDRs and qualified registries must perform a data 
validation audit to identify data errors prior to data submission to 
CMS, such as conflicting documentation within the medical chart. QCDRs 
and qualified registries must correct any deficiencies or data errors 
identified through targeted audits prior to the submission of data for 
that MIPS payment year. In addition, we would like to remind the 
commenter that third party intermediaries must certify that all data 
submitted to CMS by the third party intermediary is true, accurate, and 
complete to the best of their knowledge. This certification applies to 
all data the third party intermediary submits to CMS on behalf of a 
MIPS eligible clinician, group or virtual group, and does not exclude 
data exports directly from an EHR or other data sources. You may refer 
to the 2021 QCDR and Qualified Registry self-nomination fact sheets for 
additional information. These resources are available at https://qpp.cms.gov/about/resource-library.
    Comment: One commenter noted that the auditing of Improvement 
Activities has been and will continue to be a source of validation 
difficulty during auditing. The commenter also noted because 
improvement activities are not necessarily tracked within the EHR and 
that these items often consist of narrative information recorded and 
tracked elsewhere by the provider, they

[[Page 84935]]

should not be considered an auditable item for the third party 
intermediary. One commenter requested that if these requirements are 
finalized in the future, CMS provide discrete data points for 
improvement activities that do not require collection of data points.
    Response: We disagree that data regarding improvement activities 
should be excluded from the data validation and audit requirements for 
QCDRs and qualified registries. We appreciate the commenter's concern 
that some current clinicians and groups may have current practices for 
documenting and tracking improvement activities that may make 
validating this information more challenging. However, we do not 
believe these operational concerns should result in improvement 
activities being excluded from data validation and targeted audit 
requirements. Within the data validation and targeted audit 
requirements, QCDRs and qualified registries must submit to CMS the 
results of each data validation audit and targeted audit, including, 
among other information, how and when each deficiency or data error 
type was corrected. In addition, QCDRs and qualified registries must 
correct any deficiencies or data errors identified through targeted 
audits prior to the submission of data for that MIPS payment year. 
Regarding discrete data points for improvement activities, we interpret 
the commenter to be requesting future guidance on how to validate 
improvement activities if the activity does not require collection of 
data. However, we clarify that completion of each improvement activity 
involves some form of underlying documentation, for example, in order 
to complete the CDC training for IA_PSPA_23--Completion of CDC Training 
on Antibiotic Stewardship the module requires the MIPS eligible 
clinician to receive a certificate of completion and per the MIPS Data 
Validation Criteria document would be required to maintain this 
certificate for a period of up to 6 years in the event of a CMS audit. 
Therefore, we believe it is reasonable to require data validation for 
improvement activities.
    Comment: A few commenters stated that while a QCDR can support 
eligibility verification, CMS should support this process by creating 
scalable and secure access to this information by either pulling data 
for QCDRs or having an application programming interface that 
communicates such information. One commenter also requested that CMS 
include language in the final rule emphasizing that eligibility 
verification is ultimately the clinician's responsibility, and not the 
QCDR's.
    Response: As the submitter of data on behalf of the clinicians, we 
believe QCDR should check on clinician eligibility so that the 
clinician can make an informed decision regarding participation.
    While we understand the commenters' recommendation may relieve some 
burden on the QCDRs from verifying eligibility, it is not operationally 
feasible to depend on CMS to conduct this verification on behalf of the 
QCDRs. QCDRs should verify and track the eligibility of the clinicians 
and groups they intend to support for purposes of MIPS reporting. This 
becomes particularly important for tracking purposes, in case issues 
arise with regard to final scores and payment adjustments, as it is 
necessary for the QCDR to delineate MIPS eligible clinicians from 
voluntary participants and opt-ins.
    We provide the public, including QCDRs participating in the Quality 
Payment Program, with an Application Programming Interface (API) that 
can assist with determining eligibility for clinicians and groups which 
can be found at https://cmsgov.github.io/qpp-eligibility-docs/. 
Information can be obtained primarily by the Clinician type, by 
searching by NPI. The information contained in these endpoints includes 
basic enrollment information, associated organizations, information 
about those organizations, individual and group special status 
information.
    Comment: One commenter stated that verifying the accuracy of TINs 
and NPIs is burdensome for some QCDRs and requested that CMS provide 
clarification regarding this verification as well as allow flexibility 
in how such data are verified.
    Response: We continue to receive data that cannot be attributed to 
a specific clinician due to an inaccurate TIN, NPI, or TIN/NPI 
combination. While we understand there is a level of effort on the part 
of the QCDR that is required to verify the accuracy of TINs and NPIs, 
we believe this is an important requirement for QCDRs to track. We have 
provided suggested methods in the CY 2017 Quality Payment Program final 
rule of verifying the accuracy of TINs and NPIs (81 FR 77366), but we 
have not required QCDRs to use this approach. Any alternative process 
used by the QCDR should be reliable, valid, and capable of being 
repeated in a manner that is consistent for all verification attempts.
    Comment: One commenter requested confirmation as to how random 
human errors should be treated under the targeted data audit 
requirement when identified during the randomized audit process. 
Specifically, the commenter requested clarification on whether a 
targeted audit needs to be conducted on a separate sample universe (for 
example, on a sample that does not include any data from the sample 
used for the data validation audit in which the error was identified) 
if, for example, the only errors identified during the randomized audit 
were attributed to random human error, such as a human medical coding 
error. The commenter also requested for clarification on whether it is 
sufficient to document that a detailed review was conducted as part of 
the randomized audit process to identify the root cause of the error 
(for example, that the root cause was, in fact, attributable to random 
human error) and to establish and implement a plan for correcting any 
such random human errors that were identified.
    Response: We reiterate for QCDRs all policies regarding data 
validation audit and targeted audit requirements at Sec.  
414.1400(b)(2)(iv) and (v) must be followed. All errors, regardless of 
whether they are human-based or systems-based must be identified as a 
part of the data validation efforts. If an error is identified through 
data validation, regardless of whether the error is human-based or 
systems-based, that would then trigger the QCDR to conduct a targeted 
audit utilizing a sample that is unique to the sample that was used for 
the data validation audit. It is not sufficient to document a detailed 
review or root cause analysis that was done as a part of the data 
validation audit (previously referred to as the randomized audit). We 
believe that QCDRs should utilize a structured data validation 
methodology, inclusive or a targeted audit in instances where the data 
validation audit results in the discovery of errors. An audit process 
provides a level of structure that will lead to consistency in the type 
of findings discovered. Furthermore, we are concerned with allowing 
QCDRs discretion to conduct their root cause analysis using an 
undefined variety of methods may lead to arbitrary and incomplete 
findings. The QCDR must separately conduct the targeted audit in 
accordance with regulatory requirements in each instance in which data 
validation audit identifies one or more deficiency or data error. An 
alternative approach to the targeted audit will not be accepted. We 
will maintain our structured validation process, in which the results 
of the audit are shared in a manner that is standardized across all 
participating QCDRs and qualified registries.

[[Page 84936]]

    Comment: A few commenters stated that this requirement of data 
validation audits would create additional burden and operational 
challenges because QCDRs have no official role, delegated authority, or 
guidance from CMS as a CMS auditor. Commenters also stated that if a 
practice disagrees with the decision of a QCDR audit, there is no clear 
path as to how a QCDR could respond and be supported in their decision 
by CMS. One commenter also stated that CMS should allow Improvement 
Activities submissions that QCDRs receive be sent to CMS's QPP service 
center so that the service center can provide guidance to QCDRs on 
whether each submission can be accepted/approved.
    Response: While we understand data validation requires a level of 
effort by the QCDR, we want to note the importance of QCDRs validating 
the data they intend to submit to us for purposes of the MIPS program. 
It is our expectation that QCDRs will ensure that the data submitted is 
true, accurate, and complete. To be clear, QCDRs are not designated to 
be auditors on behalf of CMS. QCDRs are required to conduct validation 
to promote the accuracy of their own submissions. We encourage the QCDR 
to keep documentation of instances in which a clinician does not 
provide the data requested for validation, and suggest that the QCDR 
consider annotating the report with the results of their data 
validation audits to outline instances where clinicians refuse to 
cooperate. The inclusion of information of these occurrences will help 
bring such issues to our attention, and may lead to the non-compliant 
clinician's selection for auditing as described in Sec.  414.1390. 
While QCDRs are required to conduct data validation regardless of the 
clinician type and performance category; we clarify that clinicians who 
fail to submit accurate data to us, regardless of whether they use a 
third party intermediary or submits their data directly to us, will 
also be held responsible. We disagree that the QPP Service Center 
should be involved in determining data for an improvement activity are 
valid. QCDRs are expected to utilize the existing improvement activity 
guidance that may be found in the resource library at www.qpp.cms.gov 
to validate that the clinician or group has successfully completed the 
activity before it is attested to.
    Comment: Many commenters disagreed with the proposal to require 
data validation specific to performance category, submission mechanism, 
and submitter type. Commenters believe the proposal is duplicative of 
internal quality data controls and external audits already conducted; 
and data validation for clients who are manually entering data may be 
difficult to audit, as many clinicians and practices do not complete 
data entry until late in the fourth quarter of the performance period.
    Response: We disagree with the commenters objecting to the scope of 
data validation. As described in the CY 2021 PFS proposed rule (85 FR 
50324), the data validation requirements including validation specific 
to performance category, submission mechanism, and submitter type align 
with current practices currently utilized by QCDRs that have been in 
place since the 2017 performance period of the MIPS program, and 
therefore, pose no additional burden. We acknowledge that QCDRs in 
previous years of the MIPS program have performed data validation 
audits utilizing internal resources or hiring external contractors and 
have been able to share the results of their data validation with CMS. 
By establishing these data validation requirements in regulation, it is 
our intent to ensure minimum validation efforts are robust and consist 
across all QCDRs. We understand that some clinicians and practices may 
not complete data entry until late in the fourth quarter of the 
performance period, but we disagree that should be a deterring reason 
as to why QCDRs could not validate data. We encourage QCDRs to advise 
their participants to submit data throughout the year. By receiving 
data earlier in the year, not only will the QCDR be able to validate 
their data earlier, but they will be able to provide more timely 
performance feedback to their clinicians and groups in accordance with 
Sec.  414.1400(b)(2)(ii), which would allow the clinician to take 
action on the data and improve the quality of care their patients 
receive--which is one of the main goals of the program.
    Comment: One commenter disagreed with the proposal to apply this 
requirement to voluntary submitters since they would be required to 
agree to the audit requirements and their incentive to participate may 
be hampered by the additional work associated with the audit.
    Response: We appreciate the commenter's concern that data 
validation may be a disincentive to some voluntary submitters; however, 
we believe this concern is outweighed by the need to promote the 
accuracy of the data we receive. We want to note that all data 
submitted may be subjected to display on Physician Compare internet 
website of CMS (or a successor website), and that data would be 
subjected to the requirements at Sec.  414.1395. Accordingly, all data 
submitted to us will face the data validation audit and targeted audit 
requirements at Sec.  414.1400(b)(2)(iv) and (v).
    Comment: Another commenter suggested CMS may consider having QCDRs 
prepared to provide such documentation upon request, as it does for 
other audits in order to minimize burden on behalf of the vendors, 
practices they contract with, and CMS, while upholding the integrity of 
these audits. One commenter stated that the requirement to use clinical 
documentation may not be feasible for all QCDRs to complete. The 
commenter stated the QCDR may not have access to the medical record 
because they do not always have business associate agreements (BAAs) 
set up that allow for data access, and that without this access to the 
medical charts, the data validation and audit will be unable to occur.
    Response: As described at Sec.  414.1400(g)(2), all third party 
intermediaries must retain all data submitted to CMS for purposes of 
MIPS for 6 years from the end of the MIPS performance period. However, 
these documentation retention requirements are distinct from the data 
validation requirements. To be clear, QCDRs should have access to 
clinician documentation in order to complete the data validation 
requirements, and the access should be readily provided by clinicians 
who are selected through the sampling methodology. It is not sufficient 
to merely have this documentation available upon CMS request in meeting 
these data validation and targeted audit requirements since the 
validation and auditing must be completed prior to data submission.
    Comment: One commenter requested that CMS provide a template and/or 
guideline for the data validation process and report.
    Response: On an annual basis, we have provided QCDRs with data 
validation execution report templates, so they could share information 
about their data validation process and results with CMS. We refer 
readers to the Quality Payment Program resource library website at 
https://qpp.cms.gov/about/resource-library where we have published 
these in the past. At Sec.  414.1400(b)(2)(iv) and (v) we are 
finalizing regulatory requirements for annual reports to regarding data 
validation and targeting audits for the 2023 MIPS payment year and 
beyond. We intend to publish updated report templates in the QPP 
Resource Library: https://qpp.cms.gov/about/resource-library.

[[Page 84937]]

    Comment: One commenter requested that CMS publish minimum data 
accuracy requirements due to its belief that performance data is never 
100 percent accurate and since QCDRs do all that is within their power 
to ensure data accuracy, they should not incur fines or other 
disciplinary action for data accuracy issues outside their control.
    Response: Ensuring data is correct and suppressing inaccurate data 
is the responsibility of the QCDR. Accurate data is critical to 
calculate any payment differentials for clinicians in addition to 
displaying performance results on one of our compare websites. It is 
anticipated that the accuracy of data should improve over time and thus 
setting a specific reliability threshold does not allow the flexibility 
needed to preclude poorly performing vendors.
    Comment: A few commenters noted that in order to facilitate data 
validation, CMS should provide a mechanism to identify and verify the 
clinicians that are associated with a group by TIN and NPI. The 
commenters believed that QCDRs could more successfully serve clinicians 
if this information was readily available within the QPP Portal early 
in the performance year rather than requiring QCDRs to access the CMS 
Developer or Submissions API, which is not available until the third or 
fourth quarter of a reporting year.
    Response: For the provider eligibility, CMS provides the public, 
including QCDRs participating in the Quality Payment Program, with API 
that can assist with determining eligibility for clinicians and groups 
which can be found at https://cmsgov.github.io/qpp-eligibility-docs/. 
Information can be obtained primarily by the Clinician type. You can 
query the Clinician type by passing in an National Provider Identifier, 
or NPI. The information contained in these endpoints includes basic 
enrollment information, associated organizations, information about 
those organizations, individual and group special status information. 
QCDRs do have access to the public API. The API is updated when our 
eligibility data is updated for the public. Therefore, QCDRs have the 
availability to pull the data at the same time as clinicians to go into 
the QPP look up tool to check their eligibility. The final eligibility 
runs are not complete until the second eligibility determination period 
concludes, which falls on the close of the Fiscal Year. We do not allow 
TIN lookup, as this information is viewed as PII, but all data can be 
viewed by group name or NPI. In addition, we do offer third party 
intermediaries, excluding the CAHPS for MIPS vendors, the ability to 
utilize OAUTH integration to allow for more robust set of access and 
integration. Please refer to sections VII. and VIII. of this final rule 
where this process is discussed in greater detail.
    After consideration of public comments, we are finalizing the 
proposed data validation requirements and targeted audit requirements 
at Sec.  414.1400(b)(2)(iv) and (v) as proposed.
(b) QCDR Measures
    We refer readers to Sec.  414.1400(b), the CY 2017 Quality Payment 
Program final rule (81 FR 77374 through 77375), the CY 2018 Quality 
Payment Program final rule (82 FR 53813 through 53814), the CY 2019 PFS 
final rule (83 FR 59900 through 59906), the CY 2020 PFS final rule (84 
FR 63058 through 63074), and the May 8th COVID-19 IFC (85 FR 27594 
through 27595) for where we previously finalized standards and criteria 
for QCDR measures. In the CY 2021 PFS proposed rule (85 FR 50326), we 
proposed modifications to previously finalized QCDR measure 
requirements. While we understand the level of time and work needed to 
meet these requirements, we would not be grandfathering in previously 
approved QCDR measures.
(i) QCDR Measure Considerations and Requirements for Approval or 
Rejection
    We refer readers to Sec.  414.1400(b)(3), the CY 2020 PFS final 
rule (84 FR 63059 through 63073) for our previously finalized policies 
related to the QCDR measure considerations and requirements for 
approval or rejection. Through education and outreach, we have heard 
stakeholders' concerns about the complexity of reporting when there is 
a large inventory of QCDR measures to choose from, and we noted that we 
believe the proposals would help to refocus measures to those most 
meaningful to a clinician's scope of practice.
    In the 2021 PFS proposed rule, we proposed to modify a few QCDR 
measure requirements: Measures in MVPs; measure testing; duplicative 
QCDR measures; and collection of data as discussed below.
(A) QCDR Measures in MVPs
    We refer readers to section IV.A.3.a. of this final rule, where we 
discuss QCDR measures in MVPs. While we acknowledged the level of 
innovation that QCDRs have put forward as they have developed and 
implemented QCDR measures, we noted the differences between the QCDR 
measures utilized in the existing MIPS reporting method versus that of 
MVP reporting. In the current MIPS program, clinicians and groups may 
select to report on measures from a large library of what is available 
through the MIPS quality measure inventory and that of the QCDR 
measures available, if they choose to report through a QCDR. In our 
gradual transition to MVPs, we move to subsets of measures and 
activities, where clinicians may have a more focused selection of items 
to report on.
    For that reason, it is important that the measures included in an 
MVP are reliable, feasible, and valid as to not inadvertently cause a 
clinician or group an issue with submission, calculation, and scoring 
of a given measure. We refer readers to our discussion below about 
measure testing requirements for QCDR measures in MVPs.
(B) Measure Testing Requirements
    In the CMS Blueprint,\142\ measure testing enables a measure 
developer to assess the suitability of the quality measure's technical 
specifications and acquire empirical evidence to help assess the 
strengths and weaknesses of a measure with respect to the NQF Measure 
Evaluation Criteria and Guidance for Evaluating Measures for 
Endorsement. Information gathered through measure testing is part of 
full measure development, and this information can be used in 
conjunction with expert judgment to evaluate a measure. For Blueprint 
purposes, measure testing refers to testing quality measures, including 
the components of the quality measures, such as the data elements, the 
instruments, and the performance score.
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    We refer readers to the CY 2019 PFS final rule, where we gave 
notice to the public that we were considering proposing to require 
reliability and feasibility testing as an added criterion for a QCDR 
measure to be considered for MIPS in future rulemaking (83 FR 59901 
through 59902). After consideration of the previous public comments 
received, and our priority to ensure that all measures available in 
MIPS are reliable and valid thereby reducing reporting burden on 
eligible clinicians and groups, we finalized a requirement to require 
all QCDR measures to be fully developed and tested, with complete 
testing results at the clinician level, beginning with the CY 2023 
payment year in the CY 2020 PFS final rule (84 FR 40816).
(aa) Measure Testing Requirements in IFC
    In response to the PHE, we issued changes in the May 8th COVID-19 
IFC

[[Page 84938]]

(85 FR 27594 through 27595). We had heard from third party 
intermediaries, specifically QCDRs, that due to the COVID-19 pandemic 
they anticipated being unable to complete QCDR measure testing or 
collect data on QCDR measures for the 2021 MIPS performance period as 
specified at Sec.  414.1400(b)(3)(v)(C) and (D). Both QCDR measure 
approval criteria necessitate QCDRs collecting data from clinicians in 
order to assess the measure. Over 50 percent of the QCDRs approved for 
the 2020 performance period are supported by specialty societies that 
represent and support clinicians on the front lines of the COVID-19 
pandemic, or are hospitals that are directly impacted by the pandemic. 
We also anticipated that there will be a lack of available data for 
some QCDR measures because clinicians who work in specialties that are 
not primarily caring for COVID-19 patients may have their cases or 
elective procedures canceled or delayed so that resources can be 
redistributed. As a result, we anticipated that QCDRs may be unable to 
collect, and clinicians unable to submit, data on QCDR measures due to 
prioritizing the care of COVID-19 patients.
    We believed that clinicians who are on the frontlines taking care 
of COVID-19 cases should not be burdened with having to submit data to 
a QCDR for purposes of QCDR measure assessment (testing and data 
collection). In consideration of clinicians' limited resources and in 
an effort to reduce burden on clinicians and health care organizations 
that are responding to the COVID-19 pandemic, we are amending the QCDR 
measure approval criteria previously finalized in the CY 2020 PFS final 
rule (84 FR 63065 through 63068), specifically the completion of QCDR 
measure testing at Sec.  414.1400(b)(3)(v)(C) as discussed in section 
II.R.1. of the May 8th COVID-19 IFC (85 FR 27594 through 27595).
    In the CY 2020 PFS final rule (84 FR 63065 through 63067), we 
finalized at Sec.  414.1400(b)(3)(v)(C) that beginning with the 2021 
performance period, all QCDR measures must be fully developed and 
tested, with complete testing results at the clinician level, prior to 
submitting the QCDR measure at the time of self-nomination. For the 
reasons discussed in May 8th COVID-19 IFC (85 FR 27594 through 27595), 
we delayed the implementation of this policy by 1 year. Specifically, 
we amended Sec.  414.1400(b)(3)(v)(C) to state that beginning with the 
2022 performance period, all QCDR measures must be fully developed and 
tested, with complete testing results at the clinician level, prior to 
submitting the QCDR measure at the time of self-nomination.
    During this 1 year delay, we will continue to review QDCR measures 
as in past years to ensure they are valid, reliable, and align with the 
goals of the Meaningful Measure initiative. This process includes 
review by quality measure experts; QCDR policy subject matter experts; 
clinicians, including physicians, nurses, and PTs/OTs, who work on our 
support contractor team; and CMS Medical Officers. We will continue to 
review QCDR measures for potential risk of patient harm (for example, 
QCDR measures that promote clinical practices related to overuse). We 
also will continue to review QCDR measures for feasibility and accuracy 
and reliability of results. For more information, we refer readers to 
the 2020 QCDR Measure Development Handbook.
    The following is a summary of the comments we received and our 
responses.
    Comment: A few commenters supported the proposed delay of QCDR 
measure data collection requirements such that developers will have 
until the 2022 performance period to collect complete testing results 
at the clinician level prior to submitting new measures for 
consideration.
    Response: We thank commenters for their support.
    Comment: One commenter recommended that CMS gradually implement the 
requirements and continue to monitor the impact COVID-19 may have on 
QCDR testing. The commenter expressed concern that it can take a 
developer months to execute a QCDR testing contract with a testing 
vendor and that the current number of vendors available will not be 
able to meet the increased demand. The commenter recommended that CMS 
allow a grace period for the new requirements for existing measures, 
with an initial focus on testing measures reported by the majority of 
QCDR participants. For new or modified measures, the commenter 
recommended that CMS provide provisional approval and require testing 
in a future year when more data is available for testing.
    Response: We refer readers to the CY 2018 Quality Payment Program 
proposed rule (82 FR 30160) where we described our goal and sought 
comment on having fully tested QCDR measures within the MIPS program. 
Furthermore in the CY 2019 PFS final rule, we gave notice to the public 
that we were considering proposing to require reliability and 
feasibility testing as an added criteria in order for a QCDR measure to 
be considered for MIPS in future rulemaking (83 FR 59901 through 
59902). Furthermore, as we have signaled through previous rulemaking 
cycles (83 FR 59901 through 59902), we have intended to raise the bar 
for QCDR measures that are available for reporting within the MIPS 
program.
    After consideration of the public comments received in the CY 2019 
PFS final rule, and our priority to ensure that all measures available 
in MIPS are reliable and valid thereby reducing reporting burden on 
eligible clinicians and groups, we moved forward with our proposal in 
the CY 2020 PFS proposed rule. Consequently, in the CY 2020 PFS final 
rule (84 FR 63065 through 63067), we finalized at Sec.  
414.1400(b)(3)(v)(C) that beginning with the 2021 performance period, 
all QCDR measures must be fully developed and tested, with complete 
testing results at the clinician level, prior to submitting the QCDR 
measure at the time of self-nomination. For the reasons discussed in 
May 8th COVID-19 IFC (85 FR 27594 through 27595), we delayed the 
implementation of this policy by 1 year, until the 2022 performance 
period. Even before the publication of the May 8th COVID-19 IFC, QCDRs 
should have already been preparing for this measure testing to occur as 
part of the finalized policies in the CY 2020 PFS final rule. We 
believe stakeholders have had adequate notice of this requirement in 
order to prepare. Furthermore, as described in section 
IV.A.3.g.(2)(b)(i)(B) of this final rule, we are finalizing the 
proposed updates to the QCDR measure testing requirement to implement 
the measure testing requirement in an incremental manner.
    Based off experience in past performance periods of the MIPS 
program, there have been several situations where QCDRs have flagged 
for us mid performance period that they had issues collecting data on a 
QCDR measure, had trouble implementing the QCDR measure, or had 
technical issues with the measure specifications. These issues, 
identified mid performance period have led to QCDRs informing us that 
they could no longer successfully support the reporting of the impacted 
QCDR measure. Such issues have had downstream impacts on clinicians who 
have to scramble at the last minute to quickly find an alternative 
measure to report to satisfy the quality reporting requirements of the 
MIPS program. It is evident that such issues demonstrated that these 
measures lacked reliability, validity, and feasibility and should not 
have been utilized in the program. Therefore, we believe it is critical 
to implement measure-testing standards

[[Page 84939]]

that will ensure that the QCDR measures in the MIPS program are 
reliable, valid, and feasible. This requirement will avoid the 
inadvertent burden to clinicians, particularly small practices and 
rural practices, that is associated with issues that occur with QCDR 
measure during the performance period. We understand that it is 
difficult to determine how the PHE for COVID-19 will impact QCDRs, but 
believe it is imperative that QCDR measures that are available in the 
program are reliable because of the associated scoring calculations 
that are connected to payment adjustments in the MIPS program. 
Furthermore, as described in the CY 2020 PFS final rule (84 FR 63066), 
while we understand the increased time and cost burdens associated with 
measure testing, we believe the benefits of completed measure testing 
far outweigh the burdens of it. We want all measures available in the 
MIPS program to be reliable, feasible, valid, and implementable within 
the program. We want to avoid scenarios that would arise by allowing 
measures that do not meet these standards, which then may lead to 
issues with the measure mid performance period. We do not believe it is 
appropriate to have untested measures within the MIPS program since 
clinician's performance on measures have impacts on their payments. We 
acknowledge that not all QCDR measures currently approved would 
continue in the program due to business decisions by each QCDR.
    After consideration of public comments, in this final rule we are 
finalizing the delay of this policy by 1 year, such that Sec.  
414.1400(b)(3)(v)(C) states that beginning with the 2022 performance 
period, all QCDR measures must be fully developed and tested, with 
complete testing results at the clinician level, prior to submitting 
the QCDR measure at the time of self-nomination. To clarify, this 
policy is effective from May 8, 2020 through the end of the MIPS 2022 
performance period since we are finalizing further changes to this 
policy below as described in section A.3.g.(2)(b)(i)(B) of this final 
rule, where we discuss the finalization of the proposed updates to the 
QCDR measure testing requirement to implement the measure testing 
requirement in an incremental manner beginning with the 2022 
performance period.
(bb) Overview
    With this delay in mind and based on stakeholder feedback on the 
level of burden, the limited amount of time, and costs associated with 
measure testing after the CY 2020 PFS final rule published, in the 2021 
PFS proposed rule, we proposed to both further modify our QCDR measure 
testing policy generally and add testing policies for QCDR measures 
that are being considered for inclusion in MVPs. In that rule, we noted 
that we continue to believe that reliable, valid measures with robust 
testing with empirical data should be used in quality evaluation and 
payment programs. However, we discussed that we want to balance those 
interests with stakeholders' concerns. Therefore, we proposed a gradual 
approach to have fully tested QCDR measures within the MIPS program. We 
emphasized that we still believe that all QCDR measures should be fully 
tested, particularly as we rely on the data from these measures to 
score clinicians which impact their final score and associated MIPS 
payment adjustments, and as we seek to utilize QCDR measures in MVPs, 
as summarized in section IV.A.3.a of this final rule. In the 2021 PFS 
proposed rule, we proposed at Sec.  414.1400(b)(3)(v)(C)(1) that, 
generally, to be approved for the 2024 MIPS payment year, a QCDR 
measure must be face valid. To be approved for the 2025 MIPS payment 
year and future years, a QCDR measure must be face valid for the 
initial MIPS payment year for which it is approved and fully tested for 
any subsequent MIPS payment year for which it is approved. Therefore, 
we proposed to revise Sec.  414.1400(b)(3)(v)(C) to account for an 
incremental approach to require fully tested QCDR measures. We 
discussed requirements for QCDR measures considered for inclusion in an 
MVP separately. These policies are discussed in more detail further 
below.
(cc) Requirements for Existing QCDR Measures
    In the 2021 PFS proposed rule, we proposed that QCDR measures that 
were previously approved for the CY 2022 MIPS payment year, would be 
required to, at a minimum, be face valid prior to being self-nominated 
for the CY 2024 MIPS payment year. Face validity is defined in the CMS 
Measures Blueprint \143\ as the following: The extent to which a test 
appears to cover the concept it purports to measure ``at face value.'' 
It is a subjective assessment by experts of whether the measure 
reflects the quality of care (for example, the utilization of a current 
clinical guideline to frame the measure, such as using the blood 
pressure guideline of < 140/90 is a marker of quality).
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    In addition, we proposed that these measures, which were approved 
for the preceding MIPS performance year with face validity (that is, CY 
2024 MIPS payment year), would be required to be fully tested prior to 
being self-nominated for any subsequent performance periods (that is, 
CY 2025 MIPS payment year and beyond) in order to be considered for 
inclusion in the MIPS program.
    In the CY 2019 PFS final rule, we referred readers to the CMS 
Blueprint for the CMS Measures Management System (available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Blueprint.pdf) for a definition of ``fully 
developed with completed testing results at the clinician level'' (84 
FR 40817). Our Blueprint discusses both alpha and beta testing 
(Blueprint 15.0 September 2019 Page 207-208). To avoid any potential 
confusion, we clarified in the CY 2021 PFS proposed rule that for 
purposes of QCDR measures, we would expect QCDR measures to complete 
beta testing to be considered fully tested. Beta testing is defined in 
the CMS Measures Blueprint \144\ as the following: Beta testing (that 
is, field testing) generally occurs after initial technical 
specifications have been developed and is usually larger in scope than 
alpha testing. In addition to gathering further information about 
feasibility, beta tests serve as the primary means to assess scientific 
acceptability and usability of a measure. For example, beta testing 
allows for an enhanced evaluation of a measure's importance, including 
evaluation of performance thresholds, disparities analysis, and outcome 
variation. It helps in looking for opportunities for improvement in the 
population, which aids in measuring the QCDR measure's importance for 
reasons that include evidence collection to measure variability among 
comparison groups, to demonstrate the measure is not topped-out where 
most groups achieve similarly high performance levels approaching the 
measure's maximum possible value. We referred readers to the CMS 
Blueprint for the CMS Measures Management System at https://
www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-
Instruments/MMS/Downloads/

[[Page 84940]]

Blueprint.pdf for additional details regarding beta testing.
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    The following is a summary of the comments we received and our 
responses.
    Comment: Several commenters agreed with the proposal to delay the 
requirement for QCDR measures to be fully tested by 1 year and only 
require face validity for the 2021 performance period.
    Response: We thank commenters for their support. In the 2021 PFS 
proposed rule, we proposed that QCDR measures that were previously 
approved for the CY 2022 MIPS payment year, would be required to, at a 
minimum, be face valid prior to being self-nominated for the CY 2024 
MIPS payment year. We want to clarify for commenters that this policy 
would affect the 2022 performance year.
    Comment: A few commenters recommended that the requirement for full 
measure testing should be further delayed until at least 1 year after 
the PHE for COVID-19 ends. One commenter cited its preference for an 
approach where a potential measure is tested and peer reviewed by a 
committee for inclusion in the program.
    Response: In the May 8th COVID-19 IFC (85 FR 27594 through 27595), 
we already delayed the requirement due to the PHE, such that beginning 
with the 2022 performance period, all QCDR measures must be fully 
developed and tested, with complete testing results at the clinician 
level, prior to submitting the QCDR measure at the time of self-
nomination. However, in the 2021 PFS proposed rule, we proposed further 
changes, such that QCDR measures that were previously approved for the 
CY 2022 MIPS payment year, would be required to, at a minimum, be face 
valid prior to being self-nominated for the CY 2024 MIPS payment year. 
In addition, we proposed that these measures, which were approved for 
the preceding MIPS performance year with face validity (that is, CY 
2024 MIPS payment year), would be required to be fully tested prior to 
being self-nominated for any subsequent performance periods (that is, 
CY 2025 MIPS payment year and beyond) in order to be considered for 
inclusion in the MIPS program. Therefore, fully tested measures are not 
required until the CY 2025 payment year and subsequent years (CY 2023 
performance year). We believe this is a reasonable amount of time to 
prepare and balances the need to have fully tested, valid, and reliable 
measures in the MIPS program, which bases payment on quality metrics 
such as QCDR measures. While we do not specifically require QCDRs to 
utilize a process that involves peer review by a committee, we support 
those QCDRs that wish to do so.
    Comment: A few commenters requested additional clarification on the 
required process and evaluation criteria for QCDR measure testing. 
Commenters requested detailed requirements and specific targets to 
enable greater understanding of how testing should be completed, as 
well as clarification on how CMS will evaluate the measures to 
determine if they ``pass'' and whether full measure testing will 
undergo the same, similar, or a different rigor as the National Quality 
Forum's measure testing. Commenters also requested clarification on the 
likelihood of QCDRs having their measures accepted if they are not 
fully tested; how the level of testing affects the measure review 
process in the future; who is conducting the measure review process; 
and what format is being used. Other commenters suggested that CMS 
empanel specialty specific committees of knowledgeable clinicians to 
evaluate self-nominated quality measures and should a QCDR measure not 
be approved, CMS should provide specific information on what criteria 
were not met and enable the QCDR to correct the deficiencies in time 
for the measure reconsideration meeting. One commenter provided the 
following recommendations regarding QCDR measure testing requirements: 
When assessing face validity, CMS should allow for a clear and direct 
association with a clinical guideline to be sufficient to fulfill face 
validity for a measure, especially when the guidelines are released by 
organizations with a strong record of high-quality clinical guideline 
development; if a QCDR measure has been endorsed by the NQF and is 
submitted to CMS, the requirement to document measure testing 
information for CMS should be waived, as long as the NQF measure ID is 
provided; and once a thoroughly tested QCDR measure has been approved 
by CMS, the testing requirement should be waived for subsequent years 
unless CMS identifies a significant substantive change to the measure 
that would necessitate new testing.
    Response: As discussed in the proposed rule and above, in the CY 
2019 PFS final rule, we referred readers to the CMS Blueprint for the 
CMS Measures Management System (available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Blueprint.pdf) for a definition of ``fully developed with 
completed testing results at the clinician level'' (84 FR 40817). Our 
Blueprint discusses both alpha and beta testing (Blueprint 15.0 
September 2019 Page 207-208). To avoid any potential confusion, we 
clarified in the CY 2021 PFS proposed rule that for purposes of QCDR 
measures, we would expect QCDR measures to complete beta testing to be 
considered fully tested. Beta testing is defined in the CMS Measures 
Blueprint \145\ as the following: Beta testing (that is, field testing) 
generally occurs after initial technical specifications have been 
developed and is usually larger in scope than alpha testing. In 
addition to gathering further information about feasibility, beta tests 
serve as the primary means to assess scientific acceptability and 
usability of a measure. For example, beta testing allows for an 
enhanced evaluation of a measure's importance, including evaluation of 
performance thresholds, disparities analysis, and outcome variation. It 
helps in looking for opportunities for improvement in the population, 
which aids in measuring the QCDR measure's importance for reasons that 
include evidence collection to measure variability among comparison 
groups, to demonstrate the measure is not topped-out where most groups 
achieve similarly high performance levels approaching the measure's 
maximum possible value. We referred readers to the CMS Blueprint for 
the CMS Measures Management System at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Blueprint.pdf for additional details regarding beta testing.
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    \145\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Blueprint.pdf.
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    We understand the NQF's measure testing guidelines are described at 
http://www.qualityforum.org/Measuring_Performance/Submitting_Standards.aspx. While our QCDR measure testing policies 
provide an incremental approach to measure testing while being 
available in the program, we believe our measure testing policies are 
similar. Thus, we anticipate that many measures that have received NQF 
endorsement would also be easily approved for this program; however, we 
are not waiving measure testing requirements. We note that QCDRs must 
self-nominate their measures each year unless the QCDR measure was 
approved for a 2-year period. We refer readers to the CY 2020 PFS final 
rule (84 FR 63073) where we discuss this process in more detail.
    QCDR measures that do not meet the incremental requirements of 
measure testing over the 2-year period as described further above, will 
not be

[[Page 84941]]

approved for use in the program for not meeting requirements. If a QCDR 
measure is not fully tested by the self-nomination period, the QCDR 
should delay self-nomination of the QCDR measure until a future year 
once it has been fully tested.
    Comment: Several commenters disagreed with the requirement for QCDR 
measures to be fully tested. Commenters expressed concerns that 
validity testing beyond face validity is not feasible for most quality 
measures and due to the time and expense involved may cause some 
registries to no longer invest in measure development and potentially 
leave the program. One commenter noted that full measure testing fails 
to account for the significant investments that QCDRs already make when 
developing measures to ensure the accuracy of their measures, including 
vetting by clinical subject matter experts and reliance on clinical 
practice guidelines, the medical literature, and preliminary data. A 
few commenters encouraged CMS to consider alternatives to the measure 
testing process such as opening the measures for public comment.
    Response: We believe that measures should be reliable and valid 
with robust testing using empirical data prior to inclusion in a 
national pay-for-performance CMS program. Quality measurement should 
ensure measures are reliable, valid, and feasible, and this is 
supported by literature.\146\ We disagree that validity testing beyond 
face validity is not feasible, since the quality measures available in 
the MIPS quality measure inventory are fully tested. We understand 
there is time, effort, and resources involved with measure testing but 
we believe that this must be a requirement in order to ensure we have 
reliable, valid, and feasible measures in a pay-for-performance program 
such as MIPS. We do not believe that an alternative approach such as 
face validity or public comment alone would meet the same rigor of 
validity. Furthermore, QCDRs should be held to the same standards of 
requirements as other measure developers. QCDRs should be developing 
measures utilizing measure development standards that are universally 
accepted by measure developers, inclusive of standardized testing 
procedures. The utilization of clinical experts, reliance on clinical 
guidelines, medical literature, and preliminary data are common 
practices amongst measure developers to ensure measures are developed 
in a relevant manner. However, these criteria that are used to develop 
a measure, do not replace the need for measure testing which goes 
beyond measure development and ensures the measure is reliable, valid, 
and feasible.
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    \146\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Blueprint.pdf.
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    After consideration of public comments, we are finalizing our 
proposals as proposed.
(dd) Requirements for New QCDR Measures
    We proposed that for a new QCDR measure to be approved for the 2024 
MIPS payment year, a QCDR measure must be face valid; to be approved 
for the 2025 MIPS payment year and future years, a QCDR measure must be 
face valid for the initial MIPS payment year for which it is approved 
and fully tested for any subsequent MIPS payment year for which it is 
approved.
    For example, for the CY 2026 MIPS payment year (the 2024 
performance period), the self-nomination application period would open 
on July 1, 2023 and close on September 1, 2023. A QCDR that self-
nominates a new QCDR measure by September 1, 2023 would need to 
complete face validity measure testing prior to submission in order for 
the measure to be considered for the CY 2026 MIPS payment year. If that 
new QCDR measure is approved for the CY 2026 MIPS payment year, it 
would need to be fully tested by the next self-nomination date for the 
CY 2027 MIPS payment year (by no later than September 1, 2024 for the 
2025 performance period). QCDR measures that are not fully tested by 
the second year of the measure's life in MIPS (that is, second self-
nomination date), would not be considered for approval for the second 
year.
    We recognized that not all QCDR measures currently approved would 
continue in the program due to business decisions by each QCDR. We 
acknowledged that there is a cost involved with full testing of quality 
measures (see 84 FR 63173); however, we noted that we believe it is 
important that all measures used within the MIPS program are fully 
tested and reliable. We also noted that we believe this incremental 
approach in testing would allow QCDRs time to plan appropriately to 
complete measure testing in a timely, efficient, and effective manner. 
However, we encouraged QCDRs to submit fully-tested QCDR measures to 
the extent possible, as we have a strong preference for QCDR measures 
that are fully tested versus those that have only completed face 
validity testing.
    The following is a summary of the comments we received and our 
responses.
    Comment: A few commenters agreed with the proposal to require new 
QCDR measures to be face valid for the 2024 MIPS payment year and to be 
approved for the 2025 MIPS payment year and future years. A few 
commenters also agreed that a QCDR measure must be face valid for the 
initial MIPS payment year for which it is approved and fully tested for 
any subsequent MIPS payment year for which it is approved.
    Response: We thank the commenters for their support.
    Comment: Several commenters disagreed with the requirement that new 
QCDR measures must be fully tested by the subsequent performance period 
after initial approval due to their belief that the requirement is 
costly, burdensome, and arduous. A few commenters further stated that 
QCDR measures are created by subject matter experts; undergo 
significant expert vetting; are supported by literature, guidelines, 
and preliminary data, providing rigorous face validity for each 
measure; and QCDRs typically review performance data before and after 
implementing a measure in the registry. One commenter stated that these 
requirements may lead to the costs of measure development outweighing 
the benefit of operating QCDRs and that CMS is inherently making it 
impossible for small organizations to run QCDRs and develop new 
measures.
    Response: We disagree with the commenters. While we understand the 
level of effort, time, and finances involved with measure testing, we 
believe it is important that all measures in a national pay-for-
performance program such as MIPS are fully tested, as they are relied 
upon to make performance determinations and thereby corresponding 
payment adjustments. CMS is holding measures used in the QPP program to 
the same standards--whether they be measures generally available or 
measures solely submitted by QCDRs. We do acknowledge and appreciate 
the efforts and participation of QCDRs that are run by organizations of 
varying sizes, but believe it is important to hold all measures to the 
same standard, to ensure that we have reliable, valid, and feasible 
measures in the MIPS program for clinician use. We understand that 
measure testing requires a level of effort, resources, finances, and 
time in order to be completed. However, we believe that all measures 
should meet such rigorous standards in a pay-for-performance quality 
reporting program. QCDRs that require more time to test their measures,

[[Page 84942]]

may do so outside of the MIPS program, and can delay self-nominating a 
QCDR measure until the testing is appropriately completed.
    Comment: A few commenters requested that CMS modify the proposed 
requirement that testing data for new QCDR measures must be submitted 
by the next self-nomination period and change it to the second self-
nomination period due to its belief that many QCDRs rely on prospective 
data collection to generate the data needed for testing and therefore, 
will not have 12 months of data available and analyzed by the next 
self-nomination deadline (September 1). Another commenter stated that 
it would be impossible to explore and develop testing options and 
complete the testing process by the September 1, 2020 self-nomination 
deadline for the 2021 performance period.
    Response: We refer readers to the CY 2020 PFS final rule (84 FR 
63065 through 63067 and Sec.  414.1400(b)(3)(v)(C), where we first 
finalized a requirement to fully test measures beginning with the 2022 
performance period. Due to the PHE, we delayed this requirement in the 
May 8th COVID-19 IFC (85 FR 27594 through 27595), such that beginning 
with the 2022 performance period, all QCDR measures must be fully 
developed and tested, with complete testing results at the clinician 
level, prior to submitting the QCDR measure at the time of self-
nomination. In this final rule, we are further changing our 
requirements to finalize that for a new QCDR measure to be approved for 
the 2024 MIPS payment year, a QCDR measure must be face valid; to be 
approved for the 2025 MIPS payment year and future years, a QCDR 
measure must be face valid for the initial MIPS payment year for which 
it is approved and fully tested for any subsequent MIPS payment year 
for which it is approved. We believe stakeholders have had adequate 
advanced notice of this requirement. This incremental approach in 
testing would allow QCDRs time to plan appropriately to complete 
measure testing in a timely, efficient, and effective manner. While we 
understand the level of effort, time, and finances involved with 
measure testing, we believe it is important that all measures in a pay-
for-performance quality program such as MIPS are fully tested, as they 
are relied upon to make performance determinations and thereby 
corresponding payment adjustments.
    After consideration of public comments, we are finalizing our 
proposal as proposed.
(ee) Requirements for QCDR Measures Considered for MVP
    As an additional layer, we proposed at Sec.  
414.1400(b)(3)(v)(C)(2) that in order for a QCDR measure to be 
considered for inclusion in an MVP for the 2024 MIPS payment year and 
future years, a QCDR measure must be fully tested. We noted that we 
believe it is imperative to ensure that QCDR measures are fully tested 
before being included in an MVP. Unlike traditional MIPS, where 
clinicians and groups may choose from a large inventory of measures to 
report on for purposes of the quality performance category, the MVPs 
seek to create a focused selection of measures and activities relevant 
to a specific clinical topic. Since clinicians and groups who choose to 
report on MVPs will be reporting on a subset of measures and 
activities, there will be heavy reliance on the QCDR measures being 
reliable, valid, and feasible for reporting purposes. For a detailed 
discussion of MVPs, we refer readers to section IV.A.3.a. of this final 
rule.
    The following is a summary of the comments we received and our 
responses.
    Comment: Several commenters agreed with the proposal to require 
that QCDR measures that will be included in an MVP be fully tested.
    Response: We thank commenters for their support.
    Comment: One commenter stated that QCDR measures that are only 
undergoing testing should be considered for inclusion in MVPs and that 
Improvement Activity credit be given to practices involved in measure 
testing.
    Response: We disagree that measures in the testing phase should be 
considered for MVPs; inclusion should be limited to only those that are 
fully tested due to this being a pay-for-performance national program. 
With regards to improvement activity credit, we would encourage 
stakeholders to submit recommendations for improvement activities 
during the Call for Improvement Activities that occurs on an annual 
basis for consideration and potential inclusion in the program for 
future years.
    Comment: One commenter requested that CMS further delay full 
testing of QCDR measures and subsequently QCDR MVPs. A few commenters 
disagreed with the proposal to require QCDR measures to be fully tested 
at the clinician level prior to being considered for inclusion in an 
MVP due to the expense. The commenters also believe that it is 
inconsistent with the proposed timeline for QCDR measures under MIPS 
which requires face validity for performance year 2022 and full testing 
for performance year 2023.
    Response: We disagree with commenters. We believe that in order for 
QCDR measures to be considered reliable metrics in a pay-for-
performance program such as MIPS, the measures must be fully tested. 
Any delay in fully tested QCDR measures will have downstream impacts 
with regards to the timing in which these measures can be considered 
for inclusion in MVPs in future years. We also want to clarify that 
QCDR measures that were fully tested at the time of self-nomination 
(July 1, 2020 through September 1, 2020) for the 2021 performance 
period, would be eligible for inclusion in MVPs for the 2022 
performance period. We are aware that full testing of QCDR measures was 
not a requirement for the 2021 performance period, but have come across 
instances where some QCDRs have been diligently working to test or have 
completed testing their QCDR measures that are currently in the program 
and believe those fully tested QCDR measures are potentially ready to 
be considered for inclusion within an MVP. QCDR measures that are not 
fully tested will not be considered for inclusion in an MVP.
    After consideration of public comments, we are finalizing our 
proposal as proposed.
(C) Duplicative QCDR Measures
    Throughout previous rulemaking cycles, we have communicated our 
desire to eliminate duplicative QCDR measures in the MIPS program, as 
it is counterintuitive to the Meaningful Measure Initiative (84 FR 
63068). One of the methods we previously suggested to address 
duplicative measures is measure harmonization, as discussed in the CY 
2020 PFS final rule (84 FR 63068 through 63070). We have received 
comments and questions from stakeholders, requesting clarification for 
us to define what we mean by measure harmonization.
    In this rule, we intend on clarifying that measure harmonization 
means ``measures for which previously identified areas of duplication 
with other approved QCDR measures or MIPS quality measures have been 
addressed.'' We proposed to revise previously codified policies that 
refer to measure harmonization with this updated terminology.
    Therefore, we proposed to revise Sec.  414.1400(b)(3)(v)(E), to 
state, beginning with the 2022 MIPS payment year, CMS may provisionally 
approve the individual QCDR measures for 1 year with the condition that 
QCDRs

[[Page 84943]]

address certain areas of duplication with other approved QCDR measures 
or MIPS quality measures in order to be considered for the program in 
subsequent years. If such areas of duplication are not addressed, CMS 
may reject the duplicative QCDR measure.
    In addition, we proposed to revise Sec.  414.1400(b)(3)(vi) to 
state, beginning with the 2023 MIPS payment year, QCDR measures may be 
approved for 2 years, at CMS discretion by attaining approval status by 
meeting QCDR measure considerations and requirements. Upon annual 
review, CMS may revoke a QCDR measure's second year approval, if the 
QCDR measure is found to be: Topped out; duplicative of a more robust 
measure; reflects an outdated clinical guideline; or if the QCDR self-
nominating the QCDR measure is no longer in good standing.
    Furthermore, we proposed to remove two previously codified policies 
that we have identified as areas of redundancy. We proposed to remove 
Sec.  414.1400(b)(3)(vii)(H), which states whether the previously 
identified areas of duplication have been addressed as requested, and 
to remove Sec.  414.1400(b)(3)(vii)(L), which states whether the 
existing approved QCDR measure is no longer considered robust, in 
instances where new QCDR measures are considered to have a more 
vigorous quality actions, where CMS preference is to include the new 
QCDR measure rather than requesting QCDR measure harmonization. We 
noted that we believe the previously finalized regulatory text under 
Sec.  414.1400(b)(3)(vii)(A), which states QCDR measures that are 
duplicative, or identical to other QCDR measures or MIPS quality 
measures currently in the program will address instances where areas of 
duplication amongst QCDR measures are not addressed or where a QCDR 
measure approved for a previous year is duplicative with a QCDR measure 
approved for the current year.
    As a result of the proposed removals of two previously codified 
policies, we proposed technical updates to re-number the regulation 
text to reflect the removals. Therefore, in Sec.  414.1400, we proposed 
to redesignate paragraphs (b)(3)(vii)(I), (J), (K), (M), and (N) as 
paragraphs (b)(3)(vii)(H), (I), (J), (K), and (L), respectively.
    The following is a summary of the comments we received and our 
responses.
    Comment: One commenter expressed its support for removing QCDR 
measures that reflect outdated clinical guidelines or if the QCDR that 
nominated the measure is no longer in good standing. A few commenters 
agreed with CMS' proposals to revise QCDR measure harmonization 
policies and remove previously codified policies that it has identified 
as redundant due to its belief that it supports standardization of 
measures across providers and settings.
    Response: We agree that measures that reflect outdated clinical 
guidelines no longer provide accurate clinical measurement that can 
lead to quality improvement. In addition, we agree with commenters that 
a QCDR's standing in the program should impact the availability of 
their QCDR measures in the program. Furthermore, we thank commenters 
for agreeing with some of the criteria we use to retire measures from 
the program as well as our need to harmonize measures and the benefit 
it conveys to the program. Some of these benefits include fewer 
measures for clinicians to have to read through (burden reduction) as 
well as better direct comparison between providers reporting on the 
same measure as opposed to a similar measure.
    Comment: One commenter encouraged CMS to continue to encourage 
measure development programs to identify commonalities and gaps in 
existing systems rather than create new programs to identify new 
measures. Another commenter urged CMS to implement adequate safeguards 
to ensure that measure harmonization occurs only when it is clinically 
appropriate to do so.
    Response: We continue to encourage QCDRs and measure developers to 
address measurement gaps identified in the MIPS program. To clarify, we 
are not creating new programs to identify new measures but are 
utilizing our existing processes to identify measurement gaps. On an 
annual basis, we publish our CMS Quality Measure Development Plan (MDP) 
and the MDP annual report. The MDP helps us build and improve quality 
measures clinicians can report under the MIPS program. The MDP includes 
environmental scans, gap analyses, and work with stakeholders. This 
report is published on an annual basis to help us get expert input 
about the measures we need, prioritize areas of measure development, 
evaluate existing quality measures, to meet our goal value-based 
measures to support the Quality Payment Program. We refer readers to 
the Quality Payment Program Measure Development website where we have 
published the 2020 MDP Annual Report at https://www.cms.gov/Medicare/Quality-Payment-Program/Measure-Development/Measure-development. We 
encourage QCDRs to utilize the MDP as they work through the measure 
development-planning phase to determine which identified gaps they 
would like to address through measure development.
    With respect to safeguards, when measures are reviewed for areas of 
duplication, all of the similar measures are evaluated. We would 
encourage QCDRs address certain areas of duplication with other 
approved QCDR measures or MIPS quality measures in order to be 
considered for the program in subsequent years. If such areas of 
duplication are not addressed, CMS may reject the duplicative QCDR 
measure.
    Comment: One commenter disagreed with the policies to remove a QCDR 
measure before its second year for it being topped out or duplicative 
of a more robust measure.
    Response: We continue to believe that duplicative QCDR measures 
should not be in the MIPS program, as that is contradictory to the 
Meaningful Measure Initiative. Including duplicative or topped-out 
measures in the program adds to burden without meaningfully improving 
care or quality.
    Comment: A few commenters requested CMS consider certain priorities 
when identifying duplicative QCDR measures and encouraging 
harmonization, such as: Prioritizing the original measure until 
subsequent measures are proven to have surpassed it, prioritizing the 
more scientifically rigorous measure, and identifying the measure that 
best advances the goals of the program. One commenter also requested 
that CMS consider providing measure stewards specific reasons when new 
measures are identified as duplicative and provide an opportunity to 
improve or replace the existing measure.
    Response: We continue to encourage QCDRs to work collaboratively 
amongst each other to address areas of duplication within their QCDR 
measures. In this final rule, we are finalizing at Sec.  
414.1400(b)(3)(v)(E) that beginning with the 2022 MIPS payment year, we 
may provisionally approve the individual QCDR measures for 1 year with 
the condition that QCDRs address certain areas of duplication with 
other approved QCDR measures or MIPS quality measures in order to be 
considered for the program in subsequent years. If such areas of 
duplication are not addressed, we will not approve the duplicative QCDR 
measure. In our review of measures, we do try to identify new measures 
that might be duplicative and reasons why, inform QCDRs submitting 
duplicative measures, and encourage the QCDRs to address the 
duplication in a timely manner.

[[Page 84944]]

    After consideration of the public comments, we are finalizing our 
proposals as proposed.
(D) Collection of Data on QCDR Measure
    In the CY 2020 PFS final rule (84 FR 63067 through 63068), we 
finalized at Sec.  414.1400(b)(3)(v)(D) that beginning with the 2021 
performance period, QCDRs are required to collect data on a QCDR 
measure, appropriate to the measure type, prior to submitting the QCDR 
measure for CMS consideration during the self-nomination period.
(i) Delay of Data Collection in IFC
    As mentioned previously in this section of the final rule, due to 
the PHE we delayed certain requirements in the May 8th COVID-19 IFC (85 
FR 27594 through 27595). In the CY 2020 PFS final rule (84 FR 63067 
through 63068), we finalized at Sec.  414.1400(b)(3)(v)(D) that 
beginning with the 2021 performance period, QCDRs are required to 
collect data on a QCDR measure, appropriate to the measure type, prior 
to submitting the QCDR measure for CMS consideration during the self-
nomination period. For the reasons discussed in section II.R.2. of the 
May 8th COVID-19 IFC (85 FR 27594 through 27595), we delayed the 
implementation of this policy by 1 year. Specifically, we amended Sec.  
414.1400(b)(3)(v)(D) to state that beginning with the 2022 performance 
period, QCDRs are required to collect data on a QCDR measure, 
appropriate to the measure type, prior to submitting the QCDR measure 
for CMS consideration during the self-nomination period.
    During this 1-year delay, we will continue to review QDCR measures 
as in past years to ensure they are valid and identify performance gaps 
in the area of measurement. As described in the 2020 QCDR Measure 
Development Handbook, this process includes vetting the measures to 
ensure they are implementable and collectible, which includes an 
evaluation of the measure and coding constructs (for example, whether 
the measure is constructed as a ratio, proportional, or inverse 
measure). Additionally, we will review the evidence provided by the 
QCDR (for example, clinical studies and/or scientific journals) that 
would support the need for measurement in lieu of insufficient data 
collection to demonstrate that there is a measurement gap.
    The following is a summary of the comments we received and our 
responses.
    Comment: Commenters supported the delay of QCDR data collection 
requirements on count of concerns due to burden and likely delays in 
the development of new measures, problems that would only be 
exacerbated by the current PHE for COVID-19. Another commenter urged 
CMS to continue to monitor the PHE for the viability of this 
requirement for CY 2021.
    Response: We thank commenters for their support. We are continuing 
to monitor the PHE.
    After consideration of public comments, we are adopting our policy 
as finalized in the May 8th COVID-19 IFC (85 FR 27594 through 27595).
(3) Qualified Registries
    We refer readers to Sec. Sec.  414.1305 and 414.1400, the CY 2018 
Quality Payment Program final rule (82 FR 53815 through 53818), CY 2019 
PFS final rule proposed rule (83 FR 59906), and the CY 2020 PFS final 
rule (84 FR 40819 through 40820) for our previously finalized policies 
regarding qualified registries. In the CY 2021 PFS proposed rule (85 FR 
50328), we proposed a technical update to the title at Sec.  
414.1400(c) to rename it from ``qualified registry approval criteria'' 
to ``qualified registries'', to better align the title with the content 
of the regulation. In addition, we proposed requirements related to 
data validation audits and targeted audits.
    In the CY 2017 Quality Payment Program final rule, we discussed our 
expectation related to QCDRs and qualified registries would conduct 
validation on the data they intend on submitting for the MIPS 
performance period (81 FR 77384 through 77386) and provide the results 
of the data validation to CMS in the form of a data validation 
execution report by May 31st of the year following the performance 
period. Our intention was to establish our expectation that qualified 
registries would establish a process to assess whether the data are 
true, accurate, and complete prior to submitting them to CMS for 
purposes of the MIPS program. We believe it is important to establish a 
requirement that qualified registries conduct data validation to ensure 
they are actively monitoring the data they submit to CMS for purposes 
of a pay-for-performance program. In instances where a qualified 
registry discovers data are inaccurate or incomplete, the entity must 
correct the issue prior to submitting the data to CMS in order to 
provide accurate certification in accordance with Sec.  414.1400(a)(5). 
A qualified registry that submits a false certification submits data 
that is inaccurate, unusable or otherwise compromised to CMS for 
purposes of the MIPS program may be subject to remedial action or 
termination under Sec.  414.1400(f). We believe requiring qualified 
registries to validate the accuracy of the data they are submitting is 
an important safeguard to promote accurate payments under the MIPS 
program. Therefore, we proposed at Sec.  414.1400(c)(2)(iii) and (iv) 
requirements beginning with the 2023 MIPS payment year as condition of 
approval each qualified registry must conduct annual data validation 
audits and if one or more deficiencies or data errors are identified 
the qualified registry must also conduct targeted audits. We also 
proposed specific obligations for those audits as discussed below.
     We proposed to codify at Sec.  414.1400(c)(2)(iii)(A), the 
qualified registry must conduct their data validation audits prior to 
submitting any data to CMS for purposes of the MIPS program. We noted 
that we believe it is important for qualified registries to conduct 
validation audits to identify and fix concerns regarding data accuracy 
prior to submitting data to us, including potential issues related to 
data aggregation and calculation. Conducting the data validation prior 
to data submission will lead to data being more reliable and promote 
compliance with the requirement of data being true, accurate, and 
complete. In the CY 2017 Quality Payment Program final rule, we 
described this auditing using the term randomized audit (81 FR 77384). 
We proposed instead to refer to this audit as the data validation audit 
in an effort to be abundantly clear regarding our expectations that the 
qualified registry will purposefully construct a sample and conduct and 
audit that complies with specific regulatory requirements and also to 
distinguish these audits from the targeted audits discussed below and 
proposed at Sec.  414.1400(c)(2)(v).
     We proposed to codify at Sec.  414.1400(c)(2)(iii)(B), the 
qualified registry must conduct data validation on data for each 
performance category for which it will submit data, including if 
applicable the Quality, Improvement Activities, and Promoting 
Interoperability performance categories. We believe that it is 
important that data validation be done across all performance 
categories for which the qualified registry submits data since 
qualified registries must attest that data submitted to CMS is true, 
accurate, and complete and data for each of these performance 
categories can influence score calculation and payment adjustments.
     We proposed to codify at Sec.  414.1400(c)(2)(iii)(C), 
that the

[[Page 84945]]

qualified registry must conduct data validation on data for each 
submitter type for which it will submit data, including if applicable 
MIPS eligible clinicians, groups, virtual groups, voluntary 
participants, and opt-in participants. We noted that we believe it is 
important for the data submitted to CMS be accurate for all clinicians 
and groups for which the qualified registry intends on submitting data 
to the MIPS program, regardless of whether they are required to 
participate, have opted in, or have chosen to voluntarily participate. 
Therefore, we proposed to require that the data validation audits 
should account for all types of submitters that are utilizing the 
qualified registry to submit data to CMS for purposes of the MIPS 
program. We noted the importance of validating data for all submitter 
types regardless of its use for payment or public reporting. Even 
clinicians who voluntarily report to MIPS and whose data are not used 
for payment purposes could have their data publically posted on the 
Physician Compare website. We noted that we believe all data the 
qualified registry submits, regardless of its use for payment or public 
reporting, should be true, accurate, and complete.
     We proposed to codify at Sec.  414.1400(c)(2)(iii)(D) that 
the qualified registry must use clinical documentation (provided by the 
clinicians they are submitting data for) to validate that the action or 
outcome measured actually occurred or was performed. If the data a 
qualified registry intends to submit to CMS for purposes with the MIPS 
program are to demonstrate that a clinician did a particular clinical 
activity or achieved a particular clinical outcome, we noted that we 
believe meaningful validation of such data requires the qualified 
registry to use clinical documentation to confirm that the activity 
occurred or was performed.
     We proposed to codify at Sec.  414.1400(c)(2)(iii)(E), the 
qualified registry shall conduct each data validation audit using a 
sampling methodology that meets the following requirements:
    ++ Uses a sample size of at least 3 percent of the TIN/NPIs for 
which the qualified registry will submit data to CMS, except that if a 
3 percent sample size would result in fewer than 10 TIN/NPIs, the 
qualified registry must use a sample size of at least 10 TIN/NPIs, and 
if a 3 percent sample size would result in more than 50 TIN/NPIs, the 
qualified registry may use a sample size of 50 TIN/NPIs.
    ++ Uses a sample that includes at least 25 percent of the patients 
of each TIN/NPI in the sample, except that the sample for each TIN/NPI 
must include a minimum of 5 patients and does not need to include more 
than 50 patients.
    We believe the aforementioned sampling methodology is appropriate 
for multiple reasons. First, the sampling methodology criteria are 
consistent with the methodology established under the legacy Physician 
Quality Reporting System (PQRS) program and as described in the CY 2017 
Quality Payment Program final rule (81 FR 77366 through 77367). As this 
methodology has been used for many years under the legacy program, we 
believe stakeholders are well versed in executing data validation 
audits using this sampling methodology. Second, the proposed 
methodology accounts for QCDRs and qualified registries of varying 
sizes. Data validation requires a level of effort on the part of the 
qualified registry to execute a data validation plan, identify a 
sample, and collect information for purposes of chart review; 
therefore, we are cognizant that requiring a larger sample size would 
create additional burden on qualified registries and clinicians to 
account for a larger volume in TIN/NPIs and medical records for review.
     We proposed to codify at Sec.  414.1400(c)(2)(iii)(F) that 
each qualified registry data validation audit must include the 
following:
    ++ Verification of the eligibility status of each eligible 
clinician, group, virtual group, opt-in participant, and voluntary 
participant. We believe that it is important for the qualified registry 
to track the eligibility status of each clinician and group that wishes 
to use a third party intermediary to report, because accurate 
information regarding eligibility is important to ensuring payment 
adjustments are properly applied. Furthermore, verification of 
eligibility status is consistent with the requirement for qualified 
registries to track opt-in participants, as described at Sec.  
414.1400(a)(4)(iv) and in the context of clinicians who voluntarily 
report to MIPS helps ensure the accuracy of data publically posted on 
the Physician Compare website (or a successor website) of the CMS 
website.
    ++ Verification of the accuracy of Tax Identification Numbers 
(TINs) or National Provider Identifiers (NPIs). Correct TINs and NPIs 
are critical to ensure data submitted by the qualified registry are 
attributed to the correct clinicians and groups. Inaccurate NPIs or 
TINs may lead to inadvertent downstream impacts to the way clinicians 
and groups are scored, and assigned a payment adjustment.
    ++ Calculation of reporting and performance rates (for example, 
formulas included in the quality measure specifications). Qualified 
registries must follow the measure specifications when calculating 
reporting and performance rates. Calculations that deviate the formulas 
included in the quality measure specifications undercut efforts to 
ensure data are consistent, reliable, and have been calculated in a 
uniform manner.
    ++ Verification that only MIPS quality measures and qualified 
registry measures that are relevant to the performance period will be 
utilized for MIPS submission. Measure specifications for the MIPS 
quality measures and qualified registry measures go through maintenance 
on an annual basis. Use of outdated measure specifications would likely 
result in the qualified registry submitting inaccurate or compromised 
data for the clinicians and groups they support. While not all measures 
go through substantive changes on an annual basis, there are changes to 
codes that do occur annually that should be accounted for when 
programing measures. Therefore, we believe it is important that 
qualified registries are utilizing the most current version of the 
measure specification, relevant to the performance period in which they 
are participating.
     We proposed to codify at Sec.  414.1400(c)(2)(iii)(G), 
that in a form and manner and by a deadline specified by CMS, the 
qualified registry must report data validation results, including the 
overall deficiency or data error rate, the types of deficiencies or 
data errors discovered, the percentage of clinicians impacted by any 
deficiency or data error, and how and when each deficiency or data 
error type was corrected. We believe it is important that the results 
of the data validation be shared with us in order for us to understand 
the types of issues the qualified registries have encountered and what 
resolutions were executed to fix the issues. The information provided 
will help us track frequently occurring issues which may be identified 
as an area to provide further education. It is our belief that the 
report will be largely comprised of issues that were identified and 
resolved. However, if an issue has been identified and could not be 
resolved, we would want to understand what the issue is and why it 
could not be resolved. We emphasized that all data submitted to CMS by 
a qualified registry 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 as described 
in

[[Page 84946]]

Sec.  414.1400(a)(5). If a qualified registry submits a false 
certification or data that are data that are inaccurate, unusable, or 
otherwise compromised, the qualified registry may be subject to 
remedial action or termination as described at Sec.  414.1400(f).
     We proposed to codify at Sec.  414.1400(c)(2)(iv)(A) that 
if a data validation audit under Sec.  414.1400(c)(2)(iii) identifies 
one or more deficiency or data error, the qualified registry must 
conduct a targeted audit into the impact and root cause of each such 
deficiency or data error for that MIPS payment year. We believe 
targeted audits are important to further evaluate the impact of 
deficiencies or data errors to the cohort of clinicians and groups that 
the qualified registry intends to submit data for, and for qualified 
registries to determine the reason the deficiency or data error 
occurred.
     We proposed to codify at Sec.  414.1400(c)(2)(iv)(B), that 
the qualified registry must conduct any required targeted audits for 
the MIPS payment year and correct any deficiencies or data errors 
identified through such audit prior to the submission of data for that 
MIPS payment year. To promote the accuracy of the data submitted to the 
MIPS program for the payment year and to reduce the risk that the 
agency initiates payment calculations in reliance on inaccurate data, 
it is important for the qualified registry to conduct required targeted 
audits and correct any deficiencies and data errors identified through 
those audits prior to submitting the data to CMS.
     We proposed to codify at Sec.  414.1400(c)(2)(iv)(C), the 
qualified registry must conduct the targeted audit using the sampling 
methodology that meets the requirements described in paragraph 
(c)(2)(iii)(E). The sample for the targeted audit must not include data 
from the sample used for the data validation audit in which the 
deficiency or data error was identified. We believe the sampling 
methodology we proposed for data validation audits is equally 
appropriate for the conduct of targeted audits. We believe that 
adopting the same methodology for both audit types would be less 
burdensome on qualified registries than requiring these entities to 
apply a separate sampling methodology for their targeted audits. 
Provided that data in the sample for the targeted audit does not 
overlap with the data that was reviewed in the data validation audit, 
we believe the targeted audit would provide the qualified registry with 
a reasonable perspective into impact and root cause of deficiencies and 
data errors across the data to be submitted without imposing the burden 
that would result from maintaining a separate sampling methodology for 
targeted audits.
     We proposed to codify at Sec.  414.1400(c)(2)(iv)(D), in a 
form and manner and by a deadline specified by CMS, the qualified 
registry must report the results of each targeted audit, including the 
overall deficiency or data error rate, the types of deficiencies or 
data errors discovered, the percentage of clinicians impacted by each 
deficiency or data error, and how and when each error type was 
corrected. As is the case with the results of data validation audits, 
we believe it is important that the results of the targeted audits be 
shared with us in order for us to understand the types of issues the 
qualified registries have encountered and what resolutions were 
executed to fix the issues. The information provided will help us track 
frequently occurring issues which may be identified as an area to 
provide further education.
    We requested comments on the proposals, including whether 
stakeholders are concerned with implementing the policies for the 2023 
MIPS payment year, and if so, what barriers do they believe they would 
face in implementing the requirements.
    The following is a summary of the comments we received and our 
responses. We also refer readers to the QCDR section of this final rule 
(section IV.A.3.g.(2)) where qualified registries can view applicable 
comments and responses.
    Comment: A few commenters disagreed with the proposal to require 
qualified registries to conduct data validation due to their belief 
that it will unnecessarily increase burden for qualified registries who 
are already validating data prior to submission to CMS. One commenter 
disagreed with the requirement to perform data validation for each 
submitter type because of the low number of participants reporting via 
the qualified registry as individuals and stated that the randomized 
auditing on a small sample would result in the unintended consequence 
of increasing the burden of these clinicians without necessarily 
improving the quality of data submitted and that such a policy change 
would result in some practices being audited multiple times, sometimes 
within the same year, based on their submission category. Several 
commenters disagreed with the proposal to require data validation 
specific to performance category, submission mechanism, and submitter 
type due to their belief that the proposal creates unreasonable burdens 
for clinicians, qualified registries; would result in some individuals 
or groups being audited more often and less randomly in circumstances 
where the number of individuals/groups for a specific submitter type is 
lower; will impose a substantial financial burden on small, specialty 
society registries; is duplicative of internal quality data controls 
and external audits already conducted; and data validation for clients 
who are manually entering data may be difficult to audit, as many 
clinicians and practices do not complete data entry until late in the 
fourth quarter of the performance year.
    Response: We continue to believe it is important to establish a 
requirement that qualified registries conduct data validation to ensure 
they are actively monitoring the data they submit to CMS for purposes 
of a pay-for-performance program. Furthermore, at Sec.  
414.1400(c)(2)(iii) and (iv) requirements beginning with the 2023 MIPS 
payment year as condition of approval each qualified registry must 
conduct annual data validation audits and if one or more deficiencies 
or data errors are identified the qualified registry must also conduct 
targeted audits. We understand that some qualified registries may have 
a small number of clients that are submitting data through their 
registry for purposes of MIPS reporting, but believe that data 
integrity is a high priority, and believe that data validation should 
occur regardless of the size of the clinician population the third 
party intermediary supports. As a point of clarification, we do not 
require multiple data validation audits to occur within the same year. 
Our data validation sampling methodology allows qualified registries to 
select a percentage of their clients. As noted above, correct data is 
vital to inform clinicians of their quality performance--let alone 
determining payment differentials that affect all participants in the 
program.
    Comment: Another commenter stated that while they can perform a 
randomized audit requesting documentation from the EHR on Promoting 
Interoperability measure data to ensure accurate transposition and 
monitoring of errors and clinical documentation to ensure the 
Improvement Activities was attested to correctly, any errors discovered 
will be errors on the part of the practice or physician, not the 
registry.
    Response: We appreciate the commenter's observation that in some 
instances the data validation conducted by a qualified registry may 
identify errors that stem from inaccuracies in the data supplied by the 
practice or

[[Page 84947]]

physician. Data validation requirements are intended to help ensure the 
qualified registry's data submissions to CMS are true, accurate, and 
complete. Therefore, if a qualified registry identifies errors in data 
on a Promoting Interoperability measure or Improvement Activity that it 
attributes to a practice or physician, the registry has shared 
responsibility to ensure the registry's submissions to CMS do not 
include that inaccurate data.
    After consideration of the comments received, we are finalizing our 
proposals as proposed.
(4) Remedial Action and Termination of Third Party Intermediaries
    We refer readers to Sec.  414.1400(f), the CY 2017 Quality Payment 
Program final rule (81 FR 77548), CY 2019 PFS final rule (83 FR 59908 
through 59910), and the CY 2020 PFS final rule (84 FR 63077 through 
63080) for previously finalized policies for remedial action and 
termination of third party intermediaries.
    As described in Sec.  414.1400(f)(1)(i), the remedial actions CMS 
may take against a third party intermediary include requiring the third 
party intermediary to submit to CMS by a date specified by the agency a 
corrective action plan (CAP) to address the identified deficiencies or 
data issue, including that actions it will take to prevent the 
deficiencies or data issues from recurring. To clarify expectations and 
create consistency in the content of the CAPs provide by third party 
intermediaries, we proposed to revise and elaborate on the obligations 
for a CAP. Specifically, we proposed to modify Sec.  414.1400(f)(1)(i) 
such that, unless different or additional information is specified by 
CMS, the CAP submitted by the third party intermediary must address 
four issues: (1) The issues that contributed to the non-compliance; (2) 
the impact to individual clinicians, groups, or virtual groups, 
regardless of whether they are participating in the program because 
they are MIPS eligible, voluntary participating, or opting in to 
participating in the MIPS program; (3) the corrective actions to be 
implemented by the third party intermediary to ensure that the non-
compliance has been resolved will not recur in the future and (4) the 
detailed timeline for achieving compliance with the applicable 
requirements.
    We noted that we believe the four elements are generally warranted 
in each instance in which a CAP is required. First, any meaningful 
efforts at corrective action necessitate an understanding of what needs 
to be corrected. Therefore, we proposed at Sec.  414.1400(f)(1)(i)(A) 
to require that each third party intermediary be required to articulate 
the issues that contributed to the non-compliance. The third party 
intermediary must articulate what factors cause it to fail in its 
obligation to meet program requirements. For example, a survey vendor 
subject to remedial action for not completing vendor trainings would be 
required to explain what factors lead to its failure to complete 
training. We noted that we believe this analysis will allow third party 
intermediary to improve their processes to better meet existing 
requirements and will allow CMS to better understand what operational 
and other challenges third party intermediaries face in meeting program 
requirements. Second, depending on the circumstances, non-compliance by 
a third party intermediary may affect an uncertain number of clinicians 
and groups and has the potential to implicate substantial program 
dollars. Accordingly, we proposed at Sec.  414.1400(f)(1)(i)(B) to 
require that a third party intermediary subject to a CAP disclose to 
CMS the impact to individual clinicians, groups, or virtual groups, 
regardless of whether they are participating in the program because 
they are MIPS eligible, voluntary participating, or opting in to 
participating in the MIPS program. We noted that we believe this 
information regarding the scope of harms is necessary for the agency to 
assess the full program impact of the non-compliance. Furthermore, we 
believe it is important for the CAP to include this impact information 
regardless of the clinician's participation status, because non-
compliance may have programmatic implications even if it does not 
affect payment, such as for data posted on the Physician Compare 
website. Third, meaningful remedial action requires the identification 
of specific action steps both to address prior harm but to protect 
against future harms. Therefore, we proposed at Sec.  
414.1400(f)(1)(i)(C) that a third party intermediary subject to a CAP 
must address the corrective actions to be implemented by the third 
party intermediary to ensure that the non-compliance has been resolved 
and will not recur in the future. The third party intermediary will be 
expected to follow through with the implementation of the corrective 
actions and to see that the issue has been corrected permanently. It is 
important for us to understand in detail what actions the third party 
intermediary will take to resolve the issue and to evaluate the 
effectiveness of the proposed solution for long-term sustainability. 
Fourth, non-compliance must be resolved methodically and timely. 
Therefore, we proposed at Sec.  414.1400(f)(1)(i)(D) that each CAP must 
include the detailed timeline for achieving compliance with the 
applicable requirements. We solicited public comments on the proposed 
revisions to our requirements for correction action plans.
    We received one public comment on the remedial action and 
termination of third party intermediary proposals. The following is a 
summary of the comment we received and our response.
    Comment: One commenter requested more information on the proposed 
new criteria for corrective action plans and how they would be 
quantified, particularly scope of clinician impact and/or harms.
    Response: The new criteria in the regulation text at Sec.  
414.1400(f)(1)(i) clarify the content the CAPs provided by the third 
party intermediaries must include. The obligation for the CAP to 
identify impacts of the non-compliance on clinicians, groups and 
virtual groups establishes that the third party intermediary must 
supply information as to the volume and identity of clinicians, groups 
and virtual groups that are negatively impacted by the non-compliance 
of the third party intermediary. The appropriate method for quantifying 
impact will vary depending on the nature of the non-compliance. For 
example, if a third party intermediary submitted compromised data to 
CMS because it used a flawed TIN/NPI crosswalk, we would expect the CAP 
to include the total number and identifying information for the 
clinicians and groups whose data were inaccurate. The identification of 
impacts to clinicians would also helps us understand the volume of 
clinicians who may look to find a different method of reporting. Please 
refer to qpp.cms.gov for more information.
    After consideration of the comment received, we are finalizing our 
proposal as proposed.
h. Public Reporting on Physician Compare
    For previous discussions on the background of Physician Compare, we 
refer readers to the CY 2016 PFS final rule (80 FR 71116 through 
71123), the CY 2017 Quality Payment Program final rule (81 FR 77390 
through 77399), the CY 2018 Quality Payment Program final rule (82 FR 
53819 through 53832), the CY 2019 PFS final rule (83 FR 59910 through 
59915), the CY 2020 PFS final

[[Page 84948]]

rule (84 FR 63080 through 63083), and the Physician Compare Initiative 
website at https://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/physician-compare-initiative/.
(1) Definitions & Proposed Regulation Text Changes
    Physician Compare (http://www.medicare.gov/physiciancompare) draws 
its operating authority from section 10331(a)(1) of the Affordable Care 
Act, which defines the term ``Physician Compare'' to mean the internet 
website developed under this section of the statute. Physician Compare 
has continued to pursue a phased approach to public reporting under the 
Medicare Access and CHIP Reauthorization Act (MACRA) of 2015. Section 
104(f)(2) of the MACRA defines the term ``Physician Compare'' to mean 
the Physician Compare internet website of the Centers for Medicare & 
Medicaid Services (or a successor website). To more completely and 
accurately reference the website for which CMS will post information 
available for public reporting, in accordance with section 104(f)(2) of 
the MACRA, we proposed to define Physician Compare at Sec.  414.1305 to 
mean the Physician Compare internet website of the Centers for Medicare 
& Medicaid Services (or a successor website). We sought comment on the 
proposal. For ease of reference, we use the term ``Physician Compare'' 
in this final rule.
    We did not receive any public comments on defining the term 
``Physician Compare'' to mean the Physician Compare internet website of 
the Centers for Medicare & Medicaid Services (or a successor website). 
Therefore, we are finalizing the ``Physician Compare'' definition at 
Sec.  414.1305 as proposed.
4. APM Incentive Payment
(a) Overview
    Under the Quality Payment Program, Qualifying APM Participants 
(QPs) receive a 5 percent APM Incentive Payment in payment years 2019 
through 2024. In the CY 2017 Quality Payment Program final rule (81 FR 
77480 through 77489), we finalized at Sec.  414.1450(d) that this 
payment is made based on the clinician's QP status in the QP 
Performance Period that is 2 years prior (for example, the 2021 payment 
will correspond to the 2019 performance year), and at Sec.  
414.1450(b)(1) that the payment is equal to 5 percent of the estimated 
aggregate payments for covered professional services in the base period 
(the year between the QP performance and payment years). We finalized 
at Sec.  414.1450(c)(1) that the APM Incentive Payment amount is made 
to the TIN associated with the Advanced APM Entity through which an 
eligible clinician becomes a QP during the QP Performance Period. Under 
Sec.  414.1450(c)(3), if an eligible clinician becomes a QP through 
participation in multiple Advanced APMs, CMS divides the APM Incentive 
Payment proportionally between the TINs associated with the QP's 
participation in each Advanced APM based on payments for covered 
professional services during the QP Performance Period. In addition, 
under Sec.  414.1450(c)(2), we finalized that if the QP is no longer 
affiliated with the TIN associated with the QP's participation in the 
APM Entity, the APM Incentive Payment is made to the TIN listed on the 
QP's CMS-588 Electronic Funds Transfer (EFT) Application form.
    In our first year making the APM Incentive Payment, we experienced 
operational limitations that made it difficult in certain cases to 
distribute the payment to a current billing organization associated 
with the QP according to the current regulations. In particular, we 
encountered challenges when QPs are no longer affiliated with the TIN 
associated with the QP's participation in the APM Entity through which 
they attained QP status, and when we were unable to make the APM 
Incentive Payment to the TIN listed on the eligible clinician's CMS-588 
EFT Application form. In certain circumstances, it has been challenging 
to locate accurate billing organizations for some QPs 2 years after 
they earned QP status. For example, we have encountered situations such 
as inaccurate or missing billing associations for the QP because the QP 
has changed their primary billing TIN between the performance and the 
payment year, or the billing TIN through which the QP attained QP 
status is not the TIN through which CMS payments are processed, and so 
it is not possible for CMS to know that the two are in fact connected.
(b) APM Incentive Payment Amount
    In the first Quality Payment Program final rule (81 FR 77480), we 
finalized at Sec.  414.1450(b)(1) through (3) how we calculate the 
amount of the APM Incentive Payment. Specifically, we finalized that: 
(1) The amount of the APM Incentive Payment is equal to 5 percent of 
the estimated aggregate payments for covered professional services as 
defined in section 1848(k)(3)(A) of the Act furnished during the 
incentive payment base period (that is, the calendar year immediately 
preceding the payment year); (2) the estimated aggregate payment amount 
for covered professional services includes all such payments to the QP 
(NPI) via any and all of their TIN/NPI combinations; and (3) in 
calculating the estimated aggregate payment for a QP, CMS uses claims 
submitted for covered professional services with dates of service from 
January 1 through December 31 of the incentive payment base period.
    In the CY 2021 PFS proposed rule (85 FR 50332), we are clarifying 
that the APM Incentive Payment amount is calculated based on the paid 
amount of the applicable claims for covered professional services that 
are subsequently aggregated to calculate the estimated aggregate 
payments. We proposed to amend our regulation at Sec.  414.1450(b)(1) 
to reflect that clarification.
    Section 1833(z)(1)(A) of the Act specifies that the APM Incentive 
Payment is equal to 5 percent of the estimated aggregate payments for 
covered professional services as defined in section 1848(k)(3) of the 
Act. Because the APM Incentive Payment is a percentage of the estimated 
aggregate payments made, it would not be appropriate to calculate the 
APM Incentive Payment based on amounts that were allowed, but not 
actually paid by Medicare, for such covered professional services.
    We also noted that, as provided in Sec.  414.1450(b)(4) and (5), we 
exclude certain payments and adjustments, including the MIPS payment 
adjustments, when calculating the APM Incentive Payment amount.
    We sought comment on the proposal. The following is a summary of 
the comments we received in response to our proposal regarding the 
amount of the APM Incentive Payment.
    Comment: One commenter recommended CMS aggregate the APM Incentive 
Payment on the allowed amount instead of the paid amount and the 
difference should be retroactive. The commenter noted that calculating 
on the allowed amount would produce a higher bonus for eligible 
clinicians.
    Response: We appreciate the commenter feedback, however, as noted 
in the proposed rule, such an approach would be inconsistent with the 
plain language of the statute which requires that the APM Incentive 
Payment is equal to 5 percent of the estimated aggregate payments for 
covered professional services as defined in section 1848(k)(3) of the 
Act.

[[Page 84949]]

    Therefore, we are finalizing our proposal to amend the language at 
Sec.  414.1450(b)(1) to clarify our use of paid amounts in calculating 
``payments''.
(c) APM Incentive Payment Recipient
    Under our current policy as finalized at Sec.  414.1450(c), CMS 
first seeks to disburse the APM Incentive Payment to the TIN associated 
with the QP's participation with the APM Entity in the Advanced APM 
through which they earned QP status. If the QP is no longer affiliated 
with that TIN, we seek to disburse the APM Incentive Payment to the TIN 
listed on the eligible clinician's CMS-588 EFT form on the date that we 
make the payment. And if the eligible clinician becomes a QP through 
participation in multiple Advanced APMs, we seek to divide the APM 
Incentive Payment proportionally, based on payments for covered 
professional services during the QP Performance Period, and to make 
proportional payment to each of the TINs associated with the QP's 
participation with the APM Entity or APM Entities in the Advanced APMs.
    It is still our intention to reward achievement of QP status 
through participation in Advanced APMs by seeking to disburse APM 
Incentive Payments to TINs that are affiliated with an APM Entity 
through which the QP has achieved QP status, as is described in the CY 
2017 Quality Payment Program final rule (81 FR 77847). However, after 
our first year of making APM Incentive Payments, we have learned that 
the amount of time between when an eligible clinician earns QP status 
and when APM Incentive Payments are made makes it difficult to ensure 
that payments can be made for these QPs in a routine and efficient 
manner. For example, in the space of 2 years between making QP 
determinations and APM Incentive Payments, eligible clinicians may 
change TINs, join new TINs, join new APM Entities, remain in the same 
APM Entity under a new billing TIN, leave Medicare altogether, or make 
other potential changes impacting their relationship with the Medicare 
program. CMS receives updated records of the changes when APM 
participants update their payment information through the internet 
based Provider Enrollment, Chain and Ownership system (PECOS) or a CMS-
588 EFT Application, and subsequent updates to APM Participation Lists 
and Affiliated Practitioner Lists, although we note that such updates 
are not consistently and timely made across APM participants, as we 
originally believed, and therefore such lists have variable 
reliability. Further, on our own end, if we limit our initial search 
for the party or parties to which we should make the APM Incentive 
Payment to only the TIN or TINs through which the eligible clinician 
earned QP status, as is specified in our regulations at Sec.  
414.1450(c)(1) and (3), when the QP has made changes to their TIN 
affiliations, we might limit our opportunities to make the APM 
Incentive Payment to a more current TIN with which the QP is affiliated 
at the time we make the APM Incentive Payment. If we limit the TINs to 
which we will make the APM Incentive Payment to only those through 
which a QP was billing at the time they achieved QP status, we might be 
unable to identify any TIN to which we would make a payment for that QP 
during the payment year, or payments may be significantly delayed as a 
result, even in cases where a current payee TIN is available.
    Therefore, we proposed to establish in our regulation at Sec.  
414.1450(c) a revised approach to identifying the TIN(s) to which we 
make the APM Incentive Payment. We noted that this approach would 
involve looking at a QP's relationship with their TIN(s) over time, as 
well as considering the relationship the TIN(s) have with the APM 
Entity or Entities through which the eligible clinician earned QP 
status, or other APM Entities the QP may have joined in the interim. We 
stated that we believe that this revised approach will enable CMS 
accurately identify TINs with which QPs are currently receiving other 
Medicare payments, and through which they would likely anticipate 
receiving their APM Incentive Payment. We also noted that this approach 
would also prioritize, when the QP is no longer affiliated with the 
original TIN through which they achieved QP status, identifying and 
paying TINs with which QPs are affiliated at the time the APM Incentive 
Payment is made, thereby reducing the potential burden on payee TINs to 
find QPs no longer affiliated with them in order to disburse the APM 
Incentive Payment amount, as well as reducing uncertainty and delays 
for the QPs themselves as they anticipate their APM Incentive Payment.
    We also proposed to introduce a cutoff date of November 1 of each 
payment year, or 60 days from the day on which we make the initial 
round of APM Incentive Payments, whichever is later, as a point in time 
after which CMS will no longer accept new helpdesk requests from QPs or 
their representatives who have not received their payments. We 
discussed that there may be scenarios where we are unable to identify 
any appropriate TIN to which the APM Incentive Payment should be made, 
such as when the QP is no longer participating in Medicare, the QP has 
recently reassigned his or her billing rights, or where a payment TIN 
may be undergoing business transformations such that payment 
information changes during the payment year. In these cases, it is our 
goal to make correct payments for the relevant QPs as soon as feasible. 
To do so, it is necessary to establish a date after which we will not 
consider additional inquiries or additional information from QPs or 
their representatives for purposes of disbursing remaining APM 
Incentive Payments for the payment year.
    To improve and expand the ways we identify the TIN(s) to which we 
would make the APM Incentive Payment for a QP in a timelier and 
efficient manner, we proposed to sequentially apply the hierarchy in 
the following paragraph and to amend Sec.  414.1450(c) of our 
regulations to reflect such hierarchy. We proposed to begin at the 
first step in the hierarchy, and if we are unable to identify one or 
more TINs with which the QP has a current affiliation at this step, we 
move to the next and successive steps of the hierarchy until we do 
identify one or more TINs with which the QP is currently affiliated at 
the time we are distributing APM Incentive Payments. When we identify 
one or more TINs with which the QP is affiliated at a step, we would 
make the APM Incentive Payment to those TINs. We further proposed that 
if we identify more than one TIN at the applicable step in the 
hierarchy, we will divide the APM Incentive Payment proportionally 
between such TINs based on the relative paid amount for Part B covered 
professional services that are billed through each such TINs. We 
proposed the hierarchy to be:
    (1) Any TIN associated with the QP that, during the QP Performance 
Period, is associated with an APM Entity through which the eligible 
clinician achieved QP status;
    (2) Any TIN associated with the QP that, during the APM Incentive 
Payment base period, is associated with an APM Entity through which the 
eligible clinician achieved QP status;
    (3) Any TIN associated with the QP that, during the APM Incentive 
Payment base period, is associated with an APM Entity participating in 
an Advanced APM through which the eligible clinician had achieved QP 
status;
    (4) Any TIN associated with the QP that, during the APM Incentive 
Payment

[[Page 84950]]

base period, participated in an APM Entity in an Advanced APM;
    (5) Any TIN associated with the QP that, during the APM Incentive 
Payment base period, participated with an APM Entity in any track of 
the APM through which the eligible clinician achieved QP status;
    (6) Any TIN associated with the QP that, during the APM Incentive 
Payment base period, participated with an APM Entity in an APM other 
than an Advanced APM;
    (7) Any TIN associated with the QP that submitted a claim for 
covered professional services furnished by the QP during the APM 
Incentive Payment base period, even if such TIN has no relationship to 
any APM Entity or APM; then
    (8) If we have not identified any TIN associated with the QP to 
which we can make the APM Incentive Payment, we will attempt to contact 
the QP via a public notice to request their Medicare payment 
information. The QPs identified in the public notice, or any other 
eligible clinicians who believe that they are entitled to an APM 
Incentive Payment must then notify CMS of their claim as directed in 
the public notice by November 1 of the payment year, or 60 days after 
CMS announces that initial payments for the year have been made, 
whichever is later. After that time, any claims by a QP to an APM 
Incentive Payment will be forfeited for such payment year.
    We sought comment on the proposals. The following is a summary of 
the comments we received and our responses.
    Comment: Several commenters opposed our proposed hierarchy to make 
the APM Incentive Payment to the QP stating the process is too complex 
and confusing. Those commenters stated CMS should identify a more 
streamlined approach where the APM Incentive Payment would be paid 
directly to the APM Entity.
    Response: Under section 1833(z)(1)(A) of the Act, the statute 
provides that the APM Incentive payment is to be paid to the eligible 
clinician who is a QP for the year. As we explained in the CY 2017 
Quality Payment Program final rule (81 FR 77487), we make the APM 
Incentive Payment to a TIN rather than to an individual eligible 
clinician. We do not believe it would be consistent with statutory 
intent to make the APM Incentive Payment to the APM Entity or Entities 
in which the QP may have participated. Rather, we believe that it would 
be most consistent with statutory intent to locate and make the APM 
Incentive Payment to the solvent TIN with the closest and most current 
relationship to the QP. We believe that the proposed policy provides us 
with the opportunity to accurately identify as many appropriate payee 
TINs as possible prior to making the first round of payments, and that 
the proposed hierarchy will allow us to identify the most appropriate 
TIN to which to make payment. We understand that this process is 
complex, but we believe that application of the hierarchy will identify 
an appropriate payee TIN early in the process in most cases, and 
therefore, be better situated to disburse APM Incentive Payments 
earlier in the year than was possible under our current methodology.
    It has also come to our attention that there may be situations 
where a TIN associated with a QP may be in bankruptcy status; we would 
not consider this an appropriate payee TIN and would move to the next 
step in the hierarchy to identify another TIN to which to make the APM 
Incentive Payment.
    Comment: Another commenter opposed our proposal that, in the event 
we have not identified any TIN associated with a QP to which we can 
make the APM Incentive Payment, we would establish a 60-day public 
notice process to allow QPs or other eligible clinicians who believe 
they are entitled to an APM Incentive Payment to notify us of their 
claim and provide billing information or otherwise, forfeit their claim 
to payment. The commenter expressed concern that because there is no 
official date on which future APM Incentive Payments will be made, the 
proposed policy is not transparent.
    Response: We understand commenters' concerns about the need for CMS 
to complete APM Incentive Payments as quickly and predictably as 
possible. We proposed to introduce a cutoff date of November 1 of each 
payment year, or 60 days from the day on which we make the initial 
round of APM Incentive Payments, whichever is later; and to provide a 
public notice to identify the deadline by which we must receive 
requests from QPs or their representatives who have not received their 
payments. We believe establishing the cutoff date as the later of 
November 1 or 60 days after the initial round of payments are made 
creates a more predictable and finite time table for when clinicians 
could expect to receive their APM Incentive Payments. It is our goal to 
accurately make payments for all QPs as soon in the payment year as 
feasible. To do so, it is necessary to establish a date after which we 
will not consider additional inquiries or additional information from 
QPs or their representatives for purposes of disbursing any remaining 
APM Incentive Payments for the payment year.
    We are finalizing without modification our proposal to adopt and 
use the hierarchy to identify an appropriate TIN to which to make the 
APM Incentive Payment for a QP. We are also finalizing our proposal 
that, in the event we do not identify an appropriate TIN at levels one 
through seven of the hierarchy, we will publish a public notice 
requiring the remaining QPs to come forward with their claims and 
provide payment information by the specified date that is the later of 
a 60-day deadline or November 1st of the payment year, or forfeit their 
claim to an APM Incentive Payment for the year.
(d) Eligible Clinicians With No Covered Professional Services in the 
Incentive Payment Base Period
    In our experience calculating the APM Incentive Payments, it has 
come to our attention that there is a cohort of eligible clinicians who 
have been determined to be QPs for a year, and for whom an APM 
Incentive Payment has been calculated and in some cases paid, despite 
the fact that these eligible clinicians did not bill for any Part B 
covered professional services during the incentive payment base period. 
This situation arises in cases where an APM Entity is paid under the 
terms of the APM for supplemental services on behalf of an eligible 
clinician who is on their Participation List. This can occur because, 
for purposes of calculating the APM Incentive Payment, such 
supplemental service payments as described in Sec.  414.1450(b)(7) of 
our regulations are considered covered professional services for 
purposes of calculating the APM Incentive Payment.
    This scenario creates difficulty when we attempt to make the APM 
Incentive Payment for the QP because there are no relevant claims in 
our database indicating a TIN to which we should make the APM Incentive 
Payment. We noted in the CY 2021 PFS proposed rule (85 FR 50033 that we 
believe this situation is largely the result of clerical errors or 
delays, either in updates to the APM's Participation List that is 
submitted to CMS by APM participants, or through more general processes 
used to update an eligible clinician's Medicare enrollment information. 
We reminded our enrolled physicians, practitioners, group practices and 
other suppliers that it is their responsibility, in accordance with 
their APM participation and their Medicare enrollment agreement, to 
routinely update their APM participation lists that they submit 
directly to their APMs, as

[[Page 84951]]

well as their lists of enrolled providers assigned to their 
organization and associated TINs, either through the internet-based 
PECOS or using a CMS-855F Form. We reiterate that any payments 
resulting from a failure to make such updates may be considered fraud, 
waste, or abuse.
    However, in the event that a QP's APM Incentive Payment was 
calculated based solely on supplemental services payments and no 
Medicare claims for covered professional services furnished by the QP 
were submitted during the incentive payment base period, we proposed to 
categorically assign these QPs to the list of QPs that will be given 
public notice requesting updated payment information within 60 day 
deadline or November 1st of the payment year, as described in the 
proposed regulation at Sec.  414.1450(c)(8). We noted that we believe 
that in many if not most of these cases, such individuals have retired 
or otherwise ceased participation in Medicare; however, we recognized 
that there may be scenarios under which such individuals remain active, 
and noted that the proposal was meant to provide an opportunity for 
such clinicians to identify their current billing affiliation(s) or 
otherwise identify a TIN to which the APM Incentive Payment should be 
made.
    We did not receive public comments on this provision, and 
therefore, we are finalizing as proposed.
d. Qualifying APM Participant (QP) and Partial QP Determinations
(1) Overview
    In the CY 2017 Quality Payment Program final rule (81 FR 77433 
through 77450), we finalized policies relating to QP and Partial QP 
determinations. In the CY 2019 PFS final rule (83 FR 59923 through 
59925), we finalized additional policies relating to QP determinations 
and the Partial QP election to report to MIPS.
    In the CY 2021 PFS proposed rule (85 FR 50333), we proposed to:
     Update the methodology for addressing prospectively 
aligned beneficiaries for Threshold Score calculations and QP 
determinations.
     Establish a Targeted Review process for QP Determinations.
    Additionally, we clarified our policies on Advanced APM 
determinations and QP determinations in light of questions that may 
arise based on the effects of the PHE for COVID-19.
    We solicited comment on whether to allow an APM Entity to make the 
Partial QP election on behalf of all of the APM Entity's participating 
eligible clinicians.
(2) Background
    In the CY 2017 Quality Payment Program final rule (81 FR 77439 
through 77440), we finalized that QP determinations would first be made 
at the APM Entity level, after which we would make further QP 
determinations at the individual level for eligible clinicians who are 
either: (1) Participating in multiple Advanced APM Entities, none of 
which meet the QP threshold as a group; or (2) on an Affiliated 
Practitioner List that is the list used for the QP determination when 
there are no eligible clinicians on a Participation List for the APM 
Entity (81 FR 77439 through 77443). As such, the QP determination at 
the APM Entity level generally applies to all the individual eligible 
clinicians who are on a Participation List of the Advanced APM. The QP 
determination Threshold Score calculations are aggregated using data 
for all eligible clinicians participating in the APM Entity on each 
snapshot date (March 31, June 30, August 31) during the QP Performance 
Period. If the APM Entity's Threshold Score meets the relevant QP 
threshold, all individual eligible clinicians in that APM Entity would 
receive the same QP determination, applied at the NPI level, for the 
relevant performance year (PY).
(3) Attribution of Prospectively Attributed Beneficiaries in QP 
Threshold Score Calculations
    When making QP determinations, we include information for all 
attribution-eligible beneficiaries in the denominator of the patient 
count and payment amount methods used to calculate QP Threshold Scores 
as set forth in Sec.  414.1435. ``Attribution-eligible beneficiary'' is 
a term defined in our regulation at Sec.  414.1305, and the definition 
is generally based on the attribution methodology and rules for the 
particular Advanced APM. We have specified at Sec.  414.1435(b)(3) that 
a beneficiary may be counted only once in the numerator and denominator 
for a single APM Entity group, and at Sec.  414.1435(b)(4) that a 
beneficiary may be counted multiple times in the numerator and 
denominator for multiple different APM Entity groups.
    When making QP determinations, at the APM Entity or individual 
eligible clinician level, we begin by calculating Threshold Scores, 
which are the ratio of the payment amounts or patient counts for 
``attributed beneficiaries'' to the payment amounts or patient counts 
for ``attribution eligible beneficiaries.'' If this ratio (the 
Threshold Score) for the eligible clinician or APM Entity level, as 
applicable, meets or exceeds the relevant QP thresholds described at 
Sec.  414.1430(a), the relevant eligible clinicians will have attained 
QP status for a year. It has come to our attention that under our 
current methodology for calculating Threshold Scores, we include 
attribution-eligible beneficiaries in the denominator of the 
calculation for some APM Entities for whom those same beneficiaries 
could never be included in the numerator. This may happen in a scenario 
where a beneficiary is attributed to an APM Entity and as a result is 
precluded by the applicable rules for one or more APMs from attribution 
to other APM Entities in certain other APMs.
    For example, the Shared Savings Program offers the option for ACOs 
to select prospective beneficiary assignment, and prospective 
beneficiary alignment is used in the Direct Contracting Model and Next 
Generation ACO Model. When beneficiaries are prospectively attributed 
to an ACO in one of these APMs, under the rules of precedence within 
the APMs themselves, those beneficiaries are generally not available 
for attribution to participants in some other APMs, including other 
ACOs, regardless of attribution methodologies. However, the population 
of attribution-eligible beneficiaries for APM Entities in these other 
APMs still includes those prospectively aligned beneficiaries. This 
could have the effect of disadvantaging the APM Entities to which the 
beneficiaries may never be attributed, because their ratio of 
attributed beneficiaries to attribution-eligible beneficiaries will be 
lower, for reasons entirely outside the control of the relevant 
eligible clinicians and APM Entities.
    Therefore, we proposed to amend Sec.  414.1435(c)(1) of our 
regulations and add a new paragraph (c)(1)(i) to specify that 
beneficiaries who have been prospectively attributed to an APM Entity 
for a QP Performance Period will be excluded from the attribution-
eligible beneficiary count for any other APM Entity that is 
participating in an APM where that beneficiary would be ineligible to 
be added to the APM Entity's attributed beneficiary list. We noted that 
the effect of the proposed policy would be to remove such prospectively 
attributed beneficiaries from the denominators when calculating 
Threshold Scores for APM Entities or individual eligible clinicians in 
Advanced APMs that align beneficiaries retrospectively, thereby 
preventing dilution of the Threshold Score for the APM Entity or 
individual eligible clinician in an Advanced APM that uses 
retrospective attribution.

[[Page 84952]]

    We sought comment on the proposals.
    We received public comments on the removal of prospectively aligned 
beneficiaries. The following is a summary of the comments we received 
and our responses.
    Comment: We received several of comments in support of our proposal 
for the removal of prospectively attributed beneficiaries. Commenters 
requested that we clarify the impact of the policy where beneficiaries 
are attribution eligible for more than one APM Entity, but the rules of 
one or more of the APMs would make it so that the beneficiary could 
only be attributed to one of the APM Entities.
    Response: We appreciate the commenters support for the proposed 
change. The policy as proposed at Sec.  414.1435(c)(1)(i) would have 
the effect of removing those beneficiaries that are prospectively 
attributed to an APM entity from the attribution eligible population 
for all other APM entities where the beneficiary would be excluded from 
attribution.
    For example, when calculating QP determinations for a Shared 
Savings Program ACO, any attribution eligible beneficiaries who are 
prospectively assigned to another ACO, and thus have been precluded 
from assignment to the ACO in question, would be removed from the 
attribution eligible population for the ACO in our calculation. This 
policy will apply to cases where beneficiaries could not be attributed 
to multiple APM entities in a single APM or across multiple APMs.
    We are finalizing this policy as proposed.
(3) Targeted Review of QP Determinations
(i) Overview
    We proposed at Sec.  414.1455(b) to establish a targeted review 
process for limited circumstances surrounding QP determinations. As 
discussed in the CY 2021 PFS proposed rule (85 FR 50334), this targeted 
review process would provide a systematic opportunity for eligible 
clinicians to bring to our attention potential clerical errors we may 
have made, and for us to review and make corrections if warranted. We 
also proposed that, after the conclusion of the time period for 
targeted review, there would be no further review of our QP 
determination with respect to an eligible clinician for the QP 
Performance Period.
    We noted that, consistent with section 1833(z)(4) of the Act and 
under Sec.  414.1455(a) of our regulations, there is no administrative 
or judicial review under sections 1869 or 1878 of the Act or otherwise, 
of the determination that an eligible clinician is a QP or Partial QP 
under Sec.  414.1425, that an APM Entity is an Advanced APM Entity 
under Sec.  414.1410, or of the determination of the amount of the APM 
Incentive Payment under Sec.  414.1450.
(ii) Scope of Targeted Review
    We proposed at Sec.  414.1455(b)(1) that an eligible clinician or 
APM Entity may request targeted review of a QP or Partial QP 
determination only if they believe in good faith that, due to a CMS 
clerical error, an eligible clinician was omitted from a Participation 
List used for purposes of QP determinations. We noted that if we made 
such a clerical error, we believe that it would be appropriate, and we 
proposed, to assign to the erroneously omitted eligible clinician the 
most favorable QP status that was determined at the APM Entity level. 
This would be done on any snapshot dates for the relevant QP 
Performance Period on which the eligible clinician participated in the 
APM Entity. We believe that this policy is appropriate in these 
circumstances because, as a result of a CMS clerical error, the 
eligible clinician was not provided the opportunity to become a QP 
based on the level of payment amounts or patient counts through an 
Advanced APM for an APM Entity with which they were associated.
    Alternatively, if we were to recalculate an APM Entity's Threshold 
Scores for one or more of the snapshot dates in the relevant QP 
Performance Period, and the Threshold Scores no longer met the 
applicable QP threshold(s), that outcome could affect all of the 
eligible clinicians in the APM Entity group, removing their QP status. 
However, the affected eligible clinicians in the APM Entity group are 
likely to have acted in accordance with our notification of their prior 
QP determination, and may not have prepared for or reported to MIPS. In 
correcting our own clerical error with respect to some eligible 
clinicians, we do not believe it would be appropriate to revisit our 
prior QP determinations for a broader set of eligible clinicians, 
thereby potentially disadvantaging those eligible clinicians in MIPS 
scoring through no fault of their own.
    We did not proposed to conduct targeted review of potential 
omissions from Affiliated Practitioner Lists, as QP determinations for 
eligible clinicians on an Affiliated Practitioner List is made at the 
individual eligible clinician level for each of the QP Performance 
Period snapshots. As such, we would not have completed a QP 
determination for the QP Performance Period in question for the 
individual eligible clinician who has been identified prior to the 
targeted review if that eligible clinician was indeed omitted due to 
CMS clerical error. We recognize that this circumstance may occur; 
however, we believe this to be an infrequent occurrence. Additionally, 
such calculations would not be operationally feasible in order to make 
the APM Incentive Payment in a timely manner.
    We did not propose to accept targeted review requests to correct 
omissions from Participation Lists of Other Payer Advanced APMs, as 
those lists are provided to us directly by eligible clinicians and 
Other Payer Advanced APMs. As such, any clerical error would not be the 
fault of CMS.
(iii) Targeted Review Process
    In general, we proposed to align this targeted review process with 
the MIPS targeted review process as codified at Sec.  414.1385. We 
noted this alignment would reduce the likelihood of confusion and 
burden on eligible clinicians and APM Entities. We proposed to 
redesignate our regulation that reflects the statutory preclusion of 
administrative or judicial review under Sec.  414.1455(a) and (b) to 
Sec.  414.1455(a)(1) and (2) and to codify our targeted review policy 
at Sec.  414.1455(b).
    We proposed to specify at Sec.  414.1455(b) that either an eligible 
clinician or APM Entity may submit a request for targeted review. We 
also proposed that all requests for targeted review must be submitted 
during the targeted review request submission period, which is a 60-day 
period that begins on the day CMS makes available the MIPS payment 
adjustment factors for the MIPS payment year as described at Sec.  
414.1385(a)(2) of our regulations. The targeted review request 
submission period may be extended as specified by CMS. We also proposed 
that all requests for targeted review must be submitted in accordance 
with the form and manner specified by CMS.
    We proposed that a request for targeted review may be denied if the 
request is duplicative of another request for a targeted review; the 
request for targeted review is not submitted during the targeted review 
request submission period; or the request is outside the scope of the 
targeted review, as specified in Sec.  414.1455(b)(1). We noted that, 
if the targeted review request is denied, there would be no change to 
either the QP or Partial QP determination. If the targeted review 
request is approved, we will assign the most favorable Threshold Score 
and corresponding QP status determined for

[[Page 84953]]

the APM Entity in which such eligible clinician participates.
    We proposed that we would respond to each timely submitted request 
for targeted review and determine whether a targeted review is 
warranted.
    We proposed that a request for targeted review may include 
additional information in support of the request at the time it is 
submitted. We noted that in cases where CMS requests additional 
information from the eligible clinician or the APM Entity group that is 
the subject of a request for targeted review, the information must be 
provided and received by CMS within 30 days of our request. Non-
responsiveness to a CMS request for additional information may result 
in a final decision based on the information available, although 
another non-duplicative request for a targeted review may be submitted 
before the end of the targeted review request submission period.
    We proposed that if targeted review requests reveal a pattern of 
CMS error with impacts that extend beyond the eligible clinician or 
clinicians who submitted such targeted review requests, we would 
correct any additional errors that we identify regardless of whether a 
targeted review was submitted for the other eligible clinicians 
affected.
    We proposed that decisions based on the targeted review are final, 
and there is no further administrative review or appeal or judicial 
review.
    We sought comment on the proposals.
    We received public comments on the proposed targeted review process 
for QP determinations. The following is a summary of the comments we 
received and our responses.
    Comment: We received several of comments seeking an expanded scope 
of Targeted Review that would include the recalculation of individual 
eligible clinician QP determinations.
    Response: Based on past experience, our proposed targeted review 
process would address the vast majority of cases where a review has 
been necessary. Additionally, as explained in our proposal at (85 FR 
50336), performing additional individual-level QP determination 
calculations, under our current methodology, would not be operationally 
feasible given statutorily determined timelines for making the APM 
Incentive Payment. We may consider recalculation of individual eligible 
clinician QP determinations in future rulemaking.
    Comment: We received a comment stating that our proposed targeted 
review request submission period of 60 days was too short.
    Response: We recognize that participants in the Quality Payment 
Program must meet a number of deadlines. In an effort to maximize the 
efficiency of the program, we believe that the benefits of aligning 
with the MIPS targeted review process outweigh the potential benefit of 
a longer timeline for the targeted review process. Additionally, any 
further delay of the targeted review process could further delay the 
process of making timely APM incentive payments.
    Comment: We received several comments in support of our proposed 
targeted review process for QP determinations.
    Response: We appreciate the support for this proposal.
    We are finalizing this policy as proposed.
(4) PHE for COVID-19 Advanced APM Determination and QP Determinations
(i) Advanced APM Determinations
    In the CY 2021 PFS proposed rule (85 FR 50335), we noted that due 
to the PHE for COVID-19 and the urgent need to address changes to 
certain APMs during CY 2020 to respond to the extreme shifts in the 
healthcare delivery system, we are exercising its enforcement 
discretion in connection with Advanced APM determinations. 
Specifically, we will not reconsider the Advanced APM determinations of 
APMs which have already been evaluated and determined to meet the 
Advanced APM criteria for CY 2019 and CY 2020 even in the event that 
the APMs make changes to their governing documents or operations in 
such a way that, if there were a redetermination, they would no longer 
meet the criteria to be an Advanced APM. Furthermore, we will evaluate 
all APMs in future years with the understanding that any provisions of 
the Participation Agreement or governing regulation designed in 
response to the PHE for COVID-19 will not be considered to the extent 
they would prevent the APM from meeting the Advanced APM criteria for a 
year.
    We noted that the following APMs are considered Advanced APMs for 
2020:
     Bundled Payments for Care Improvement Advanced Model;
     Comprehensive Care for Joint Replacement Payment Model 
(CEHRT Track);
     Comprehensive Primary Care Plus Model;
     Comprehensive ESRD Care Model (LDO arrangement and Non LDO 
Two Sided Risk Arrangement);
     Maryland Total Cost of Care Model (Care Redesign Program; 
Maryland Primary Care Program);
     Medicare Shared Savings Program (Track 2, Track 3, Basic 
Track Level E, and the ENHANCED Track);
     Medicare Accountable Care Organization (ACO) Track 1+ 
Model;
     Next Generation ACO Model;
     Oncology Care Model (Two-Sided Risk Arrangements);
     Vermont All-Payer ACO Model (Vermont Medicare ACO 
Initiative).
    We note that the following APMs are considered Advanced APMs for 
2019:
     Bundled Payments for Care Improvement Advanced Model;
     Comprehensive Care for Joint Replacement Payment Model 
(CEHRT Track);
     Comprehensive Primary Care Plus Model;
     Comprehensive ESRD Care Model (LDO arrangement and Non LDO 
Two Sided Risk Arrangement);
     Maryland Total Cost of Care Model (Care Redesign Program; 
Maryland Primary Care Program);
     Medicare Shared Savings Program (Track 2, Track 3, Basic 
Track Level E, and the ENHANCED Track);
     Medicare Accountable Care Organization (ACO) Track 1+ 
Model;
     Next Generation ACO Model;
     Oncology Care Model (Two-Sided Risk Arrangements);
     Vermont All-Payer ACO Model (Vermont Medicare ACO 
Initiative).
(ii) QP Determinations
    As discussed in the CY 2021 PFS proposed rule (85 FR 50336), we 
also understand that the PHE for COVID-19 may lead to the adoption of 
an earlier end date for certain APMs based on amendments to the APM's 
governing documentation, such as a Participation Agreement. For 
example, an Advanced APM governed by a Participation Agreement was 
originally scheduled to end on December 31, 2020, and the amended 
Participation Agreement may revise the ending date to July 1, 2020. In 
the event that such changes are made to a Participation Agreement to 
modify the end date of an Advanced APM in response to the PHE for 
COVID-19, we would not consider this to be a termination from an 
Advanced APM under Sec.  414.1425(c)(5) or (6) of our regulations. As 
such, we would not revoke the QP status of eligible clinician 
participants in the Advanced APM on that basis.
    We noted that we are aware that circumstances resulting from the 
PHE for COVID-19 could affect the results of QP and Partial QP 
determinations for the 2020 QP Performance Period, as compared to what 
those determinations would otherwise be in absence of the PHE for 
COVID-19.

[[Page 84954]]

    However, after considering whether changes in our methodology to 
address the PHE for COVID-19 were warranted, we determined that any 
change to the QP determination methodology could have unintended 
negative consequences for Advanced APM participants as practice 
patterns have shifted even in areas with a low volume of COVID-19 
cases. We noted that with the duration, scope, and severity of the PHE 
for COVID-19 being unknown, it is impossible to predict the potential 
impact both in terms of scale and which providers may be most likely to 
be affected. As such, we noted that we are concerned that making 
changes to the QP determination methodology would be more likely to 
inadvertently pick winners (those who would benefit from the change in 
methodology by achieving higher scores) and losers (those who would 
score better under our normal methodology than under a changed one) 
than it would be to generate relief from the PHE for COVID-19 across 
the board. We also noted that we anticipate that there would be 
significant challenges resulting from modifying QP calculations with so 
many unknown variables at play, and are concerned that any changes to 
our methodology could result in delays in the timing of our announcing 
QP status.
    We discussed our belief that Advanced APM participants benefit from 
timely and predictable QP determinations. With all of these 
considerations in mind, we clarified that, apart from the exercise of 
enforcement discretion explained above, we would continue to perform QP 
determinations as established in our regulations at Sec. Sec.  
414.1305, 414.1425, 414.1430, 414.1435, and 414.1440 for the 2020 QP 
Performance Period, without modifications to address the PHE for COVID-
19.

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

A. General

    Section 1877 of the Act prohibits a physician from referring a 
Medicare beneficiary for certain designated health services to an 
entity with which the physician (or a member of the physician's 
immediate family) has a financial relationship, unless the financial 
relationship satisfies all requirements of an applicable exception. 
Section 1877 of the Act also prohibits the entity from submitting 
claims to Medicare or billing the beneficiary or any other individual 
or entity for designated health services that are furnished as a result 
of a prohibited referral.
    Section 1877(h)(6) of the Act and Sec.  411.351 of our regulations 
specify that the following items and services are designated health 
services:
     Clinical laboratory services.
     Physical therapy, occupational therapy, and outpatient 
speech-language pathology services.
     Radiology and certain other imaging services.
     Radiation therapy services and supplies.
     Durable medical equipment and supplies.
     Parenteral and enteral nutrients, equipment, and supplies.
     Prosthetics, orthotics, and prosthetic devices and 
supplies.
     Home health services.
     Outpatient prescription drugs.
     Inpatient and outpatient hospital services.

B. Annual Update to the Code List

1. Background
    In Sec.  411.351, we specify that the entire scope of four 
categories of designated health services is defined in a list of CPT/
HCPCS codes (the Code List), which is updated annually to account for 
changes in the most recent CPT and HCPCS Level II publications. The 
categories defined and updated in this manner are:
     Clinical laboratory services.
     Physical therapy, occupational therapy, and outpatient 
speech-language pathology services.
     Radiology and certain other imaging services.
     Radiation therapy services and supplies.
    The Code List also identifies those items and services that may 
qualify for either of the following two exceptions to the physician 
self-referral prohibitions:
     EPO and other dialysis-related drugs (Sec.  411.355(g)).
     Preventive screening tests, immunizations, and vaccines 
(Sec.  411.355(h)).
    The definition of ``designated health services'' at Sec.  411.351 
excludes services for which payment is made by Medicare as part of a 
composite rate (unless the services are specifically included in the 
statutory or regulatory lists of items and services that are designated 
health services and are themselves payable through a composite rate, 
such as home health and inpatient and outpatient hospital services). 
Effective January 1, 2011, EPO and dialysis-related drugs furnished in 
or by an ESRD facility (except drugs for which there are no injectable 
equivalents or other forms of administration), have been reimbursed 
under a composite rate known as the ESRD prospective payment system 
(ESRD PPS) (75 FR 49030). Accordingly, EPO and any dialysis-related 
drugs that are paid for under ESRD PPS are not designated health 
services and are not listed among the drugs that could qualify for the 
exception at Sec.  411.355(g) for EPO and other dialysis-related drugs 
furnished by an ESRD facility.
    ESRD-related oral-only drugs, which are drugs or biologicals with 
no injectable equivalents or other forms of administration other than 
an oral form, were scheduled to be paid under ESRD PPS beginning 
January 1, 2014 (75 FR 49044). However, there have been several delays 
of the implementation of payment of these drugs under ESRD PPS. On 
December 19, 2014, section 204 of the Stephen Beck, Jr., Achieving a 
Better Life Experience Act of 2014 (ABLE) (Pub. L. 113-295) was enacted 
and delayed the inclusion of these oral-only drugs under the ESRD PPS 
until 2025. Until that time, such drugs furnished in or by an ESRD 
facility are not paid as part of a composite rate and, thus, are 
designated health services.
    The United States is responding to an outbreak of respiratory 
disease caused by a novel coronavirus. The virus has been named 
``severe acute respiratory syndrome coronavirus 2'' (``SARS-CoV-2'') 
and the disease it causes has been named ``coronavirus disease 2019'' 
(``COVID-19''). In response to the COVID-19 outbreak, the American 
Medical Association (AMA) has established and published new CPT codes 
on its website to identify currently available SARS-CoV-2 tests (see 
https://www.ama-assn.org/practice-management/cpt/covid-19-cpt-coding-and-guidance). As of the effective date of this rule, tests for COVID-
19 are designated health services, as they fall within the category of 
``clinical laboratory services.''
    The AMA has also established and published two new CPT codes to 
identify each of two COVID-19 vaccines under development, both of which 
are included on the Code List as qualifying for the exception at Sec.  
411.355(h). There are additional COVID-19 vaccines still under 
development, and we anticipate that new CPT or HCPCS codes will be 
established to identify those vaccines as they become available. As 
noted above, in order to qualify for the exception at Sec.  411.355(h), 
a vaccine must be included on the Code List. Therefore, in order to 
ensure that any COVID-19 vaccine to which a CPT or HCPCS code applies 
prior to the publication of the CY 2022 Code List qualifies for the 
exception at Sec.  411.355(h), we are including language in the CY 2021 
Code List to address such vaccines. Under

[[Page 84955]]

this final regulation, the physician self-referral prohibitions do not 
apply to CPT code 90749 (unlisted vaccine/toxoid) when it is used to 
identify a COVID-19 vaccine or to any future CPT or HCPCS code 
designated for a COVID-19 vaccine. This is in addition to the other 
codes listed on the Code List that relate to the application of Sec.  
411.355(h). The inclusion of CPT code 90749 on the Code List is not 
intended and should not be considered to direct or approve the use of 
CPT code 90749 for the identification and billing of any COVID-19 
vaccine. Coding and billing guidance is expected as COVID-19 vaccines 
become available and coverage and billing policies are developed. We 
are making this revision to the Code List to ensure that the physician 
self-referral law does not impede the availability of COVID-19 
vaccines, when they are available, for Medicare (and other) patients. 
CPT and HCPCS codes assigned to any COVID-19 vaccine(s) will be posted 
on CMS.gov as they become available.
    The Code List was last updated in Tables 67 and 68 of the CY 2020 
PFS final rule (84 FR 63100).
2. Response to Comments
    We received no comments relating to the Code List that became 
effective January 1, 2020.
3. Revisions Effective for CY 2021
    The updated, comprehensive Code List effective January 1, 2021, is 
available on our website at https://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/List_of_Codes.
    Additions and deletions to the Code List conform it to the most 
recent publications of CPT and HCPCS Level II and to changes in 
Medicare coverage policy and payment status.
    Tables 58 and 59 identify the additions and deletions, 
respectively, to the comprehensive Code List that become effective 
January 1, 2021. Tables 58 and 59 also identify the additions and 
deletions to the list of codes used to identify the items and services 
that may qualify for the exception in Sec.  411.355(g) (regarding 
dialysis-related outpatient prescription drugs furnished in or by an 
ESRD facility) and in Sec.  411.355(h) (regarding preventive screening 
tests, immunizations, and vaccines).
BILLING CODE 4120-01-P

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[[Page 84957]]


[GRAPHIC] [TIFF OMITTED] TR28DE20.106

BILLING CODE 4120-01-C

VI. Waiver of Delay in Effective Date for This Final Rule

    We are committed to ensuring that we fulfill our statutory 
obligation to update the PFS as required by law and have worked 
diligently in that regard. We ordinarily provide a 60-day delay in the 
effective date of final rules after the date they are issued in 
accordance with the Congressional Review Act (CRA) (5 U.S.C. 
801(a)(3)). However, 5 U.S.C. 808(2) provides that, if an agency finds 
good cause that notice and public procedures are impracticable, 
unnecessary, or contrary to the public interest, the rule shall take 
effect at such time as the agency determines.
    As discussed in the CY 2021 PFS proposed rule (85 FR 50074, 50336), 
the United States is responding to an outbreak of respiratory disease 
caused by a novel (new) coronavirus that has now been detected in more 
than 190 locations internationally, including in all 50 States and the 
District of Columbia. The virus has been named ``SARS CoV 2'' and the 
disease it causes has been named ``coronavirus disease 2019'' 
(abbreviated ``COVID 19'').
    On January 30, 2020, the International Health Regulations Emergency 
Committee of the World Health Organization (WHO) declared the outbreak 
a ``Public Health Emergency of International Concern'' (PHEIC). On 
January 31, 2020, Health and Human Services Secretary, Alex M. Azar II, 
declared a PHE for the United States to aid the nation's healthcare 
community in responding to COVID-19. On March 11, 2020, the WHO 
publicly characterized COVID-19 as a pandemic. On March 13, 2020 the 
President of the United States declared the COVID-19 outbreak a 
national emergency.
    The PFS payment rule is necessary to annually review and update the 
payment systems, and it is critical to ensure that the payment policies 
for these systems are effective on the first day of the year to which 
they are intended to apply. Due to CMS prioritizing efforts in support 
of containing and combatting the PHE for COVID-19, and devoting 
significant resources to that end, we announced in the proposed rule 
that this CY 2021 PFS final rule would not be completed in accordance 
with our usual schedule for this rulemaking, which aims for a 
publication date of at least 60 days before the start of the year to 
which it applies. We announced that we may need up to an additional 30 
days to complete the work needed on this final rule.
    Therefore, in light of the PHE for COVID-19, and the resulting 
strain on CMS's resources to that end, it was impracticable for CMS to 
publish this final rule 60 days prior to the beginning of the upcoming 
year, and CMS has determined that, for good cause, it would be contrary 
to the public interest to delay the effective date of this final rule 
beyond January 1, 2021; and we are waiving the 60-day delay in 
effective date, pursuant to 5 U.S.C. 808(2), and this CY 2021 PFS final 
rule will be effective 30 days after publication. Accordingly, we are 
providing a 30-day delay in the effective date of the final rule in 
accordance with the Administrative Procedure Act (5 U.S.C. 553(d)), 
which ordinarily requires a 30-day delay in the effective date of a 
final rule from the date of its public availability in the Federal 
Register, and section 1871(e)(1)(B)(i) of the Act, which generally 
prohibits a substantive rule from taking effect before the end of the 
30-day period beginning on the date of its public availability.

VII. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 et 
seq.), 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. For the purposes of the PRA and 
this section of the preamble, collection of information is defined 
under 5 CFR 1320.3(c) of OMB's implementing regulations.
    To fairly evaluate whether an information collection should be 
approved by OMB, PRA section 3506(c)(2)(A) requires that we solicit 
comment on the following issues:

[[Page 84958]]

     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 solicited public comment on each of the required issues under 
section 3506(c)(2)(A) of the PRA for the following information 
collection requirements.

A. Wage Estimates

    To derive average costs, we used data from the U.S. Bureau of Labor 
Statistics' May 2019 National Occupational Employment and Wage 
Estimates for all salary estimates (http://www.bls.gov/oes/current/oes_nat.htm). In this regard, Table 60 presents the mean hourly wage, 
the cost of fringe benefits and overhead (calculated at 100 percent of 
salary), and the adjusted hourly wage.
[GRAPHIC] [TIFF OMITTED] TR28DE20.107

    As indicated, we adjusted 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 employer, and because methods of estimating these costs 
vary widely from study to study. Nonetheless, we believe that doubling 
the hourly wage to estimate total cost is a reasonably accurate 
estimation method.
    For the CY 2019 and CY 2020 PFS final rules, we used the BLS wage 
rate for ``Physicians and Surgeons'' (occupation code 29-1060) to 
estimate the burden for Physicians. In BLS' most recent set of 
occupational wage rates dated May 2019, they have discontinued this 
occupation in their wage data. As a result, in order to estimate the 
burden for Physicians, we are using a rate of $212.78/hr which is the 
average of the mean wage rates for Anesthesiologists; Family Medicine 
Physicians; General Internal Medicine Physicians; Obstetricians and 
Gynecologists; Pediatricians, General; Physicians, All Other; and 
Ophthalmologists, Except Pediatric; Psychiatrists; and Surgeons, Except 
Ophthalmologists [($251.66/hr + $205.06/hr + $193.70/hr + $224.62/hr + 
$177.32/hr + $195.62/hr + $211.96/hr + $242.34/hr) / 8].

B. Information Collection Requirements (ICRs)

1. ICRs Regarding Modifications to OTP Enrollment Process (Sec.  
424.67)
    The following requirement and burden changes will be submitted to 
OMB for approval under control numbers 0938-0685 and 0938-1377 
(respectively, CMS-855A and CMS-855B).
a. Form CMS-855B Completion--Estimates in November 15, 2019 Final Rule
    In the aforementioned November 15, 2019 final rule (84 FR 62568), 
we prepared estimates of the hour and cost burdens to OTPs in 
completing the Form CMS-855B (Medicare Enrollment Application Clinics/
Group Practices and Certain Other Suppliers). We are restating them in 
the current rule to help stakeholders better understand the burdens 
associated with our changes to Sec.  424.67.
    Based on SAMHSA statistics and our internal data, we estimated in 
the November 15, 2019 final rule that: (1) About 1,700 certified and 
accredited OTPs were eligible for Medicare enrollment; and (2) 200 OTPs 
would become certified by SAMHSA in the next 3 years (or roughly 67 per 
year). This brought the total number of OTPs eligible to enroll during 
this 3-year period to approximately 1,900.
    We projected that it would take each OTP an average of 3 hours to 
obtain and furnish the required information on the Form CMS-855B and a 
new supplement thereto designed to capture data unique to OTPs. Per our 
experience, we believed that the OTP's medical secretary would secure 
and report the data on the Form CMS-855B and supplement. We estimated 
that this task

[[Page 84959]]

would take approximately 2.5 hours, of which about 30 minutes would 
involve completion of the supplement. In addition, a health diagnosing 
and treating practitioner of the OTP would review and sign the form, a 
process we estimated would take 30 minutes.
    Using BLS' May 2018 wage estimates, we consequently projected a 
first-year burden of 5,301 hours (1,767 entities x 3 hr) at a cost of 
$244,146 [1,767 entities ((2.5 hr x $35.66/hr) + (0.5 hr x $98.04/
hr))]; a second-year burden of 201 hours (67 entities x 3 hr) at a cost 
of $9,257 [67 entities x ((2.5 hr x $35.66/hr) + (0.5 hr $98.04/hr))]; 
and a third-year burden of 198 hours [66 entities x 3 hr) at a cost of 
$9,119 (66 entities x ((2.5 hr x $35.66/hr) + (0.5 hr x $98.04/hr))]. 
In aggregate, we estimated a total 3-year burden of 5,700 hours (5,301 
hr + 201 hr + 198 hr) at a cost of $262,522 ($244,146 + $9,257 + 
$9,119). When averaged over the typical 3-year OMB approval period, we 
estimated an annual burden of 1,900 hours (5,700 hr/3) at a cost of 
$87,507 ($262,522/3).
b. Revisions to Sec.  424.67
(1) Completion of Form CMS-855A
    We foresee three main implications associated with our changes to 
Sec.  424.67. First, newly enrolling OTPs would be able to complete and 
submit a Form CMS-855A (Medicare Enrollment Application--Institutional 
Providers) instead of a Form CMS-855B. Second, we anticipate that 
numerous OTPs that are currently enrolled via the Form CMS-855B would 
terminate the latter enrollments and complete/submit a Form CMS-855A 
application in order to bill for OTP services via the 837I. (As stated 
in revised Sec.  424.67(c), an OTP cannot be enrolled via both the Form 
CMS-855A and Form CMS-855B; it must choose one of these two enrollment 
mechanisms.) Third, it is possible that some OTPs that enroll using the 
Form CMS-855A (pursuant to revised Sec.  424.67(b)) would later change 
their enrollment to a Form CMS-855B.
    In preparing the following OTP enrollment estimates, we: (1) 
Reviewed internal PECOS and billing data concerning existing OTP Form 
CMS-855 enrollments and claim submissions; and (2) considered feedback 
recently received from the OTP community regarding potential billing 
and enrollment options. Based on this, we project that over the first 3 
years of our changes to Sec.  424.67:
     Roughly one-half (or 33) of the previously estimated 67 
annually enrolling OTPs (that is, in Years 2 and 3 and beyond) would 
elect to complete a Form CMS-855A rather than a Form CMS-855B.
     Approximately 300 currently enrolled OTPs would change 
their enrollment from a Form CMS-855B to a Form CMS-855A.
     About 10 OTPs that enroll using the Form CMS-855A would 
later change their enrollment to a Form CMS-855B.
(a) New OTPs Enrolling Via the Form CMS-855A
    We estimate that it would take each OTP approximately 4 hours to 
secure and provide the relevant data on the Form CMS-855A and the new 
supplement thereto (which would capture OTP-specific information). 
Consistent with our experience, the OTP's medical secretary would 
obtain and report information on the Form CMS-855A and supplement, a 
task that would take roughly 3.5 hours (about 30 minutes of which would 
involve completion of the supplement). A health diagnosing and treating 
practitioner of the OTP would spend 30 minutes reviewing and signing 
the form.
    Given the preceding data, we project an annual burden for new OTPs 
seeking to complete a Form CMS-855A of 132 hours (4 hr x 33 OTPs) at a 
cost of $5,855 (33 OTPs x ((3.5 hr x $36.62/hr) + (0.5 hr x $98.52/
hr)). Since these OTPs would not be completing the Form CMS-855B as 
originally anticipated in the November 15, 2019 final rule and approved 
by OMB in that rule's collection of information request, we must revise 
the Form CMS-855B estimates identified therein. Using the hour and wage 
burdens from that rule, we project a Form CMS-855B annual burden 
reduction of 99 hours (33 OTPs x 3 hr) at a cost of $4,560 (33 OTPs x 
(2.5 hr x $35.66/hr) + (0.5 hr x $98.04/hr)).
(b) Enrolled OTPs Transitioning to Form CMS-855A or Form CMS-855B 
Enrollment
    As already mentioned, we believe that roughly:
    ++ 300 currently enrolled OTPs would change their enrollment from a 
Form CMS-855B to a Form CMS-855A.
    ++ 10 OTPs that enroll using the Form CMS-855A would later change 
their enrollment to a Form CMS-855B.
    This would involve the OTP's completion of a Form CMS-855A or Form 
CMS-855B application as a new enrollment. We note that in our proposed 
estimates, we had stated that these OTPs would also need to report the 
voluntary termination of their existing Form CMS-855 enrollment via the 
latter form (that is, if the OTP is ceasing its Form CMS-855B 
enrollment, it would report this via a Form CMS-855B voluntary 
termination submission). Upon further analysis and reflection, this 
step will not be necessary; termination of the prior enrollment will 
done by the Medicare contractor systematically. Accordingly, we are not 
finalizing our estimates of the burden associated with completing a 
Form CMS-855 voluntary termination application.
(i) Transition to Form CMS-855A Enrollment
    Under our previously mentioned Form CMS-855A hour and wage 
estimates, we project a total burden for new Form CMS-855A enrollments 
pursuant to revised Sec.  424.67(b) of 1,200 hours (300 OTPs x 4 hr) at 
a cost of $53,229 (300 OTPs x ((3.5 hr x $36.62/hr) + (0.5 hr x $98.52/
hr)). We believe this burden would be incurred exclusively in the first 
year following our changes; it is very likely these OTPs would wish to 
pursue Form CMS-855A enrollment as soon as possible in order to bill 
via the 837I. Over the first 3 years, the average annual burden would 
be 400 hours (1,200 hr/3) at a cost of $17,743 ($53,229/3).
(ii) Transition to Form CMS-855B Enrollment
    In line with our hour and wage estimates previously referenced in 
this section VII.B.1. of this final rule, we project a total burden for 
new Form CMS-855B enrollments under Sec.  424.67(c)(2) of 30 hours (10 
OTPs x 3 hr) at a cost of $1,480 (10 OTPs x ((2.5 hr x $36.62/hr) + 
(0.5 hr x $98.52/hr)). We anticipate that changes to a Form CMS-855B 
enrollment would occur in the second and third years following the 
effective date of our revisions. This is because Year 1 would mostly 
involve these new OTPs enrolling for the first time via the Form-855A; 
only in the succeeding 2 years would they switch to a Form CMS-855B 
enrollment. We thus project that the average annual burden in the first 
3 years would be 10 hours (30 hr/3) at a cost of $469 ($1,408/3).
(2) Total Annual Burden
    In light of foregoing estimates, and when averaged over the typical 
3-year OMB approval period, we estimate the following:
     Form CMS-855A--The total annual increased burden would be 
532 hours (132 hr + 400 hr) at a cost of $23,598 ($5,855 + $17,743).
     Form CMS-855B--We project a reduction in annual burden of 
-89 hours (-99 hr-10 hr) and $4,091 (-$4,560-$469).

[[Page 84960]]

(3) Application Fee
    Under Sec.  424.67(b)(2), an enrolling OTP must comply with the 
application fee requirements in Sec.  424.514. This means, in short, 
that an OTP must pay the required application fee as part of the 
enrollment process. The application fee does not meet the definition of 
a ``collection of information'' and, as such, is not subject to the 
requirements of the PRA. Although we did not set out such burden under 
this section of the preamble, the cost is included under the Regulatory 
Impact Analysis section.
(4) Fingerprinting
    We discussed in section III.B. of this final rule that certain OTPs 
are subject to the high-risk level of categorical screening under Sec.  
424.518. Said screening includes the submission of a set of 
fingerprints (via FBI Applicant Fingerprint Card FD-258) for a national 
background check from all individuals who maintain a 5 percent or 
greater direct or indirect ownership interest in the provider or 
supplier. In the November 15, 2019 final rule, we calculated the hour 
and cost burden associated with this activity, basing our estimates on 
an anticipated 1,900 total OTP enrollees over the 3-year period 
following publication of that rule.
    We do not believe our revisions to Sec.  424.67 would involve any 
additional or reduced fingerprinting burden for two reasons. First, we 
specify in revised Sec.  424.67(b)(3)(ii) that, in effect, Form CMS-
855B-enrolled OTPs that are changing to a Form CMS-855A enrollment need 
only undergo the limited level of categorical screening (Sec.  424.518) 
if they have (as part of their Form CMS-855 enrollment) already 
successfully completed the moderate or high level of categorical 
screening under that same regulatory section. Since completion of 
moderate or high level screening (as applicable) would have been 
required for Form CMS-855B OTP enrollment, these OTPs (previously 
estimated at 300 total) would not have to again undergo fingerprinting 
as part of their Form CMS-855A enrollment. Second, and with the 
exception of the 300 new enrollments mentioned in the previous 
sentence, we do not foresee additional enrolling OTPs beyond: (1) The 
1,900 which we estimated in the November 15, 2019 final rule; and (2) 
the roughly 67 newly enrolling OTPs in Year 2 and Year 3 and annually 
thereafter. In other words, the only change we project would be in the 
type of Form CMS-855 application these OTPs may complete, not the 
number of anticipated enrollees. As such, the total fingerprinting 
burden would not change.
    We received no comments regarding our ICR estimates pertaining to 
OTP provider enrollment.
2. ICRs Regarding the Medicare Shared Savings Program (42 CFR Part 425)
    Section 1899(e) of the Act provides that chapter 35 of title 44 
U.S.C., which includes such provisions as the PRA, shall not apply to 
the Shared Savings Program. Accordingly, we are not setting out burden 
under the authority of the PRA. Please refer to sections VIII.H.7.a., 
VIII.H.7.b., VIII.H.7.c., and VIII.H.8. of this final rule for a 
discussion of the impacts associated with this rule's changes to the 
Shared Savings Program's quality reporting requirements, beneficiary 
assignment methodology, and repayment mechanism requirements, and 
section VIII.H.7.c. of this final rule for a discussion of the impacts 
associated with finalization of Shared Savings Program policies 
established in the May 8th COVID-19 IFC.
3. ICRs Regarding the Requirement for Electronic Prescribing for 
Controlled Substances for a Covered Part D Drug Under a Prescription 
Drug Plan or an MA-PD Plan Sec.  423.160(a)
    When ready, the following changes will be submitted to OMB through 
the standard PRA process for approval under control number 0938-TBD 
(CMS-10755). The standard PRA process includes the publication of 60- 
and 30-day Federal Register notices, which we expect to publish shortly 
after the publication of this final rule. Please note that the proposed 
rule indicated (85 FR 50340) that the changes would be submitted under 
control number 0938-0763 (CMS-R-262). However, based on internal review 
we have since determined that the changes should be set out under a new 
collection of information request. Importantly, the new collection of 
information request (0938-TBD; CMS-10755) has no effect on our proposed 
and final requirements and burden estimates. Rather, we are simply 
changing the location of those requirements and burden estimates. 
Please note that OMB will issue the new control number when ready. In 
the meantime it is to be determined (or ``TBD''). The new collection of 
information request's CMS identification number (CMS-10755) is not 
subject to change.
    We are implementing section 2003 of the SUPPORT for Patients and 
Communities Act, which requires that the prescribing of a Schedule II, 
III, IV, or V controlled substance under Medicare Part D be done 
electronically in accordance with an electronic prescription drug 
program beginning January 1, 2021, subject to any exceptions, which HHS 
may specify. We are requiring prescribers to use the NCPDP SCRIPT 
2017071 standard for Electronic Prescription for Controlled Substances 
(EPCS) prescription transmissions beginning January 1, 2021.
    In the first year of implementation, we expect that prescribers 
would have to revise their policies and procedures and-train staff on 
this new requirement. Based on our conversations with providers, EHR 
vendors, and Part D plans, we understand that because electronic 
prescribing is so widespread and vendors train the staff directly and 
set-up their systems, we estimate that this transition could be 
completed with a one-time burden of 5 hours at $36.62/hr by an 
Administrative Assistant or Medical Secretary. We solicited comments on 
this assumption and, we received several public comments related to the 
numbers used for this burden estimate assumption for the Electronic 
Prescribing for Controlled Substances for a Covered Part D Drug Under a 
Prescription Drug Plan or an MA-PD Plan.
    Comment: Several commenters expressed concerns that CMS' proposal 
assumes these functionalities to be successful, when in actuality they 
still require significant fixes and delayed implementation timelines. 
Perhaps the biggest challenge clinicians will face, commenters stated, 
is incorporating EPCS into their EHRs, and most clinician practices are 
not in a position to cover the costs and acquire the necessary 
resources for technical or system upgrades required by EHR vendors--
especially rural and small practices. Commenters stated that due to the 
PHE for COVID-19, many practices have been forced to delay or cancel 
implementation altogether of EHRs that support EPCS due to the 
implementation cost. Commenters expressed concern that practices that 
do not currently even have the capability to prescribe electronically 
would be forced to purchase such a software. A commenter supported the 
intent to facilitate efficiency, convenience, and better security with 
the implementation of EPCS, but encourages CMS to avoid unreasonable 
burden imposed upon clinicians and delay compliance until at least 
January 1, 2023.
    Response: We are aware of the difficulties that many clinicians may 
face when implementing EPCS. Given that the mandate is statutory with 
potentially broad public health

[[Page 84961]]

implications, we believe a January 1, 2021 effective date complies with 
the statutory intent and would enable the safety and other benefits 
previously discussed to be put in place during the current pandemic. 
However, to help ensure that the burden on prescribers is not 
unreasonable, we will be finalizing a compliance date of January 1, 
2022 such that prescribers who do not implement the NCPDP SCRIPT 
2017071 standard for electronic prescribing of Schedule II, III, IV, 
and V controlled substances until January 1, 2022 will still be 
considered compliant with the requirement. We have also adjusted the 
estimate of the provider burden to accurately reflect fixing any issues 
that may arise.
    Comment: One commenter expressed concern with the health care 
provider burden associated with reporting EPCS transactions to CMS.
    Response: Based on internal CMS data, there are 425,000 Part D 
prescribing practices. Based on the increasing rate of doctors 
conducting e-prescribing thus far in light of the current social 
distancing guidelines, currently, 61 percent of Part D prescribers have 
electronic prescribing capabilities absent the requirement. Therefore, 
the one-time burden to implement this provision is 828,750 hours 
(165,750 prescribers * 5 hr) at a cost of $30,348,825 (828,750 hr * 
$36.62/hr). Based on the modeling that we have seen, we have found that 
EHR companies provide the initial set-up of e-prescribing software free 
of charge, provided the prescribers pay the per transaction cost of 
$1.88 mentioned previously. Based on the comments received, we 
understand that implementing EPCS can lead to technological glitches, 
and then fixing those issues. We understand that the EHR companies 
remedy the issues free of charge. However, we understand that such 
fixes take time away from the medical office staff. We estimate that 
such fixes would take the staff approximately 1 extra hour when 
averaged across all prescribers. As a result, we have changed our one-
time burden estimate from 5 hours to 6 hours per provider, which means 
a total of 994,500 hours (165,750 * 6 hr) at a cost of $36,418,590 
(994,500 hr * 36.62).
4. ICRs Regarding the Medicare Diabetes Prevention Program (MDPP) 
Expanded Model
    In section III.P. of this final rule, we finalize policies 
necessary to allow certain flexibilities for Medicare enrolled MDPP 
suppliers and eligible beneficiaries in the MDPP Expanded Model during 
a PHE. Section 1115A(d)(3) of the Act exempts Innovation Center model 
tests and expansions, which include the MDPP expanded model, from the 
provisions of the PRA.
5. The Quality Payment Program (42 CFR Part 414 and Section IV. of This 
Final Rule)
    The following QPP-specific ICRs reflect this rule's finalized 
policy changes and policies that have been finalized in our CY 2017 and 
2018 Quality Payment Program final rules (81 FR 77008 and 82 FR 53568, 
respectively), and our CY 2019 and CY 2020 PFS final rules (83 FR 59452 
and 84 FR 62568, respectively).
a. Background
(1) ICRs Associated With MIPS and Advanced APMs
    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 (see section VII.B.5.b of this final 
rule); QCDR self-nomination applications and other requirements (see 
section VII.B.5.c.(2) of this final rule); qualified registry self-
nomination applications and other requirements (see section 
VII.B.5.c.(3) of this final rule); CAHPS survey vendor applications 
(see section VII.B.5.c.(4) of this final rule); Open Authorization 
credentialing and token request process (see section VII.B.5.d of this 
final rule); Quality Payment Program Identity Management Application 
Process (see section VII.B.5.e.(3) of this final rule); quality 
performance category data submission by Medicare Part B claims 
collection type (see section VII.B.5.e.(4) of this final rule), QCDR 
and MIPS CQM collection type (see section VII.B.5.e.(5) of this final 
rule), eCQM collection type (see section VII.B.5.e.(6) of this final 
rule), and CMS Web Interface collection type (see section VII.B.5.e.(7) 
of this final rule); CAHPS for MIPS survey beneficiary participation 
(see section VII.B.5.e.(8) of this final rule); group registration for 
CMS Web Interface (see section VII.B.5.e.(9) of this final rule); group 
registration for CAHPS for MIPS survey (see section VII.B.5.e.(10) of 
this final rule); call for quality measures (see section VII.B.5.f of 
this final rule); reweighting applications for Promoting 
Interoperability and other performance categories (see section 
VII.B.5.g.(2) of this final rule); Promoting Interoperability 
performance category data submission (see section VII.B.5.g.(3) of this 
final rule); call for Promoting Interoperability measures (see section 
VII.B.5.h of this final rule); improvement activities performance 
category data submission (see section VII.B.5.i of this final rule); 
nomination of improvement activities (see section VII.B.5.j of this 
final rule); nomination of MVPs (see section VII.B.5.k of this final 
rule); and opt-out of Physician Compare for voluntary participants (see 
section VII.B.5.o of this final rule).
    The ICRs for Advanced APMs consist of: Partial Qualifying APM 
Participant (QP) election (section VII.B.5.m of this final rule); Other 
Payer Advanced APM identification: Payer Initiated and Eligible 
Clinician Initiated Processes (sections VII.B.5.n.(1) and (2) of this 
final rule); and submission of data for QP determinations under the 
All-Payer Combination Option (section VII.B.5.n.(3) of this final 
rule).
(2) Summary of Quality Payment Program Changes: MIPS
    Nine MIPS ICRs [(1) QCDR self-nomination applications, (2) 
Qualified Registry self-nomination applications, (3) quality 
performance category data submission by QCDR and MIPS CQM collection 
type, (4) quality performance category data submission by eCQM 
collection type, (5) quality performance category data submission by 
CMS Web Interface collection type, (6) group registration for the CMS 
Web Interface, (7) CAHPS for MIPS survey beneficiary participation, (8) 
nomination of improvement activities, and (9) reweighting applications 
for Promoting Interoperability and other performance categories] show 
changes in burden due to finalized policies. In aggregate, we estimate 
the policies will result in a net increase in burden of +1,163 hours 
and +$120,391 for the 2021 MIPS performance period and -4,763 hours and 
-$421,117 for the 2022 MIPS performance period. The provisions 
discussed in section VII.A.3.g. to require QCDRs and qualified 
registries to conduct targeted audits if one or more deficiencies or 
data errors are identified in an annual data validation audit will 
increase the annual burden hours for both QCDRs and qualified 
registries by a range of 5 to 10 hours per audit. The provision 
discussed in section IV.A.3.c.(1)(c) of this final rule to sunset the 
CMS Web Interface measures as a collection type/submission type 
starting with the 2022 MIPS performance period will result in removal 
of the quality performance category data submission by CMS Web 
Interface collection type and group registration for the CMS Web 
Interface ICRs beginning with the 2022 MIPS performance period. The 
same provision will increase the number of respondents for both the 
MIPS CQM and QCDR and eCQM collection types for

[[Page 84962]]

the quality performance category beginning with the 2022 MIPS 
performance period as we assume respondents who previously submitted 
via the CMS Web Interface collection type will alternatively utilize 
one of these collection types to submit quality data in the 2022 MIPS 
performance period. The provision discussed in section 
IV.A.3.c.(1)(f)(i) of this final rule to add a survey-based measure on 
telehealth that assesses patient-reported usage of telehealth services 
to the CAHPS for MIPS Survey will increase the time required for 
beneficiaries to respond to the survey by 0.2 minutes (0.0033 hours) 
per beneficiary. The provision discussed in section 
IV.A.3.c.(3)(b)(i)(B)(bb) of this final rule to require nominated 
improvement activities to be linked to existing and related quality and 
cost measures, as applicable and feasible will increase the time by 1 
hour per improvement activity nominated. Finally, the provision 
discussed in section IV.A.3.c.(5)(e) of this final rule to allow APM 
Entities the ability to submit an extreme and uncontrollable 
circumstances exception application will increase our estimated number 
of respondents by 7 APM Entities. The remaining changes to our 
currently approved burden estimates are adjustments due to the use of 
updated data sources available at the time of publication of this final 
rule.
    We have also added two new ICRs (Open Authorization (OAuth) 
Credentialing and Token Request Process (see section VII.B.5.d of this 
final rule) and the Nomination of MVPs (see section VII.B.5.k of this 
final rule). The Open Authorization (OAuth) Credentialing and Token 
Request Process ICR reflects the burden associated with the 
availability of a new process for all submitter types to request 
approval to submit data via direct upload to CMS. The Nomination of 
MVPs reflects the burden associated with a new process available for 
all stakeholders to nominate MVPs for inclusion in the Quality Payment 
Program.
    We are not making any changes or adjustments to the following ICRs: 
Registration for virtual groups, CAHPS survey vendor applications, 
Quality Payment Program Identity Management Application Process, group 
registration for CAHPS for MIPS survey; call for MIPS quality measures; 
and call for Promoting Interoperability measures. See section VII.B.5. 
of this final rule for a summary of the ICRs, the overall burden 
estimates, and a summary of the assumption and data changes affecting 
each ICR.
    The accuracy of our estimates of the total burden for data 
submission under the quality, Promoting Interoperability, and 
improvement activities performance categories may be impacted due to 
two primary reasons. First, we are unable to predict with 100 percent 
certainty who will be a QP. New eligible clinician participants in 
Advanced APMs who become QPs would be excluded from MIPS reporting 
requirements and payment adjustments, and as such, unlikely to report 
under MIPS; while some current Advanced APM participants may end 
participation such that the APM Entity's eligible clinicians would not 
be QPs for a year based on Sec.  414.1425(c)(5), and thus be required 
to report under MIPS. Second, it is difficult to predict what Partial 
QPs, who can elect whether to report to MIPS, will do in the 2021 MIPS 
performance period compared to the 2019 MIPS performance period, and 
therefore, the actual number of Advanced APM participants and how they 
elect to submit data may be different than our estimates. However, we 
believe our estimates are the most appropriate given the available 
data.
(3) Summary of Quality Payment Program Changes: Advanced APMs
    For these ICRs (identified above under, ``ICRs Associated with MIPS 
and Advanced APMs''), the changes to currently approved burden 
estimates are adjustments based on updated projections for the 2021 
MIPS performance period. We are not making any changes to the Other 
Payer Advanced APM identification: Eligible Clinician Initiated Process 
and submission of Data for QP determinations under the All-Payer 
Combination Option ICRs.
(4) Framework for Understanding the Burden of MIPS Data Submission
    Because of the wide range of information collection requirements 
under MIPS, Table 61 presents a framework for understanding how the 
organizations permitted or required to submit data on behalf of 
clinicians vary across the types of data, and whether the clinician is 
a MIPS eligible clinician or other eligible clinician voluntarily 
submitting data, MIPS APM participant, or an Advanced APM participant. 
As shown in the first row of Table 61, 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 data submission requirements as groups, and therefore, we will 
refer only to groups for the remainder of this section unless otherwise 
noted. Because MIPS eligible clinicians are not required to submit 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 61.
    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. As discussed in section IV.A.3.b. of this final 
rule, for clinicians in APM Entities, the APM Performance Pathway is 
available for both ACO and non ACOs to submit quality data. Due to data 
limitations and our inability to determine who would use the APM 
Performance Pathway versus the traditional MIPS submission mechanism 
for the 2021 MIPS performance period, we assume ACO APM Entities will 
submit data through the APM Performance Pathway, using the CMS Web 
Interface option, and non-ACO APM Entities would participate through 
traditional MIPS, thereby submitting as an individual or group rather 
than as an entity.
    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 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 described 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.
    Eligible clinicians who attain Partial QP status 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).
BILLING CODE 4120-01-P

[[Page 84963]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.108

BILLING CODE 4120-01-C
    The policies finalized in the CY 2017 and CY 2018 Quality Payment 
Program final rules, the CY 2019 and CY 2020 PFS final rules, and 
continued in this

[[Page 84964]]

final rule create some additional data collection requirements not 
listed in Table 61. These additional data collections, some of which 
are currently approved by OMB under the control numbers 0938-1314 
(Quality Payment Program, CMS-10621) and 0938-1222 (CAHPS for MIPS, 
CMS-10450), are as follows:
Additional ICRs Related to MIPS Third-Party Intermediaries (See Section 
VII.B.5.c)
     Self-nomination of new and returning QCDRs (81 FR 77507 
through 77508, 82 FR 53906 through 53908, and 83 FR 59998 through 
60000) (OMB 0938-1314).
     Self-nomination of new and returning registries (81 FR 
77507 through 77508, 82 FR 53906 through 53908, and 83 FR 59997 through 
59998) (OMB 0938-1314).
     Approval process for new and returning CAHPS for MIPS 
survey vendors (82 FR 53908) (OMB 0938-1222).
     Open Authorization Credentialing and Token Request Process 
(New) (OMB 0938-1314) (see section VII.B.5.d).
Additional ICRs Related to the Data Submission and the Quality 
Performance Category (See Section VII.B.5.e)
     CAHPS for MIPS survey completion by beneficiaries (81 FR 
77509, 82 FR 53916 through 53917, and 83 FR 60008 through 60009) (OMB 
0938-1222).
     Quality Payment Program Identity Management Application 
Process (82 FR 53914 and 83 FR 60003 through 60004) (OMB 0938-1314).
Additional ICRs Related to the Promoting Interoperability Performance 
Category (See Section VII.B.5.g)
     Reweighting Applications for Promoting Interoperability 
and other performance categories (82 FR 53918 and 83 FR 60011 through 
60012) (OMB 0938-1314).
Additional ICRs Related To Call for New MIPS Measures and Activities 
(See Sections VII.B.5.f, VII.B.5.h, VII.B.5.j. and VII.B.5.k)
     Nomination of improvement activities (82 FR 53922 and 83 
FR 60017 through 60018) (OMB 0938-1314).
     Call for new Promoting Interoperability measures (83 FR 
60014 through 60015) (OMB 0938-1314).
     Call for MIPS quality measures (83 FR 60010 through 60011) 
(OMB 0938-1314).
     Nomination of MVPs (OMB 0938-1314).
Additional ICRs Related to MIPS (See Section VII.B.5.o)
     Opt out of performance data display on Physician Compare 
for voluntary reporters under MIPS (82 FR 53924 through 53925 and 83 FR 
60022) (OMB 0938-1314).
Additional ICRs Related to APMs (See Sections VII.B.5.m and VII.B.5.n)
     Partial QP Election (81 FR 77512 through 77513, 82 FR 
53922 through 53923, and 83 FR 60018 through 60019) (OMB 0938-1314).
     Other Payer Advanced APM determinations: Payer Initiated 
Process (82 FR 53923 through 53924 and 83 FR 60019 through 60020) (OMB 
0938-1314).
     Other Payer Advanced APM determinations: Eligible 
Clinician Initiated Process (82 FR 53924 and 83 FR 60020) (OMB 0938-
1314).
     Submission of Data for All-Payer QP Determinations (83 FR 
60021) (OMB 0938-1314).
b. ICRs Regarding the Virtual Group Election (Sec.  414.1315)
    This rule is not implementing any new or revised collection of 
information requirements or burden 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.
c. ICRs Regarding Third-Party Intermediaries (Sec.  414.1400)
    In section IV.A.3.g. of this rule, we discuss multiple changes to 
the third party intermediary regulations at Sec.  414.1400. 
Specifically, we are: (1) Amending current requirements for approval of 
third party intermediaries to take into account past performance and 
provision of inaccurate information regarding MIPS program requirements 
to eligible clinicians; (2) requiring attendance by all third party 
intermediaries for training and support sessions; (3) requiring that 
QCDRs and qualified registries must conduct an annual data validation 
audit and if one or more deficiencies or data errors are identified 
also conduct targeted audits; (4) incrementally increasing requirements 
for QCDR measure testing and clarify what is meant by full testing; and 
(5) requiring third party intermediaries to submit a CAP to address 
identified deficiencies and data issues, as well as actions to prevent 
recurrence. The collection of information burdens associated with each 
of these topics are discussed separately below for qualified 
registries, QCDRs, and survey vendors.
(1) Background
    Under MIPS, the 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 either one quality performance category measure, or towards 
an improvement activity, can be submitted via CMS-approved survey 
vendors. Entities seeking approval to submit data on behalf of 
clinicians as a qualified registry, QCDR, or survey vendor must 
complete a self-nominate process annually.\147\ The processes for self-
nomination for entities seeking approval as qualified registries and 
QCDRs are similar with the exception that QCDRs have the option to 
nominate QCDR measures for approval for the reporting of quality 
performance category data. Therefore, differences between QCDRs and 
qualified registry self-nomination are associated with the preparation 
of QCDR measures for approval.
---------------------------------------------------------------------------

    \147\ As stated in the CY 2019 PFS final rule (83 FR 53998), 
health IT vendors are not included in the burden estimates for MIPS.
---------------------------------------------------------------------------

(2) QCDR Self-Nomination Applications
    The requirements and burden associated with this rule's data 
submission changes related to QCDRs will be submitted to OMB for 
approval under control number 0938-1314 (CMS-10621). For simplicity and 
due to limitations in data available, the changes in burden for QCDRs 
and qualified registries associated with the finalized policies 
regarding CAPs have been incorporated into the discussion of burden for 
qualified registries.
(a) Self-Nomination Process and Other Requirements
    We refer readers to Sec.  414.1400(a)(4) which states that QCDRs 
interested in submitting MIPS data to us on behalf of a MIPS eligible 
clinician, group, or virtual group will need to complete a self-
nomination process to be considered for approval to do so. We also 
refer readers to Sec.  414.1400(b) and the CY 2017 Quality Payment 
Program final rule (81 FR 77507 through 77508), CY 2018 Quality Payment 
Program final rule (82 FR 53906 through 53908), CY 2019 PFS final rule 
(83 FR 59998 through 60000), and the CY 2020 PFS final rule (84 FR 
63116 through 63121) for our previously finalized requirements and 
burden for self-

[[Page 84965]]

nomination of QCDRs and nomination of QCDR measures.
    In section VII.A.3.g.(2)(a) of this rule, we are codifying that 
beginning with the 2023 payment year as a condition of approval each 
QCDR must conduct annual data validation audits that conform to the 
requirements in Sec.  414.1400(b)(2)(iv), including specific 
obligations discussed in detail in those sections, and if one or more 
deficiencies or data errors are identified the QCDR must also conduct 
targeted audits that conform to the Sec.  414.1400(b)(2)(v) including 
specific obligations discussed in detail in those sections. In 
particular, we are codifying at Sec.  414.1400(b)(2)(iv)(G), that in a 
form and manner and by a deadline specified by CMS, the QCDR must 
report the results of each data validation audit, including the overall 
deficiency or data error rate, the types of deficiencies or data errors 
discovered, the percentage of clinicians impacted by any deficiency or 
data error, and how and when each deficiency or data error type was 
corrected. In addition, we are codifying at Sec.  414.1400(b)(2)(v)(D), 
that in a form and manner and by a deadline specified by CMS, the QCDR 
must report the results of each targeted audit, including the overall 
deficiency or data error rate, the types of deficiencies or data errors 
discovered, the percentage of clinicians impacted by each deficiency or 
data error, and how and when each deficiency or data error type was 
corrected. We are not revising our burden estimates as a result of the 
provision to codify that QCDRs must conduct particular data validation 
audits and report data validation results because we believe the 
burdens of the data validation requirements are not greater than 
existing expectations for which we have already accounted the 
associated burden as stated in the CY 2017 Quality Payment Program 
final rule (81 FR 77383 through 77384) and the CY 2019 PFS final rule 
(83 FR 59998 through 59999) and previously submitted to OMB for 
approval under control number 0938-1314 (CMS-10621).
    With regard to the provision to require QCDRs to conduct targeted 
audits if one or more data errors are identified during data validation 
audits, we solicited comment on the burdens associated with the 
requirements for data validation audits and targeted audits, including 
expected frequency of targeted audits and the anticipated scope of 
effort related to submitting results to assist in estimating the burden 
associated with this provision, but received no comments. However, we 
are including burden estimates associated with this finalized 
requirement based on our best available analysis. Due to the unknown 
scope of patient records that may need to be audited, we estimate a 
range of effort to complete a targeted data audit from a minimum of 5 
hours to a maximum of 10 hours at a cost ranging from $462.30 ($92.46/
hr x 5 hrs) to $924.60 ($92.46/hr x 10 hrs) per targeted audit. In the 
2019 MIPS performance period, 23 of the 77 QCDRs (30%) that submitted 
2019 MIPS quality data were required to complete a targeted audit. 
Based on the results of the 2020 self-nomination period, 58 QCDRs have 
been approved for the 2021 MIPS performance period; assuming the same 
percentage, we estimate 17 QCDRs (58 x 30%) will be required to 
complete targeted audits. Therefore we estimate the total impact 
associated with QCDRs completing targeted audits will range from 85 
hours (17 audits x 5 hrs/audit) at a cost of $7,859 (17 audits x 
$462.30/audit) to 170 hours (17 audits x 10 hrs/audit) at a cost of 
$15,718 (17 audits x $924.60/audit). We also discuss additional impacts 
of this provision in section VIII.H.15.e.(4)(d) of the Regulatory 
Impact Analysis.
    In section VII.A.3.g.(1)(b)(iii) of this rule, we are codifying 
that beginning with the 2023 MIPS payment year, third party 
intermediaries must attend and complete training and support sessions 
in the form and manner and at the times, specified by CMS. Due to the 
nature of the information provided during these calls and because the 
training requirements as applied to qualified registries and QDCRs are 
similar to existing expectations for these entities, we are not 
revising our burden estimates as a result of the provisions. However, 
we refer readers to section VIII.H.15.e.(4)(d) of this final rule for 
discussion of our estimates of overall impact.
    In section VII.A.3.g.(1)(b)(ii) of this rule, we discussed that the 
determination of whether to approve as entity as a third party 
intermediary for a MIPS performance period may take into account: (1) 
Whether the entity failed to comply with requirements of third party 
intermediaries for any prior MIPS payment year for which it was 
approved as third party intermediary; and (2) whether the entity 
provided inaccurate information regarding the requirements of this 
subpart to any eligible clinician. Because this provision does not 
require any additional effort for affected entities but instead allows 
CMS to utilize already available information to make approval 
decisions, collection of information burden is unaffected for all 
entities. In addition, we do not anticipate this provision will result 
in any QCDRs electing not to self-nominate during the 2021 MIPS 
performance period, but believe it is possible this may occur. However, 
we have neither any data nor knowledge of intent from previously 
approved QCDRs with which to support making any changes to our burden 
estimates as a result of this policy. We solicited public feedback to 
help us determine if there are any burden implications. We did not 
receive comments related to this provision.
    For this rule, we are adjusting the number of QCDRs we assume will 
self-nominate for the CY 2022 performance period from the currently 
approved estimate of 76 to 82, an increase of 6 from the currently 
approved estimate based on the number of self-nominations received 
during the CY 2020 nomination period which was ongoing at the time the 
CY 2021 PFS proposed rule was published. As discussed in section 
IV.A.3.g, some commenters expressed their opinion that specific 
requirements as well as the totality of requirements imposed on QCDRs 
may result in some QCDRs electing to no longer participate in QPP. 
Without specific information regarding the intent of each QCDR, we are 
unable to determine if a future decrease in QCDR participation will 
occur. We note that additional requirements for QCDRs were finalized in 
the CY 2020 PFS final rule and there was an increase in QCDRs self-
nominating during the subsequent CY 2020 self-nomination period. We 
continue to update our burden estimates annually as we receive updated 
data; if QCDRs elect to end their participation in the future, we will 
adjust our burden estimates when the corresponding data is available.
(b) QCDR Measure Requirements
    Previously, we finalized a requirement to require all QCDR measures 
to be fully developed and tested, with complete testing results at the 
clinician level, beginning with the CY 2021 performance period in the 
CY 2020 PFS final rule (84 FR 40816). In the May 8th COVID-19 IFC-2 (85 
FR 27594 through 27595), we delayed this requirement such that 
beginning with the CY 2022 performance period, all QCDR measures must 
be fully developed and tested, with complete testing results at the 
clinician level, prior to submitting the QCDR measure at the time of 
self-nomination. In section VII.A.3.g.(2)(b)(i)(B) of this rule, we 
discussed an incremental approach to require fully tested QCDR 
measures. Specifically, at Sec.  414.1400(b)(3)(v)(C)(1)we are 
finalizing that QCDR measures that were previously approved for the CY 
2020

[[Page 84966]]

performance period, would be required to, at a minimum, be face valid 
prior to being self-nominated for the CY 2022 performance period/CY 
2024 payment year. To be approved for the 2025 MIPS payment year and 
future years, a QCDR measure must be face valid for the initial MIPS 
payment year for which it is approved and fully tested for any 
subsequent MIPS payment year for which it is approved. In order for the 
QCDR measure to be considered for approval, testing must be completed 
at the clinician level by the time the measure is self-nominated. 
However, to be included in an MVP for the 2024 MIPS payment year and 
future years, a QCDR measure must be fully tested. QCDR measures that 
were previously approved for the 2020 performance period, will be 
required to, at a minimum, be face valid prior to being self-nominated 
for the CY 2022 performance period, and would be required to be fully 
tested prior to being self-nominated for any subsequent performance 
periods in order to be considered for inclusion in the MIPS program. 
Because these provisions are not modifying the final testing 
requirements for QCDR measures but are instead are making modifications 
to the phasing and timeline for implementation of previously finalized 
requirements for QCDR measures other than those which will be included 
in an MVP, we are not making any changes to our currently approved 
burden estimates; however, we refer readers to section 
VIII.H.15.e.(4)(d) of this final rule for discussion of impacts 
associated with this provision. Such burden estimates and requirements 
are currently approved by OMB under control number 0938-1314 (CMS-
10621). We solicited comment on our burden estimates and assumptions 
associated with these provisions regarding the testing of QCDR measures 
including those which will be included in an MVP. We did not receive 
comments related to our burden estimates and assumptions regarding the 
testing of QCDR measures.
    We assume 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 rate of $92.46/hr. Considering 
that the time per QCDR associated with the self-nomination process 
range from a minimum of 5.5 hours to a maximum of 8 hours, we estimate 
that the annual burden will range from 451 hours (82 QCDRs x 5.5 hr) to 
656 hours (82 QCDRs x 8 hr) at a cost ranging from $41,699 (451 hr x 
$92.46/hr) and $60,654 (656 hr x $92.46/hr), respectively. Combined 
with our estimate of annual burden for targeted audits, the total 
burden estimate ranging from 536 hours (451 + 85) at a cost of $49,559 
($41,699 + 7,859) to 826 hours (656 +170) at a cost of $76,372 ($60,654 
+ $15,718) (see Table 62).
    Based on the assumptions discussed in this section, 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.
[GRAPHIC] [TIFF OMITTED] TR28DE20.109

    As shown in Table 63, using the unchanged currently approved per 
respondent burden estimate, the increase in respondents from 76 to 82 
results in an increase of between +33 (+6 respondents x 5.5 hr/
respondent) and +48 hours (+6 respondents x 8 hr/respondent) at a cost 
of between +$3,051 (6 respondents x $508.53/respondent) and +$4,438 (6 
respondents x $739.68/respondent). The finalized policy to require 
targeted audits as necessary results in an increase of between +85 (17 
audits x 5hrs/audit) and +170 (17 audits x 10 hrs/audit) at a cost of 
between $7,859 (17 audits x $462.30/audit) and $15,718 (17 audits x 
$924.60/audit). In aggregate, we estimate a total increase in burden of 
between +118 hours (33 + 85) at a cost $10,911 ($3,051 + $7,859) and 
+218 hours (48 + 170) at a cost of $20,156 ($4,438 + $15,718).

[[Page 84967]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.110

    (3) Qualified Registry Self-Nomination Process and Other 
Requirements
    The requirements and burden associated with this rule's data 
submission changes related to qualified registries and QCDRs will be 
submitted to OMB for approval under control number 0938-1314 (CMS-
10621).
    We refer readers to Sec.  414.1400(a)(4) which states that 
qualified registries interested in submitting MIPS data to us on behalf 
of MIPS eligible clinicians, groups, or virtual groups need to complete 
a self-nomination process to be considered for approval to do so. We 
also refer readers to Sec.  414.1400 (c) and the CY 2017 Quality 
Payment Program final rule (81 FR 77507 through 77508), CY 2018 Quality 
Payment Program final rule (82 FR 53906 through 53908), CY 2019 PFS 
final rule (83 FR 59997 through 59998), and the CY 2020 PFS final rule 
(84 FR 63114 through 63116) for our previously finalized requirements 
and burden for self-nomination of qualified registries.
    In section IV.A.3.g.(3) of this rule, we are codifying that 
beginning with the 2023 payment year as a condition of approval each 
qualified registry must conduct annual data validation audits that 
conform to the requirements in Sec.  414.1400(b)(2)(iv), including 
specific obligations discussed in detail in those sections and if one 
or more deficiencies or data errors are identified the qualified 
registry must also conduct targeted audits that conform to the Sec.  
414.1400(b)(2)(v) including specific obligations discussed in detail in 
those sections. In particular, we are codifying at Sec.  
414.1400(c)(2)(iii)(G), that in a form and manner and by a deadline 
specified by CMS, the qualified registry must report data validation 
results, including the overall deficiency or data error rate, the types 
of deficiencies or data errors discovered, the percentage of clinicians 
impacted by any deficiency or data error, and how and when each 
deficiency or data error type was corrected. In addition, we are 
codifying at Sec.  414.1400(c)(2)(iv)(D), in a form and manner and by a 
deadline specified by CMS, the qualified registry must report the 
results of each targeted audit, including the overall deficiency or 
data error rate, the types of deficiencies or data errors discovered, 
the percentage of clinicians impacted by each deficiency or data error, 
and how and when each error type was corrected. We are not revising our 
burden estimates as a result of the provision to codify that qualified 
registries must conduct particular data validation audits and report 
data validation results because we believe the burdens of the data 
validation requirements are not greater than existing expectations for 
which we have already accounted for the associated burden as stated in 
the CY 2017 Quality Payment Program final rule (81 FR 77383 through 
77384) and the CY 2019 PFS final rule (83 FR 59998 through 59999) and 
previously submitted to OMB for approval under control number 0938-1314 
(CMS-10621).
    With regard to the provision to require qualified registries 
conduct targeted audits if one or more data errors are identified 
during data validation audits, we solicited comment on the burdens 
associated with the requirements for data validation audits and 
targeted audits, including expected frequency of targeted audits and 
the anticipated scope of effort related to submitting results to assist 
in estimating the burden associated with this provision, but did not 
receive any. However, we are including burden estimates associated with 
this finalized requirement based on our best available analysis. Due to 
the unknown scope of patient records that may need to be audited, we 
estimate a range of effort to complete a targeted data audit from a 
minimum of 5 hours to a maximum of 10 hours at a cost ranging from 
$462.30 ($92.46/hr x 5 hrs) to $924.60 ($92.46/hr x 10 hrs) per 
targeted audit. In the 2019 MIPS performance period, 37 of the 84 QCDRs 
(44%) that submitted 2019 MIPS quality data were required to complete a 
targeted audit. Based on the results of the 2020 self-nomination 
period, 127 qualified registries have been approved for the 2021 MIPS 
performance period; assuming the same percentage, we estimate 56 
qualified registries (127 x 44%) will be required to complete targeted 
audits. Therefore we estimate the total impact associated with 
qualified registries completing targeted audits will range from 280 
hours (56 audits x 5 hrs/audit) at a cost of $25,889 (56 audits x 
$462.30/audit) to 560 hours (56 audits x 10 hrs/audit) at a cost of 
$51,778 (56 audits x $924.60/audit). We also discuss additional impacts 
of this provision in section VIII.H.15.e.(4)(d) of the Regulatory 
Impact Analysis.
    In sections VII.A.3.g.(1)(b)(iii) of this rule, we are codifying 
that beginning with the 2023 MIPS payment year, third party 
intermediaries must attend and complete training and support sessions 
in the form and manner, and at the times specified, by CMS. Due to the 
nature of the information provided during these calls and because the 
training requirements as applied to qualified registries and QDCRs are 
similar to existing expectations for these entities, we are not 
revising our burden estimates as a result of these provisions. However, 
we do refer readers to section VIII.H.15.e.(4)(d) of this final rule 
for discussion of our estimates of the overall impact of this provision 
for all third party intermediaries.
    In section VII.A.3.g.(1)(b)(ii) of this rule, we discussed that the 
determination of whether to approve an entity as a third party 
intermediary for a MIPS performance period may take into account: (1) 
Whether the entity failed to comply with requirements of third party 
intermediaries for any prior MIPS payment year for which it was 
approved as third party intermediary; and (2) whether the entity 
provided inaccurate information regarding the requirements of the 
subpart to any eligible clinician. Because this provision does not 
require any additional effort for

[[Page 84968]]

affected entities but instead allows CMS to utilize already available 
information to make approval decisions, collection of information 
burden is unaffected for all entities. We also do not anticipate this 
provision will result in any qualified registries or other third party 
intermediaries electing not to self-nominate during the 2021 MIPS 
performance period, but believe it is possible this may occur. However, 
we have neither any data nor knowledge of intent from previously 
approved qualified registries or other third party intermediaries with 
which to support making any changes to our burden estimates as a result 
of this provision. We are solicited public feedback to help us 
determine if there are any burden implications. We did not receive 
comments related to burden implications of this provision.
    In section VII.A.3.g.(4) of this final rule, we are modifying the 
existing requirement at Sec.  1400(f)(1)(i) requiring third party 
intermediaries to submit to CMS by a date specified by the agency a 
Corrective Action Plan (CAP) to address the identified deficiencies or 
data issue, including the actions it will take to prevent the 
deficiencies or data issues from recurring. While the requirement for 
third party intermediaries to submit a CAP was finalized in our CY 2017 
Quality Payment Program final rule (81 FR 77389), we did not specify 
the information that must be included to be included in the CAP and 
neglected to identify the burden associated with the required 
information. We are correcting that oversight in this final rule. In 
addition, to clarify expectations and create consistency in the content 
of the CAPs provide by third party intermediaries, we are revising and 
elaborating on the obligations for a CAP in this final rule. 
Specifically, we are modifying Sec.  414.1400(f)(1)(i) such that, 
unless different or additional information is specified by CMS, the CAP 
submitted by the third party intermediary must address four issues: (1) 
The issues that contributed to the non-compliance; (2) the impact to 
individual clinicians, groups, or virtual groups, regardless of whether 
they are participating in the program because they are MIPS eligible, 
voluntary participating, or opting in to participating in the MIPS 
program; (3) the corrective actions to be implemented by the third 
party intermediary to ensure that the non-compliance has been resolved 
will not recur in the future and (4) the detailed timeline for 
achieving compliance with the applicable requirements. We have 
historically received a total of 34 CAPs over the 3-year period of CY 
2017-2019 (an average of 11.3 per year). As third party intermediaries 
become increasingly effective at identifying data issues and 
discrepancies prior to submitting data to CMS and accounting for the 
estimated decrease in number of QCDRs and qualified registries self-
nominating in the 2020 MIPS performance period compared to the 2019 
MIPS performance period (from 350 to 229), we anticipate the annual 
number of CAPs received to decrease to fewer than 10 per year (83 FR 
59997 through 60000 and 84 FR 63114 through 63121). The effort involved 
in developing a CAP including the detail specified in this final rule 
and submitting it to CMS is likely to be no more than 3 hours for a 
computer systems analyst at a rate of $92.46/hr. In aggregate we 
estimate an annual burden of no more than 30 hours (3 hr x 10 CAPs) at 
a cost of $2,774 (30 hr x $92.46/hr) for third party intermediaries to 
develop and submit a CAP. Because we are unable to predict how many of 
the estimated 10 third party intermediaries submitting CAPs will be 
qualified registries, QCDRs, survey vendors, or health IT vendors; for 
simplicity we are adding the burden to the currently approved burden 
for qualified registries.
    For this final rule, we are adjusting the number of qualified 
registries we assume will self-nominate for the CY 2022 performance 
period from the currently approved estimate of 153 to 183, an increase 
of 30 from the currently approved estimate and CY 2021 PFS proposed 
rule (85 FR 50347) based on the number of self-nominations received 
during the CY 2020 nomination period which was ongoing at the time the 
CY 2021 PFS proposed rule was published.
    As discussed in section IV.A.3.g, some commenters expressed their 
opinion that specific requirements as well as the totality of 
requirements imposed on qualified registries may result in some 
qualified registries electing to no longer participate in QPP. Without 
specific information regarding the intent of each qualified registry, 
we are unable to determine if a future decrease in qualified registry 
participation will occur. We note that additional requirements for 
qualified registries were finalized in the CY 2020 PFS final rule and 
there was an increase in qualified registries self-nominating during 
the subsequent CY 2020 self-nomination period. We continue to update 
our burden estimates annually as we receive updated data; if qualified 
registries elect to end their participation in the future, we will 
adjust our burden estimates when the corresponding data is available.
    We assume that the staff involved in the qualified registry self-
nomination process will continue to be computer systems analysts or 
their equivalent, who have an average labor rate of $92.46/hr. 
Considering that the time per qualified registry associated with the 
self-nomination process range from a minimum of 0.5 hours to a maximum 
of 3 hours, we estimate that the annual burden will range from 91.5 
hours (183 qualified registries x 0.5 hr) to 549 hours (183 qualified 
registries x 3 hr) at a cost ranging from $8,460 (91.5 hr x $92.46/hr) 
and $50,760 (549 hr x $92.46/hr), respectively (see Table 64). Combined 
with our estimates of burden associated with completing targeted audits 
and developing and submitting a CAP, our total burden estimate ranges 
from 401.5 hours (91.5 + 30 + 280) to 1,139 (549 + 30 + 560) at a cost 
between $37,123 ($8,460 + $2,774 + $25,889) and $105,312 ($50,760 + 
$2,774 + $51,778).
    Based on the assumptions discussed in this section, 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.

[[Page 84969]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.111

    As shown in Table 65, using the unchanged currently approved per 
respondent burden estimate, the increase in respondents from 153 to 183 
results in an increase of between +15 hours (+30 respondents x 0.5 hr/
respondent) and +90 hours (+30 respondents x 3 hr/respondent) at a cost 
of between +$1,387 (+30 respondents x $46.23/respondent) and +$8,321 
(+30 respondents x $277.38/respondent). The finalized policy to require 
targeted audits as necessary results in an increase of between +280 (56 
audits x 5 hrs/audit) and +560 (56 audits x 10 hrs/audit) at a cost of 
between $25,889 (56 audits x $462.30/audit) and $51,778 (56 audits x 
$924.60/audit). When combined with our estimate of +30 hours at a cost 
of +$2,774 for developing and submitting CAPs, the total aggregate 
change ranges from +325 hours (15 + 30 + 280) to +680 hours (90 + 30 + 
560) at a cost ranging from +$30,050 ($1,387 + $2,774 + $25,889) to 
+$62,873 ($8,321 + $2,774 + $51,778).
[GRAPHIC] [TIFF OMITTED] TR28DE20.112

(4) Survey Vendor Requirements
    This rule is not implementing any new or revised collection of 
information requirements or burden related to CMS-approved CAHPS for 
MIPS survey vendors. The 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.
(5) Health IT Vendors
    This rule is not implementing any new or revised collection of 
information requirements or burden related to health IT vendors and we 
do not anticipate any changes to the CEHRT process as a result of 
provisions promulgated in this final rule. Consequently, we are not 
setting out burden or making any changes under the 0938-1314 (CMS-
10621) control number.
d. Open Authorization (OAuth) Credentialing and Token Request Process
    In the CY 2017 Quality Payment Program final rule (81 FR 77035), we 
finalized the initial MIPS data submission terminology at Sec.  
414.1305 and requirements at Sec.  414.1325, as well as the associated 
burden estimates. As discussed in the CY 2019 PFS final rule (83 FR 
59747 through 59748), it subsequently came to our attention that the 
way we had previously described data submission did not precisely 
reflect the experience users have when submitting data to us. To ensure 
clarity and precision for all users, we amended the terminology at 
Sec.  414.1305 to more precisely reflect this experience and made 
conforming amendments to Sec.  414.1325 and other MIPS regulations. 
Among the newly defined terms was ``submission type'', which we defined 
at Sec.  414.1305 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

[[Page 84970]]

Interface. We stated in the CY 2019 PFS final rule that the direct 
submission type allows users to transmit data through a computer-to-
computer interaction, such as an Application Programming Interface 
(API).
    Beginning in the 2021 MIPS performance period, CMS will offer the 
Open Authorization (OAuth) Credentialing and Token Request Process. 
This process utilizes an API to allow users to transmit data through a 
computer-to-computer interaction. As such, it is an alternate means of 
operationalizing the previously established direct submission type. The 
process first requires software developers to apply for production 
OAuth credentials to the submissions API by registering their 
application so that it can interact with the system providing OAuth 
capabilities. Next, the developer must request a meeting with the 
Quality Payment Program development team. During this meeting, the 
requesting organization will demonstrate their application's use of 
OAuth to successfully submit data in the Submissions API test 
environment. The requesting organization will also provide 
documentation about their terms of service, privacy policy, and related 
information for review by the Quality Payment Program team. If further 
clarification is required about any of the documentation or 
application, the Quality Payment Program team will follow up with the 
requesting organization. Once approved, the Quality Payment Program 
development team will issue production OAuth credentials to the 
requesting organization's point of contact. Detailed instructions for 
the authentication process and application for organizations to request 
OAuth credentials are available at https://cmsgov.github.io/qpp-submissions-docs/.
    The following burden estimates are associated with the first year 
of data collection for the OAuth Credentialing and Token Request 
Process. This process is available to all submitter types to be 
approved to submit data via the direct submission type. However, we 
assume the only parties that will elect to undergo the process will be 
health IT vendors or other third party intermediaries, as we believe 
these are the most likely parties to be developing applications. The 
burden associated with this ICR belongs only to the application 
developer; QPP participants will not be required to do anything 
additional to submit their data. For third party intermediaries, OAuth 
Credentialing will allow QPP participants to use their own QPP 
credentials to login through the third party intermediary's application 
to submit their data and view performance feedback from QPP. The burden 
associated with the OAuth Credentialing and Token Request Process will 
be submitted to OMB for approval under control number 0938-1314 (CMS-
10621). We refer readers to Sec.  414.1400(a)(2) and the CY 2017 
Quality Payment Program final rule (81 FR 77363 through 77364) and as 
further revised in the CY 2019 and CY 2020 PFS final rules at Sec.  
414.1400(a)(2) (83 FR 60088 and 84 FR 63052) for our current policy 
regarding the types of MIPS data third party intermediaries may submit.
    As stated in the CY 2020 PFS final rule (84 FR 63049) we are aware 
of stakeholders' desire to have a more cohesive participation 
experience across all performance categories under MIPS. We are 
offering this process in support of our current requirements for QCDRs 
and qualified registries to be able to submit data for all MIPS 
performance categories and health IT vendors to be able to submit data 
for at least one MIPS performance category (84 FR 63052 and 84 FR 
63076) as well as our desire to further reduce administrative burden 
for clinicians to participate in MIPS. As we discuss in sections 
VII.B.5.e.(5), VII.B.5.e.(6), VII.B.5.(e).7, VII.B.5.g, and VII.B.5.i 
of this final rule individual clinicians or groups may submit their 
quality measures using the direct submission type via the MIPS CQM and 
QCDR, eCQM, or CMS Web Interface (only for the 2021 MIPS performance 
period) collection types as well as their Promoting Interoperability 
measures and improvement activities through the same direct submission 
type. Entities that receive approval for their applications through 
this process will be able to provide QPP participants a more 
comprehensive and less administratively burdensome experience using the 
direct submission type.
    We estimate it would take approximately 1 hour at $92.46/hr for a 
computer systems analyst (or their equivalent) to provide documentation 
and any follow-up communication via email. We estimate that for during 
the 2021 MIPS performance period, 15 submitter types, consisting of 
third party intermediaries will complete this process to be approved 
for the CY 2022 submission period. We expect health IT vendors to adopt 
this method initially, with limited further adoption by QCDRs and 
Qualified Registries in future years. As shown in Table 66, we estimate 
it would take 1 hour at $92.46/hr for a computer systems analyst (or 
their equivalent) to complete the process. We estimate an annual burden 
of 15 hours (15 vendors x 1 hr) at a cost of $1,387 (15 hr x $92.46/hr) 
or $92.46 per organization ($1,387/15 vendors).
[GRAPHIC] [TIFF OMITTED] TR28DE20.113

e. ICRs Regarding Quality Data Submission (Sec. Sec.  414.1325 and 
414.1335)
(1) Background
    We refer readers to the CY 2017 Quality Payment Program final rule 
(81 FR 77502 through 77503), CY 2018 Quality Payment Program final rule 
(82 FR 53908 through 53912), CY 2019 PFS final rule (83 FR 60000 
through 60003), and the CY 2020 PFS final rule (84 FR 63121 through 
63124) for our previously finalized requirements for data submission 
for the quality performance category.
    Under our current policies, two groups of clinicians must submit 
quality data under MIPS: Those who submit as

[[Page 84971]]

MIPS eligible clinicians and those who opt to submit data voluntarily 
but are not subject to MIPS payment adjustments. Clinicians are 
ineligible for MIPS payment adjustments 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 as 
an individual or as a group.
(2) Changes and Adjustments to Quality Performance Category Respondents
    To determine which QPs should be excluded from MIPS, we used the 
first snapshot of the QP List for CY 2020 that contains participation 
in Advanced APMs as of March 31, 2020, that could be connected into our 
respondent data and are the best estimate of future expected QPs. From 
this data, we calculated the QP determinations as described in the 
Qualifying APM Participant (QP) definition at Sec.  414.1305 for the 
2021 QP Performance Period. We assumed that all Partial QPs will 
participate in MIPS data collections. Due to data limitations, we could 
not identify specific clinicians who have not yet enrolled in APMs, but 
who may become QPs in the future 2021 QP Performance Period (and 
therefore will no longer need to submit data to MIPS); hence, our model 
may underestimate or overestimate the number of respondents.
    In the CY 2019 PFS final rule, we finalized limiting the Medicare 
Part B claims collection type to small practices beginning with the 
2021 MIPS payment year and allowing clinicians in small practices to 
report Medicare Part B claims as a group or as individuals (83 FR 
59752). In the CY 2020 PFS final rule, we provided a set of assumptions 
and an approach to account for the clinicians not in small practices 
for whom the Medicare Part B claims collection type will no longer be 
available as an option for collecting and reporting quality data (84 FR 
63121 through 63122). Because we continued to use 2018 MIPS performance 
period data to estimate the number of respondents in the CY 2021 PFS 
proposed rule, we used the same methodology. For this final rule, we 
are using 2019 MIPS performance period respondent data which inherently 
includes the impacts of the aforementioned policies finalized in the CY 
2019 PFS final rule; therefore, we no longer need to make any further 
adjustments to account for them.
    There may be an undercount in submissions because of the extreme 
and uncontrollable circumstances policy due to the PHE for COVID-19, 
that allowed clinicians to elect not to submit during the submission 
period for the 2019 MIPS performance period that we are using to inform 
our burden estimates. Despite this limitation, we believe the data from 
the 2019 MIPS performance period is still the best data source 
available as it most accurately reflects the impacts of policies 
finalized in previous rules and trend toward increased group reporting.
    In section IV.A.3.c.(1)(c) of this rule, we are finalizing to 
sunset the CMS Web Interface measures as a collection type/submission 
type starting with the 2022 performance period. As a result, groups of 
25 or more clinicians that previously submitted quality performance 
data via the CMS Web Interface will be required to use an alternate 
collection type beginning with the 2022 performance period, which will 
have to be either the MIPS CQM and QCDR or eCQM collection type. While 
we know that 111 groups submitted quality performance data via the CMS 
Web Interface in the 2019 MIPS performance period, we are not able to 
ascertain what alternative collection type(s) the groups would elect. 
In order to estimate the number of groups that will select each of 
these collection types, we first clustered the number of groups which 
submitted data via the CMS Web Interface collection type during the 
2019 MIPS performance period by practice size (between 25 and 49 
clinicians, between 50 and 99 clinicians, etc.). Then, for each 
cluster, we allocated these groups to each of the MIPS CQM and QCDR and 
eCQM collection types based on the percent of TINs that submitted MIPS 
data via these two collection types. For example, of the 1,638 TINs 
with a practice size of 25 to 49 clinicians which submitted data for 
the 2019 MIPS performance period, 1,086 (66 percent) submitted data via 
the MIPS CQM and QCDR collection type and 552 (34 percent) submitted 
data via the eCQM collection type. We applied these percentages to the 
11 TINs with a practice size of 25 to 49 clinicians which submitted 
data via the CMS Web Interface collection type for the 2019 MIPS 
performance period to estimate that 7 (11 TINs x 0.73) would elect to 
submit data via the MIPS CQM and QCDR collection type and the remaining 
4 (11 TINs x 0.27) would elect to submit data via the eCQM collection 
type. In total, beginning with the 2022 performance period, we estimate 
that 45 of the 111 groups that submitted data via the CMS Web Interface 
collection type for the 2019 MIPS performance period will submit 
quality data via the MIPS CQM and QCDR collection type and 66 groups 
will now submit quality data via the eCQM collection type. Note that 
the 111 groups is an increase of 7 from our currently approved estimate 
of 104 groups due to updated data (84 FR 63123) (111 groups-104 
groups). We also performed this analysis to determine the number of 
clinicians that would be affected and would need to submit quality data 
via an alternate collection type beginning with the 2022 performance 
period. In total, of the estimated 45,599 individual clinicians 
affected by this provision, we estimate that 11,432 would submit 
quality data as part of a group via the MIPS CQM and QCDR collection 
type and 34,167 would submit quality data as part of a group via the 
eCQM collection type. These estimates are reflected in Tables 66 and 68 
and the associated changes in burden are reflected in Tables 72, 74, 
and 76. In aggregate, as discussed in sections VII.B.5.e.(5), (6), (7), 
and (9) of this final rule, we estimate the provision to sunset the CMS 
Web Interface measures as a collection type/submission type will result 
in a net decrease in quality performance data reporting burden while 
acknowledging the additional financial impacts on clinicians as 
discussed in section VIII.H.15.e.(4)(b)(i) of the Regulatory Impact 
Analysis.
    We assume that 100 percent of ACO APM Entities will submit quality 
data to CMS as required under their models. While we do not believe 
there is additional reporting for ACO APM entities, consistent with 
assumptions used in the CY 2019 and CY 2020 PFS final rules (83 FR 
60000 through 60001 and 84 FR 63122), we include all quality data 
voluntarily submitted by MIPS APM participants made at the individual 
or TIN-level in our respondent estimates. As stated in section 
VII.5.a.(4) of this final rule, we assume non-ACO APM Entities will 
participate through traditional MIPS and submit as an individual or 
group rather than as an entity. To estimate who will be a MIPS APM 
participant in the 2021 MIPS performance period, we used the latest QP 
List for the first snapshot data of the 2020 QP performance period and 
supplemented with clinicians who are in an APM in 2020 but not in the 
2020 snapshot. This file was selected to better reflect the expected 
increase in the number of MIPS APMs in future years compared to 
previous APM eligibility files. Based on this information, if we 
determine that a MIPS eligible clinician will not be scored as a MIPS 
APM, then their reporting assumption is based on their

[[Page 84972]]

reporting as a group or individual for the CY 2019 MIPS performance 
period.
    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 APMs. The burden is excluded as 
sections 1899(e) and 1115A(d)(3) of the Act (42 U.S.C. 1395jjj(e) and 
1315a(d)(3), respectively) state that 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.\148\ Tables 66, 67, 
and 68 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.
---------------------------------------------------------------------------

    \148\ Our estimates do reflect the burden on MIPS APM 
participants of submitting Promoting Interoperability performance 
category data, which is outside the requirements of their APMs.
---------------------------------------------------------------------------

    Table 66 provides our estimated counts of clinicians that will 
submit quality performance category data as MIPS individual clinicians 
or groups in the 2021 and 2022 MIPS performance periods based on data 
from the 2019 MIPS performance period.
    For the 2021 MIPS performance period, respondents will have the 
option to submit quality performance category data via Medicare Part B 
claims, direct, and log in and upload submission types, and Web 
Interface. For the 2022 MIPS performance period, respondents will no 
longer have the option to submit quality performance category data via 
the Web Interface. We estimate the burden for collecting data via 
collection type: Medicare Part B claims, QCDR and MIPS CQMs, eCQMs, and 
the CMS Web Interface. We believe that, while estimating burden by 
submission type may be better aligned with the way clinicians 
participate with the Quality Payment Program, it is more important to 
reduce confusion and enable greater transparency by maintain 
consistency with previous rulemaking.
    As shown in Table 66, using participation data from the 2019 MIPS 
performance period combined with the estimate of QPs for the 2021 
performance period, we estimate a total of 651,514 clinicians will 
submit quality data as individuals or groups in each of the 2021 and 
2022 MIPS performance periods, a decrease of 129,091 clinicians when 
compared to our estimate of 780,605 clinicians in the CY 2020 PFS final 
rule (84 FR 63122) and a decrease of 140,547 from the estimate of 
792,061 in the CY 2021 PFS proposed rule due to availability of updated 
data from the 2019 MIPS performance period (85 FR 50350). For the 2021 
performance period, we estimate 29,273 clinicians will submit data as 
individuals for the Medicare Part B claims collection type; 284,509 
clinicians will submit data as individuals or as part of groups for the 
MIPS CQM and QCDR collection type; 292,133 clinicians will submit data 
as individuals or as part of groups via eCQM collection types; and 
45,599 clinicians will submit as part of groups via the CMS Web 
Interface. Compared to the CY 2021 PFS proposed rule (85 FR 50350), 
these are decreases from the estimates of 94,587 and 410,518 for 
Medicare Part B claims and MIPS CQM and QCDR collection types, 
respectively; and increases from the estimates of 286,956 and 0 for the 
eCQM and CMS Web Interface collection types, respectively. These 
adjustments are due to the availability of updated data from the 2019 
MIPS performance period and the delay in sunsetting the CMS Web 
Interface from the 2021 performance period to the 2022 performance 
period. For the 2022 performance period, we estimate 29,273 clinicians 
will submit data as individuals for the Medicare Part B claims 
collection type; 295,941 clinicians will submit data as individuals or 
as part of groups for the MIPS CQM and QCDR collection type; 326,300 
clinicians will submit data as individuals or as part of groups via the 
eCQM collection type.
    Table 67 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.
[GRAPHIC] [TIFF OMITTED] TR28DE20.114

    Because MIPS eligible clinicians may submit data for multiple 
collection types for a single performance category, 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 during the 2019 MIPS performance period. We captured 
the burden of any eligible clinician that may have historically 
collected via multiple collection types, as we assume they will 
continue to collect via multiple collection types and that our MIPS 
scoring methodology will take the highest score where the same measure 
is submitted via multiple collection types.
    Table 68 uses methods similar to those described to estimate the 
number of clinicians that will submit data as

[[Page 84973]]

individual clinicians via each collection type in the 2021 and 2022 
MIPS performance periods. For both the 2021 and 2022 performance 
periods, we estimate that approximately 29,273 clinicians will submit 
data as individuals using the Medicare Part B claims collection type; 
approximately 41,340 clinicians will submit data as individuals using 
MIPS CQM and QCDR collection type; and approximately 42,255 clinicians 
will submit data as individuals using eCQMs collection type. Based on 
availability of updated data from the 2019 MIPS performance period, 
these are decreases from the currently approved estimates of 94,846 and 
100,269 for the Medicare Part B claims and MIPS CQM and QCDR collection 
types, respectively; and an increase from the currently approved 
estimate of 38,935 for the eCQM collection type.
[GRAPHIC] [TIFF OMITTED] TR28DE20.115

    Consistent with the policy finalized in the CY 2018 Quality Payment 
Program final rule that for MIPS eligible clinicians who collect 
measures via Medicare Part B 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 and thus, the same 
clinician may be counted as a respondent for more than one collection 
type. Therefore, our columns in Table 68 are not mutually exclusive.
    Table 69 provides our estimated counts of groups or virtual groups 
that will submit quality data on behalf of clinicians for each 
collection type in the 2021 and 2022 MIPS performance periods. We 
assume that groups that submitted quality data as groups in the 2019 
MIPS performance period 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 2021 and 2022 MIPS 
performance periods. Specifically, for the 2021 performance period we 
estimate that 11,559 groups and virtual groups will submit data for the 
MIPS CQM and QCDR collection type on behalf of 243,169 clinicians; 
8,154 groups and virtual groups will submit for eCQM collection types 
on behalf of 249,878 eligible clinicians; and 111 groups will submit 
data via the CMS Web Interface on behalf of 45,599 clinicians. These 
are increases from the currently approved estimates of 10,949, 4,398, 
and 104 groups and virtual groups for the MIPS CQM and QCDR, eCQM, and 
CMS Web Interface collection types, respectively; due to the 
availability of updated data from the 2019 MIPS performance period. For 
the 2022 performance period we estimate that 11,604 groups and virtual 
groups will submit data for the MIPS CQM and QCDR collection type on 
behalf of 254,601 clinicians and 8,220 groups and virtual groups will 
submit for eCQM collection types on behalf of 284,045 eligible 
clinicians. In section IV.A.3.(b) of this rule, we discuss the APM 
Performance Pathway for clinicians in APM Entities. The APM Performance 
Pathway is available for APM entities and as discussed in section 
IV.A.3.(b).(3)(a) we are finalizing an alternate measure set consisting 
of the CMS Web Interface measures for the 2021 MIPS performance period. 
However, as the data does not exist for APM performance pathway or MIPS 
quality measures for non-ACO APM entities, we assume non-ACO APM 
Entities would participate through traditional MIPS and base our 
estimates on submissions received in the 2019 MIPS performance period.

[[Page 84974]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.116

    The burden associated with the 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' workflows. 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 measures 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. 
For example, clinicians submitting data via the Medicare Part B claims 
collection type need to integrate the capture of quality data codes for 
each encounter whereas clinicians submitting via the eCQM collection 
types may have quality measures automated as part of their EHR 
implementation.
    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 estimated 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 Medicare Part B claims, MIPS CQM and QCDR, and 
eCQM collection types, we also assume that, on average, each clinician 
or group will submit 6 quality measures. In terms of the quality 
measures available for clinicians and groups to report for the 2021 
MIPS performance period, the total number of quality measures will be 
209. The new MIPS quality measures finalized for inclusion in MIPS for 
the 2021 MIPS performance period and future years are found in Table 
Group A of Appendix 1; MIPS quality measures with finalized substantive 
changes can be found in Table Group D of Appendix 1; and MIPS quality 
measures finalized for removal can be found in Table Group C of 
Appendix 1. These measures are stratified by collection type in Table 
70, as well as counts of new, removed, and substantively changed 
measures.
[GRAPHIC] [TIFF OMITTED] TR28DE20.117

    For the 2021 MIPS performance period, there is a net reduction of 9 
quality measures across all collection types compared to the 218 
measures finalized for the 2020 MIPS performance period (84 FR 63124). 
Specifically, as discussed in section IV.A.3.c.(1)(d), we are adding 2 
new administrative claims outcome measures, removing 14 quality 
measures, and make substantive updates to 113 quality measures. We do 
not anticipate that removing these measures will increase or decrease 
the reporting burden on clinicians and groups as respondents generally 
are still required to submit quality data for 6 measures.
(3) Quality Payment Program Identity Management Application Process
    This rule is not implementing any new or revised collection of 
information requirements or burden related to the identity management 
application process. The requirements and burden are currently approved 
by OMB under control number 0938-1314 (CMS-10621). Consequently, we are 
not

[[Page 84975]]

making any identity management application process changes under that 
control number.
(4) Quality Data Submission by Clinicians: Medicare Part B Claims-Based 
Collection Type
    This rule is not implementing any new or revised collection of 
information requirements related to the submission of Medicare Part B 
claims data for the quality performance category. However, we are 
adjusting our currently approved burden estimates based on more recent 
data. The following burden 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 77501 through 77504), CY 2018 Quality Payment Program final rule 
(82 FR 53912), CY 2019 PFS final rule (83 FR 60004 through 60005), and 
the CY 2020 PFS final rule (84 FR 63124 through 63126) for our 
previously finalized requirements and burden for quality data 
submission via the Medicare Part B claims collection type.
    As noted in Table 67, based on 2019 MIPS performance period data, 
we assume that 29,273 individual clinicians will collect and submit 
quality data via the Medicare Part B claims collection type. This rule 
is adjusting the number of Medicare Part B claims respondents from the 
currently approved estimate of 94,846 to 29,273 (a decrease of 65,573) 
based on more recent data. This is an increase/decrease of 65,314 from 
the estimate of 94,587 provided in the CY 2021 PFS proposed rule (85 FR 
50352).
    As shown in Table 71, consistent with our currently approved per 
response time figures, we estimate that the burden of quality data 
submission using Medicare Part B claims will range from 0.15 hours (9 
minutes) at a cost of $13.87 (0.15 hr x $92.46/hr) to 7.2 hours at a 
cost of $665.71 (7.2 hr x $92.46/hr). The burden will involve becoming 
familiar with MIPS quality measure specifications. We believe that the 
start-up cost for a clinician's practice to review measure 
specifications is 7 hours, consisting of 3 hours at $110.74/hr for a 
medical and health services manager, 1 hour at $212.78/hr for a 
physician, 1 hour at $46.64/hr for an LPN, 1 hour at $92.46/hr for a 
computer systems analyst, and 1 hour at $39.06/hr for a billing and 
posting clerk. We are not revising our currently approved per response 
time estimates.
    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 time ranges from 209,302 hours (7.15 hr x 
29,273 clinicians) to 415,677 hours (14.2 hr x 29,273 clinicians). The 
estimated annual cost (per clinician) ranges from $737.03 [(0.15 hr x 
$92.46/hr) + (3 hr x $110.74/hr) + (1 hr x $92.46/hr) + (1 hr x $46.64/
hr) + (1 hr x $39.06/hr) + (1 hr x $212.78/hr)] to a maximum of 
$1,388.87 [(7.2 hr x $92.46/hr) + (3 hr x $110.74/hr) + (1 hr x $92.46/
hr) + (1 hr x $46.64/hr) + (1 hr x $39.06/hr) + (1 hr x $212.78/hr)]. 
The total annual cost ranges from a minimum of $21,575,050 (29,273 
clinicians x $737.03) to a maximum of $40,656,450 (29,273 clinicians x 
$1,388.87).
    Table 71 summarizes the range of total annual burden associated 
with clinicians submitting quality data via Medicare Part B claims.

[[Page 84976]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.118

    As shown in Table 72, using the unchanged currently approved per 
respondent burden estimates which range from $737.03 to $1,388.87, the 
decrease in number of respondents from 94,846 to 29,273 results in a 
total adjustment of between -468,847 hours (-65,573 respondents x 7.15 
hr/respondent) at a cost of -$48,329,203 (-65,573 respondents x 
$737.03/respondent) and -931,136 hours (-65,573 respondents x 14.2 hr/
respondent) at a cost of -$91,072,504 (-65,573 respondents x $1,388.87/
respondent). For purposes of calculating total burden associated with 
the final rule as shown in Tables 100, 101, and 103, only the maximum 
burden is used.
[GRAPHIC] [TIFF OMITTED] TR28DE20.119


[[Page 84977]]


(5) Quality Data Submission by Individuals and Groups Using MIPS CQM 
and QCDR Collection Types
    The following requirement and burden 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 77504 through 77505), CY 2018 Quality Payment Program final rule 
(82 FR 53912 through 53914), CY 2019 PFS final rule (83 FR 60005 
through 60006), and the CY 2020 PFS final rule (84 FR 63127 through 
63128) for our previously finalized requirements and burden for quality 
data submission via the MIPS CQM and QCDR collection types.
    In the CY 2021 PFS proposed rule (85 FR 50290), we proposed to 
sunset the CMS Web Interface measures as a collection type/submission 
type starting with the 2021 MIPS performance period. As discussed in 
section IV.A.3.c.(1)(c) of this final rule, we are finalizing to sunset 
the CMS Web Interface measures as a collection type/submission type 
starting with the 2022 MIPS performance period. Using the methodology 
discussed in section VII.B.5.e.(1) of this final rule, for the 2022 
MIPS performance period, we estimate 45 additional groups will submit 
quality data via the MIPS CQM and QCDR collection type due to the 
sunsetting of the CMS Web Interface measures as a collection type/
submission type after the 2021 MIPS performance period.
    As noted in Tables 67, 68, and 69, and based on 2019 MIPS 
performance period data, for the 2021 performance period, we assume 
that 284,509 clinicians will submit quality data as individuals or 
groups using MIPS CQM or QCDR collection types; 41,340 clinicians will 
submit as individuals and the remaining 243,169 clinicians will submit 
as members of 11,559 groups and virtual groups. This is a decrease of 
63,496 individuals and increase of 488 groups from the estimates of 
104,836 individuals and 11,071 groups provided in the CY 2021 PFS 
proposed rule due to availability of updated data (85 FR 50353). For 
the 2022 performance period, we assume that 295,957 clinicians will 
submit quality data as individuals or groups using MIPS CQM or QCDR 
collection types; 41,340 clinicians will submit as individuals and the 
remaining 254,601 clinicians will submit as members of 11,604 groups 
and virtual groups. 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 intermediary 
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 quality measure specifications 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 $891.13. This consists of 
3 hours at $92.46/hr for a computer systems analyst (or their 
equivalent) to submit quality data along with 2 hours at $110.74/hr for 
a medical and health services manager, 1 hour at $92.46/hr for a 
computer systems analyst, 1 hour at $46.64/hr for a LPN, 1 hour at 
$39.06/hr for a billing clerk, and 1 hour at $212.78/hr for a physician 
to review measure specifications. Additionally, clinicians and groups 
who do not submit data directly 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) at $92.46/hr for a 
computer systems analyst at a cost of $7.70 (0.083 hr x $92.46/hr). 
Overall we estimate a cost of $897.47/response [(3 hr x $92.46/hr) + (2 
hr x $110.74/hr) + (1 hr x $212.78/hr) + (1 hr x $92.46/hr) + (1 hr x 
$46.64/hr) + (1 hr x $39.06/hr) + (0.083 hr x $92.46/hr)].
    In aggregate, we estimate a burden of 480,482 hours [9.083 hr/
response x (41,340 clinicians submitting as individuals + 11,559 groups 
submitting via QCDR or MIPS CQM on behalf of individual clinicians or 
52,899 responses)] at a cost of $47,475,487 (52,899 responses x 
$897.47/response) for the 2021 performance period. For the 2022 
performance period, we estimate a burden of 480,890 hours [9.083 hr/
response x (41,340 clinicians submitting as individuals + 11,604 groups 
submitting via QCDR or MIPS CQM on behalf of individual clinicians or 
52,944 responses)] at a cost of $47,515,873 (52,944 responses x 
$897.47/response). Based on these assumptions, we have estimated in 
Table 73 the burden for these submissions.

[[Page 84978]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.120

    As shown in Table 74, using the unchanged currently approved per 
respondent burden estimate, the decrease of 58,319 respondents from 
111,218 to 52,899 for the 2021 performance period results in a decrease 
of -529,711 hours (-58,319 respondents x 9.083 hr/respondent) and -
$52,339,796 (-58,319 respondents x $897.47/respondent). For the 2022 
performance period, the decrease of 58,274 respondents from 111,218 to 
52,944 results in a decrease of -529,303 hours (-58,264 respondents x 
9.083 hr/respondent) and -$52,299,410 (-58,274 respondents x $897.47/
respondent).

[[Page 84979]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.121

(6) Quality Data Submission by Clinicians and Groups: eCQM Collection 
Type
    The following requirement and burden 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 77505 through 77506), CY 2018 Quality Payment Program final rule 
(82 FR 53914 through 53915), CY 2019 PFS final rule (83 FR 60006 
through 60007), and the CY 2020 PFS final rule (84 FR 63128 through 
63130) for our previously finalized requirements and burden for quality 
data submission via the eCQM collection types.
    In the CY 2021 PFS proposed rule (85 FR 50290), we proposed to 
sunset the CMS Web Interface measures as a collection type/submission 
type starting with the 2021 MIPS performance period. As discussed in 
section IV.A.3.c.(1)(c) of this final rule, we are finalizing to sunset 
the CMS Web Interface measures as a collection type/submission type 
starting with the 2022 MIPS performance period. Using the methodology 
discussed in section VII.B.5.e.(1) of this final rule, for the 2022 
MIPS performance period, we estimate 66 additional groups will submit 
quality data via the eCQM collection type due to the sunsetting of the 
CMS Web Interface measures as a collection type/submission type after 
the 2021 MIPS performance period.
    Based on 2019 MIPS performance period data, for the 2021 
performance period, we assume that 292,133 clinicians will elect to use 
the eCQM collection type; 42,255 clinicians are expected to submit 
eCQMs as individuals; and 8,154 groups and virtual groups are expected 
to submit eCQMs on behalf of the remaining 249,878 clinicians. This is 
an increase of 778 individuals and 3,680 groups from the estimates of 
41,477 individuals and 4,474 groups provided in the CY 2021 PFS 
proposed rule due to availability of updated data (85 FR 50355). For 
the 2022 performance period, we assume that 320,003 clinicians will 
elect to use the eCQM collection type; 42,255 clinicians are expected 
to submit eCQMs as individuals; and 8,220 groups and virtual groups are 
expected to submit eCQMs on behalf of the remaining 284,045 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.
    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 a third-party intermediary 
to derive data from their CEHRT and submit it 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 CEHRT, and submit the 
necessary data to a QCDR/qualified registry 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 a health IT vendor to submit 
the data on their behalf. This includes extracting the necessary 
clinical data from their CEHRT and submitting the necessary data to a 
QCDR/qualified registry.
    We estimate that it will take no more than 2 hours at $92.46/hr for 
a computer systems analyst to submit the actual data file. The burden 
will also involve becoming familiar with MIPS quality measure 
specifications. In this regard, we estimate it will take 6 hours for a 
clinician or group to review measure specifications. Of that time, we 
estimate 2 hours at $110.74/hr for a medical and health services 
manager, 1 hour at $212.78/hr for a physician, 1 hour at $92.46/hr for 
a computer systems analyst, 1 hour at $46.64/hr for an LPN, and 1 hour 
at $39.06/hr for a billing clerk. Overall we estimate a cost of 
$797.34/response [(2 hr x $92.46/hr) + (2 hr x $110.74/hr) + (1 hr x 
$212.78/hr) + (1 hr x $92.46/hr) + (1 hr x $46.64/hr) + (1 hr x $39.06/
hr)].
    In aggregate, for the 2021 performance period, we estimate a burden 
of 403,272 hours (8 hr x 50,409 groups and clinicians submitting as 
individuals) at a cost of $40,193,112 (50,409 responses x $797.34/
response). For the 2022 performance period, we estimate a burden of 
403,800 hours (8 hr x 50,475 groups and clinicians submitting as 
individuals) at a cost of $40,245,737 (50,475 responses x $797.34/
response). Based on these assumptions, we have estimated in Table 75 
the burden for these submissions.

[[Page 84980]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.122

    As shown in Table 76, using the unchanged currently approved per 
respondent burden estimate, the increase of 7,076 respondents from 
43,333 to 50,409 for the 2021 performance period results in a total 
difference of +56,608 hours (+7,076 respondents x 8 hr/respondent) at a 
cost of +$5,641,978 (+7,076 respondents x $797.34/respondent). For the 
2022 performance period, the increase of 7,142 respondents from 43,333 
to 50,475 results in a total difference of +57,136 hours (+7,142 
respondents x 8 hr/respondent) at a cost of +$5,694,603 (+7,142 
respondents x $797.34/respondent).
[GRAPHIC] [TIFF OMITTED] TR28DE20.123


[[Page 84981]]


(7) Quality Data Submission via CMS Web Interface
    The requirements and burden will be submitted to OMB for approval 
under control number 0938-1314 (CMS-10621).
    In the CY 2021 PFS proposed rule, we proposed to sunset the CMS Web 
Interface measures as a collection type/submission type starting with 
the 2021 MIPS performance period (85 FR 50290). As a result, we did not 
provide a burden estimate for quality data submission via the CMS Web 
Interface for the 2021 performance period. As discussed in section 
IV.A.3.c.(1)(c) of this final rule, we are finalizing to sunset the CMS 
Web Interface measures as a collection type/submission type starting 
with the 2022 MIPS performance period; therefore, we are now providing 
a burden estimate for the 2021 MIPS performance period.
    We assume that 111 groups will submit quality data via the CMS Web 
Interface based on the number of groups who completed 100 percent of 
reporting quality data via the Web Interface in the 2019 MIPS 
performance period. This is an increase of 7 groups from the currently 
approved number of 104 groups provided in the CY 2020 PFS final rule 
(84 FR 63130) due to receipt of more current data. We estimate that 
45,599 clinicians will submit as part of groups via this method, a 
decrease of 874 from our currently approved estimate of 46,473 
clinicians.
    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. Our burden estimate for submission includes the time (61.67 
hours) needed for each group to populate data fields in the web 
interface with information on approximately 248 eligible assigned 
Medicare beneficiaries and 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 a burden for the 2021 performance period of 
6,845 hours (111 groups x 61.67 hr) at a cost of $632,923 (6,845 hr x 
$92.46/hr). For the 2022 performance period, we estimate a burden of 
zero due to our assumption that all Web Interface respondents will 
alternately utilize either the MIPS CQM and QCDR or eCQM collection 
types. Based on the assumptions discussed in this section, Table 77 
summarizes the burden for groups submitting to MIPS via the CMS Web 
Interface.
[GRAPHIC] [TIFF OMITTED] TR28DE20.124

    As shown in Table 78, using our unchanged currently approved per 
respondent burden estimate, the increase in number of respondents 
results in a total adjustment of +432 hours (+7 respondents x 61.67 hr) 
at $39,914 (+431.7 hr x $92.46/hr) for the 2021 MIPS Performance 
Period. For the 2022 MIPS performance period, our burden estimate is 0 
hours and $0.
[GRAPHIC] [TIFF OMITTED] TR28DE20.125


[[Page 84982]]


(8) Beneficiary Responses to CAHPS for MIPS Survey
    In this final rule, we are revising the requirements for the CAHPS 
for MIPS survey which will result in updates to the CAHPS for MIPS 
survey instrument which is currently approved by OMB under control 
number 0938-1222 (CMS-10450). The survey instrument is not ready at 
this time, therefore we will make the updated survey instrument and 
burden available for public review through a stand-alone non-rule 
Federal Register notice that is expected to publish in early CY 2021.
    We refer readers to the CY 2017 Quality Payment Program final rule 
(81 FR 77509), CY 2018 Quality Payment Program final rule (82 FR 53916 
through 53917), and CY 2019 PFS final rule (83 FR 60009 through 60010 
for our previously finalized requirements and burden for beneficiary 
responses to the CAHPS for MIPS survey.
    In section IV.A.3.c.(1)(f)(ii), we are: (1) Revising and codifying 
at Sec.  414.1305 the definition of primary care services used in the 
MIPS assignment methodology to include virtual primary care visits and 
telehealth visits to determine patient assignment to groups starting in 
the 2021 CAHPS for MIPS survey; and (2) revising the CAHPS for MIPS 
Survey cover page to include a reference to care received in telehealth 
settings. We do not believe any of these provisions will impact the 
number of groups electing to have the CAHPS for MIPS survey 
administered on their behalf, the number of beneficiaries who complete 
the survey, or the time required for a beneficiary to complete the 
survey. In the future, if additional data becomes available, we may 
revise our assumptions at that time.
    Additionally, in IV.A.2.c.(1)(e)(i), we are adding a survey-based 
measure on telehealth that assesses patient-reported usage of 
telehealth services to the performance year 2021 CAHPS for MIPS Survey. 
Currently, the CAHPS for MIPS survey instrument contains 58 questions 
and we estimate it requires a beneficiary 12.9 minutes on average to 
complete it, or approximately 0.2 minutes per question. We assume this 
provision will result in 1 additional question being added to the 
survey which would result in the total time to complete the survey 
increasing from 12.9 minutes (0.215 hr) to 13.1 minutes (0.2183 hr) per 
beneficiary, or an increase of 0.2 minutes (0.0033 hr).
    Based on the number of beneficiaries who completely or partially 
responded to the survey in the 2019 MIPS performance period, we assume 
that 29,952 beneficiaries will respond to the survey during the 2021 
MIPS performance period. This is a decrease of 9,087 from our currently 
approved estimate of 39,039 beneficiaries and a decrease of 37 
beneficiaries from the CY 2020 PFS proposed rule due to updated data. 
Using this updated number of respondents and our revised estimate of 
burden per respondent, we estimate an annual burden of 6,540 hours 
(29,952 respondents x 0.2183 hr/respondent) at a cost of $168,196 
(6,540 hr x $25.72/hr). Table 79 shows the estimated annual burden for 
beneficiaries to participate in the CAHPS for MIPS Survey.
[GRAPHIC] [TIFF OMITTED] TR28DE20.126

    Independent of the change in burden per respondent, the decrease of 
-9,087 respondents from 39,039 to 29,952 results in a difference of -
1,954 hours (-9,087 respondents x 0.215 hr/respondent) at a cost of -
$50,250 (-9,087 hrs x $25.72/hr). Accounting for the change in number 
of respondents, the increase in burden per respondent from 0.215 hours 
to 0.2183 hours results in a difference of +100 hours (29,952 
respondents x 0.0033 hr/respondent) at a cost of $2,568 (100 hrs x 
$25.72/hr). As shown in Table 80, the aggregate change in burden is -
1,854 hours (100 hours-1,954 hours) at a cost of -$47,682 ($2,568-
$50,250).
[GRAPHIC] [TIFF OMITTED] TR28DE20.127


[[Page 84983]]


    The revised survey and burden will be released to the public via 
the standard non-rule PRA process which includes the publication of 60- 
and 30-day Federal Register notices.
(9) Group Registration for CMS Web Interface
    The requirements and burden will be submitted to OMB for approval 
under control number 0938-1314 (CMS-10621).
    In the CY 2021 PFS proposed rule, we proposed to sunset the CMS Web 
Interface measures as a collection type/submission type starting with 
the 2021 MIPS performance period (85 FR 50290). As a result, we did not 
provide a burden estimate for group registration for the CMS Web 
Interface for the 2021 performance period. As discussed in section 
IV.A.3.c.(1)(c) of this final rule, we are finalizing to sunset the CMS 
Web Interface measures as a collection type/submission type starting 
with the 2022 MIPS performance period; therefore, are now providing a 
burden estimate for both the 2021 and 2022 MIPS performance period.
    Groups interested in participating in MIPS using the CMS Web 
Interface for the first time must complete an online 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 81, we estimate that the registration process for 
groups under MIPS involves approximately 0.25 hours at $92.46/hr for a 
computer systems analyst (or their equivalent) to register the group.
    In this rule, we are adjusting the number of respondents from 69 to 
90 based on more recent data; an increase of 21 from the 69 groups 
currently approved by OMB and our estimate in the CY 2021 PFS proposed 
rule (85 FR 50358). Because we are finalizing to sunset the CMS Web 
Interface beginning with the 2022 MIPS performance period, it is 
possible that fewer groups will elect to register to submit quality 
data for the first time in the performance year prior to the collection 
type/submission type no longer being available; however, we currently 
have no data with which to estimate what the associated reduction may 
be. Therefore, we continue to assume that approximately 90 groups will 
elect to use the CMS Web Interface for the first time during the 2020 
MIPS performance period based on the number of new registrations 
received during the CY 2020 registration period. As shown in Table 81, 
we estimate a burden of 22.5 hours (90 new registrations x 0.25 hr/
registration) at a cost of $2,080 (22.5 hr x $92.46/hr).
[GRAPHIC] [TIFF OMITTED] TR28DE20.128

    As shown in Table 82 using our unchanged currently approved per 
respondent burden estimates, 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 +5.25 hours (+21 respondents x 
0.25 hours/respondent) at a cost of $485 (+21 groups x 0.25 hr x 
$92.46/hr) for the 2021 MIPS performance period. For the 2022 MIPS 
performance period, our burden estimate is 0 hours and $0.
[GRAPHIC] [TIFF OMITTED] TR28DE20.129

(10) Group Registration for CAHPS for MIPS Survey
    This rule is not implementing any new or revised collection of 
information requirements or burden related to the group registration 
for the CAHPS for MIPS Survey. The CAHPS for MIPS survey requirements 
and burden are currently approved by OMB under control number 0938-1222 
(CMS-10450). Consequently, we are not making any changes to burden for 
CAHPS for MIPS survey group registration under that control number.

[[Page 84984]]

f. ICRs Regarding the Call for MIPS Quality Measures
    This rule is not implementing any new or revised collection of 
information requirements or burden related to the call for MIPS quality 
measures. The requirements and burden are currently approved by OMB 
under control number 0938-1314 (CMS-10621). Consequently, we are not 
making any call for MIPS quality measure changes under that control 
number.
g. ICRs Regarding Promoting Interoperability Data (Sec. Sec.  414.1375 
and 414.1380)
(1) Background
    For the 2021 MIPS performance period, clinicians and groups can 
submit Promoting Interoperability data through direct, log in and 
upload, or log in and attest submission types. 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 
individuals and groups 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. The following burden 
estimates show only incremental hours required above and beyond the 
time already accounted for in the quality data submission process. 
Although 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.
(2) Reweighting Applications for Promoting Interoperability and Other 
Performance Categories
    The requirements and burden associated with this rule's data 
submission 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 
(82 FR 53918 through 53919), CY 2019 PFS final rule (83 FR 60011 
through 60012), and the CY 2020 PFS final rule (84 FR 63134 through 
63135) for our previously finalized requirements and burden for 
reweighting applications for Promoting Interoperability and other 
performance categories.
    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, quality, cost, and/or improvement activities 
performance categories under specific circumstances (81 FR 77240 
through 77243, 82 FR 53680 through 53686, and 82 FR 53783 through 
53785). Respondents who apply for a reweighting for the quality, cost, 
and/or improvement activities performance categories have the option of 
applying for reweighting for the Promoting Interoperability performance 
category on the same online form. We assume that respondents applying 
for a reweighting of the Promoting Interoperability performance 
category due to extreme and uncontrollable circumstances will also 
request a reweighting of at least one of the other performance 
categories simultaneously and not submit multiple reweighting 
applications.
    Table 83 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. Based on the number of reweighting 
applications received by December 31, 2019 for the 2019 MIPS 
performance period, we assume 51,098 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 clinicians in small practices) or EHR 
decertification and an additional 994 respondents will submit a request 
to reweight one or more of the quality, cost, Promoting 
Interoperability, or improvement activity performance categories due to 
an extreme or uncontrollable circumstance, for a total of 52,092 
reweighting applications submitted. This is an increase of 21,472 
respondents compared to our currently approved estimate of 30,620 
respondents (84 FR 63134). Similar to the data used to estimate the 
number of respondents in the CY 2020 PFS final rule, our respondent 
estimate includes a significant number of applications submitted as a 
result of a data issue CMS was made aware of and is specific to a 
single third-party intermediary. While we do not anticipate similar 
data issues to occur in each performance period, we do believe future 
similar incidents may occur and are electing to use this data without 
adjustment to reflect this belief. Our respondent estimate is also 
based on data that does not include applications submitted during the 
extended period ending April 30, 2020 due to the PHE for COVID-19, as 
we do not believe it would be an accurate basis for future estimates of 
application submissions. Of our total respondent estimate of 52,092, we 
estimate that 35,986 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 16,106 respondents will submit a request for 
reweighting the Promoting Interoperability performance category to zero 
percent as a small practice experiencing a significant hardship.
    In section IV.A.3.c.(5)(e), we discussed that, beginning with the 
2022 MIPS payment year (2020 performance year), APM Entities may submit 
an extreme and uncontrollable circumstances exception application for 
all four performance categories and applicable to all MIPS eligible 
clinicians in the APM Entity group. As previously discussed in section 
VII.B.5.a.(4) of this final rule, due to data limitations and our 
inability to determine who would use the APM Performance Pathway versus 
the traditional MIPS submission mechanism for the 2021 MIPS performance 
period, we assume ACO APM Entities will submit data through the APM 
Performance Pathway and non-ACO APM Entities would participate through 
traditional MIPS, thereby submitting as an individual or group rather 
than as an entity. Therefore, we limited our analysis to ACOs that were 
eligible for an exception due to extreme and uncontrollable 
circumstances during the 2019 MIPS performance period and elected not 
to report quality data. Based on this data, we estimate 7 APM Entities 
will submit an extreme and uncontrollable circumstances exception 
application for the 2021 MIPS performance period. Combined with our 
aforementioned estimate of 52,092 eligible clinicians and groups, the 
total estimated number of respondents for the 2021 MIPS performance 
period is 52,099.
    The application to request a reweighting to zero percent only 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

[[Page 84985]]

impair the clinician or group's ability to submit Promoting 
Interoperability data, as well as some proof of circumstances beyond 
the clinician's control. The application for reweighting of the 
quality, cost, Promoting Interoperability, and/or improvement 
activities performance categories due to extreme and uncontrollable 
circumstances requires the same information with the exception of there 
being only one option for the type of hardship experienced. We continue 
to estimate it will take 0.25 hours at $92.46/hr for a computer system 
analyst to complete and submit the application. As shown in Table 83, 
we estimate an annual burden of 13,025 hours (52,099 applications x 
0.25 hr/application) and $1,204,268 (13,025 hr x $92.46/hr).
[GRAPHIC] [TIFF OMITTED] TR28DE20.130

    As shown in Table 84, using our unchanged currently approved per 
respondent burden estimate, the increased number of respondents results 
in a total adjustment of 5,370 hours (21,479 respondents x 0.25 hr/
respondent) and $496,487 (5,370 hr x $92.46/hr).
[GRAPHIC] [TIFF OMITTED] TR28DE20.131

(3) Submitting Promoting Interoperability Data
    We did not propose any new or revised collection of information 
requirements related to the submission of data for the Promoting 
Interoperability performance category. However, we are adjusting our 
currently approved burden estimates based on more recent data. The 
burden 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 77509 through 77511), CY 2018 Quality Payment Program final rule 
(82 FR 53919 through 53920), CY 2019 PFS final rule (83 FR 60013 
through 60014), and the CY 2020 PFS final rule (84 FR 63135 through 
63137) for our previously finalized requirements and burden for 
submission of data for the Promoting Interoperability performance 
category.
    In this final rule, we did not propose any changes to our current 
criteria for automatic reweighting of the Promoting Interoperability 
performance category for certain MIPS eligible clinicians or MIPS 
eligible clinicians who have experienced a significant hardship or 
decertification of an EHR.
    In section IV.A.3.c.(4)(b) of this rule, we are adding Sec.  
414.1320(g)(1), which would establish a performance period for the 
Promoting Interoperability performance category of 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. Because this does not change the number of required 
Promoting Interoperability measures that must be reported, we are not 
making any changes to our burden assumptions.
    In section IV.3.c.(4)(c)(ii)(b) we are adding the HIE bi-
directional exchange measure for the 2021 performance period and 
subsequent years as an optional alternative to the two existing 
measures: The Support Electronic Referral Loops by Sending Health 
Information measure and the Support Electronic Referral Loops by 
Receiving and Incorporating Health Information

[[Page 84986]]

measure. This provision provides clinicians the option of either 
reporting the new measure or the two existing measures. Because the new 
HIE measure is an optional alternative instead of a new requirement and 
the provision does not change the number of required Promoting 
Interoperability measures that must be reported, we are not making any 
changes to our burden assumptions.
    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) and CY 2019 PFS final rule (83 FR 59822-59823), we 
established that eligible clinicians in MIPS APMs (including the Shared 
Savings Program) may report for the Promoting Interoperability 
performance category as an APM Entity group, individuals, or a group. 
Because we are not making changes at Sec.  414.1375 to the scoring for 
APM entities as a result of our provision in section IV.A.3.(b) of this 
final rule to establish an APM Performance Pathway, our reporting 
assumptions for clinician in MIPS APMs remains unchanged.
    As shown in Table 85, based on data from the 2019 MIPS performance 
period, we estimate that a total of 53,636 respondents consisting of 
42,110 individual MIPS eligible clinicians and 11,526 groups and 
virtual groups will submit Promoting Interoperability data. Since our 
CY 2020 PFS final rule estimated 74,281 respondents, this represents a 
decrease of 20,645 respondents (53,636 respondents-74,281 active 
respondents). This is a decrease of 20,636 individuals and 3,227 groups 
from the estimates of 62,746 individuals and 14,753 groups provided in 
the CY 2021 PFS proposed rule due to availability of updated data (85 
FR 50360).
    We assume that MIPS eligible clinicians previously scored under the 
APM scoring standard, as described in the CY 2020 PFS final rule, will 
continue to submit Promoting Interoperability data (84 FR 63006) in a 
similar way through the APM Performance Pathway. As a result, we do not 
anticipate any change in burden. Each MIPS eligible clinician in an APM 
Entity reports data for the Promoting Interoperability performance 
category through either their group TIN or individual reporting. 
Sections 1899 and 1115A of the Act (42 U.S.C. 1395jjj and 42 U.S.C. 
1315a, respectively) state that the Shared Savings Program and the 
testing, evaluation, and expansion of Innovation Center models are not 
subject to the PRA. However, in the CY 2019 PFS final rule, we 
established that MIPS eligible clinicians who participate in the Shared 
Savings Program are no longer limited to reporting for the Promoting 
Interoperability performance category through their ACO participant TIN 
(83 FR 59822 through 59823). Burden estimates for this final rule 
assume group TIN-level reporting as we believe this is the most 
reasonable assumption for the Shared Savings Program, which requires 
that ACOs include full TINs as ACO participants. As we receive updated 
information which reflects the actual number of Promoting 
Interoperability data submissions submitted by Shared Savings Program 
ACO participants, we will update our burden estimates accordingly.
[GRAPHIC] [TIFF OMITTED] TR28DE20.132

    We continue to estimate the time required for an individual or 
group to submit Promoting Interoperability data to be 2.67 hours. As 
shown in Table 86, the total burden estimate for submitting data on the 
specified Promoting Interoperability objectives and measures is 
estimated to be 143,029 hours (53,636 respondents x 2.67 incremental 
hours for a computer analyst's time above and beyond the physician, 
medical and health services manager, and computer system's analyst time 
required to submit quality data) and $13,224,492 (143,029 hr x $92.46/
hr)).

[[Page 84987]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.133

    As shown in Table 87, using our unchanged currently approved per 
respondent burden estimate, the decrease in number of respondents 
results in a total adjustment of -55,054 hours (-20,645 respondents x 
2.67 hr/respondent) at a cost of -$5,090,231 (-55,054 hr x $92.46/hr).
[GRAPHIC] [TIFF OMITTED] TR28DE20.134

h. ICRs Regarding the Nomination of Promoting Interoperability (PI) 
Measures
    This rule is not implementing any new or revised collection of 
information requirements or burden related to the nomination of 
Promoting Interoperability measures. The requirements and burden are 
currently approved by OMB under control number 0938-1314 (CMS-10621). 
Consequently, we are not making any changes under that control number.
i. ICRs Regarding Improvement Activities Submission (Sec. Sec.  
414.1305, 414.1355, 414.1360, and 414.1365)
    We are adjusting 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).
    We refer readers to the CY 2017 Quality Payment Program final rule 
(81 FR 77511 through 77512), CY 2018 Quality Payment Program final rule 
(82 FR 53920 through 53922), CY 2019 PFS final rule (83 FR 60015 
through 60017), and the CY 2020 PFS final rule (84 FR 63138 through 
63140) for our previously finalized requirements and burden for 
submission of data for the Improvement Activities performance category.
    In this final rule, we did not make any changes to our requirements 
associated with criteria for attesting to specific improvement 
activities.
    As discussed in section IV.A.3.c.(3)(b)(iii) of this rule, we are 
finalizing the removal of one obsolete improvement activity, 
modification of two existing improvement activities, and adoption of 
the COVID-19 improvement activity added via IFC. We refer readers to 
Appendix 2 of this final rule for further details. Because MIPS 
eligible clinicians are still required to submit the same number of 
activities and the per response time for each activity is uniform, we 
do not expect these provisions to affect our currently approved 
information collection burden estimates.
    In section IV.A.3.b.(3)(c) of this rule, we outline how we would 
assign a score for the Improvement Activities performance category for 
MIPS APMs. We will assign Improvement Activities scores to APM 
participants in the APP based on the requirements of participation in 
APMs. To develop the Improvement Activities score for MIPS APMs, we 
will compare requirements of the APM with the list of Improvement 
Activities measures for the applicable year, and score those measures 
as they would otherwise be scored according to Sec.  414.1355. In the 
event a MIPS APM participant does not actually perform an activity for 
which Improvement Activities credit would otherwise be assigned under 
this provision, the MIPS APM participant would not receive credit for 
the associated Improvement Activity. In the event that the assigned 
score does not represent the maximum improvement activities score, we 
specify that MIPS eligible clinicians reporting through the APP would 
have the opportunity to report additional improvement activities that 
then would be applied towards their scores. Our burden estimates assume 
there will be no improvement activities burden for MIPS APM 
participants electing the APP. We will assign the improvement

[[Page 84988]]

activities performance category score at the APM Entity level.
    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 submission types, and CMS Web Interface will also submit 
improvement activities data. In the 2020 and prior MIPS performance 
periods, individuals and groups submitting data for the quality 
performance category through a MIPS CQM or QCDR that did not also 
support reporting of data for the Promoting Interoperability or 
improvement activity performance categories would be required to submit 
data for these performance categories using an alternate submission 
type, the policies requiring qualified registries and QCDRs to be able 
to submit data for all three of the MIPS performance categories 
identified in Sec.  414.1400(a)(2) will help to alleviate this issue. 
As finalized 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. Similar to our assumption in the CY 2018 
Quality Payment Program final rule, our burden estimates assume that 
the MIPS APM models for the 2021 MIPS performance period will qualify 
for the maximum improvement activities performance category score and, 
as such, APM Entities will not submit any additional improvement 
activities. (82 FR 53921 through 53922).
    As represented in Table 88, based on 2019 MIPS performance period 
data, we estimate that a total of 79,927 respondents consisting of 
62,603 individual clinicians and 17,324 groups will submit improvement 
activities during the 2021 MIPS performance period. Since our currently 
approved burden sets out 103,813 respondents, this represents a 
decrease of-23,886 respondents (79,927 respondents--103,813 active 
respondents). This is a decrease of 23,157 individuals and an increase 
of 610 groups from the estimates of 85,760 individuals and 16,714 
groups provided in the CY 2021 PFS proposed rule due to availability of 
updated data (85 FR 50362).
    As discussed in sections VII.B.5.e.(2) and VII.B.5.g.(3) of this 
final rule regarding our estimate of clinicians and groups submitting 
data for the quality and Promoting Interoperability performance 
categories, we have updated our estimates for the number of clinicians 
and groups that will submit improvement activities data based on 
projections of the number of eligible clinicians that were not QPs or 
members of an ACO in the 2019 MIPS performance period but will be in 
the 2021 MIPS performance period, and will therefore not be required to 
submit improvement activities data.
[GRAPHIC] [TIFF OMITTED] TR28DE20.135

    Consistent with the CY 2020 PFS final rule, we continue to estimate 
that the per response time required per individual or group is 5 
minutes 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 (84 
FR 63140).
    As shown in Table 89, we estimate an annual burden of 6,661 hours 
(79,927 responses x 5 minutes/60) and $615,838 (6,661 hr x $92.46/hr)).

[[Page 84989]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.136

    As shown in Table 90, using our unchanged currently approved per 
respondent burden estimate, the decrease of -23,886 in the number of 
respondents results in an adjustment of -1,990 hours (-23,886 responses 
x 5 minutes/60) at a cost of -$184,041 (-1,990 hr x $92.46/hr).
[GRAPHIC] [TIFF OMITTED] TR28DE20.137

j. ICRs Regarding the Nomination of Improvement Activities (Sec.  
414.1360)
    The requirements and burden associated with this rule's data 
submission 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 
(82 FR 53922), CY 2019 PFS final rule (83 FR 60017 through 60018), and 
the CY 2020 PFS final rule (84 FR 63141) for our previously finalized 
requirements and information collection burden for the nomination of 
improvement activities.
    In the CY 2018 Quality Payment Program final rule, for the 2018 and 
future MIPS performance periods, stakeholders were provided an 
opportunity to propose new activities formally via the Annual Call for 
Activities nomination form that was posted on the CMS website (82 FR 
53657). In section IV.A.3.c.(3)(b)(i)(B)(bb) of this rule, we are 
requiring nominated improvement activities to be linked to existing and 
related quality and cost measures, as applicable and feasible. Similar 
to the burden assumptions finalized in the CY 2020 PFS final rule for 
the nomination of quality measures, we believe this will require 
approximately 0.6 hours at $110.74/hr for a medical and health services 
manager and 0.4 hours at $212.78/hr for a physician to research 
existing measures and provide a rationale for the linkage (84 FR 
63132). We previously estimated it would require 1.2 hours for a 
medical and health services manager or equivalent and 0.8 hours for a 
physician to nominate an improvement activity (84 FR 63141). Combined 
with our currently approved burden estimate, we now estimate 1.8 hours 
at $110.74/hr for a medical and health services manager or equivalent 
and 1.2 hours at $212.78/hr for a physician to nominate an improvement 
activity. This represents a change of +0.6 hours (1.8 hr--1.2 hr) for a 
medical and health services manager or equivalent and +0.4 hours (1.2 
hr--0.8 hr) for a physician and an overall increase of 1 hour.
    In section IV.A.3.c.(3)(b)(i)(A)(bb), we are making an exception to 
the established timeframe for nomination of improvement activities, 
such that during a PHE, stakeholders can nominate improvement 
activities outside of the established Annual Call for Activities 
timeframe. Instead of only accepting nominations and modifications 
submitted February 1st through June 30th each year, we would accept 
nominations for the duration of the PHE as long as the improvement 
activity is still relevant. No other aspects of the Annual Call for 
Activities process would be affected (for example, criteria for 
nominating improvement activities, considerations for selection of 
improvement activities, or weighting policies would all still apply). 
While we expect additional nominations may be received as a result of 
this change, we do not have any data with which to estimate what the 
additional number may be. As a result, our burden estimate remains 
unchanged due to this provision. Additionally, in section 
IV.A.3.c.(3)(b)(ii)(B), beginning with the CY 2021 performance period 
and future years, we will consider agency-nominated improvement 
activities. Because these nominations would be submitted by federal 
agencies, the associated time is exempt from the PRA, and therefore, 
not included in our estimates. We also refer readers to

[[Page 84990]]

section VIII.H.15.e.(4)(c) where we discuss our impact analysis.
    Due to the PHE for COVID-19, we continue to use our currently 
approved assumption that we will receive 31 nominations of new or 
modified activities which will be evaluated for the Improvement 
Activities Under Consideration (IAUC) list for possible inclusion in 
the CY 2022 Improvement Activities Inventory as we believe this 
estimate is more realistic than basing our estimate on the number of 
nominations received during the 2020 Annual Call for Activities.
    As shown in Table 91, we estimate an annual information collection 
burden of 93 hours (31 nominations x 3 hr/nomination) at a cost of 
$14,095 (31 x [(1.8 hr x $110.74/hr) + (1.2 hr x $212.78/hr)]).
[GRAPHIC] [TIFF OMITTED] TR28DE20.138

    As shown in Table 92, using our unchanged estimate of the number of 
activities nominated, the increase in the burden per nomination results 
in a change of 31 hours (31 nominations x 1 hr/nomination) at a cost of 
$4,698 (31 activities x [(0.6 hr x $110.74/hr) + (0.4 hr x $212.78/
hr)]).
[GRAPHIC] [TIFF OMITTED] TR28DE20.139

k. Nomination of MVPs
    The following reflects the burden associated with the first year of 
data collection associated with a new process available for all 
clinicians/third party intermediaries to nominate MVPs for inclusion in 
the Quality Payment Program. The requirements and burden associated 
with the Nomination of MVPs will be submitted to OMB for approval under 
control number 0938-1314 (CMS-10621).
    Beginning with the 2022 performance period, we are requiring 
stakeholders to formally submit their MVP candidates utilizing a 
standardized template, which will be published in the QPP resource 
library for future implementation. Stakeholders should submit all 
information including a description of how their MVP abides by the MVP 
development criteria as described in section IV.A.3.a.(2)(a)(i) of this 
final rule, and provide rationales as to why specific measures and 
activities were chosen to construct the MVP. As MVP candidates are 
received, they will be reviewed, vetted, and evaluated by CMS and our 
contractors to determine if the MVP is feasible and ready for inclusion 
in the upcoming performance period. For the 2021 MIPS performance 
period, we assume 25 MVP nominations will be received and the estimated 
time required to submit all required information is 12 hours per 
nomination. We solicited comment on our estimate of the time required 
to nominate an MVP. We did not receive comments related to the estimate 
of time required to nominate an MVP.
    Similar to the call for quality measures, nomination of Promoting 
Interoperability measures, and the nomination of improvement 
activities, we assume MVP nomination will be performed by both practice 
administration staff or their equivalents and clinicians. We estimate 
7.2 hours at $110.74/hr for a medical and health services manager or 
equivalent and 4.8 hours at $212.78/hr for a physician to nominate an 
MVP. As shown in Table 93, we estimate an annual burden of 300 hours 
(25 nominations x 12 hr/nomination) at a cost of $45,467 (25 x [(7.2 hr 
x $110.74/hr) + (4.8 hr x $212.78/hr)]).

[[Page 84991]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.140

l. 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; CMS-1500 and CMS-1490S) 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, the provisions of this final rule do not result in the need 
to add or revise or delete any claims data fields. Consequently, we are 
not setting out burden or making any changes under the 0938-1197 
control number.
m. ICRs Regarding Partial QP Elections (Sec. Sec.  414.1310(b) and 
414.1430)
    This rule did not propose any new or revised collection of 
information requirements related to the Partial QP Elections to 
participate in MIPS as a MIPS eligible clinician. However, we are 
adjusting our currently approved burden estimates based on updated 
projections for the 2021 MIPS performance period. The burden will be 
submitted to OMB for approval under control number 0938-1314 (CMS-
10621).
    As shown in Table 94, based on our predictive QP analysis for the 
2021 QP performance period, which accounts for historical response 
rates in performance year 2019, we estimate that 100 APM Entities and 
200 eligible clinicians (representing approximately 2,500 Partial QPs) 
will make the election to participate as a Partial QP in MIPS, a total 
of 300 elections which is a decrease of 1,722 from the 2,022 elections 
that are currently approved by OMB under the aforementioned control 
number. We continue to 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 75 hours (300 
respondents x 0.25 hr/election) and $6,935 (75 hr x $92.46/hr).
[GRAPHIC] [TIFF OMITTED] TR28DE20.141

    As shown in Table 95, using our unchanged currently approved per 
respondent burden estimate, the decrease in the number of Partial QP 
elections results in an adjustment of -430.5 hours (-1,722 elections x 
0.25 hr) from our currently approved burden of 505.5 hours at a cost of 
-$39,804 (-430.5 hr x $92.46/hr) (84 FR 63142).

[[Page 84992]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.142

n. ICRs Regarding Other Payer Advanced APM Determinations: Payer-
Initiated Process (Sec.  414.1445) and Eligible Clinician Initiated 
Process (Sec.  414.1445)
    The following burden will be submitted to OMB for approval under 
control number 0938-1314 (CMS-10621).
(1) Payer Initiated Process (Sec.  414.1445)
    This rule is not implementing any new or revised collection of 
information requirements related to the Payer-Initiated Process. 
However, we are adjusting our currently approved burden estimates based 
on updated projections for the 2021 MIPS performance period. As 
mentioned above, the adjusted burden will be submitted to OMB for 
approval.
    As shown in Table 96, based on the actual number of requests 
received in the 2019 QP performance period, we estimate that in CY 2021 
for the 2022 QP performance period 80 payer-initiated requests for 
Other Payer Advanced APM determinations will be submitted (10 Medicaid 
payers, 50 Medicare Advantage Organizations, and 20 remaining other 
payers), a decrease of 30 from the 110 total requests currently 
approved by OMB under the aforementioned control number. We continue to 
estimate it will take 10 hours for a computer system analyst per 
arrangement submission. We estimate an annual burden of 800 hours (80 
submissions x 10 hr/submission) and $73,968 (800 hr x $92.46/hr).
[GRAPHIC] [TIFF OMITTED] TR28DE20.143

    As shown in Table 97, using our unchanged currently approved per 
respondent burden estimate, the decrease in the number of payer-
initiated requests from 110 to 80 results in an adjustment of -300 
hours (-30 requests x 10 hr) from our currently approved burden of 
1,100 hours at a cost of -$27,738 (-300 hr x $92.46/hr) (84 FR 63143).
[GRAPHIC] [TIFF OMITTED] TR28DE20.144


[[Page 84993]]


(2) Eligible Clinician Initiated Process (Sec.  414.1445)
    This rule is not implementing any new or revised collection of 
information requirements or burden related to the Eligible-Clinician 
Initiated Process. The requirements and burden are currently approved 
by OMB under control number 0938-1314 (CMS-10621). Consequently, we are 
not making any changes to the eligible clinician initiated process 
under that control number.
(3) Submission of Data for QP Determinations Under the All-Payer 
Combination Option (Sec.  414.1440)
    This rule is not implementing any new or revised collection of 
information requirements related to the Submission of Data for QP 
Determinations under the All-Payer Combination Option. The requirements 
and burden are currently approved by OMB under control number 0938-1314 
(CMS-10621). Consequently, we are not making any changes to the QP 
Determinations under the All-Payer Combination Option under that 
control number.
o. ICRs Regarding Voluntary Participants Election To Opt-Out of 
Performance Data Display on Physician Compare (Sec.  414.1395)
    This rule is not implementing any new or revised collection of 
information requirements related to the election by voluntary 
participants to opt-out of public reporting on Physician Compare. 
However, we are adjusting our currently approved burden estimates based 
on data from the 2019 MIPS performance period. The burden 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 
(82 FR 53924 through 53925), CY 2019 PFS final rule (83 FR 60022), and 
the CY 2020 PFS final rule (84 FR 63145 through 63146) for our 
previously finalized requirements and burden for voluntary participants 
to opt-out of public reporting on Physician Compare.
    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 3,486 (0.10 x 34,860 
voluntary MIPS participants) clinicians and groups, a decrease of -
6,556 from the currently approved estimate of 10,042 and a decrease of 
6,418 from the estimate of 9,904 provided in the CY 2021 PFS proposed 
rule due to availability of updated data (85 FR 50367). Voluntary MIPS 
participants are clinicians that are not QPs and are expected to be 
excluded from MIPS after applying the eligibility requirements set out 
in the CY 2019 PFS final rule but have elected to submit data to MIPS. 
As discussed in the RIA section of the CY 2019 PFS final rule, we 
estimate that 33 percent of clinicians that exceed one (1) of the low-
volume criteria, but not all three (3), will elect to opt-in to MIPS, 
become MIPS eligible, and no longer be considered a voluntary reporter 
(83 FR 60050).
    Table 98 shows that for these voluntary participants, we continue 
to estimate it will take 0.25 hours for a computer system analyst to 
submit a request to opt-out. In aggregate, we estimate an annual burden 
of 871.5 hours (3,486 requests x 0.25 hr/request) and $80,579 (871.5 hr 
x $92.46/hr).
[GRAPHIC] [TIFF OMITTED] TR28DE20.145

    As shown in Table 99, using our unchanged currently approved per 
respondent burden estimate, the decrease of -6,556 opt outs by 
voluntary participants results in an adjustment of -1,639 hours (-6,556 
requests x 0.25 hr) at a cost of -$151,542 (-1,639 hr x $92.46/hr).
[GRAPHIC] [TIFF OMITTED] TR28DE20.146


[[Page 84994]]


p. Summary of Annual Quality Payment Program Burden Estimates
    Table 100 summarizes this final rule's burden estimates for the 
Quality Payment Program for both the 2021 and 2022 performance periods. 
In the CY 2020 PFS final rule, the total estimated burden was 2,932,649 
hours at a cost of $279,550,490 ($279,573,747--$23,257) (84 FR 63146). 
Accounting for updated wage rates and the subset of all Quality Payment 
Program ICRs discussed in this rule compared to the CY 2020 PFS final 
rule, the total estimated annual burden of continuing policies and 
information set forth in the CY 2020 PFS final rule into the 2021 and 
2022 MIPS performance periods is 2,938,128 hours at a cost of 
$287,216,853; an increase of 5,479 hours and $7,666,363. To understand 
the burden implications of the policies in this rule, we provide an 
estimate of the total burden associated with continuing the policies 
and information collections set forth in the CY 2020 PFS final rule 
into the 2021 and 2022 MIPS performance periods. This burden estimate 
of 1,478,504 hours at a cost of $144,456,084 reflects the availability 
of more accurate data to account for all potential respondents and 
submissions across all the performance categories and more accurately 
reflect the exclusion of QPs from all MIPS performance categories, a 
difference of -1,459,624 hours and -$142,760,769. This burden estimate 
is lower than the burden approved for information collection related to 
the CY 2020 PFS final rule due to updated data and assumptions as well 
as the addition of the Open Authorization Credentialing and Token 
Request Process information collection, which is not a result of any 
new or revised policies in this rule or finalized in any previous final 
rule, but rather an operational improvement. The difference of -4,763 
hours (1,459,624 hours -1,462,534 hours-1,854 hours) and -$421,117 
($142,760,769-$143,134,204-$47,681) between this estimate and the total 
burden shown in Table 103 is the reduction in burden associated with 
impacts of the policy to sunset the CMS Web Interface measures as a 
collection type/submission type; partially offset by an increase in 
burden due to a new information collection for nomination of MVPs, the 
policies to require QCDRs and qualified registries to conduct targeted 
audits as necessary, the policy to add a survey-based measure on 
telehealth that assesses patient-reported usage of telehealth services 
to the CAHPS for MIPS Survey, the policy to allow APM Entities to 
submit an extreme and uncontrollable circumstances exception 
application, and the policy to require nominated improvement activities 
to be linked to existing and related quality and cost measures, as 
applicable and feasible. We have included Table 100 to assist in 
understanding these differences. Note that the difference between the 
burden estimates for the 2021 and 2022 MIPS performance periods is 
entirely due to the finalized policy to sunset the CMS Web Interface 
measures as a collection type/submission type beginning in the 2022 
MIPS performance period.
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[[Page 84996]]


[GRAPHIC] [TIFF OMITTED] TR28DE20.149

    Table 102 provides the reasons for changes in the estimated burden 
for information collections in the Quality Payment Program segment of 
this final rule. We have divided the reasons for our change in burden 
into those related to new policies and those related to adjustments in 
burden from continued Quality Payment Program Year 4 policies that 
reflect updated data and revised methods.

[[Page 84997]]

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[[Page 84998]]


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C. Summary of Annual Burden Estimates for Requirements
[GRAPHIC] [TIFF OMITTED] TR28DE20.152


[[Page 84999]]


BILLING CODE 4120-01-C

VIII. Regulatory Impact Analysis

A. Statement of Need

    This final rule would make 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, the Bipartisan 
Budget Act of 2018, and sections 2005, 6063, and 6111 of the SUPPORT 
for Patients and Communities Act of 2018. This final rule would also 
make changes to payment policy and other related policies for Medicare 
Part B.
    This final rule is necessary to make policy changes under Medicare 
fee-for-service. Therefore, we included a detailed Regulatory Impact 
Analysis (RIA) to assess all costs and benefits of available regulatory 
alternatives and explained the selection of these regulatory approaches 
that we believe adhere to statutory requirements and, to the extent 
feasible, maximize net benefits.

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 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). An RIA 
must be prepared for major rules with economically significant effects 
($100 million or more in any 1 year). We estimated, as discussed in 
this section, that the PFS provisions included in this final 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 http://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 
final rule is intended to comply with the RFA requirements regarding 
significant impact on a substantial number of small entities.
    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 NPPs 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 final rule will 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 2020, that 
threshold is approximately $156 million. This final 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 final rule 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,'' was issued on January 30, 2017. This 
final rule is expected to be an E.O. 13771 regulatory action. We 
estimate the rule generates $1.23 million in annualized costs in 2016 
dollars, discounted at 7 percent relative to year 2016 over a perpetual 
time horizon. Details on the estimated costs of this rule can be found 
in the preceding and subsequent 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 final 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 final rule, we 
discussed 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 final rule. We are unaware of any 
relevant federal

[[Page 85000]]

rules that duplicate, overlap, or conflict with this final rule. The 
relevant sections of this final 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 
compared payment rates for CY 2020 with payment rates for CY 2021 using 
CY 2019 Medicare utilization. The payment impacts in this final 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 will 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 (CLFS).
    The PFS update adjustment factor for CY 2021, as required by 
section 1848(d)(19) of the Act, is 0.00 percent before applying other 
adjustments.
    To calculate the CY 2021 PFS conversion factor (CF), we multiplied 
the product of the current year CF and the update adjustment factor by 
the budget neutrality adjustment described in the preceding paragraphs. 
We estimate the CY 2021 PFS CF to be 32.4085 which reflects the budget 
neutrality adjustment under section 1848(c)(2)(B)(ii)(II) of the Act 
and the 0.00 percent update adjustment factor specified under section 
1848(d)(19) of the Act. We estimate the CY 2021 anesthesia CF to be 
20.0547 which reflects the same overall PFS adjustments with the 
addition of anesthesia-specific PE and MP adjustments.
[GRAPHIC] [TIFF OMITTED] TR28DE20.153

[GRAPHIC] [TIFF OMITTED] TR28DE20.154

    Table 106 shows the payment impact on PFS services of the policies 
contained final 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 will be different from those shown in 
Table 106 (CY 2021 PFS Estimated Impact on Total Allowed Charges by 
Specialty). The following is an explanation of the information 
represented in Table 106.
     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 2019 utilization and CY 
2020 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 2021 impact on total allowed charges of the changes in 
the work RVUs, including the impact of changes due to potentially 
misvalued codes.
     Column D (Impact of PE RVU Changes): This column shows the 
estimated CY 2021 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 2021 impact on total allowed charges of the changes in the 
MP RVUs.
     Column F (Combined Impact): This column shows the 
estimated CY 2021 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.
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[[Page 85002]]


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BILLING CODE 4120-01-C
2. CY 2021 PFS Impact Discussion
a. Changes in RVUs
    The most widespread specialty impacts of the RVU changes are 
generally related to the changes to RVUs for specific services 
resulting from the misvalued code initiative, including RVUs for new 
and revised codes. The estimated impacts for some specialties, 
including endocrinology, rheumatology, family practice, and hematology/
oncology reflect increases relative to other physician specialties. 
These increases can largely be attributed to previously finalized 
policies for increases in valuation for office/outpatient E/M visits 
which constitute nearly 20 percent of total spending under the PFS. 
These increases are also due to increases in value for particular 
services following the recommendations from the American Medical 
Association (AMA)'s Relative Value Scale Update Committee (RUC) and CMS 
review, increased payments as a result of finalized updates to supply 
and equipment pricing, and the continuing implementation of the 
adjustment to indirect PE allocation for some office-based services. 
For nephrologists, the increase in the valuations of the ESRD monthly 
capitation payments that have office/outpatient E/M visits explicitly 
included in their valuations result in estimated impacts of +6 percent. 
For clinical social workers and clinical psychologists, to the increase 
in the valuations for certain behavioral health services that are 
analogous to office/outpatient E/M visits result in estimated impacts 
of 0 to 1 percent.
    The estimated impacts for several specialties, including radiology, 
nurse anesthetists, pathology, and cardiac surgery reflect decreases in 
payments relative to payment to other physician specialties which are 
largely the result of the redistributive effects of previously 
finalized changes to the office/outpatient E/M visits taking effect in 
2021. These decreases are also due to the revaluation of individual 
procedures reviewed by the AMA's RUC and CMS, as well as decreased 
payments as a result of continuing implementation of the previously 
finalized updates to supply and equipment pricing. The estimated 
impacts also reflect decreased payments due to continued implementation 
of previously finalized code-level reductions that are being phased in 
over several years. For the physical/occupational therapy specialty, 
estimated impacts of -9 percent reflect increased valuations for 
therapy evaluation services that are analogous to office/outpatient E/M 
visits. However, therapy evaluation services do not account for a large 
portion of allowed charges for these specialties.
    For emergency medicine practitioners, estimated impacts of -6 
percent reflect a 2 percent gain as a result of increased valuations to 
emergency department visits using specialty society recommendations to 
maintain relativity with office/outpatient E/M visits. However, the 
magnitude of the office/outpatient E/M visit valuations are dampening 
the effect of increased valuations for the emergency department (ED) 
visits. 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 CLFS. As a result, the 
estimated 5 percent decrease for CY 2021 is only applicable to 
approximately 17 percent of the Medicare payment to these entities.
    We often receive comments regarding the changes in RVUs displayed 
on the specialty impact table (Table 106), including comments received 
in response to the 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 Table 106 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 106 displays the estimated CY 2021 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 2021 PFS final rule website at http://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 http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/.
    We received public comments about the impacts of this provision. 
The following is a summary of the comments we received and our 
response.
    Comment: In general, commenters from physician specialties who saw 
projected increases related to our previously finalized revaluation of 
the office/outpatient E/M code set, our implementation of HCPCS code 
G2211, and our revaluations of services analogous to office/outpatient 
E/Ms

[[Page 85003]]

were supportive, while those commenters from physician specialties who 
projected decreases objected. Many commenters expressed concern with 
the budget neutrality adjustments associated with implementing our 
previously finalized revaluation of the office/outpatient E/M codes, 
particularly for those specialties who do not bill for office/
outpatient E/M visits.
    Response: While we understand the concerns articulated by 
commenters, our approach to making the required budget neutrality 
adjustment to account for changes in expenditures resulting from 
changes to RVUs, including those for the office/outpatient E/M code set 
and other similar services, is consistent with the approach we have 
applied to achieve budget neutrality in the past in accordance with the 
requirements of the statute. The statutory waiver authorities available 
to the Secretary following a public health emergency declaration, which 
are largely established in section 1135 of the Act, do not include 
waiver authority that would allow for implementation of changes to the 
PFS outside of the budget neutrality requirements in statute. The 
changes we make to RVUs are directed at setting appropriate resource-
based relative values in accordance with section 1848 of the Act, and 
any increases or decreases in estimated payments associated with our 
finalized policies are purely a result of our longstanding budget 
neutrality process.
    Comment: Several commenters suggested that the Secretary use waiver 
authority in response to the PHE for COVID-19 to implement the 
revaluations to the office/outpatient E/M visits, analogous services, 
and HCPCS code G2211 without application of the budget neutrality 
adjustment. Several other commenters requested that CMS exempt 
specialties that do not predominantly bill for office/outpatient E/M 
services from the budget neutrality adjustment.
    Response: While we understand the concerns articulated by the 
commenters, we reiterate that 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. The Secretary's waiver authority pursuant to the public 
health emergency declaration for COVID-19 does not extend to authorize 
changes to the PFS outside of budget neutrality. Additionally, section 
1848 of the Act does not grant the Secretary the authority to exempt 
categories of physicians or practitioners from the budget neutrality 
adjustments.
    Comment: Some commenters requested that CMS provide additional 
analysis on the potential impact of our finalized policies on small 
businesses.
    Response: We appreciate the interest from commenters and the 
request that we provide additional analysis on the potential impact of 
our finalized policies on small businesses. Our discussion of the 
potential impacts complies with RFA requirements regarding significant 
impact on a substantial number of small entities. Our longstanding 
policy for our impacts discussion is to provide analysis at the level 
of certain specialties, as identified in the specialty information 
captured in our Medicare provider enrollment files. We would note that 
the lack of granular, national and publicly available data that could 
be used to identify variability between localities, business types, and 
the specific mixture of Medicare/non-Medicare payment for a given 
business makes it difficult to project impacts on small businesses 
using our standard process.

D. Effect of Changes Related to Telehealth Services

    As discussed in section II.F. of this final rule, we are adding 
nine new codes to the list of Medicare telehealth services list for CY 
2021. These codes are:

 Group Psychotherapy (CPT 90853)
 Domiciliary, Rest Home, or Custodial Care services, 
Established patients (CPT 99334-99335)
 Home Visits, Established Patient (CPT 99347-99348)
 Cognitive Assessment and Care Planning Services (CPT 99483)
 Visit Complexity Inherent to Certain Office/Outpatient E/Ms 
(HCPCS G2211)
 Prolonged Services (HCPCS G2212)
 Psychological and Neuropsychological Testing (CPT 96121)

    We are also adding the following services to the list of Medicare 
telehealth services provisionally on a category 3 basis:

 Domiciliary, Rest Home, or Custodial Care services, 
Established patients (CPT 99336-99337)
 Home Visits, Established Patient (CPT 99349-99350)
 Emergency Department Visits, Levels 1-5 (CPT 99281-99285)
 Nursing facilities discharge day management (CPT 99315-99316)
 Psychological and Neuropsychological Testing (CPT 96130-96133; 
CPT 96136-96139)
 Therapy Services, Physical and Occupational Therapy, All 
levels (CPT 97161-97168; CPT 97110, 97112, 97116, 97535, 97750, 97755, 
97760, 97761, 92521-92524, 92507)
 Hospital discharge day management (CPT 99238-99239)
 Inpatient Neonatal and Pediatric Critical Care, Subsequent 
(CPT 99469, 99472, 99476)
 Continuing Neonatal Intensive Care Services (CPT 99478-99480)
 Critical Care Services (CPT 99291-99292)
 End-Stage Renal Disease Monthly Capitation Payment codes (CPT 
90952, 90953, 90956, 90959, and 90962)
 Subsequent Observation and Observation Discharge Day 
Management (CPT 99217; CPT 99224-99226)

    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 
additions, we estimate there will only be a negligible impact on PFS 
expenditures from these additions. For example, services already on the 
list of permanent telehealth services are furnished via telehealth, on 
average, less than 0.1 percent of the time they are reported overall. 
The statutory payment requirements for Medicare telehealth services 
under section 1834(m) of the Act, such as the originating site 
requirements related to geographic location and site of service, limit 
increases in utilization outside of the PHE for the COVID-19 pandemic; 
however, we believe there is value in allowing physicians to furnish 
these additional services via telehealth, and for patients to receive 
broader access to this care through telehealth. Additionally, for 
services added to the Medicare telehealth list on a Category 3 basis, 
outside of the circumstances of the PHE for COVID-19, all of the 
statutory restrictions will also apply to these services. Even with the 
addition of the category 3 services for an additional year, we do not 
anticipate any significant increase in utilization after the PHE for 
COVID-ends. We note that due to flexibilities implemented during the 
PHE for the COVID-19 pandemic, particularly waivers of the statutory 
geographic and site-of-service restrictions, has led to increased 
utilization of telehealth services; \149\

[[Page 85004]]

however, we do not believe we have sufficient data to draw any further 
conclusions. CMS will need to conduct additional analyses once there 
are sufficient data such as a full year's worth of claims that will 
allow us to consider the effects of the PHE on utilization in the 
context of the annual/seasonal variations observed in the claims data 
that exist from one year to the next. Such analysis would inform CMS 
options for adopting any flexibilities on a permanent basis, as allowed 
by Medicare statute outside of the circumstances of the PHE. This 
information would also be taken into consideration for future 
ratesetting under the PFS.
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    \149\ https://aspe.hhs.gov/pdf-report/medicare-beneficiary-use-telehealth, https://aspe.hhs.gov/system/files/pdf/264071/Medicare-FFS-Spending-Utilization.pdf.
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E. Effect of Changes Related to Scopes of Practice

    As discussed in section II.G. Scopes of Practice for PFS Services, 
of this final rule, we will allow certain NPPs to supervise diagnostic 
tests, which would authorize NPs, CNSs, PAs, CNMs, and CRNAs to provide 
the appropriate level of supervision assigned to diagnostic tests, to 
the extent authorized under State law and scope of practice. As for all 
services they furnish, in accordance with statute, the NP, CNS or PA 
necessarily would be working either under physician supervision or in 
collaboration with a physician. This flexibility may increase the 
capacity and availability of practitioners who can supervise diagnostic 
tests, which would alleviate some of the demand on physicians as the 
only source to perform this particular function.
    We solicited comment on state scope of practice rules and they 
extent to which they specified supervision requirements for the 
supervision of diagnostic tests. Some commenters provided information 
on specific tests and thoughts on what practitioners could supervise 
such tests, these commenters provided information indicating that 
psychological and neuropsychological diagnostic tests are not within 
the scope of practice of the proposed NPPs, and require special 
training only available to psychologists and physicians. While this 
information provides some context to our policy discussion, overall, we 
have not located national detailed information indicating the degree to 
which NPP scope of practice includes supervision of auxiliary staff, 
especially for the subset of services that are diagnostic tests and 
note that here is a wide range of diagnostic tests, from a simple strep 
throat swab to more sophisticated and/or invasive tests such as X-rays 
and cardiology procedures. We would need to understand the scope of 
practice for many types of auxiliary staff (some of whom are not 
licensed) who could potentially provide these tests under the 
supervision of an NPP, including RNs, LPNs, medical assistants, 
radiologic technicians, and many others. However, as discussed earlier 
in this rule, our intent regarding this supervision flexibility is to 
allow NPPs with separate benefit categories under Medicare law to 
supervise the performance of diagnostic tests, regardless of the 
specific category of diagnostic tests, only to the extent their scope 
of practice and State laws authorize them to do so.
    To the extent practice patterns change, there could be induced 
utilization that would increase costs, but this might be offset by 
reduced payment rates because direct payment to NPPs is at a lower rate 
than payment to physicians.
    An alternative in the case of the provision concerning supervision 
of diagnostic tests was to maintain the status quo. That is, we noted 
that we could maintain the basic rule under Sec.  410.32(b)(1) that 
allows only physicians as defined under Medicare law to supervise the 
performance of diagnostic tests. In that case, the pool of 
practitioners who could supervise diagnostic tests would remain at 
current levels and certain NPPs would be limited under Medicare from 
practicing to the full extent allowed by their state license and scope 
of practice.
    We are finalizing the proposal to allow a physical therapist (PT) 
or occupational therapist (OT)--whether they are an enrolled private 
practice PT or OT or a therapist working for an institutional 
provider--who establishes a therapy maintenance program to assign the 
duties to a PTA or OTA, as clinically appropriate, to perform 
maintenance therapy services. We added this as a flexibility under the 
May 8th COVID-19 IFC for the duration of the PHE for COVID-19 based on 
respondents' feedback on scope of practice following the President's 
E.O. 13890. Our current requirements for maintenance therapy services 
restrict a PT's/OT's ability to delegate the performance of maintenance 
therapy services to PTAs and OTAs which is counter to the therapist's 
ability to use PTAs/OTAs in furnishing rehabilitative outpatient 
physical or occupational therapy services. In the CY 2021 PFS proposed 
rule (85 FR 50147), we proposed to allow PTs/OTs to oversee and 
delegate to a PTA or OTA the performance of physical and occupational 
therapy services in the same way, whether the therapy services are part 
of a plan of care geared toward rehabilitative or maintenance therapy. 
While therapy services furnished by PTs/OTs and their PTAs/OTAs are 
separately payable when they occur in different time slots (that is, if 
the PT/PTA or OT/OTA work together at the same time in furnishing a 
service to the patient, only one service is payable), we noted that we 
did not believe that there would be an increase in utilization since it 
is of no consequence whether the PTA/OTA is furnishing the service as 
rehabilitative or maintenance therapy. Additionally, we note that 
beginning January 1, 2022, payment for services furnished in whole or 
in part by a PTA/OTA (when the part by the PTA/OTA separate from the 
part of furnished by the PT/OT exceeds 10 percent of the service) will 
be paid at a lower rate (85 percent of the PFS fee schedule amount) 
which could offset any nominal increase in service volume. The 
alternative option--maintaining the status quo to require the PT/OT to 
personally furnish all maintenance therapy services, would not address 
the mandates established in E.O. 13890. Currently, in SNF and home 
health settings when payment for therapy is made under Part A, 
maintenance therapy can be furnished by a PT/OT or delegated to be 
performed by a PTA/OTA, and this provision would permit this to occur 
in all settings when therapy is paid under Part B.

F. Effect of Changes to Bundled Payments Under the PFS for Substance 
Use Disorders (HCPCS Codes G2086, G2087, and G2088)

    As discussed in section II.H. of this final rule, Valuation of 
Specific Codes, we are expanding the bundled payments described by 
HCPCS codes G2086, G2087, and G2088, finalized in the CY 2020 PFS final 
rule (84 FR 62673) to be inclusive of all SUDs. As noted in the CY 2020 
PFS final rule (84 FR 62673), if a patient's treatment involves MAT, 
this bundled payment would not include payment for the medication 
itself. Billing and payment for medications under Medicare Part B or 
Part D would remain unchanged. We note that payment for the codes would 
be budget neutral under the PFS and therefore have no cost impact on 
PFS spending; however, this policy may have impacts on billing 
practices and services provided.
    Currently, the codes most frequently used when billing for 
treatment of SUD include the E/M visit codes, psychotherapy codes, 
SBIRT codes, and potentially the Behavioral Health Integration codes. 
HCPCS codes G2086-G2088 offer a bundled payment that would allow a more 
streamlined

[[Page 85005]]

approach to billing in cases where all of the services described in the 
code descriptors are furnished. We note that these codes provide an 
option for billing, but are not required; therefore, in cases where 
only select services are being furnished, practitioners may continue to 
bill for the code that most accurately describes the service that was 
furnished, which could be, for example, an E/M visit code.

G. Effect of Modifications to Medicare Coverage for Opioid Use Disorder 
(OUD) Treatment Services Furnished by Opioid Treatment Programs (OTPs)

    Section 2005 of the Substance Use-Disorder Prevention That Promotes 
Opioid Recovery and Treatment for Patients and Communities (SUPPORT) 
Act established a new Medicare Part B benefit for OUD treatment 
services furnished by OTPs on or after January 1, 2020. As part of CY 
2020 PFS rulemaking, we implemented coverage requirements, created new 
coding to describe bundled episodes of care for the treatment of OUD, 
and established payment methodologies to determine the payment amounts 
for the drug and non-drug components of an episode of care.
    For CY 2021, we are creating two new add-on codes, one add-on code 
for nasal naloxone and another add-on code for injectable naloxone. 
Both add-on codes include a non-drug component for overdose education 
furnished in conjunction with naloxone. We are pricing nasal naloxone 
based upon the methodology set forth in section 1847A of the Act, 
except that the payment amount shall be ASP + 0. The price being 
finalized for the nasal naloxone add-on code is $92.13, which includes 
a payment of $2.53 for overdose education. We are contractor-pricing 
the injectable naloxone and will also include a payment of $2.53 for 
overdose education. We are limiting Medicare payment to OTPs for 
naloxone to one add-on code (HCPCS code G2215 or G2216) every 30 days, 
however, we will allow exceptions to this limit in the case where the 
beneficiary overdoses and uses the initial supply of naloxone dispensed 
by the OTP, to the extent that it is medically reasonable and necessary 
to furnish additional naloxone.
    The estimated net Part B cost impact of the add-on codes for 
naloxone for CY 2021 is $0.5 million. The estimated net Part B 10-year 
impact is $5.6 million. This estimate is based on several assumptions. 
First, commenters noted that nasal naloxone is the most common 
formulation given to patients in an OTP and the price is being 
finalized is $92.13. This cost is to be updated to reflect changes in 
the average sales price (ASP); however, since future ASP updates are 
not available, the Medicare Economic Index (MEI) was used as a proxy. 
Based on partial 2020 utilization of the OTP benefit through September, 
roughly 20,000 beneficiaries received treatment at an OTP at some point 
during that time. We assumed that this would reach 25,000 by the end of 
2020, and growth in future years would be consistent with projected 
growth in Part B fee-for-service enrollment. We assumed that 
beneficiaries who are provided naloxone would receive at least one 
supply of nasal naloxone as a standard part of the program because they 
are likely to be at risk for an overdose. A much smaller portion would 
receive a second supply, since it would only be provided if the first 
supply has been used. We assumed that approximately 1.1 doses would be 
provided per beneficiary. This figure is based on an August 2020 OIG 
report regarding opioid use under Medicare Part D, and it represents 
the average number of prescriptions per person receiving naloxone 
between 2016 and 2019 (see Exhibit B-2 on page 14).\150\ We assumed 
that roughly 25 percent of beneficiaries receiving treatment OTPs would 
be provided with naloxone, because they may already have it from 
another source, and some OTPs may not have it available. The estimate 
also took into account that this benefit is not subject to beneficiary 
cost sharing. Additionally, any change to FFS benefits has an 
associated impact on payments to Medicare Advantage (MA) plans, so an 
adjustment was made to reflect this based on the projected distribution 
of spending in each year. Based on current projections, payments to MA 
plans represent roughly 46 percent of total Part B spending in 2022 
this share and is expected to grow to almost 50 percent by 2030. This 
estimate also takes into account a premium offset which represents the 
impact on the Medicare program due to the change in the Part B premium 
as a result of the new add-on payment to OTPs for naloxone. In other 
words, since benefit spending is higher, the Part B premium will also 
be higher, which partially offsets the impact on benefit spending. The 
Part B FFS enrollment projections and MEI assumptions are based on the 
President's Fiscal Year 2021 Budget baseline that was released in 
February of 2020.
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    \150\ https://oig.hhs.gov/oei/reports/OEI-02-20-00320.pdf.
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    We believe that the benefits associated with establishing payment 
for naloxone and overdose education in the OTP setting justify the cost 
of the provision. As noted in section II.I. of this final rule, 
Modifications Related to Medicare Coverage for Opioid Use Disorder 
(OUD) Treatment Services Furnished by Opioid Treatment Programs (OTPs), 
U.S. Surgeon General Jerome M. Adams, M.D., M.P.H. released a public 
health advisory stating that, ``Research shows that when naloxone and 
overdose education are available to community members, overdose deaths 
decrease in those communities. Therefore, increasing the availability 
and targeted distribution of naloxone is a critical component of our 
efforts to reduce opioid-related overdose deaths and, when combined 
with the availability of effective treatment, to ending the opioid 
epidemic.'' \151\ We are adding naloxone and overdose education 
furnished in conjunction with naloxone to the definition of OUD 
treatment services in order to increase access to this important 
emergency treatment and to allow OTPs to be paid under Medicare for 
dispensing naloxone to Medicare beneficiaries who are receiving other 
OUD treatment services from the OTP. We believe allowing beneficiaries 
to access this important emergency treatment at the OTP may help 
decrease barriers to access because there are no copayments for 
services furnished by OTPs and beneficiaries will not need to visit a 
separate provider to access naloxone.
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    \151\ https://www.hhs.gov/surgeongeneral/priorities/opioids-and-addiction/naloxone-advisory/index.html.
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H. Other Provisions of the Regulation

1. Clinical Laboratory Fee Schedule: Revised Data Reporting Period and 
Phase-In of Payment Reductions
    In section III.A. of this final rule, we discuss statutory 
revisions to the data reporting period and phase-in of payment 
reductions. In accordance with section 105(a) of the FCAA and section 
3718 of the CARES Act, we are making certain conforming changes to the 
data reporting and payment requirements in our regulations at part 414, 
subpart G. Specifically, for clinical diagnostic laboratory tests 
(CDLTs) that are not advanced diagnostic laboratory tests (ADLTs), we 
are revising Sec.  414.504(a)(1) to indicate that initially, data 
reporting begins January 1, 2017 and is required every 3 years 
beginning January 2022. This revision delays the next data reporting 
period under the CLFS by 2 years, that is, it will require the next 
data reporting during the period of January 1, 2022 through March 31, 
2022. Subsequently, the next private payor

[[Page 85006]]

rate-based CLFS update will be effective January 1, 2023 instead of 
January 1, 2021. In addition, we are making conforming changes to our 
requirements for the phase-in of payment reductions to reflect the 
CARES Act amendments. Specifically, we are revising Sec.  414.507(d) to 
indicate that for CY 2021, payment may not be reduced by more than 0.0 
percent as compared to the amount established for CY 2020, and for CYs 
2022 through 2024, payment may not be reduced by more than 15 percent 
as compared to the amount established for the preceding year.
    We recognize that private payor rates for CDLTs paid on the CLFS 
and the volumes paid at each rate for each test, which are used to 
determine the weighted medians of private payor rates, have changed 
since the first data collection period (January 1, 2016 through June 
30, 2016) and data reporting period (January 1, 2017 through March 31, 
2017). In addition, as discussed in section III.A. of this final rule, 
in the CY 2019 PFS final rule (83 FR 59671 through 59676), we amended 
the definition of applicable laboratory to include hospital outreach 
laboratories that bill Medicare Part B using the CMS-1450 14x Type of 
Bill. As such, the conforming regulatory changes to the data reporting 
period would delay using updated private payor rate data and data 
reported by hospital outreach laboratories to set revised CLFS payment 
rates.
    Due to the unforeseen changes in private payor rates, inclusion of 
hospital outreach laboratory data, and unpredictable nature of test 
volumes and their impact on calculating updated weighted medians 
private payor rates, we are uncertain as to whether the delay in data 
reporting would result in a measurable budgetary impact. In other 
words, in order to comprehend the impact of delayed reporting and 
subsequent implementation of updated CLFS rates, we would need to 
calculate weighted medians of private payor rates based on new data and 
compare the revised rates to the current rates. As such, we believe 
that we will only know the impact of the delay in data reporting after 
collecting actual updated applicable information from applicable 
laboratories, including the collection of private payor rate data from 
applicable hospital outreach laboratories, and calculate the updated 
weighted medians of private payor rates.
    With regard to the conforming changes to our requirements for the 
phase-in of payment reductions, we note that this revision shifts the 
15 percent limitation on payment reductions from CYs 2021 through 2023, 
to CYs 2022 through 2024. Therefore, we believe this conforming 
regulatory amendment to the phase-in of payment reductions in Sec.  
414.507(d) is budget neutral for scoring purposes.
2. OTP Provider Enrollment Regulation Updates for Institutional Claim 
Submissions
    We stated in section VII. of this final rule that:
     Section 424.67(b)(2) requires newly enrolling OTPs to pay 
an application fee at the time of enrollment under Sec.  424.514.
     300 currently enrolled OTPs would change their enrollment 
from a Form CMS-855B to a Form CMS-855A. We project that all such 
changes will occur in CY 2021.
     10 OTPs that enroll using the Form CMS-855A would later 
change their enrollment to a Form CMS-855B. We project that these 
changes will occur in CY 2022 and CY 2023 (roughly 5 changes per year).
    These 310 OTPs would be required to pay an application fee because 
said change to a Form CMS-855A or Form CMS-855B enrollment would 
constitute a new/initial enrollment.
    The application fees for each of the past 3 calendar years (CY) 
were or are $569 (CY 2018), $586, (CY 2019), and $595 (CY 2020). 
Consistent with Sec.  424.514, the differing fee amounts are predicated 
on changes/increases in the Consumer Price Index (CPI) for all urban 
consumers (all items; United State city average, CPI-U) for the 12-
month period ending on June 30 of the previous year. As stated in a 
notice published in the November 23, 2020 Federal Register titled 
``Medicare, Medicaid, and Children's Health Insurance Programs; 
Provider Enrollment Application Fee Amount for Calendar Year 2021'' (85 
FR 74724), the fee amount for CY 2021 will be $599. This results in a 
total application fee cost for OTP changes to a Form CMS-855A 
enrollment of $179,700 ($599 x 300 OTPs).
    Although we cannot predict changes to the CPI beyond CY 2021, the 
fee amounts between 2019 and 2021 increased by an average of $6 per 
year. We believe this is a reasonable barometer with which to estimate 
(strictly for projecting the total application fee costs for the 10 
OTPs that we believe will switch to a Form CMS-855B enrollment) the 
fees for CY 2022 and CY 2023. Accordingly, we project a fee of $605 in 
CY 2022 and $611 in CY 2023. This results in a total application fee 
cost of $3,025 ($605 x 5 OTPs) in CY 2022 and $3,055 in CY 2023 ($611 x 
5 OTPs). Over the next 3 years, therefore, the total application fee 
cost will be $185,780 ($179,700 + $3,025 + $3,055).
    We received no comments on our application fee estimates.
3. Payment for Principal Care Management (PCM) Services in Rural Health 
Clinics (RHCs) and Federally Qualified Health Centers (FQHCs)
    After reviewing the PFS, FQHC, and RHC historical spending, 
including the first quarter of calendar year 2020 spending for the new 
principal care management codes under the PFS, we estimate the addition 
of these codes (G2064 and G2065) to G0511 would have a negligible 
impact on Medicare spending.
4. Changes to the Federally Qualified Health Center Prospective Payment 
System (FQHC PPS) for CY 2021: Rebasing and Revising of the FQHC Market 
Basket
    The CY 2021 FQHC market basket and multi-factor productivity 
adjustment is 0.1 percentage point higher under the 2017-based FQHC 
market basket (1.7 percent) compared to under the 2013-based market 
basket (1.6 percent). Therefore, the economic impact of finalizing the 
FQHC market basket rebasing and revising for CY 2021 is approximately 
$1M and we consider this impact to be negligible. We determined this 
amount by applying a factor of 0.001 to the FQHC baseline, which was 
approximately $1,100 million in calendar year 2019. Over the next 10 
years the rebasing methodology results in, at most, a difference of 0.1 
percent compared to the prior methodology but it is not always higher. 
The difference in the payment updates is projected to be higher in the 
next 2 years but then lower or the same beyond that. Therefore, this 
initial negligible cost decreases over time and overall estimated 
spending will likely be unaffected.
5. Comprehensive Screenings for Seniors: Section 2002 of the Substance 
Use-Disorder Prevention That Promote Opioid Recovery and Treatment for 
Patients and Communities Act (SUPPORT Act)
    We are implementing section 2002 of the Support Act by adding 
regulatory language to the existing Initial Preventive Physical 
Examination (IPPE) and Annual Wellness Visit (AWV) regulations to 
explicitly include elements regarding screening for potential substance 
use disorders and a review of current opioid prescriptions. We expect 
the new regulatory elements to add minimal burden since review of 
medical and social history, risk factor

[[Page 85007]]

identification, education, counseling, and referrals are already 
fundamental parts of the IPPE and AWV. Standard documentation in the 
medical record that these services were furnished would not change 
based on these new requirements. We note that in section VIII.C.2.a. of 
this RIA, we discuss the increase in payment for E/M visits in general. 
Accordingly, the increase in payment for E/M visits applies to the IPPE 
and AWV and the impact to 2021 expenditures is included in section 
VIII.C.2.a. of this RIA.
6. Medicaid Promoting Interoperability Program Requirements for 
Eligible Professionals (EPs)
    In the Medicaid Promoting Interoperability Program, to keep 
electronic clinical quality measure (eCQM) specifications current and 
minimize complexity, we are aligning the eCQMs available for Medicaid 
EPs in 2021 with those available for MIPS eligible clinicians for the 
CY 2021 performance period. We anticipate that this alignment will 
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 will 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 
2021. Not implementing this alignment could lead to increased burden 
because EPs might have to report on different eCQMs for the Medicaid 
Promoting Interoperability Program, if they opt to report on newly 
added eCQMs for MIPS. We expect that this policy will have only a 
minimal impact on states, by requiring minor adjustments to state 
systems for 2021 to maintain current eCQM lists and specifications. 
Based on a sampling of funding requests, each state typically spends, 
on average, approximately $670,000 per year to operate its Medicaid 
Promoting Interoperability Program attestation system for EPs. Only a 
small fraction of those costs is typically attributable to updating 
eCQM specifications. We estimate that the costs for updating eCQM 
specifications under the policy will be approximately $100,000 per 
state. State expenditures to make any systems changes that will be 
required as a result of the provision will most likely be eligible for 
90 percent federal financial participation.
    For 2021, we are requiring that Medicaid EPs 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 
will generally align with the MIPS data submission requirement for 
eligible clinicians using the eCQM collection type for the quality 
performance category, which is established in Sec.  414.1335(a)(1). If 
no outcome or high priority measure is relevant to a Medicaid EP's 
scope of practice, he or she could report on any six eCQMs that are 
relevant. This policy will be a continuation of our policy for 2020 and 
we believe it will not create new burden for EPs or states.
7. Medicare Shared Savings Program
a. Modifications to the Shared Savings Program Quality Reporting 
Requirements and Quality Performance Standard for Performance Year 2021 
and Subsequent Performance Years
    In section III.G.1.c. of this final rule, we are finalizing a 
modified version of our original proposal to allow for a gradual phase-
in of the increase in the level of quality performance that would be 
required for all ACOs to meet the Shared Savings Program quality 
performance standard and the retention of the CMS Web Interface 
collection type for performance year 2021. The quality performance 
standard is the minimum performance level ACOs must achieve in order to 
share in any savings earned, avoid maximum losses under certain payment 
tracks, and avoid quality-related compliance actions.
    Specifically, we are finalizing that an ACO would meet the quality 
performance standard if:

     For performance years 2021 and 2022, the ACO achieves a 
quality performance score that is equivalent to or higher than the 30th 
percentile across all MIPS Quality performance category scores; and
     For performance year 2023 and subsequent performance 
years, the ACO achieves a quality performance score that is equivalent 
to or higher than the 40th percentile across all MIPS Quality 
performance category scores.
    We are also finalizing our proposal to exclude entities/providers 
eligible for facility-based scoring from the determination of the 
overall MIPS Quality performance category score because facility-based 
scoring is determined using the Hospital Value Based Purchasing (HVBP) 
Total Performance Score (TPS), which includes quality and cost. Please 
refer to section III.G.1.c. of this final rule for a detailed 
discussion of the policies used to inform the impacts for the change to 
the quality performance standard.
    Our analysis of quality performance data reported by ACOs for 
performance years starting during 2019 indicates that the 
methodological changes in ACO quality scoring will reduce the mean ACO 
quality score relative to recent historical performance years where ACO 
quality performance scores have averaged 90 percent or more. Despite an 
expectation for a decreasing score for most ACOs and potentially a 
slight increase in the fraction of ACOs failing to achieve the minimum 
threshold for qualifying for potential shared savings, the provision is 
estimated to marginally increase overall shared savings payments to 
ACOs initially because ACOs that meet the quality performance standard 
will be eligible to share in savings at the maximum sharing rate, 
rather than subject to variable sharing rates based on their quality 
performance score. Our best estimate is that shared savings payments to 
ACOs will increase by $60 million for the 2021 performance year because 
of these changes, representing an increase in shared savings payments 
of only about 3 percent of projected total gross measured savings for 
ACOs earning shared savings for that year. The corresponding estimated 
increase in payments to ACOs would slightly decrease to $40 million in 
2022 because, beginning that year, ACOs would no longer have the option 
of utilizing the Web Interface reporting option, which is projected to 
be favorable for most ACOs. Then for 2023 when the quality performance 
standard will increase to the 40th percentile across all MIPS Quality 
performance category scores, assuming the distribution of ACO quality 
performance scores remains static from the 2019 base data, we project 
roughly 1-in-5 ACOs could fall below the 40th percentile and therefore 
shared savings payments to ACOs would decrease by approximately $100 
million for that performance year. In total, these estimates sum to 
roughly a budget neutral outcome across the 3-year performance years 
covering 2021-2023.
    These estimates (and in particular the estimated $100 million 
reduction in shared savings payments in 2023) could differ if the 
universe of MIPS Quality performance category scores improves relative 
to ACOs' quality performance scores, or alternatively if ACOs, 
particularly ACOs at risk of failing, respond to the methodology change 
by boosting their performance, especially by 2023 when the quality 
performance standard is to be increased from the 30th to the 40th 
percentile. Taking into account such possibilities indicates the

[[Page 85008]]

combined 3-year impact of the changes to the quality performance 
standard could differ from the budget neutral projection by up to +/-
$200 million. Recognizing the uncertainty regarding these estimates, we 
will continue to monitor emerging performance to determine the impact 
of a measured increase to the quality performance standard and may 
revisit the policy in a future rulemaking in order to promote an 
attainable standard and degree of improvement based on initial 
performance under the new methodology.
b. Modifications to the Shared Savings Program Beneficiary Assignment 
Methodology and Repayment Mechanism Requirements
    We do not anticipate a material aggregate impact for the other 
changes we are finalizing related to the Shared Savings Program, 
specifically the changes related to repayment mechanism requirements 
(section III.G.3. of this final rule) and the assignment methodology 
(section III.G.2. of this final rule); however, the assignment 
methodology provisions may have differing effects on a subset of 
participating ACOs, for example by changing the competing ACO to which 
a beneficiary ultimately is assigned, for a small subset of 
beneficiaries.
c. Finalization of Shared Savings Program Policies Established in the 
May 8th COVID-19 IFC
    As discussed in section III.G.5 of this final rule, in the May 8th 
COVID-19 IFC we modified Shared Savings Program policies including to 
forgo the 2021 application cycle and allow eligible ACOs to elect a 1-
year extension of their agreement period; allow eligible ACOs to 
temporarily freeze their position along the BASIC track's glide path 
for PY 2021; and adjust certain program calculations to remove Parts A 
and B expenditures for episodes of care for treatment of COVID-19; and 
expand the definition of primary care services used in determining 
beneficiary assignment to include telehealth codes for virtual check-
ins, e-visits, and telephonic communication. We also clarified the 
applicability of the program's extreme and uncontrollable circumstances 
policy to mitigate shared losses for the period of the PHE for COVID-
19, beginning in January 2020 and for duration of the PHE for COVID-19. 
We are finalizing the Shared Savings Program's May 8th COVID-19 IFC 
provisions through this final rule with the following modifications. As 
discussed in section III.G.5.d. of this final rule, we are revising the 
regulation at Sec.  425.611(b)(1)(ii) to align the timeframe for 
identifying discharges for acute care inpatient services for treatment 
of COVID-19 furnished by non-IPPS providers with the timeframe for the 
20 percent adjustment to payments under the IPPS for individuals 
diagnosed with COVID-19 (which applies to discharges occurring during 
the PHE for COVID-19), for purposes of identifying episodes of care for 
treatment of COVID-19. As discussed in section III.G.5.e.(3) of this 
final rule, we are revising the regulation at Sec.  425.400(c)(2) to 
specify that the additional primary care service codes will be used in 
conducting beneficiary assignment when the assignment window (as 
defined in Sec.  425.20) for a benchmark or performance year includes 
any month(s) during the PHE for COVID-19 defined in Sec.  400.200. We 
are also adding a new provision at Sec.  425.400(c)(2)(ii) to specify 
that we will apply the additional primary care service codes, specified 
in Sec.  425.400(c)(2)(i) (as renumbered), to all months of the 
assignment window (as defined in Sec.  425.20), when the assignment 
window includes any month(s) of the PHE for COVID-19 as defined in 
Sec.  400.200.
    In total, the changes to the Shared Savings Program described in 
the May 8th COVID-19 IFC were estimated to reduce program spending by 
$1.43 billion over the 2020 to 2025 period (ranging from a reduction of 
$790 million to $2.12 billion), with most of the reduction ($1.11 
billion) attributable to performance year 2020. We do not anticipate a 
material aggregate impact from the aforementioned revisions to Sec.  
425.611(b)(1)(ii), specified in section III.G.5.d. of this final rule, 
and Sec.  425.400(c)(2), specified in section III.G.5.e.(3) of this 
final rule.
8. Modifications to Medicare Shared Savings Program Quality Reporting 
Requirements for Performance Year 2020 and Finalization of Shared 
Savings Program Policies Established in the March 31st COVID-19 IFC
    As discussed in section III.I.1. of this final rule, we are 
finalizing our proposal to waive the CAHPS for ACOs reporting 
requirement for performance year 2020 and will assign automatic full 
credit to all ACOs for the CAHPS for ACOs survey measures. Based on 
recent ACO performance on the CAHPS measures, we estimate moving to a 
100 percent score for the CAHPS measures will increase the final 
quality score for the group of all non-new ACOs by roughly 2 percentage 
points. This would translate to an estimated increase in total shared 
savings payments to ACOs of approximately $20 million.
    As discussed in section III.I.3. of this final rule, in the March 
31st COVID-19 IFC, we modified the extreme and uncontrollable 
circumstances policy to eliminate the restriction that the policy 
applies only if the quality reporting period is not extended. We are 
finalizing this change without modification in this final rule. The 
total impact of extending the extreme and uncontrollable circumstances 
policy despite the extension of the quality reporting period for 2019 
is estimated to be $20 million with a range of uncertainty in such 
estimate spanning $15 million to $25 million.
9. Removal of Selected National Coverage Determinations
    We proposed to remove nine older NCDs that no longer contain 
clinically pertinent and current information or that involve items or 
services that are used infrequently by beneficiaries. We are removing 
six of the nine proposed. Generally, proactively removing obsolete or 
unnecessary NCDs removes barriers to innovation and reduces burden for 
stakeholders and CMS. The NCDs fall into two impact categories. First, 
eliminating an NCD for items and services that were previously covered 
means that the item or service will no longer be automatically covered 
by Medicare. Instead, the coverage determinations for those items and 
services will be made by Medicare Administrative Contractors (MACs). 
Second, if the previous NCD barred coverage for an item or service 
under title XVIII, MACs would now be able to cover the item or service 
if the MAC determines that such action is appropriate under the 
statute. We believe that allowing local contractor flexibility in these 
cases better serves the needs of the Medicare program and its 
beneficiaries since we believe the future utilization for items and 
services within these policies will be limited, each affecting less 
than one percent of the Medicare FFS population.
    For the three NCDs that are going from limited coverage to MAC 
discretion, claims data from 2019 show that less than one percent of 
the Medicare population are affected. Specifically, CMS provides 
limited coverage for specific conditions under NCD 20.5, Extracorporeal 
Immunoadsorption (ECI) using Protein A Columns, where CMS paid 1,918 
Medicare FFS claims for 118 beneficiaries for a total expenditure of 
$3,757,178.36. Under NCD 100.9, Implantation of Gastroesophageal Reflux 
Device, CMS received no claims in

[[Page 85009]]

2019. CMS provides coverage for FDA approved labeled indications under 
NCD 110.19, Abarelix, and no claims were submitted in 2019 because the 
device is no longer marketed. If under MAC discretion, these items and 
services continue to be covered, we estimate there will be de minimis 
change to 2021 expenditures, compared to 2019. However, we note that 
MAC discretion may result in the MACs determining that in particular 
instances of these items and services, a noncoverage decision may be 
appropriate for the patient, which could result in a decrease in 2021 
expenditures, compared to 2019. The three NCDs that we are not removing 
in this final rule, were also in this limited coverage category 
explained above. The current NCDs will continue to apply and we 
estimate there will be little significant difference in expenditures 
from 2019 to 2021. NCD 110.14, Apheresis (Therapeutic Pheresis), CMS 
paid 84,539 Medicare FFS claims for 10,641 beneficiaries for a total 
expenditure of $77,486,916.37. Under NCD 190.1, Histocompatability 
Testing, CMS paid 4,986 Medicare FFS claims for 2,525 beneficiaries for 
a total expenditure of $206,085.04. For NCD 190.3, Cytogenetic Studies, 
CMS paid 163,522 Medicare FFS claims for 145,212 beneficiaries for a 
total expenditure of $18,997,807.17.
    For the three non-coverage NCDs we are removing, we would not 
expect to find historical claims data. We broadly noncover both 
Electrosleep Therapy (NCD 30.4) and Magnetic Resonance Imaging (NCD 
220.2.1) for all indications. We noncover FDG PET (NCD 220.6.16) for 
three specific conditions. Because these NCDs provide for noncoverage, 
we do not have accurate claims data to estimate total impact. However, 
based on the diagnoses and services, we expect future claims to affect 
less than one percent of Medicare FFS beneficiaries. Furthermore, 
removing a national noncoverage NCD may reduce burden for stakeholders 
and CMS. It may also remove barriers to innovations and increase 
patient access to technologies that may now be beneficial for some 
uses.
10. Requirement for Electronic Prescribing for Controlled Substances 
for a Covered Part D Drug Under a Prescription Drug Plan or an MA-PD 
Plan
    This provision does not have any cost to stakeholders other than 
what is reflected in the Collection of Information section of this 
final rule, including cost to Medicare. We expect this to be a one-time 
burden estimate of 994,500 hours (165,750 * 6 hr) at a cost of 
$36,418,590 (994,500 hr * 36.62) to prescribers.
    We received public comments about the impacts of this policy. The 
following is a summary of the comments we received and our responses.
    Comment: Several commenters noted the health care provider costs 
involved in implementing EPCS. One commenter recommended that CMS work 
with ONC to ensure that the cost of acquiring the electronic 
prescribing standard is part of the EHR certification criteria and to 
ensure that EHR developers cannot charge additional fees for building 
in this prescribing standard. Accordingly, the commenter requested that 
HHS take steps to minimize the cost of EPCS requirements to physician 
practices. Another commenter stated that their practice has delayed 
implementing EPCS due to the need to upgrade their EHR software, which 
has proven to be costly. The commenter stated that given the pandemic 
impact that amount is now unaffordable for their small primary care 
practice. Another commenter acknowledged that EPCS implementation costs 
can be high but that a prudent buyer of software support can find less 
expensive options.
    Response: We share concerns about high health care provider costs 
associated with implementing EPCS, particularly during the PHE. An 
article in the Journal of the American Medical Association states that 
physicians in small private practices around the country have reported 
steep declines in revenues. Declining revenues have been so significant 
that some of practices have turned to GoFundMe.\152\ However, neither 
ONC nor CMS have the authority to reduce EHR vendor charges for 
upgrades. We encourage those who provide software solutions to support 
EPCS make their products as accessible as possible and, as prescribers 
who do not implement the standard until 2022 will still be considered 
compliant, software providers will have more time to review their costs 
and for providers time to evaluate and chose among available options.
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    \152\ https://jamanetwork.com/journals/jama/fullarticle/2767633.
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    We have reflected these costs in our burden estimate in the 
Collection of Information section of this rule.
11. Medicare Part B Drug Payment for Drugs Approved Through the Pathway 
Established Under Section 505(b)(2) of the Food, Drug, and Cosmetic Act
    As discussed in section III.L. of this final rule, we are not 
finalizing the section 505(b)(2) drug product proposals or the proposed 
corresponding regulation text changes for 2021. Thus, there are no 
impacts for CY 2021.
12. Updates to Certified Electronic Health Record Technology Due to the 
21st Century Cures Act
    In section III.M. of this final rule, we are updating the 
definitions of CEHRT for the Promoting Interoperability Programs and 
for the MIPS Promoting Interoperability performance category. We are 
finalizing that health care providers may use technology certified to 
either the existing or updated 2015 Edition certification criteria, 
with the extended compliance date of December 31, 2022, as described in 
timelines finalized in the 21st Century Cures Act final rule (85 FR 
25670) and the ONC interim final rule (85 FR 70064). After that time, 
when ONC only allows certification under the 2015 Edition Cures Update, 
health care providers must use only technology certified to the 2015 
Edition Cures Update. Additionally, in section III.M.3.b, we are also 
implementing flexibility such that participants in the Hospital IQR 
Program may use either the 2015 Edition certification criteria, or the 
2015 Edition Cures update for CEHRT beginning in the CY 2020 reporting 
period/FY 2022 payment determination.
    With the final policies, eligible hospitals and clinicians, and 
eligible clinicians will be required to update their EHR technology to 
meet the CEHRT definition under the 2015 Edition Cures Update. It is 
important to note that the regulatory impacts of the ONC 21st Century 
Cures Act final rule account for the quantified and unquantified costs 
and benefits to hospitals and clinicians associated with acquiring 
technology certified to the 2015 Edition Cures Update (85 FR 25905 
through 25938). Specifically, ONC based their analysis regarding the 
number of hospitals, CAHs, and eligible clinicians that would be 
impacted by their regulatory action on the number of hospitals, CAHs, 
and eligible professionals that have historically participated in the 
CMS EHR Incentive Programs (now called the Promoting Interoperability 
Programs and the MIPS Promoting Interoperability performance category) 
(85 FR 25908). Because we expect that the eligibility criteria proposed 
under this rule will be a subset of those who participated in the EHR 
Incentive Programs (for example, the MIPS program has eligibility 
criteria for low-volume that the EHR Incentive program did not have), 
this regulatory impact analysis assumes that the cost to program 
participants to acquire the

[[Page 85010]]

upgraded technology has been accounted for under the ONC 21st Century 
Cures Act final rule. However, we acknowledged ambiguity in attributing 
impacts from the ONC 21st Century Cures Act final rule and this policy 
and requested comment that would help with identification of effects 
that are dependent on these new regulatory provisions. (We further 
noted that if the ambiguity is ultimately resolved such that all the 
costs are attributed to the ONC 21st Century Cures Act final rule, 
leaving no costs associated with this final rule's certified EHR 
provisions, then these provisions would also yield no benefits.) We did 
not receive comments on the additional effects of these regulatory 
provisions and therefore finalize that there is not additional burden 
or benefit beyond what is captured in the ONC 21st Century Cures act 
final rule.
13. Proposal To Establish New Code Categories
    In section III.N. of this final rule, we maintain the existing 4 
Level II HCPCS codes (J0572 through and including J0575), to identify 
the current array of buprenorphine/naloxone products available on the 
U.S. market. The number of codes available for health care providers 
and coders to identify and report on claims remains constant, and 
therefore no additional burden is placed on coders or health care 
providers.
14. Medicare Diabetes Prevention Program Expanded Model Emergency 
Policy
a. Effects on Beneficiaries
    In section III.O. of this final rule, we are finalizing certain 
Medicare Diabetes Prevention Program (MDPP) expanded model policies to 
allow CMS to remove the once per life time benefit for some MDPP 
beneficiaries, increase the number of virtual sessions, allow MDPP 
suppliers to start new cohorts, and allow certain MDPP suppliers to 
deliver time-limited virtual MDPP sessions in the event of extreme and 
uncontrollable circumstances that would adversely affect access to MDPP 
services. These changes would apply during the PHE for COVID-19 and any 
future 1135 waiver event, in the emergency area during the emergency 
period, as defined under section 1135(g) of the Act, when the Secretary 
has authorized waivers under section 1135 for such emergency area and 
period and CMS has determined that the 1135 waiver event may disrupt 
in-person MDPP services.
    Throughout the rulemaking for the MDPP expanded model, we sought to 
ensure that the set of MDPP services would be delivered in-person, in a 
classroom-based setting, within an established interval timeline. At 
the time, the priority was placed on establishing a structured service 
that, when delivered within the confines of the rule, would create the 
least risk of fraud and abuse, increase the likelihood of success, and 
maintain the integrity of the data collected for evaluation purposes. 
However, circumstances such as the PHE for COVID-19 have led CMS to 
make changes to the MDPP expanded model, and to implement an Emergency 
Policy for MDPP that allows for temporary flexibilities and that 
prioritizes availability and continuity of services for MDPP suppliers 
and MDPP beneficiaries impacted by section 1135 waiver events.
    In the March 31st COVID-19 IFC, we sought to ensure that the set of 
MDPP services that had already started when the PHE for COVID-19 began 
could continue given the guidance from CDC that Medicare age 
beneficiaries stay home. The priority was to allow for temporary 
flexibilities that prioritize availability and continuity of services 
for MDPP suppliers and MDPP beneficiaries impacted by the PHE for 
COVID-19. Given the extended duration of the PHE for COVID-19, we are 
finalizing the regulations in the March 31st COVID-19 IFC, amend the 
MDPP expanded model to revise certain MDPP policies during the PHE for 
COVID-19 and any future 1135 waiver event where such 1135 waiver event 
may cause a disruption to in-person MDPP services. These temporary 
flexibilities allow beneficiaries to either continue to have access to 
set of MDPP services through virtual sessions, pause in-person set of 
MDPP services and resume with the most recent attendance session of 
record, or restart MDPP from the beginning in accordance with the March 
31st COVID-19 IFC (85 FR 19230). Under the current MDPP regulations, as 
implemented in the IFC, and for future section 1135 events, should MDPP 
suppliers deliver set of MDPP services virtually and beneficiaries opt 
to continue with the set of MDPP services virtually during the 1135 
waiver event, those beneficiaries are not eligible to restart the set 
of MDPP services at a later date.
b. Effects on the Market
    At this point, we cannot make clear estimates of the true costs of 
the MDPP Emergency Policy costs given the current Medicare enrollment. 
For an example, as part of the COVID-19 flexibilities, we are using 
authority under section 1135 of the Act to waive the supplier 
enrollment application fee for any applications submitted on or after 
March 1, 2020 in response to COVID-19. This, along with CDC's promotion 
of the temporary application fee waiver to its DPRP registered 
organizations, have led to an increase in MDPP supplier enrollment 
applications and approved suppliers. Currently, more than 266 
organizations nationally are enrolled as MDPP suppliers, representing 
966 locations across the US and its territories.
    For the current PHE for COVID-19, we anticipated in the March 31st 
COVID-19 IFC that of the 1,818 beneficiaries identified through our 
monitoring data and the CDC's Diabetes Prevention Recognition Program 
(DPRP) data, 1,358 beneficiaries may be impacted by allowing both the 
once-per-lifetime benefit and the minimum weight loss requirement to be 
waived for those beneficiaries in the first 12 months of MDPP. Of 
those, we assumed that roughly half of the beneficiaries will want to 
restart their set of MDPP services after the PHE for COVID-19 ends, 
with a $279,748 cost impact of our waiving the once-per-lifetime 
benefit as part of the COVID-19 flexibilities, assuming that the 
estimated cost of year 1 of MDPP is $412.
    For this MDPP Emergency Policy, we are updating our assumptions, 
based on subsequent data from the CDC regarding DPRP organizations' 
plans for managing their existing cohorts during the PHE for COVID-19, 
which include either continuing with their cohorts virtually, pausing 
set of MDPP services and restarting them virtually, or restarting at a 
later date after the emergency event ends. Based on these data, we 
assume that 20 percent of MDPP suppliers and 20 percent of 
beneficiaries will want to restart the set of MDPP services at the 
first core session after the emergency event ends, taking advantage of 
the once-per-lifetime requirement removal. We assume that future 
emergencies will be more geographic-specific, resulting from a natural 
disaster versus the national-level PHE for COVID-19. For future 
emergencies, we assume that 2,500 beneficiaries will be enrolled in 
MDPP in the impacted geographic region. We note that this number is 
currently an overestimate, and over time, it will likely be an 
underestimate. We also note that these assumptions are incorrect in 
cases where a geographic region suffers widespread damage, including to 
electrical and/or telecommunications systems. This assumption is based 
on number of suppliers who have reported to the CDC that they are 
pausing their services during the current PHE for COVID-19.

[[Page 85011]]

For the current 1135 event, we are assuming 20 percent of 2,500 
beneficiaries will want to take advantage of the waiver in 2020. In 
this scenario, we assume there would be no virtual or physical access 
to set of MDPP services for some time, and the supplier will need to 
either pause or restart classes altogether until such infrastructure 
systems are back in place. We also assume that beneficiaries who opt to 
continue with the set of MDPP services virtually are within the first 
12 months of the MDPP core service period, and will not be eligible to 
take advantage of the waived once-per-lifetime limit; and beneficiaries 
who are in year 2 of the set of MDPP services, as demonstrated by the 
effective date of the first core session, are not eligible to restart 
MDPP at the beginning. The cost per impacted geographic area of the 
removal of the once-per-lifetime limit is estimated to be $209,000. 
This assumes that MDPP suppliers are paid an estimated $418 due to 
beneficiaries reaching the following performance milestones: 
Beneficiary attended 9 sessions, and reached the 5 percent weight loss 
during interval 2 of the core maintenance session, and attended the 
required core maintenance sessions.
[GRAPHIC] [TIFF OMITTED] TR28DE20.157

15. Changes Due to Updates to the Quality Payment Program
    In section IV.A. of this final rule, we included our finalized 
policies for the Quality Payment Program. In this section of the final 
rule, we present the overall and incremental impacts to the number of 
expected QPs and associated APM Incentive Payments. In MIPS, we 
estimate the total MIPS eligible population and the payment impacts by 
practice size for the 2021 MIPS performance period based on various 
finalized policies to modify the MIPS final score and the performance 
threshold discussed in section IV.A.3.e.(3) of this final rule and 
additional performance threshold finalized in the CY 2020 PFS final 
rule (84 FR 63040). For this RIA, we updated performance period and 
eligibility data to reflect information submitted in the 2019 MIPS 
performance period.
a. Estimated APM 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, for 
the applicable performance period, will receive a lump-sum APM 
Incentive Payment equal to 5 percent of their estimated aggregate 
payment amounts for Medicare covered professional services furnished 
during the calendar year immediately preceding the payment year. 
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 allows eligible clinicians to 
become QPs by meeting the QP payment amount or patient count threshold 
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 
payments for covered professional services furnished by an eligible 
clinician during that year. Eligible clinicians who become QPs for a 
year are not subject to MIPS reporting requirements and payment 
adjustments. Eligible clinicians who do not become QPs, but meet a 
lower threshold to become Partial QPs for the year, may elect to report 
to MIPS and, if they elect to report, would then be scored under MIPS 
and receive a MIPS payment adjustment. Partial QPs are not eligible to 
receive the APM Incentive Payment. For the 2021 QP Performance Period, 
as set forth in Sec.  414.1430(a)(2), Partial QPs are eligible 
clinicians in Advanced APMs who have at least 50 percent, but less than 
75 percent, of their payments for Part B covered professional services 
through an APM Entity, or furnish Part B covered professional services 
to at least 35 percent, but less than 50 percent, of their Medicare 
beneficiaries through an APM Entity. This MIPS payment adjustment may 
be positive, negative, or neutral. If an eligible clinician does not 
attain either QP or Partial QP status, and does not meet any another 
exemption category, the eligible clinician would be subject to MIPS, 
would report to MIPS, and would receive the corresponding MIPS payment 
adjustment.
    Beginning in payment year 2026, the Conversion Factor (CF) used to 
calculate 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 the CF used to calculate 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 PFS services in a payment year 
based on performance during a prior performance period. Although the 
statute establishes overall payment rate and procedure parameters until 
2026 and beyond, this impact

[[Page 85012]]

analysis covers only the fifth payment year (2023 payment year) of the 
Quality Payment Program.
    Overall, we estimate that for the 2021 QP Performance Period 
between 196,000 and 252,000 eligible clinicians will become QPs, 
therefore be excluded from MIPS, and qualify for the lump sum APM 
incentive payment in Payment Year 2023 based on 5 percent of their Part 
B paid amounts for covered professional services in the preceding year. 
These paid amounts for QPs are estimated to be between approximately 
$14,000 million and $18,500 million in total for the 2021 performance 
year. The analysis for this final rule used the 2019 third snapshot 
participation file. We based APM Incentive Payment Amounts on paid 
amounts with service dates of January 1, through September 30, 2019. We 
multiplied the calculated amounts by 1.5 to approximate payment amounts 
for the full calendar year. We estimate that the total lump sum APM 
Incentive Payments will be approximately $700-900 million for the 2023 
Quality Payment Program payment year.
    In section IV.F.10.b. of this final rule, we projected 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 2021 QP Performance Period, as well as some Advanced APMs 
anticipated to be operational during the 2021 QP Performance Period. 
The projections also reflect an estimated number of eligible clinicians 
that would attain QP status through the All-Payer Combination Option. 
We note that the Next Generation ACO Model, previously scheduled to 
conclude December 2020, the Comprehensive Care for Joint Replacement 
Payment Model (CEHRT Track), currently scheduled to conclude March 31, 
2021, have been included in our analysis as we anticipate that these 
models will be Advanced APMs in 2021. The following APMs are expected 
to be Advanced APMs for the 2021 QP Performance Period:
     Bundled Payments for Care Improvement Advanced Model;
     Comprehensive Care for Joint Replacement Payment Model 
(CEHRT Track), if extended;
     Comprehensive Primary Care Plus (CPC+) Model;
     Direct Contracting Model;
     Kidney Care Choices Model;
     Maryland Total Cost of Care Model (Care Redesign Program; 
Maryland Primary Care Program);
     Medicare Shared Savings Program (Track 2, Track 3, Basic 
Track Level E, and the ENHANCED Track);
     Medicare ACO Track 1+ Model;
     Next Generation ACO Model, if extended;
     Oncology Care Model (Two-Sided Risk Arrangements);
     Primary Care First (PCF) Model; and
     Vermont All-Payer ACO Model (Vermont Medicare ACO 
Initiative).
    We used the Participation Lists and Affiliated Practitioner Lists, 
as applicable, (see 81 FR 77444 through 77445 for information on the 
APM Participant Lists and QP determinations) for the Predictive QP 
determination file for 2019 to estimate the number of QPs, total Part B 
paid amounts for covered professional services, and the aggregate total 
of APM Incentive Payments for the 2021 QP Performance Period. We 
examined the extent to which Advanced APM participants would meet the 
QP Thresholds of having at least 75 percent of their Part B covered 
professional services or at least 50 percent of their Medicare 
beneficiaries furnished Part B covered professional services through 
the APM Entity.
b. Impact for the 2022 MIPS Payment Year
    In section IV.A.3.d.(2)(a) of this final rule, we finalized the 
proposal to double the total points available for the complex patient 
bonus to up to 10 points. We expect this finalized policy to result in 
the median bonus to increase by 3 points, thus increasing MIPS final 
scores at the median by 3 points. We do not know the effects of the PHE 
for COVID-19 and its effect on MIPS performance in 2020, so we did not 
recreate the analysis and payment distributions with the updated bonus 
for the 2020 MIPS performance period. We expect the higher MIPS final 
scores would result in smaller payment adjustments for two reasons. 
First, we expect reductions to the budget neutral pool due to the 
higher scores. Second, for clinicians above the performance threshold 
or additional performance threshold, an increased score would mean more 
clinicians sharing the budget neutral pool and additional $500 million 
for exceptional performance and potentially lowering the scaling factor 
that is applied to the MIPS payment adjustment and additional payment 
adjustment.
c. Impact of the PHE for COVID-19 on CY 2019 QPP Performance Period 
Submissions Data
    The PHE for COVID-19 overlapped with the CY 2019 submissions period 
and led us to trigger our automatic extreme and uncontrollable 
circumstances policy for the entire U.S. for the 2019 MIPS performance 
period. This policy means that clinicians who did not submit any 
information to MIPS or for certain performance categories could have 
the performance category scores reweighted (instead of receiving a 
performance category score of 0). We also published in the March 31st 
COVID-19 IFC in which we updated our application-based extreme and 
uncontrollable circumstances policy to provide more flexibility for 
clinicians impacted by the PHE for COVID-19. Specifically, we extended 
the application deadline from December 31, 2019 to April 30, 2020, and 
also modified the policy at Sec.  414.1380(c)(2)(i)(A)(6) to create an 
exception for the 2019 performance period/2021 MIPS payment year only, 
such that if a MIPS eligible clinician demonstrates through an 
application submitted to CMS that they have been adversely affected by 
the PHE for the COVID-19 pandemic, but also submits data for the 
quality, Promoting Interoperability, or improvement activities 
performance categories, the performance categories for which data are 
submitted would still be reweighted and the data submission would not 
effectively void the application for reweighting (85 FR 19278).
    As a result of these policies, we needed to assess whether it would 
be appropriate to use CY 2019 QPP submissions data to assess CY 2021 
MIPS performance and whether adjustments would need to be made to the 
data because clinicians did not submit information. To do so, we 
examined the distribution of final scores for clinicians who submitted 
data to MIPS for the CY 2019 performance period, irrespective if they 
applied for the application-based extreme and uncontrollable 
circumstances policy we established in the March 31st COVID-19 IFC, and 
compared the levels of non-engagement in MIPS to the CY 2018 
performance period. When we considered whether we should remove 
clinicians who received reweighting due to our triggering of the 
automatic extreme and uncontrollable circumstances policy due to the 
PHE for COVID-19, we found excluding clinicians under this policy led 
to an increase in the number of clinicians not engaged with MIPS 
compared to the CY

[[Page 85013]]

2021 PFS proposed rule RIA, which uses CY 2018 MIPS submissions data. 
These clinicians who did not submit data for the CY 2019 submissions 
period did not have shared characteristics that would warrant 
adjustment for their missing data. Therefore, we selected to only 
exclude clinicians who qualified for automatic E&U prior to COVID-19 to 
be consistent with the RIA methodology in previous years. When we 
considered clinicians impacted by updates to the application-based 
COVID-19 extreme and uncontrollable circumstances policy as finalized 
(85 FR 19278) on the CY 2019 submissions data, we found that including 
clinicians affected by the application-based extreme and uncontrollable 
circumstances policy in our CY 2021 PFS final rule RIA model did not 
lead to a meaningful difference in the distribution scores compared to 
when we used CY 2018 Quality Payment Program submissions data. Given 
these findings, we decided to use the CY 2019 submissions data and 
continued to exclude clinicians who were affected by the automatic 
extreme and uncontrollable circumstances prior to the PHE for COVID-19 
as finalized (82 FR 53895 through 53900).
    To avoid overestimating the positive payment adjustments for the 
2021 MIPS performance period due to the increased number of MIPS 
eligible clinicians who are not engaged, we adjusted the paid amount of 
non-engaged clinicians for the CY 2021 MIPS performance period to equal 
their proportion of paid amount prior to the PHE for COVID-19. We 
conducted a sensitivity analysis to examine the expected payment 
adjustment for the CY 2021 MIPS performance period in the absence of an 
adjustment to the paid amount. The results from this sensitivity 
analysis are presented in section VIII.H.15.e.(3) of this final rule.
d. Estimated Number of Clinicians Eligible for MIPS Eligibility for the 
2023 MIPS Payment Year
(1) Methodology To Assess MIPS Eligibility
(a) Clinicians Included in the Model Prior To Applying the Low-Volume 
Threshold Exclusion
    To estimate the number of MIPS eligible clinicians for the 2021 
MIPS performance period in this final rule, our scoring model used a 
combination of the first determination period from the 2020 MIPS 
performance period (from October 1, 2018 to September 30, 2019) and 
data from the end of calendar year 2019 (from October 1, 2019 to 
December 31, 2019). The first determination period from the 2020 MIPS 
performance period eligibility file was selected as it was the most 
recent eligibility file available. We included 1.6 million clinicians 
(see Table 108) who had PFS claims from October 1, 2018 to December 31, 
2019. As discussed in section VIII.H.15.c. of this final rule, we 
excluded from our analysis individual clinicians who were affected by 
the automatic extreme and uncontrollable circumstances policy finalized 
for the 2018 MIPS performance period/2020 MIPS payment year in the CY 
2019 PFS final rule (83 FR 59876) prior to the PHE for COVID-19 as we 
are unable to predict how these clinicians would perform in a year 
where there was no extreme and uncontrollable event. We also excluded 
from our analysis submissions from clinicians that are CPC+ 
practitioners due to data limitations and an inability to model their 
behavior within the APM Performance Pathway. Finally, we did not 
exclude submitters with one or more categories identified as being 
suppressed as a result of bad data for the CY 2019 performance period 
because we did not receive the list of CY 2019 submissions considered 
as bad data in time for this final rule.
    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 as an individual 
or as a group. Therefore, we excluded these clinicians when calculating 
the estimate of clinicians eligible for MIPS.
    For the estimated MIPS eligible population for the 2023 MIPS 
payment year, we restricted our analysis 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); a physical therapist, occupational therapist, speech-language 
pathologist, audiologist, clinical psychologist, and registered 
dietitian or nutrition professional as finalized in the CY 2019 PFS 
final rule (83 FR 60076).
    As noted previously, we excluded QPs from our scoring model since 
these clinicians are not MIPS eligible clinicians. To determine which 
clinicians in the initial population of 1.6 million should be excluded 
as QPs, we used Advanced APM payment and patient percentages from the 
APM Participant List for the first snapshot date for the 2020 QP 
performance period, supplemented by the most recent 2019 performance 
period APM participation data for those clinicians not on the 2020 
first snapshot list. From this data, we calculated the QP 
determinations as described in the Qualifying APM Participant 
definition at Sec.  414.1305 for the 2021 QP performance period. We 
assumed that all Partial QPs would elect to participate in MIPS and 
included them in our scoring model and eligibility counts. The 
projected number of QPs excluded from our model is 172,530. Due to data 
limitations, we could not identify specific clinicians who may become 
QPs in the 2021 Medicare QP Performance Period; hence, our model may 
underestimate or 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 used the enrollment 
date from the 2019 Quality Payment Program performance period data.
(b) Assumptions Related To Applying the Low-Volume Threshold Exclusion
    The low-volume threshold policy may be applied at the individual 
(that is, TIN/NPI) or group (that is, TIN) levels based on how data are 
submitted or at the APM Entity level if the clinician is part of an APM 
Entity in a MIPS APM (hereafter, a MIPS APM Entity) that elects to 
submit to MIPS. A clinician or group that exceeds at least one but not 
all three low-volume threshold criteria may become MIPS eligible by 
electing to opt-in and subsequently submitting data to MIPS, thereby 
getting measured on performance and receiving a MIPS payment 
adjustment. Our method of modeling opt-in participation is described 
later in this section.
    Table 108 presents the estimated MIPS eligibility status and the 
associated PFS allowed charges of clinicians in the initial population 
of 1.6 million clinicians in the analysis of the 2021 MIPS performance 
period after using 2019 MIPS performance period data and applying the 
finalized policies for the 2021 MIPS performance period.
    To apply the low-volume threshold, we need to understand whether 
clinicians participate as a group, virtual group, APM entity, or as 
individuals. For the purposes of this regulatory impact analysis, we 
made assumptions as to which clinicians would elect group reporting, 
virtual group or APM Entity reporting. One extreme and unlikely 
assumption is that no practices elect

[[Page 85014]]

group reporting, virtual group reporting, or participate in an APM 
Entity that elects MIPS reporting and the low-volume threshold is 
applied at the individual level. Although we believe a scenario in 
which clinicians would only participate as individuals is unlikely, 
this assumption is important because it quantifies the minimum number 
of MIPS eligible clinicians. For this final rule model, we estimate 
approximately 228,000 clinicians \153\ would be MIPS eligible because 
they exceed the low volume threshold as individuals and are not 
otherwise excluded. In Table 108, we identify these clinicians as 
having ``required eligibility.''
---------------------------------------------------------------------------

    \153\ The count of 227,488 MIPS eligible clinicians for required 
eligibility includes those who participated in MIPS (200,373 MIPS 
eligible clinicians), as well as those who did not participate 
(27,115 MIPS eligible clinicians).
---------------------------------------------------------------------------

    For this RIA, we assume the following participation requirements 
for virtual groups and MIPS APM Entities that elect to participate in 
MIPS. We assume that TINs that registered as a virtual group for the CY 
2019 MIPS performance period will continue to do so for the CY 2021 
MIPS performance period. Due to data limitations and our inability to 
determine who would use the APM Performance Pathway versus the 
traditional MIPS submission mechanism for the 2021 MIPS performance 
period, our model assumes ACO APM Entities would elect to submit data 
to MIPS through the APM Performance Pathway and that participants in 
non-ACO APM Entities would participate in MIPS as an individual or 
group rather than as an APM Entity. We included those who are in MIPS 
APM ACOs in the 2019 performance period as well as the additional 
clinicians in the first snapshot date of the 2020 QP performance 
period.
    Finally, we assume that groups that submitted to MIPS as a group 
will continue to do so for the CY 2021 MIPS performance period. Using 
CY 2019 MIPS performance period data, we can identify group reporting 
through the submission of improvement activities, Promoting 
Interoperability, or quality performance category data. Using these 
assumptions, we identified approximately 661,000 MIPS eligible 
clinicians who are eligible because they had the low-volume threshold 
applied to an identified group, APM entity, or virtual groups. In Table 
108, we identify these clinicians who do not meet the low-volume 
threshold individually but are assumed to submit to MIPS as a group, 
virtual group or MIPS APM as having ``group eligibility.''
    To model the opt-in policy finalized in the CY 2019 PFS final rule 
(83 FR 59735), we updated our methodology from the CY 2021 PFS proposed 
rule (85 FR 50384 through 50387) because actual opt-in participation 
data became available with the transition to the use of CY 2019 
performance period data. We assumed clinicians who exceeded at least 
one but not all low-volume threshold criteria and who elected to opt-in 
to MIPS and submitted data for the CY 2019 MIPS performance period 
would also elect to opt-in to MIPS for the CY 2021 MIPS performance 
period.
    These clinicians who met this opt-in participation assumption are 
identified in Table 108 as ``Opt-In eligibility''. In this final rule 
analysis, we estimate an additional 2,300 clinicians would be eligible 
through this ``opt-in'' policy for a total MIPS eligible clinician 
population of approximately 891,000. The leads to an associated $72 
billion allowed PFS charges estimated to be included in the 2021 MIPS 
performance period.

[[Page 85015]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.158

    There are approximately 382,000 clinicians who are not MIPS 
eligible, but could be if their practice decides to participate or they 
elect to opt-in. We describe this group as ``Potentially MIPS 
eligible''. These clinicians would be included as MIPS eligible in 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 the MIPS eligible clinician population could be 
as high as 1.3 million clinicians.
    Finally, there are some clinicians who would not be MIPS eligible 
either because they and their group are below

[[Page 85016]]

the low-volume threshold on all three criteria (approximately 83,000) 
or because they are excluded for other reasons (approximately 270,000).
    Since eligibility among many clinicians is contingent on submission 
to MIPS as a group, virtual group, APM participation in a MIPS APM 
Entity that elects to report to MIPS, or election to opt-in, we will 
not know the number of MIPS eligible clinicians until the submission 
period for the 2021 MIPS performance period is closed. For this impact 
analysis, we used the estimated population of 890,742 MIPS eligible 
clinicians described above.
e. Estimated Impacts on Payments to MIPS Eligible Clinicians for the 
2023 MIPS Payment Year
(1) Summary of Approach
    In sections IV.A.3.c., IV.A.3.d. and IV.A.3.e. of this final rule, 
we present several provisions which impact the measures and activities 
that impact the performance category scores, final score calculation, 
and the MIPS payment adjustment. We discuss these changes in more 
detail in section VIII.H.15.e.(2) of this RIA as we describe our 
methodology to estimate MIPS payments for the 2023 MIPS payment year. 
We note that some of the MIPS policies in the CY 2020 PFS final rule 
were only defined for the 2020 MIPS performance period and 2022 MIPS 
payment year and did not continue to future years, such as the quality 
and cost performance category weights. Because we did not have category 
weights for the 2021 MIPS performance period, we could not calculate a 
final score for the 2021 MIPS performance period and 2023 MIPS payment 
year. Therefore, we could not create a baseline for the 2021 
performance period that would allow us to fully distinguish between the 
impact of the previously finalized policies for the 2021 performance 
period and the finalized policies for the 2021 performance period. Our 
impact analysis looks at the total effect of the previously finalized 
and newly finalized MIPS policies on the MIPS final score and payment 
adjustment for the CY 2021 MIPS performance period/CY 2023 MIPS payment 
year.
    The payment impact for a MIPS eligible clinician is based on the 
clinician's final score, which is a value determined by their 
performance (as an individual, group, virtual group, or APM Entity) in 
the four MIPS performance categories: Quality, cost, improvement 
activities, and Promoting Interoperability. As discussed in section 
VIII.H.15.e.(2) of this final rule, we generally used the most recently 
available data from the Quality Payment Program which is data submitted 
for the 2019 MIPS performance period.
    The estimated payment impacts presented in this final 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 
that clinicians earn 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, that would not be affected by 
MIPS payment adjustment factors.
(2) Methodology To Assess Impact
    To estimate participation in MIPS for the CY 2021 Quality Payment 
Program for this final rule, we generally used 2019 MIPS performance 
period data. Our scoring model included the 890,742 estimated MIPS 
eligible clinicians as described in section VIII.H.15.b of this RIA.
    To estimate the impact of MIPS policies on MIPS eligible 
clinicians, we generally used the 2019 MIPS performance period data, 
including data submitted for the quality, improvement activities, and 
Promoting Interoperability performance categories. We supplemented this 
information with CAHPS for MIPS and CAHPS for ACOs, the revised total 
per capita cost measure and Medicare Spending Per Beneficiary (MSPB) 
clinician measures that were finalized in the CY 2020 PFS final rule 
(84 FR 62969 through 62977), and other data sets.\154\ We calculated a 
hypothetical final score for the 2021 MIPS performance period/2023 MIPS 
payment year for each MIPS eligible clinician using score estimates 
described in this section for quality, cost, Promoting 
Interoperability, and improvement activities performance categories.
---------------------------------------------------------------------------

    \154\ Data submitted to MIPS for the 2018 MIPS performance 
period data was used for the improvement score for the quality 
performance category. We also incorporated some additional data 
sources when available to represent more current data.
---------------------------------------------------------------------------

(a) Methodology To Estimate the Quality Performance Category Score
    We estimated the quality performance category score using a similar 
methodology described in the CY 2020 PFS final rule (84 FR 63168 
through 63169) with the following modifications that reflect the newly 
finalized policies for the 2021 MIPS performance period. As discussed 
in section IV.A.3.c.(1)(e)(i) of this final rule, we finalized as 
proposed to replace the All-Cause Readmission measure with the Hospital 
Wide Readmission measure and add the hip-knee complications measure for 
those for whom it is applicable. We used testing data for these new 
administrative claims measures.
    As discussed in section IV.A.3.d.(1)(b) of this final rule, we are 
not finalizing our intent to use a performance period benchmark as 
opposed to a historical benchmark. Therefore, we used the 2019 MIPS 
performance period benchmarks because the performance data for this 
analysis came primarily from the 2019 MIPS performance period. The one 
exception where we used the 2019 MIPS performance period benchmarks was 
when we identified measures subject to the topped out scoring cap that 
was finalized (82 FR 53721 through 53727) using the 2020 MIPS 
performance period benchmark file. As discussed in section IV.A.3.c.(1) 
of this final rule, we applied the finalized quality performance 
category weight of 40 percent for the 2021 MIPS performance period.
    Finally, we finalized the APM Performance Pathway policies as 
described in section IV.A.3.b. of this final rule. The APM Performance 
Pathway is available for APM entities and as discussed in section 
IV.A.3.(b).(3).(a) we are finalizing an alternate measure set 
consisting of the Web Interface measures for the CY 2021 performance 
period. For our RIA model, we assumed clinicians in APM Entities would 
continue to use the Web Interface collection type, if available, over 
the APM Performance Pathway. Due to data limitations, our analysis only 
applied Web Interface and the APM Performance Pathway scoring policies 
to ACO APM Entities. For ACOs, quality performance under the finalized 
APM Performance Pathway was modeled using Web Interface data for 2019 
from the 2019 performance period submissions data. For the multiple 
chronic condition unplanned admissions measure under the APM 
Performance Pathway, the 2019 Shared Savings Program and the 2018 Next 
Generation ACO Model public use files

[[Page 85017]]

were used.\155\ To estimate the Hospital Wide Readmission measure as 
finalized in section IV.A.3.c.(1)(e)(i), we aggregated the score for 
APM Entities. Data does not exist for APM performance pathway or MIPS 
quality measures for non-ACO APM Entities. Therefore, we assumed due to 
data limitations these non-ACO APM entities would not participate in 
the APP although they can participate in APP, either through the APP 
measures or Web Interface for the CY 2021 performance period. For the 
purposes of modeling, we assumed that their participating clinicians 
(or their groups) would participate in regular MIPS, and scored those 
clinicians using the available MIPS submissions of the clinician or its 
group. Therefore, because of data limitations our results may 
overestimate or underestimate the number of APM Entities that elect to 
participate in MIPS as an APM Entity and how they elect to participate.
---------------------------------------------------------------------------

    \155\ The public use files for the 2019 Medicare Shared Savings 
Program and 2018 Next Generation ACO Model can be accessed at 
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/program-data and https://innovation.cms.gov/innovation-models/next-generation-aco-model.
---------------------------------------------------------------------------

(b) Methodology To Estimate the Cost Performance Category Score
    In section IV.A.3.c.(2) of this final rule, we finalized as 
proposed a cost performance category weight of 20 percent for the 2021 
MIPS performance period. We estimated the cost performance category 
score using the methodology described in the CY 2020 PFS final rule (84 
FR 63169).
(c) Methodology To Estimate the Facility-Based Measurement Scoring
    As finalized in the CY 2019 PFS final rule (83 FR 59856), we 
determine the eligible clinician's MIPS cost and quality performance 
category score in facility-based measurement based on Hospital VBP 
Program Total Performance Score for eligible clinicians or groups who 
meet the eligibility criteria, which we designed to identify those who 
primarily furnish services within a hospital. We estimated the 
facility-based score using the scoring policies finalized in the CY2018 
Quality Payment Program final rule (82 FR 53763) and the methodology 
described in the CY 2020 PFS final rule (84 FR 63169).
(d) Methodology To Estimate the Promoting Interoperability Performance 
Category Score
    In section IV.3.c.(4)(c)(ii)(B), we are finalizing as proposed to 
add the HIE bi-directional exchange measure for the 2021 performance 
period and subsequent years as an optional alternative to the two 
existing measures: The Support Electronic Referral Loops by Sending 
Health Information measure and the Support Electronic Referral Loops by 
Receiving and Incorporating Health Information measure. This provision 
provides clinicians the option of either reporting the new measure or 
the two existing measures. In section IV.3.c.(4)(c)(i) of this final 
rule, we finalized as proposed for the PDMP measure to remain optional 
and to double the bonus points from 5 to 10 points.
    We used the CY 2019 MIPS Promoting Interoperability performance 
period data submissions data to estimate CY 2021 MIPS performance for 
the Promoting Interoperability performance category. Due to technical 
limitations, the data used do not capture the following policy changes 
between the CY 2019 and CY 2021 performance periods: (1) The doubling 
of the bonus points for clinicians who submitted the PDMP measure, (2) 
the removal of the Verify Opioid Treatment Agreement measure data, a 
measure that was finalized in the CY 2019 performance period (83 FR 
59806) but removed in the CY 2020 performance period (84 FR 62994), and 
(3) the adoption of the finalized Health Information Exchange bi-
directional exchange measure for the CY 2021 performance period. As a 
result, the estimated Promoting Interoperability performance category 
scores for the CY 2021 performance period may be a slight over- or 
under-estimate of performance in the Promoting Interoperability 
performance category.
(e) Methodology To Estimate the Improvement Activities Performance 
Category Score
    We modeled the improvement activities performance category score 
based on CY 2019 MIPS performance period data and APM participation 
identified in section VIII.H.15.b of this final rule. We continued to 
apply the methodology described in the CY 2020 PFS final rule (84 FR 
63170) to assign an improvement activities performance category score. 
For the APM participants identified in section IV.A.3.b.(2) of this 
final rule, as there was no APM performance pathway score in the 
previous final rule, we assigned an improvement activity performance 
category score of 100 percent.
(f) Methodology To Estimate the Complex Patient Bonus
    In section IV.A.3.d.(2)(a) of this final rule, we finalized as 
proposed to continue the complex patient bonus for the 2021 MIPS 
performance period. Consistent with the policy to define complex 
patients as those with high medical risk or with dual eligibility, our 
scoring model used the complex patient bonus information calculated for 
the 2019 performance period data.
(g) Methodology To Estimate the Final Score
    As discussed in sections IV.A.3.c.(1)(b), IV.A.3.c.(2)(a), and 
summarized in section IV.A.3.d.(2)(b) of this final rule, our model 
assigned 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 any performance category, we redistributed 
the weights according to section IV.A.3.d.(2)(b)(iii) of this final 
rule.
(h) Methodology To Estimate the MIPS Payment Adjustment
    As described in section IV.A.3.e.(2) of this final rule, we applied 
the finalized 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.
    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 additional payment adjustment for exceptional 
performance (as finalized under Sec.  414.1405), using the performance 
threshold of 60 points previously finalized in the CY 2020 PFS final 
rule (84 FR 63037) and the previously finalized additional performance 
threshold of 85 points (84 FR 63039 through 63040). In the alternatives 
considered discussed in section VIII.I.2. of this rule, we include the 
key statistics if the performance threshold was 50 as proposed in the 
CY 2021 PFS proposed rule (85 FR 50318). We used these resulting 
parameters to estimate the positive or negative MIPS payment adjustment 
based on the estimated final score and the paid amount for covered

[[Page 85018]]

professional services furnished by the MIPS eligible clinician. As 
discussed in section VIII.H.15.c. of this final rule, we adjusted the 
paid amount of non-engaged clinicians to equal their proportion of paid 
amount prior to the PHE for COVID-19.
(3) Impact of Payments by Practice Size
    Using the assumptions provided above, our model estimates that $458 
million would be redistributed through budget neutrality and that $500 
million would be distributed to MIPS eligible clinicians that meet or 
exceed the additional performance threshold. The mean final score is 
79.80 and the median is 85.27.
    The model further estimates that the maximum positive payment 
adjustments are 5.3 percent after considering the MIPS payment 
adjustment and the additional MIPS payment adjustment for exceptional 
performance. In the alternatives considered discussed in section 
VIII.I.2. of this rule, we include the details of the model in which 
the performance threshold was set to 50, which had been proposed in the 
2021 PFS proposed rule. In this alternate model, $388 million would be 
redistributed through budget neutrality and the maximum positive 
payment adjustments would be 4.9 percent.
    Table 109 shows the impact of the payment adjustments by practice 
size and based on whether clinicians are expected to submit data to 
MIPS. We estimate that a smaller proportion of clinicians in small 
practices (1-15 clinicians) who participate in MIPS will receive a 
positive or neutral payment adjustment compared to larger sized 
practices. Table 109 also shows that 93.0 percent of MIPS eligible 
clinicians that participate in MIPS are expected to receive positive or 
neutral payment adjustments. We want to highlight that we are using 
2019 MIPS performance period submissions data to simulate a 2021 MIPS 
performance period final score, and it is likely that there will be 
changes that we cannot account for at this time, including services and 
payments disrupted by the PHE for COVID-19 or clinicians changing 
behavior because of the performance thresholds increased for the 2021 
MIPS performance period to avoid a negative payment adjustment. In 
particular, we have not accounted for potential clinicians who might 
elect to apply for the extreme and uncontrollable circumstances 
policies for the CY 2021 performance period that we discuss in section 
IV.A.3.d.(2)(b)(iv)(B) of this final rule.
    The combined impact of negative and positive adjustments and the 
additional positive adjustments for exceptional performance as a 
percent of paid amount among those that do not submit data to MIPS was 
not the maximum negative payment adjustment of 9 percent possible 
because some MIPS eligible clinicians that do not submit data to MIPS 
receive a non-zero score for the cost performance category, which 
utilizes administrative claims data and does not require separate data 
submission to MIPS. Among those who we estimate would not submit data 
to MIPS, 85 percent are in small practices (22,956 out of 27,115 
clinicians who do not submit data). 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, which we 
describe in section H.15.e.(4)(b)(iv) of this final rule. We intend to 
continue working with stakeholders to improve engagement in MIPS among 
clinicians in small practices. It should also be noted that the 
estimated number of clinicians who do not submit data to MIPS may be an 
overestimate of non-engagement in MIPS for the CY 2021 MIPS performance 
period. This is because the PHE for COVID-19 may have resulted in fewer 
clinicians submitting data to MIPS or more clinicians may elect to 
apply for the extreme and uncontrollable circumstances policies due to 
the PHE for COVID-19 for 2021 MIPS performance period. Therefore, 
engagement levels in MIPS for the CY 2021 MIPS performance period may 
be differ from these reported estimates. We also note this 
participation data is generally based off participation for the 2019 
performance period, which is associated with the 2021 MIPS payment year 
and had a performance threshold of 30 points, and that participation 
may change for the 2021 performance period when the performance 
threshold is 60 points.

[[Page 85019]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.159

    As a sensitivity analysis of our COVID-19 adjustment on paid 
amount, we ran a model that did not adjust the paid amount of non-
engaged clinicians to equal their proportion of paid amount prior to 
the PHE for COVID-19, our model estimates that $601 million would be 
redistributed through budget neutrality. The model further estimates 
that the maximum positive payment adjustments are 5.9 percent after 
considering the MIPS payment adjustment and the additional MIPS payment 
adjustment for exceptional performance.
(4) Additional Impacts From Outside Payment Adjustments
(a) Burden Overall
    In addition to the payment adjustments, we are finalizing several 
policies that have an impact on burden in the CY 2021 and CY 2022 MIPS 
performance periods. In section VII.B.5 of this final rule, we outline 
the costs of data collection that includes both policy updates and 
adjustments due to the use of updated data sources. For each finalized 
proposal included in this regulation which impacts our estimate of 
collection burden, the incremental burden for each is summarized in 
Table 110. We also provide additional burden discussions that we are 
not able to quantify.

[[Page 85020]]

[GRAPHIC] [TIFF OMITTED] TR28DE20.160

(b) Additional Impacts to Clinicians
(i) Web Interface
    As discussed in section IV.A.3.c.(1)(c) of this final rule, we are 
finalizing to sunset the CMS Web Interface measures as a collection 
type for groups and virtual groups with 25 or more eligible clinicians 
starting with the 2022 performance period. We recognize that the sunset 
of the CMS Web Interface for groups and virtual groups may be 
burdensome to current groups and virtual groups submitting quality data 
on CMS Web Interface measures. Such groups and virtual groups will need 
to select a different collection type/submission type and redesign 
their systems to be able to interact with the new collection type/
submission type. Given that the Medicare Part B claims collection type 
is limited to small practices, the alternatives for these groups and 
virtual groups will be either the MIPS CQM, QCDR or eCQM collection 
types. Given the size of the affected groups and virtual groups, we 
believe the majority are likely to already be using a QCDR, qualified 
registry, or EHR as part of their practice workflow. Of the 3,613 TINs 
comprised of 25 or more clinicians who submitted MIPS data via a 
collection type other than the CMS Web Interface, 57 percent reported 
via the MIPS CQM and QCDR collection type and 43 percent reported via 
the eCQM collection type. For groups converting from Web Interface, 
there will be some non-recurring costs associated with modifying 
clinical and MIPS data reporting workflows to utilize an alternate 
collection type. For any remaining groups and virtual groups there will 
also be registry fees paid to a QCDR or qualified registry or the 
financial expense of purchasing/licensing and deploying an EHR system. 
Because we are unable to assess either the existing workflows of each 
individual group and virtual group or the decisions each group and 
virtual group will make in response to this finalized proposal, we 
cannot quantify the resulting economic impact. While there may be an 
initial increase in burden for current groups and virtual groups 
utilizing the CMS Web Interface measures having to transition to the 
utilization of a different collection type/submission type, we 
recognize that we will also be reducing reporting requirements. Groups 
and virtual groups will no longer have to completely report on all pre-
determined CMS Web Interface measures and will be able to select their 
own measures (at least 6) to report.
    Groups and virtual groups account for less than 20 percent of 
organizations utilizing the CMS Web Interface measures while ACOs 
participating in the Medicare Shared Savings Program and Next 
Generation ACO Model account for more than 80 percent. With an 80 
percent reduction and a continued decrease interest of groups and 
virtual groups seeking to report quality data on CMS Web Interface 
measures, it is not fiscally viable, feasible, or sustainable for MIPS 
to continue to make available the CMS Web Interface measures as a 
collection type/submission type. There would be proportionally higher 
costs associated with the operationalization and maintenance of the CMS 
Web Interface with a significantly smaller number of groups and virtual 
groups utilizing the CMS Web Interface. In assessing the utilization of 
the CMS Web Interface by groups and virtual groups, there has been a 
substantial decrease in participation each year since the inception of 
MIPS in the 2017 performance period. From 2017 to 2019, the number of 
groups eligible to report quality measures via the CMS Web Interface 
(groups registered to utilize the

[[Page 85021]]

CMS Web Interface) decreased by approximately 45 percent. Similarly, 
the number of groups utilizing the CMS Web Interface as a collection 
type decreased by approximately 40 percent from 2017 to 2019. In our 
cost analysis, operating and maintaining the CMS Web Interface for 
significantly smaller number of groups and virtual groups would not be 
cost-effective. To operate and maintain the CMS Web Interface measures 
solely for groups and virtual groups, there would be an increase in 
cost and needed resources under MIPS associated with the items such as 
the establishment and maintenance of CMS Web Interface benchmarks, 
assignment and sampling, technical support, and education and outreach; 
thus, there would be proportionally higher costs associated with the 
operationalization and maintenance of the CMS Web Interface with a 
significantly smaller number of groups and virtual groups utilizing the 
CMS Web Interface measures as a collection type/submission type.
(ii) Administrative Claims Measure
    As discussed in section IV.A.3.c.(1)(d), we are finalizing as 
proposed to add two new administrative claims measures beginning in the 
2021 MIPS performance period and for future performance periods. We 
acknowledge there are administrative burdens and related financial 
costs associated with each administrative claims measure that 
clinicians, groups, and organizations may choose to monitor. However, 
because these costs can vary significantly due to organizational size, 
number of administrative claims measures being reported, volume of 
clinicians reporting each measure, and the specific methods employed to 
improve performance, we are unable to provide an estimate of the 
financial impact each clinician, group, or organization may experience. 
In summary, we are acknowledging that while there is no data submission 
requirements per Sec.  414.1325(a)(2)(i) for administrative claim 
measures, there may be associated costs for clinicians and group 
practices to monitor new administrative claim measures; however, we are 
unable to quantify that impact.
(iii) Modifications to the Improvement Activities Inventory
    As discussed in section IV.A.3.c.(3)(b)(iii) of this final rule, we 
are finalizing the removal of one obsolete improvement activity, 
modification of two existing improvement activities, and adoption of 
the COVID-19 improvement activity added via IFC. We refer readers to 
Appendix 2 of this final rule for further details. We do not believe 
these finalized changes to the inventory will impact time or financial 
burden on stakeholders because MIPS eligible clinicians are still 
required to submit the same number of activities and the per response 
time for each activity is uniform. We do not expect these finalized 
changes to the inventory to affect our currently approved information 
collection burden estimates in terms of neither the number of estimated 
respondents nor the burden per response. We anticipate that the vast 
majority of clinicians performing improvement activities, to comply 
with existing MIPS policies, will continue to perform the same 
activities under the policies established in this final rule because 
previously finalized improvement activities continue to apply for the 
current and future years unless otherwise modified per rulemaking (82 
FR 54175). Most of the improvement activities in the Inventory remain 
unchanged for the 2020 MIPS performance period.
(c) Stakeholders Nominating Improvement Activities
    In section IV.A.3.c.(3)(b)(i)(A)(bb) of this final rule, we are 
finalizing as proposed to make an exception to the established 
timeframe for nomination of improvement activities, such that during a 
PHE, stakeholders can nominate improvement activities outside of the 
established Annual Call for Activities timeframe. While we expect 
additional nominations may be received as a result of this exception, 
we do not have any data with which to estimate what the additional 
number may be but we assume the additional costs associated with 
nominating new improvement activities are unchanged. Additionally, in 
section IV.A.3.c.(3)(b)(ii)(B) of this rule, we are finalizing as 
proposed beginning with the CY 2021 performance period and future years 
to consider agency-nominated improvement activities. We are unable to 
estimate the number of improvement activity nominations we will 
receive, but similar to the per respondent estimate we have provided in 
section VII.B.5.j. of this final rule, we assume it will require 3 
hours at $55.75/hr for a GS-13 Step 5 to nominate an improvement 
activity for a total cost of $167.25 (3 hrs x $55.75/hr) per activity.
(iv) Impact on Small Practices
    As described in section VIII.H.15.e.(3) of this final rule RIA, we 
found 85 percent of clinicians who did not submit data to MIPS were in 
small practices. However, the estimated number of MIPS eligible 
clinicians who do not submit data and receive a negative payment 
adjustment, including those in small practices, may be smaller in the 
CY 2021 performance period due to the PHE for COVID-19. For example, 
clinicians in small practices may avoid a negative payment adjustment 
due to non-engagement if they apply for the application-based extreme 
and uncontrollable circumstances policy exception for the CY 2021 
performance period. Furthermore, CMS is committed to identifying 
flexibilities and options to help clinicians in small practices 
participate meaningfully and successfully in MIPS. Specifically, CMS 
excludes individual MIPS eligible clinicians or groups with less than 
or equal to $90,000 in allowed charges for covered professional 
services under the Medicare PFS, fewer than or equal to 200 Medicare 
Part B patients who are furnished covered professional services under 
the Medicare PFS, or fewer than or equal to 200 covered professional 
services under the Medicare PFS. We continue to give solo practitioners 
and practices with 10 or fewer clinicians the choice to form a virtual 
group to participate with other practices. For the quality performance 
category, we continue to: (1) Allow clinicians in small practices to 
continue submitting quality data for covered professional services at 
both the individual and group level through the Medicare Part B claims 
submission type; (2) award small practices 3 points for quality 
measures that don't meet data completeness requirements; and (3) award 
6 bonus points to small practices, as long as one measure is submitted. 
For the Promoting Interoperability performance category, we continue to 
allow clinicians to apply to have this category reweighted to zero (if 
not qualified for automatic reweighting) for: (1) Small practices; (2) 
clinicians with insufficient internet connectivity; (3) clinicians with 
extreme and uncontrollable circumstances; (4) lack of control over 
availability of certified EHR technology (CEHRT); and (5) use of 
decertified EHR technology. For the improvement activities performance 
category, small practices and those in rural locations and in health 
professional shortage areas (or HPSAs) have reduced reporting 
requirements. For small practices or those located in a rural or HPSAs: 
(1) Medium-weighted activities are worth 20 points of the total 
category score; and (2) High-weighted activities are worth 40 points of 
the total category score. Finally, in terms of technical assistance, we 
launched the Small, Underserved,

[[Page 85022]]

and Rural Support initiative to provide free, customized technical 
assistance to clinicians in small practices. This 5-year program was 
funded by the Medicare Access and CHIP Reauthorization Act (MACRA). The 
Quality Payment Program technical assistance initiative in 2017 was 
part of our comprehensive education and outreach effort to help 
clinicians successfully participate in the Quality Payment Program. Our 
technical assistance achieved notable success during the first 2 years 
of the program, including receiving customer satisfaction ratings of 
99.8 percent in 2017 and 98.7 percent in 2018. We also recognize that 
our technical assistance initiative led to a 95 percent participate 
rate in 2017.
(d) Impact on Third Party Intermediaries
    In section IV.A.3.g. of this rule, we finalized as proposed 
multiple changes to the third party intermediary regulations at Sec.  
414.1400. Specifically, we are: (1) Amending current requirements for 
approval of third party intermediaries to take into account past 
performance and provision of inaccurate information regarding MIPS 
program requirements to eligible clinicians; (2) requiring attendance 
by all third party intermediaries for training and support sessions; 
(3) requiring that QCDRs and qualified registries must conduct an 
annual data validation audit and if one or more deficiencies or data 
errors are identified also conduct targeted audits; (4) incrementally 
increasing requirements for QCDR measure testing and clarify what is 
meant by full testing; and (5) requiring third party intermediaries to 
submit a CAP to address identified deficiencies and data issues as well 
as actions to prevent recurrence.
    With regard to the amendments to current requirements for approval 
of third party intermediaries, we do not anticipate this to require any 
additional effort for affected entities as the revision is to allow CMS 
to utilize already available information to make approval decisions.
    The finalized requirement for attendance at training and support 
sessions and the associated burdens on third parties closely aligns to 
expectations previously established in the CY 2017 Quality Payment 
Program final rule (81 FR 77367 through 77374) and (81 FR 77384 through 
77386). With regard to survey vendors, we previously finalized the CMS-
approved survey vendor approval criteria in Sec.  414.1400(e) as 
discussed in the CY 2018 PFS final rule (83 FR 59907 through 59908). 
Among the approval criteria, Sec.  414.1400(e)(3) established the 
requirement that the entity has successfully completed, and has 
required its subcontractors to successfully complete, vendor 
training(s) administered by CMS or its contractors. Therefore, we 
assume no additional impact for survey vendors as a result of this 
finalized proposal. We do not have data on the number of health IT 
vendors that missed training and support sessions, but the most recent 
data cites 684 health IT developers through program year 2016 of the 
Medicare EHR Incentive Program.\156\ In CY 2019, 16 total training and 
support sessions were missed by 14 QCDRs and 33 total sessions were 
missed by 27 qualified registries. Based on historical frequency and 
duration, we expect future training and support sessions to continue 
occurring monthly for approximately 2 hours each. For QCDRs and 
qualified registries, we estimate an impact of 98 hours [(16 sessions 
by QCDRs + 33 sessions by qualified registries) x 2 hours]. We lack 
insight into the exact occupation of session attendees, but for 
estimating purposes we assume a Physician labor rate of $212.78/hr and 
estimate a total burden of $20,852 ($212.78/hr x 98 hours).
---------------------------------------------------------------------------

    \156\ https://dashboard.healthit.gov/quickstats/pages/FIG-Vendors-of-EHRs-to-Participating-Professionals.php.
---------------------------------------------------------------------------

    We do not anticipate a significant impact to QCDRs and qualified 
registries resulting from the finalized proposal to require QCDRs and 
qualified registries to conduct an annual data validation audit and if 
one or more deficiencies or data errors are identified also conduct 
targeted audits. First, we are not revising our burden estimates 
because the finalized data validation requirements are similar to 
existing expectations which we have already accounted for the 
associated burden as stated in the CY 2017 Quality Payment Program 
final rule (81 FR 77383 through 77384) and the CY 2019 PFS final rule 
(83 FR 59998 through 59999). Second, we believe that the finalized 
requirements for conduct of the data validation audits are aligned with 
methods and procedures which stakeholders currently utilize.
    With regard to the proposal to require QCDRs and qualified 
registries to conduct targeted audits if one or more data errors are 
identified during data validation audits, we sought comment on the 
expected frequency of targeted audits and the anticipated scope of 
effort. We did not receive comments related to the expected frequency 
of targeted audits and the anticipated scope of the effort. However, we 
are including burden estimates associated with this finalized 
requirement in section VII.B.5.c.(2) and (3) of the Collection of 
Information for this rule. Due to the unknown scope of patient records 
that may need to be audited, we estimate a range of effort to complete 
a targeted data audit from a minimum of 5 hours to a maximum of 10 
hours at a cost ranging from $462.30 ($92.46/hr x 5 hrs) to $924.60 
($92.46/hr x 10 hrs) per targeted audit. In the 2019 MIPS performance 
period, 37 of the 84 qualified registries (44%) and 23 of the 77 QCDRs 
(30%) that submitted 2019 MIPS quality data were required to complete a 
targeted audit. Based on the results of the 2020 self-nomination 
period, 58 QCDRs and 127 qualified registries have been approved for 
the 2021 MIPS performance period; assuming the same percentages, we 
estimate a total of 73 QCDRs and qualified registries (58 x 30% + 127 x 
44%) will be required to complete targeted audits. Per these 
assumptions, we estimate the total impact associated with completing 
targeted audits will range from 365 hours (73 audits x 5 hrs/audit) at 
a cost of $33,748 (73 audits x $462.30/audit) to 730 hours (73 audits x 
10 hrs/audit) at a cost of $67,496 (73 audits x $924.60/audit).
    Because the finalized proposal to incrementally increase 
requirements for QCDR measure testing is not changing the requirements 
for fully testing measures, but is instead implementing an incremental 
approach to achieve previously finalized requirements, we do not 
anticipate any additional impact as a result of the finalized policy.
    As discussed in section VII.B.5.c.(3) of this rule, we estimate the 
total burden impact associated with the provision to require CAPs to be 
30 hours (10 respondents x 3 hr/respondent) at a cost of $2,774 for all 
respondents (10 respondents x $277.38/respondent).
f. Assumptions & Limitations
    We note several limitations to our estimates of clinicians' MIPS 
eligibility and participation, negative MIPS payment adjustments, and 
positive payment adjustments for the 2023 MIPS payment year. Due to the 
PHE for COVID-19, we are aware that there may be changes in health care 
delivery and billing patterns that will impact results for the 2023 
MIPS payment year that we were not able to model with our historic data 
sources. The scoring model results presented in this final rule assume 
that CY 2019 Quality Payment Program data submissions and performance 
are representative of CY 2021 Quality Payment Program data submissions 
and performance. The estimated performance for CY 2021 MIPS

[[Page 85023]]

performance period using CY 2019 Quality Payment Program data may be 
underestimated because the performance threshold to avoid a negative 
payment adjustment for the 2019 MIPS performance period/2021 MIPS 
payment year was significantly lower (30 out of 100 points) than the 
performance threshold for the 2021 MIPS performance period/2023 MIPS 
payment year (60 out of 100). We anticipate clinicians may submit more 
performance categories to meet the higher performance threshold to 
avoid a negative payment adjustment. Finally, with the PHE for COVID-19 
continuing in the 2021 MIPS performance period, we are uncertain of how 
many clinicians will apply for extreme and uncontrollable circumstances 
policy and not be required to submit data to MIPS.
    In our MIPS eligible clinician assumptions, we assumed that 
clinicians who elected to opt-in in the CY 2019 Quality Payment Program 
and submitted data would continue to elect to opt-in in the CY 2020 
performance period. It is difficult to predict whether clinicians will 
elect to opt-in to participate in MIPS with the finalized policies.
    There are additional limitations to our estimates: (1) 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 109; and (2) our cost data does not overlap with CY 2019 
so we may not be capturing performance for all clinicians. Due to the 
limitations described, there is considerable uncertainty around our 
estimates that is difficult to quantify.

I. Alternatives Considered

    This final 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 
exercised, presents rationale for our policies and, where relevant, 
alternatives that were considered. For purposes of the payment impact 
on PFS services of the policies contained in this final rule, we 
presented the estimated impact on total allowed charges by specialty.
1. Alternatives Considered for the MDPP Expanded Model Emergency Policy
    For the MDPP Expanded Model Emergency Policy, no alternatives were 
considered. If we do not take action it will have an extremely negative 
impact to MDPP supplier and beneficiaries; which would threaten the 
success of the entire expanded model; as beneficiaries would become 
ineligible and not be able to finish the program, MDPP suppliers would 
not be paid for services rendered, and no new cohorts of set of MDPP 
services could be started, effectively ending the expanded model test.
2. Alternatives Considered for the Quality Payment Program
    For purposes of the payment impact on the Quality Payment Program, 
we view the performance threshold as a critical factor affecting the 
distribution of payment adjustments. We ran a separate model with a 
performance threshold of 50 which was previously proposed in the CY 
2021 PFS proposed rule (85 FR 50318) as an alternative to the finalized 
performance threshold of 60. The model with a performance threshold of 
50 has the same mean and median final score as our model of finalized 
policies since the performance threshold does not change the final 
score. We estimate that $388 million would be redistributed through 
budget neutrality. There would be a maximum payment adjustment of 4.9 
percent after considering the MIPS payment adjustment and the 
additional MIPS payment adjustment for exceptional performance. In 
addition, 4.5 percent of MIPS eligible clinicians would receive a 
negative payment adjustment among those that submit data.
    In addition, we view the cost performance category weight as a 
critical factor affecting final scores. We ran two separate models with 
cost performance category weights of 15 and 30, with corresponding 
quality performance category weights of 45 and 30, respectively (as an 
alternative to the finalized cost performance category weight of 20 and 
quality performance category weight of 40) to estimate the impact of 
keeping the weights consistent with the CY 2020 PFS final rule and a 
more aggressive increase in the cost performance category weight. The 
model with a cost performance category weight of 15 has a mean score of 
80.21 and a median score of 86.07. The model with a cost performance 
category weight of 30 has a mean score of 78.38 and a median score 
83.18. We refer readers to section IV.A.3.c.(2)(a) for additional 
discussion on the selection of the cost performance category weight.
    Finally, we report the findings if Web Interface were removed as a 
collection type in the CY 2021 performance period. The model with the 
removal of Web Interface as a collection type has a final score mean of 
78.36 and median of 83.05. We estimate that $459 million would be 
redistributed through budget neutrality. There would be a maximum 
payment adjustment of 6.6 percent after considering the MIPS payment 
adjustment and the additional MIPS payment adjustment for exceptional 
performance. In addition, 7.2 percent of MIPS eligible clinicians would 
receive a negative payment adjustment among those that submit data.
3. Alternatives Considered for Changes Related to Scopes of Practice
    With regard to the proposal concerning supervision of diagnostic 
tests by certain NPPs, an alternative would be to maintain the status 
quo. That is, we could maintain the basic rule under Sec.  410.32(b)(1) 
that allows only physicians as defined under Medicare law to supervise 
the performance of diagnostic tests. In that case, the pool of 
practitioners who could supervise diagnostic tests would remain at 
current levels and certain NPPs would be limited under Medicare from 
practicing to the full extent allowed by their state license and scope 
of practice. However, this alternative would fail to address the 
mandates established in E.O. 13890.
    With regard to the provision to allow a PTA/OTA to furnish 
maintenance therapy services, an alternative would be maintaining the 
status quo to require the PT/OT to personally furnish all maintenance 
therapy services. However, this alternative would not address the 
mandates established in E.O. 13890. It would also be inconsistent with 
our policy in SNF and home health settings when payment for therapy is 
made under Part A, maintenance therapy can be furnished by a PT/OT or 
delegated to be performed by a PTA/OTA.
4. Alternatives Considered for Refinements to Values for Certain 
Services To Reflect Revisions to Payment for Office/Outpatient 
Evaluation and Management (E/M) Visits and Promote Payment Stability 
During the PHE for COVID-19
    As we noted in section II.F. of this final rule, we sought comment 
on how we might refine the utilization assumptions for HCPCS add on 
code G2211. In the proposed rule, we assumed that HCPCS add-on code 
G2211 would be reported with all office/outpatient visits for the 
specialties listed in the following public use file at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/CY2020-PFS-FR-EM-Add-on-Code.zip.

[[Page 85024]]

    As we discussed in section II.F. of this final rule, we considered 
alternative assumptions regarding utilization for HCPCS add-on code 
G2211. Several commenters suggested that CMS reduce its utilization 
assumptions to between 10 percent and 25 percent of reported office/
outpatient E/M visits and could range as high as 25 percent of reported 
office/outpatient E/M visits. These commenters cited that it would take 
time for medical societies to educate their members about appropriate 
use, ongoing implementation of the office/outpatient E/M visit codes, 
electronic health records integration, and the persistence of the 
COVID-19 pandemic in many parts of the country. Thus, one alternative 
was to assume that HCPCS add-on code G2211 would be reported for 25 
percent of office/outpatient E/M visits listed in the public use file. 
As we noted in section II.F. of this final rule, while we generally 
agree with commenters that practitioners will not report HCPCS add-on 
code G2211 with every visit, we disagree that it will be as low as 25 
percent of all reported visits.
    We also considered an alternative where these specialties would 
report HCPCS add-on code G2211 with their office/outpatient E/M visits 
90 percent of the time. As we noted in section II.F. of this final 
rule, because we are not implementing any additional policies that 
restrict the billing of this code, we are assuming that utilization 
will be 90 percent of office/outpatient E/M visits for these 
specialties.

J. Impact on Beneficiaries

    We do not believe these provisions will have a negative impact on 
beneficiaries given overall PFS budget neutrality.
1. Medicare Diabetes Prevention Program Expanded Model Emergency Policy
    This change would have a positive impact on affected MDPP 
beneficiaries, as it would allow them to maintain eligibility for the 
program, and request virtual sessions if needed for successful 
completion of attendance and weight loss milestones. It would also 
allow them to start set of MDPP services virtually, allowing remote 
digital technology to capture body weight measurement or self-reported 
weight measurements from a participant's personal home digital scale. 
Finally, if continuing with set of MDPP services is not an option for 
beneficiaries during the PHE for COVID-19, the Emergency Policy allows 
beneficiaries to restart their set of MDPP services, maximizing 
beneficiary options and access to MDPP both during the PHE for COVID-19 
and after it ends.
2. 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 PFS, would 
have a positive impact and improve the quality and value of care 
provided to Medicare beneficiaries. For example, several of the new 
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.

K. 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 assumed that the total number of unique 
commenters on this year's proposed 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 this 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 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 recognized 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 $110.74 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 
for the staff to review half of this rule. For each facility that 
reviews the rule, the estimated cost is $885.92 (8.0 hours x $110.74). 
Therefore, we estimated that the total cost of reviewing this 
regulation is $35,637,904 ($885.92 x 40,227 reviewers on this year's 
proposed rule).

L. Accounting Statement

    As required by OMB Circular A-4 (available at http://www.whitehouse.gov/omb/circulars/a004/a-4.pdf), in Tables 111 and 112 
(Accounting Statements), we have prepared an accounting statement. This 
estimate includes growth in incurred benefits from CY 2020 to CY 2021 
based on the FY 2021 President's Budget baseline.
[GRAPHIC] [TIFF OMITTED] TR28DE20.161


[[Page 85025]]


[GRAPHIC] [TIFF OMITTED] TR28DE20.162

M. Conclusion

    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 an RIA. 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 400

    Grant programs-health, Health facilities, Health maintenance 
organizations (HMO), Medicaid, Medicare, Reporting and recordkeeping 
requirements.

42 CFR Part 410

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

42 CFR Part 414

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

42 CFR Part 415

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

42 CFR Part 423

    Administrative practice and procedure, Emergency medical services, 
Health facilities, Health maintenance organizations (HMO), Health 
professionals, Medicare, Penalties, Privacy, Reporting and 
recordkeeping requirements.

42 CFR Part 424

    Emergency medical services, Health facilities, Health professions, 
Medicare, Reporting and recordkeeping requirements.

42 CFR Part 425

    Administrative practice and procedure, Health facilities, Health 
professions, Medicare, Reporting and recordkeeping requirements.

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

PART 400--INTRODUCTION; DEFINITIONS

0
1. The authority citation for part 400 continues to read as follows:

    Authority:  42 U.S.C. 1302 and 1395hh, and 44 U.S.C. Chapter 35.


0
2. Section 400.200 is amended by revising the definition of ``Public 
Health Emergency'' to read as follows:


Sec.  400.200  General definitions.

* * * * *
    Public Health Emergency (PHE) means the Public Health Emergency 
determined to exist nationwide as of January 27, 2020, by the Secretary 
pursuant to section 319 of the Public Health Service Act on January 31, 
2020, as a result of confirmed cases of COVID-19, including any 
subsequent renewals.
* * * * *

PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS

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

    Authority:  42 U.S.C. 1302, 1395m, 1395hh, 1395rr, and 1395ddd.


0
4. Section 410.15 is amended in paragraph (a)--
0
a. By adding a definition for ``A review of any current opioid 
prescriptions'' in alphabetical order;
0
b. In the definition of ``First annual wellness visit providing 
personalized prevention plan services'' by revising paragraph (xi) and 
adding paragraphs (xii) and (xiii);
0
c. In the definition of ``Subsequent annual wellness visit providing 
personalized prevention plan services'' by revising paragraph (ix) and 
adding paragraphs (x) and (xi).
    The additions and revisions read as follows:


Sec.  410.15  Annual wellness visits providing Personalized Prevention 
Plan Services: Conditions for and limitations on coverage.

    (a) * * *
    A review of any current opioid prescriptions means, with respect to 
the individual determined to have a current prescription for opioids, 
all of the following:
    (i) A review of the potential risk factors to the individual for 
opioid use disorder;
    (ii) An evaluation of the individual's severity of pain and current 
treatment plan;
    (iii) The provision of information on non-opioid treatment options; 
and
    (iv) A referral to a specialist, as appropriate.
* * * * *
    First annual wellness visit providing personalized prevention plan 
services * * *
    (xi) Furnishing of a review of any current opioid prescriptions as 
that term is defined in this section.
    (xii) Screening for potential substance use disorders including a 
review of the individual's potential risk factors for substance use 
disorder and referral for treatment as appropriate.
    (xiii) Any other element determined appropriate through the 
national coverage determination process.
* * * * *
    Subsequent annual wellness visit providing personalized prevention 
plan services * * *
    (ix) Furnishing of a review of any current opioid prescriptions as 
that term is defined in this section.
    (x) Screening for potential substance use disorders including a 
review of the individual's potential risk factors for substance use 
disorder and referral for treatment as appropriate.
    (xi) Any other element determined appropriate through the national 
coverage determination process.
* * * * *

0
5. Section 410.16 is amended in paragraph (a)--
0
a. By adding the definition for ``A review of any current opioid 
prescriptions'' in alphabetical order;

[[Page 85026]]

0
b. In the definition of ``Initial preventive physical examination'' by 
revising paragraphs (6) and (7) and adding paragraphs (8) and (9).
    The additions and revisions read as follows:


Sec.  410.16  Initial preventive physical examination: Conditions for 
and limitations on coverage.

    (a) * * *
    A review of any current opioid prescriptions means, with respect to 
the individual determined to have a current prescription for opioids, 
all of the following:
    (i) A review of the potential risk factors to the individual for 
opioid use disorder;
    (ii) An evaluation of the individual's severity of pain and current 
treatment plan;
    (iii) The provision of information on non-opioid treatment options; 
and
    (iv) A referral to a specialist, as appropriate.
* * * * *
    Initial preventive physical examination * * *
    (6) A review of any current opioid prescriptions as defined in this 
section.
    (7) Screening for potential substance use disorders to include a 
review of the individual's potential risk factors for substance use 
disorder and referral for treatment as appropriate.
    (8) Education, counseling, and referral, as deemed appropriate by 
the physician or qualified nonphysician practitioner, based on the 
results of the review and evaluation services described in this 
section.
    (9) Education, counseling, and referral, including a brief written 
plan such as a checklist provided to the individual for obtaining an 
electrocardiogram, as appropriate, and the appropriate screening and 
other preventive services that are covered as separate Medicare Part B 
benefits as described in sections 1861(s)(10), (jj), (nn), (oo), (pp), 
(qq)(1), (rr), (uu), (vv), (xx)(1), (yy), (bbb), and (ddd) of the Act.
* * * * *

0
6. Section 410.32 is amended by--
0
a. Revising paragraphs (b)(1) and (b)(2)(iii)(B);
0
b. Adding paragraph (b)(2)(ix); and
0
c. Revising paragraph (b)(3)(ii).
    The revisions and addition read as follows:


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

* * * * *
    (b) * * *
    (1) Basic rule. Except as indicated in paragraph (b)(2) of this 
section, 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 the appropriate level of supervision 
by a physician as defined in section 1861(r) of the Act or, to the 
extent that they are authorized to do so under their scope of practice 
and applicable State law, by a nurse practitioner, clinical nurse 
specialist, physician assistant, certified registered nurse 
anesthetist, or a certified nurse-midwife. Services furnished without 
the required level of supervision are not reasonable and necessary (see 
Sec.  411.15(k)(1) of this chapter).
    (2) * * *
    (iii) * * *
    (B) Furnished under the general supervision of a physician or 
clinical psychologist; or under the general supervision of a nurse 
practitioner, clinical nurse specialist, physician assistant, certified 
registered nurse anesthetist or certified nurse-midwife, to the extent 
they are authorized to perform the tests under their scope of practice 
and applicable State laws.
* * * * *
    (ix) Diagnostic tests performed by a physician assistant authorized 
to perform the tests under their scope of practice and applicable State 
laws.
    (3) * * *
    (ii) Direct supervision in the office setting means the physician 
(or other supervising practitioner) must be present in the office suite 
and immediately available to furnish assistance and direction 
throughout the performance of the procedure. It does not mean that the 
physician (or other supervising practitioner) must be present in the 
room when the procedure is performed. Until the later of the end of the 
calendar year in which the PHE as defined in Sec.  400.200 of this 
chapter ends or, December 31, 2021, the presence of the physician (or 
other practitioner) includes virtual presence through audio/video real-
time communications technology (excluding audio-only).
* * * * *

0
7. Section 410.67 is amended--
0
a. In paragraph (b), by revising paragraph (7) and adding paragraph (8) 
in the definition of ``Opioid use disorder treatment service'';
0
b. By revising paragraph (d)(2)(i)(A); and
0
c. By adding paragraph (d)(4)(i)(E).
    The additions and revision read as follows:


Sec.  410.67  Medicare coverage and payment of Opioid use disorder 
treatment services furnished by Opioid treatment programs.

* * * * *
    (b) * * *
    Opioid use disorder treatment service * * *
    (7) Periodic assessment services required under Sec.  8.12(f)(4) of 
this title, that are furnished during a face-to-face encounter, 
including services furnished via two-way interactive audio-video 
communication technology, as clinically appropriate, and in compliance 
with all applicable requirements. During the Public Health Emergency, 
as defined in Sec.  400.200 of this chapter, in cases where a 
beneficiary does not have access to two-way audio-video communications 
technology, periodic assessments can be furnished using audio-only 
telephone calls if all other applicable requirements are met.
    (8) Opioid antagonist medications that are approved by the Food and 
Drug Administration under section 505 of the Federal Food, Drug, and 
Cosmetic Act for the emergency treatment of known or suspected opioid 
overdose and overdose education furnished in conjunction with opioid 
antagonist medication.
* * * * *
    (d) * * *
    (2) * * *
    (i) * * *
    (A) Implantable and injectable medications. For implantable and 
injectable medications, the payment is determined using the methodology 
set forth in section 1847A of the Act, except that the payment amount 
must be 100 percent of the ASP, if ASP is used; and the payment must be 
100 percent of the wholesale acquisition cost (WAC), if WAC is used.
* * * * *
    (4) * * *
    (i) * * *
    (E) Take-home supply of opioid antagonist medications that are 
approved by the Food and Drug Administration under section 505 of the 
Federal, Food, Drug and Cosmetic Act for the emergency treatment of 
known or suspected opioid overdose and overdose education furnished in 
conjunction with opioid antagonist medication, an adjustment will be 
made when these medications are dispensed. This adjustment will be 
limited to once every 30 days, except when a further take home supply 
of these medications is medically reasonable and necessary. The opioid 
treatment program must document in the medical record the reason(s) for 
the exception. The amount of the drug component of the

[[Page 85027]]

adjustment will be determined using the methodology in paragraph 
(d)(2)(i) of this section. The amount of the non-drug component of the 
adjustment will be determined based on the CY 2020 Medicare payment 
rate for CPT code 96161.
* * * * *

0
8. Section 410.78 is amended by revising paragraph (a)(3) and (f) to 
read as follows:


Sec.  410.78  Telehealth services.

    (a) * * *
    (3) Interactive telecommunications system means multimedia 
communications equipment that includes, at a minimum, audio and video 
equipment permitting two-way, real-time interactive communication 
between the patient and distant site physician or practitioner.
* * * * *
    (f) Process for adding or deleting services. Except as otherwise 
provided in this paragraph (f), changes to the list of Medicare 
telehealth services are made through the annual physician fee schedule 
rulemaking process. During the Public Health Emergency, as defined in 
Sec.  400.200 of this chapter, we will use a subregulatory process to 
modify the services included on the Medicare telehealth list during the 
Public Health Emergency, taking into consideration infection control, 
patient safety, and other public health concerns resulting from the 
emergency. CMS maintains the list of services that are Medicare 
telehealth services under this section, including the current HCPCS 
codes that describe the services on the CMS website.

0
9. Section 410.79 is amended by revising paragraphs (c)(3)(i) and (ii) 
and (e) to read as follows:


Sec.  410.79  Medicare Diabetes Prevention Program expanded model: 
Conditions of coverage.

* * * * *
    (c) * * *
    (3) * * *
    (i) Except as set forth in paragraph (c)(3)(ii) of this section--
    (A) The MDPP services period ends upon completion of the core 
services period described in paragraph (c)(2)(i) of this section, 
unless the MDPP beneficiary qualifies for the first ongoing maintenance 
session interval, in accordance with paragraph (c)(1)(ii) of this 
section.
    (B) If the MDPP beneficiary qualifies for the first ongoing 
maintenance session interval as described in paragraph (c)(1)(ii) of 
this section, the MDPP services period ends upon completion of that 
maintenance session interval, unless the MDPP beneficiary qualifies for 
a subsequent ongoing maintenance session interval, in accordance with 
paragraph (c)(1)(iii) of this section, in which case the MDPP service 
period ends upon completion of the last ongoing maintenance session 
interval for which the beneficiary qualified.
    (ii) In the case of an applicable 1135 waiver event as defined in 
paragraph (e) of this section, the MDPP services period may be 
suspended and resumed or restarted in accordance with paragraph (e) of 
this section.
* * * * *
    (e) MDPP expanded model emergency policy. (1) Notwithstanding 
paragraphs (a) through (d) of this section, the policies described in 
this paragraph (e) apply during the Public Health Emergency (PHE) as 
defined in Sec.  400.200 of this chapter and during any future 1135 
waiver event that CMS determines may disrupts in-person MDPP services 
(an ``applicable 1135 waiver event''). For purposes of this paragraph 
(e), ``1135 waiver event'' means an emergency period and emergency 
area, as such terms are defined in section 1135(g) of the Act, for 
which the Secretary has authorized one or more waivers under section 
1135 of the Act.
    (2)(i) CMS determines that an 1135 waiver event may disrupt in-
person MDPP services if MDPP suppliers would likely be unable to 
conduct classes in-person, or MDPP beneficiaries would likely be unable 
to attend in-person classes, for reasons related to health, safety, or 
site availability or suitability. Health and safety reasons may 
include, but are not limited to, the avoidance of transmission of 
contagious diseases, compliance with laws and regulations during an 
1135 waiver event, or the physical safety of MDPP beneficiaries and 
MDPP coaches, as defined in Sec.  424.205(a) of this chapter, during an 
1135 waiver event.
    (ii) If CMS determines that an 1135 waiver event may disrupt in-
person MDPP services, CMS will communicate such determination for 
purposes of the policies described in this paragraph (e), to all 
affected MDPP suppliers.
    (3) The following changes apply under this paragraph (e), when CMS 
has determined that an 1135 waiver event may disrupt in-person MDPP 
services:
    (i) The in-person attendance requirements of paragraphs 
(c)(1)(ii)(A) and (c)(1)(iii)(A) of this section do not apply.
    (ii) MDPP suppliers may start new cohorts during the PHE as defined 
in Sec.  400.200 of this chapter or an applicable 1135 waiver event 
only if a baseline weight measurement can be obtained as described in 
paragraph (e)(3)(iii) of this section.
    (iii) MDPP suppliers can obtain weight measurements for MDPP 
beneficiaries for the baseline weight and any weight loss based 
performance achievement goals in the following manner:
    (A) In-person, when the weight measurement can be obtained safely 
and in compliance with all applicable laws and regulations;
    (B) Via digital technology, such as scales that transmit weights 
securely via wireless or cellular transmission; or
    (C) Self-reported weight measurements from the at-home digital 
scale of the MDPP beneficiary. Self-reported weights must be obtained 
during live, synchronous online video technology, such as video 
chatting or video conferencing, wherein the MDPP coach observes the 
beneficiary weighing themselves and views the weight indicated on the 
at-home digital scale, a date-stamped photo or video recording of the 
beneficiary's weight with the beneficiary visible on the scale, or a 
recording of the beneficiary's weight, with the beneficiary visible on 
the scale, submitted by the MDPP beneficiary to the MDPP supplier. The 
photo or video must clearly document the weight of the MDPP beneficiary 
as it appears on his/her digital scale on the date associated with the 
billable MDPP session.
    (iv) The virtual session limits described in paragraphs (d)(2) and 
(d)(3)(i) and (ii) of this section do not apply, and MDPP suppliers may 
provide all MDPP sessions virtually during the PHE as defined in Sec.  
400.200 of this chapter or applicable 1135 waiver event. If the 
beneficiary began the MDPP services period virtually, or changed from 
in-person to virtual services during the PHE as defined in Sec.  
400.200 of this chapter or applicable 1135 waiver event, he/she may 
continue to receive the MDPP set of services virtually even after the 
PHE or 1135 waiver event has concluded, until the end of the 
beneficiary's MDPP services period, so long as the provision of virtual 
services complies with all of the following requirements:
    (A) The curriculum furnished during the virtual session addresses 
the same CDC-approved DPP curriculum topic as the regularly scheduled 
session.
    (B) The MDPP supplier furnishes to the MDPP beneficiary a maximum 
of one virtual make-up session on the same day as a regularly scheduled 
session.

[[Page 85028]]

    (C) The MDPP supplier furnishes to the MDPP beneficiary a maximum 
of one virtual make-up session per week.
    (D) Virtual sessions are furnished in a manner consistent with the 
DPRP standards for virtual sessions.
    (E) The MDPP supplier offers virtual sessions only upon an 
individual MDPP beneficiary's request or agreement to receive services 
virtually.
    (F) The MDPP supplier offers to an MDPP beneficiary:
    (1) No more than 16 virtual sessions offered weekly during the core 
session period, months 1 through 6 of the MDPP services period;
    (2) No more than 6 virtual sessions offered monthly during the core 
maintenance session interval periods, months 7 through 12 of the MDPP 
services period; and
    (3) No more than 12 virtual sessions offered monthly during the 
ongoing maintenance session intervals, months 13 through 24.
    (v) MDPP suppliers may suspend the in-person delivery of the set of 
MDPP services, when necessary due to the applicable 1135 waiver event, 
and subsequently resume in-person services either upon the end date of 
the 1135 waiver event emergency period or an effective date specified 
by CMS. Upon resumption of the set of MDPP services on an in-person 
basis, the following paragraphs apply:
    (A) Beneficiaries who were receiving MDPP services as of March 31, 
2020 whose in-person sessions are suspended due to the PHE as defined 
in Sec.  400.200 of this chapter may elect to restart the set of MDPP 
services at the beginning or resume with the most recent attendance 
session of record.
    (B) Beneficiaries who begin the set of MDPP services on or after 
January 1, 2021 who are in the first 12 months of the set of MDPP 
services as of the start of an applicable 1135 waiver event, whose in-
person sessions are suspended due to the applicable 1135 waiver event, 
and who elect not to continue with MDPP services virtually, may elect 
to restart the set of MDPP services at the beginning or may resume with 
the most recent attendance session of record.
    (C) Beneficiaries who began the set of MDPP services on or after 
January 1, 2021 who are in the second year of the set of MDPP services 
as of the start of an applicable 1135 waiver event, whose in-person 
sessions are suspended due to the applicable 1135 waiver event, and who 
elect not to continue with MDPP services virtually, may restart the 
ongoing maintenance session interval in which they were participating 
at the start of the applicable 1135 waiver event or may resume with the 
most recent attendance session of record.
    (D) Beneficiaries whose in-person sessions are suspended due to the 
applicable 1135 waiver event who elect to continue with MDPP services 
virtually, as described in paragraph (e)(2)(i) of this section, are not 
eligible to restart the set of MDPP services at a later date, but may 
elect to suspend the virtual set of MDPP services and resume the set of 
in-person MDPP services with the most recent attendance session of 
record.
    (E) Beneficiaries may make an election as described in paragraph 
(e)(3)(v)(A), (B), (C), or (D) of this section, as applicable, only one 
time per applicable1135 waiver event.
    (F) Beneficiary eligibility, as described in paragraph (c)(1)(i) of 
this section, will not be impacted by any changes to the beneficiary's 
body mass index (BMI) or reduction in hemoglobin A1c, fasting plasma 
glucose, or 2-hour plasma glucose test values achieved during the set 
of MDPP services or any intervening time in which a beneficiary has 
suspended the set of MDPP services. MDPP suppliers will utilize the 
following weight measurements as the baseline weight for purposes of 
determining all weight-loss achievements:
    (1) For an MDPP beneficiary who began receiving the set of MDPP 
services before March 31, 2020, has suspended services during an 
applicable 1135 waiver event, and then elects to restart the set of 
MDPP services at the first core session, the MDPP supplier must record 
a new baseline weight on the date of first core session that restarts 
the set of MDPP services.
    (2) For an MDPP beneficiary who began receiving the set of MDPP 
services on or after January 1, 2021, has suspended services during an 
applicable 1135 waiver event, and then resumes the set of MDPP services 
either at the most recent attendance session of record or restarts the 
ongoing maintenance session interval in which they were participating 
at the start of the applicable 1135 waiver event, the MDPP supplier 
must use the baseline weight recorded at the beneficiary's first core 
session.
    (vi) The minimum weight loss requirements for beneficiary 
eligibility in the ongoing maintenance session intervals described in 
paragraphs (c)(1)(ii)(B) and (c)(1)(iii)(B) of this section are waived 
only for MDPP beneficiaries who were receiving the MDPP set of services 
prior to January 1, 2021.

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

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

    Authority: 42 U.S.C. 1302, 1395hh, and 1395rr(b)(l).


0
11. Section 414.502 is amended by revising the definitions of ``Data 
collection period'' and ``Data reporting period'' to read as follows:


Sec.  414.502  Definitions.

* * * * *
    Data collection period is the 6 months from January 1 through June 
30 during which applicable information is collected and that precedes 
the data reporting period, except that for the data reporting period of 
January 1, 2022 through March 31, 2022, the data collection period is 
January 1, 2019 through June 30, 2019.
    Data reporting period is the 3-month period, January 1 through 
March 31, during which a reporting entity reports applicable 
information to CMS and that follows the preceding data collection 
period, except that for the data collection period of January 1, 2019 
through June 30, 2019, the data reporting period is January 1, 2022 
through March 31, 2022.
* * * * *

0
12. Section 414.504 is amended by revising paragraph (a)(1) to read as 
follows:


Sec.  414.504  Data reporting requirements.

    (a) * * *
    (1) For CDLTs that are not ADLTs, initially January 1, 2017 and 
every 3 years beginning January 1, 2022.
* * * * *

0
13. Section 414.507 is amended by revising paragraphs (d) introductory 
text and (d)(4) and adding paragraph (d)(7) to read as follows:


Sec.  414.507  Payment for clinical diagnostic laboratory tests.

* * * * *
    (d) Phase-in of payment reductions. For years 2018 through 2024, 
the payment rates established under this section for each CDLT that is 
not a new ADLT or new CDLT, may not be reduced by more than the 
following amounts for--
* * * * *
    (4) 2021--0.0 percent of the payment rate established in 2020.
* * * * *
    (7) 2024--15 percent of the payment rate established in 2023.
* * * * *

[[Page 85029]]


0
14. Section 414.1305 is amended--
0
a. By revising the definition of ``Attestation'';
0
b. In the definition of ``Certified Electronic Health Record Technology 
(CEHRT)'' by revising paragraphs (1)(ii)(D) and (2)(ii) introductory 
text;
0
c. By revising the definition of ``Collection type'';
0
d. By removing the definition of ``Full TIN APM'';
0
e. By revising the definitions of ``Low-volume threshold'', 
``Meaningful EHR user for MIPS'', and ``MIPS APM'';
0
f. By adding definition for ``Physician Compare'' in alphabetical 
order; and
0
g. By revising the definitions of ``Primary care services'', 
``Submission type'', and ``Submitter type''.
    The revisions and addition read as follows:


Sec.  414.1305  Definitions.

* * * * *
    Attestation means a secure mechanism, specified by CMS, with 
respect to a particular performance period, whereby a MIPS eligible 
clinician or group may submit the required data for the Promoting 
Interoperability or the improvement activities performance categories 
of MIPS in a manner specified by CMS.
* * * * *
    Certified Electronic Health Record Technology (CEHRT) * * *
    (1) * * *
    (ii) * * *
    (D) The certification criteria that are necessary to report on 
applicable objectives and measures specified for the MIPS Promoting 
Interoperability performance category, including the applicable measure 
calculation certification criterion at 45 CFR 170.314(g)(1) or (2) or 
45 CFR 170.315(g)(1) or (2) for all certification criteria that support 
an objective with a percentage-based measure.
* * * * *
    (2) * * *
    (ii) Necessary to report on applicable objectives and measures 
specified for the MIPS Promoting Interoperability performance category 
including the following:
* * * * *
    Collection type means a set of quality measures with comparable 
specifications and data completeness criteria, as applicable, 
including, but not limited to: Electronic clinical quality measures 
(eCQMs); MIPS Clinical Quality Measures (MIPS CQMs); QCDR measures; 
Medicare Part B claims measures; for the 2019 through 2023 MIPS payment 
years, CMS Web Interface measures; the CAHPS for MIPS survey; and 
administrative claims measures.
* * * * *
    Low-volume threshold means:
    (1) For the 2019 MIPS payment year, the low-volume threshold that 
applies to an individual eligible clinician, group, or APM Entity 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, group, or APM Entity 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) For the 2021 and 2022 MIPS payment years, the low-volume 
threshold that applies to an individual eligible clinician, group, or 
APM Entity 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, group, or APM Entity 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.
    (5) Beginning with the 2023 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.
    Meaningful EHR user for MIPS means a MIPS eligible clinician who 
possesses CEHRT, uses the functionality of CEHRT, and reports on 
applicable objectives and measures specified for the Promoting 
Interoperability performance category for a performance period in the 
form and manner specified by CMS, supports information exchange and the 
prevention of health information blocking, and engages in activities 
related to supporting providers with the performance of CEHRT.
* * * * *
    MIPS APM means:
    (1) For the 2019 through 2022 MIPS payment years, an APM that meets 
the criteria specified under Sec.  414.1370(b).
    (2) Beginning with the 2023 MIPS payment year, an APM that meets 
the criteria as set forth in Sec.  414.1367(b).
* * * * *
    Physician Compare means the Physician Compare internet website of 
the Centers for Medicare & Medicaid Services (or a successor website).
    Primary care services for purposes of CMS Web Interface and CAHPS 
for MIPS survey beneficiary assignment means the set of services 
identified by the following:
    (1) CPT codes:
    (i) 99201 through 99215 (codes for office or other outpatient visit 
for the evaluation and management of a patient); 99304 through 99318 
(codes for professional services furnished in a nursing facility, 
excluding professional services furnished in a SNF for claims 
identified by place of service (POS) modifier 31); 99319 through 99340 
(codes for patient domiciliary, rest home, or custodial care visit); 
99341 through 99350 (codes for evaluation and management services 
furnished in a patient's home for claims identified by POS modifier 
12); 99487, 99489, and 99490 (codes for chronic care management); and 
99495 and 99496 (codes for transitional care management services); and
    (ii) Beginning with the 2023 MIPS payment year, 99421, 99422, and 
99423 (codes for online digital evaluation and management services (e-
visit)); 99441,

[[Page 85030]]

99442, and 99443 (codes for telephone evaluation and management 
services); and 96160 and 96161 (codes for administration of health risk 
assessment).
    (2) HCPCS codes:
    (i) G0402 (code for the Welcome to Medicare visit); and G0438 and 
G0439 (codes for the annual wellness visits); and
    (ii) Beginning with the 2023 MIPS payment year, G2010 (code for 
remote evaluation of patient video/images); and G2012 (code for virtual 
check-in).
* * * * *
    Submission type means the mechanism by which the submitter type 
submits data to CMS, including, but not limited to:
    (1) Direct;
    (2) Log in and upload;
    (3) Log in and attest;
    (4) Medicare Part B claims; and
    (5) For the 2019 through 2023 MIPS payment years, the CMS Web 
Interface.
    Submitter type means the MIPS eligible clinician, group, Virtual 
Group, APM Entity, or third party intermediary acting on behalf of a 
MIPS eligible clinician, group, Virtual Group, or APM Entity, as 
applicable, that submits data on measures and activities under MIPS.
* * * * *

0
15. Section 414.1310 is amended by revising paragraphs (b)(1)(iii) and 
(e)(1) to read as follows:


Sec.  414.1310  Applicability.

* * * * *
    (b) * * *
    (1) * * *
    (iii) Does not exceed the low volume threshold.
    (A) Beginning with the 2021 MIPS payment year, if an individual 
eligible clinician or group 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 or group is 
treated as a MIPS eligible clinician for the applicable MIPS payment 
year. For such solo practitioners and groups that elect to participate 
in MIPS as a virtual group (except for APM Entity groups in MIPS APMs), 
the virtual group election under Sec.  414.1315 constitutes an election 
under this paragraph (b)(1)(iii)(A) and results in the solo 
practitioners and groups being treated as MIPS eligible clinicians for 
the applicable MIPS payment year.
    (B) For the 2021 and 2022 MIPS payment years, if an 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 APM Entity group is treated as a MIPS eligible 
clinician for the applicable MIPS payment year. For such 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 MIPS payment year.
* * * * *
    (e) * * *
    (1) Except as provided under Sec. Sec.  414.1317(b) and 
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.
* * * * *

0
16. Section 414.1317 is added to read as follows:


Sec.  414.1317  APM Entity groups.

    (a) APM entity group determination. The APM Entity group will be 
determined according to the requirements set forth in Sec.  
414.1425(b)(1).
    (1) In addition to the dates set forth in Sec.  414.1425(b)(1), for 
purposes of MIPS, the APM Entity group includes an eligible clinician 
who is on a Participation List on December 31 of the MIPS performance 
period.
    (2) For purposes of MIPS scoring, the APM Entity group will be 
comprised only of those eligible clinicians within the APM Entity group 
who are determined to be MIPS eligible at the individual or group 
level.
    (3) For purposes of calculating the APM Entity group score, MIPS 
scores submitted by virtual groups will not be included.
    (b) APM Entity group scoring. The MIPS final score calculated for 
the APM Entity is applied to each MIPS eligible clinician in the APM 
Entity group. The MIPS payment adjustment is applied at the TIN/NPI 
level for each of the MIPS eligible clinicians in the APM Entity group.
    (1) Determination of performance category score for each MIPS 
eligible clinician in an APM Entity. For APM Entities, where a 
performance category is not reported by the APM Entity, CMS uses one 
score for each MIPS eligible clinician in an APM Entity group to derive 
a single average APM Entity score for the performance category. The 
applicable score for each MIPS eligible clinician is the higher of 
either:
    (i) A group score based on the measure data for the performance 
category reported by a TIN for the MIPS eligible clinician according to 
MIPS submission and reporting requirements for groups.
    (ii) An individual score based on the measure data for the 
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 in an APM Entity 
receives an exception from the reporting requirements, such eligible 
clinician will be assigned a null score when CMS calculates the APM 
Entity's performance category score.
    (2) Cost scoring for APM Entity groups. The cost performance 
category weight is zero percent for APM Entities in MIPS APMs.
    (3) Improvement scoring for APM Entity groups. For an APM Entity 
for which CMS calculated a total performance category score for one or 
more participants in the APM Entity for the preceding MIPS performance 
period, CMS calculates an improvement score for each performance 
category for which a previous year's total performance category score 
is available as specified in Sec.  414.1380(b).
    (4) Extreme and uncontrollable circumstances. Beginning with the 
2022 MIPS payment year, an APM Entity may submit to CMS an application 
described at Sec.  414.1380(c)(2)(i)(A)(6) and (c)(2)(i)(C)(2) 
requesting reweighting of all four MIPS performance categories and for 
all MIPS eligible clinicians in the APM Entity group, based on extreme 
and uncontrollable circumstances.
    (i) An APM Entity must demonstrate in its application to CMS that 
greater than 75 percent of its participant MIPS eligible clinicians 
would be eligible for reweighting the Promoting Interoperability 
performance category for the applicable performance period.
    (ii) If CMS approves the request for reweighting based on an APM 
Entity's application, and if MIPS data are submitted for the APM Entity 
for the applicable performance period, all four of the MIPS performance 
categories will be reweighted for the APM Entity group notwithstanding 
the data submission.

0
17. Section 414.1320 is amended by revising paragraphs (d) introductory 
text and (d)(1) and adding paragraph (g) to read as follows:


Sec.  414.1320  MIPS performance period.

* * * * *
    (d) Beginning with the 2023 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, except as otherwise specified for 
administrative claims-

[[Page 85031]]

based measures in the MIPS final list of quality measures described in 
Sec.  414.1330(a)(1).
* * * * *
    (g) For purposes of the 2024 MIPS payment year and each subsequent 
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
18. Section 414.1325 is amended by revising paragraph (c)(1) to read as 
follows:


Sec.  414.1325  Data submission requirements.

* * * * *
    (c) * * *
    (1) For the quality performance category, the direct; login and 
upload; Medicare Part B claims (beginning with the 2021 MIPS payment 
year, for small practices only); and for the 2019 through 2023 MIPS 
payment years, 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.
* * * * *

0
19. Section 414.1330 is amended by adding paragraphs (b)(4) and (5) to 
read as follows:


Sec.  414.1330  Quality performance category.

* * * * *
    (b) * * *
    (4) 40 percent of a MIPS eligible clinician's final score for the 
MIPS payment year 2023.
    (5) 30 percent of a MIPS eligible clinician's final score for the 
MIPS payment year 2024 and future years.

0
20. Section 414.1350 is amended by adding paragraphs (d)(4) and (5) to 
read as follows:


Sec.  414.1350  Cost performance category.

* * * * *
    (d) * * *
    (4) 20 percent of the MIPS final score for MIPS payment year 2023.
    (5) 30 percent of the MIPS final score for MIPS payment year 2024 
and each subsequent MIPS payment year.

0
21. Section 414.1367 is added to read as follows:


Sec.  414.1367  APM performance pathway.

    (a) General. Beginning with the 2023 MIPS payment year, the APM 
Performance Pathway is a MIPS scoring methodology available to MIPS 
eligible clinicians identified on the Participation List or Affiliated 
Practitioner List of an APM Entity participating in a MIPS APM.
    (b) Criteria for MIPS APMs. MIPS APMs are those in which:
    (1) APM Entities participate in the APM under an agreement with CMS 
or through a law or regulation; and
    (2) The APM bases payment on quality measures and cost/utilization.
    (c) MIPS performance category scoring in the APM Performance 
Pathway--(1) Quality. Except as provided in paragraphs (c)(1)(i) and 
(ii) of this section, the quality performance category score is 
calculated for a MIPS eligible clinician, group, or APM Entity group in 
accordance with Sec.  414.1380(b)(1) based on the APM Performance 
Pathway quality measure set established by CMS through rulemaking for a 
MIPS payment year.
    (i) Each submitted measure that does not have a benchmark or meet 
the case minimum requirement is excluded from the MIPS eligible 
clinician, group, or APM Entity group's total measure achievement 
points and total available measure achievement points.
    (ii) Any measure that is identified as topped out is not subject to 
the scoring cap described at Sec.  414.1380(b)(1)(iv).
    (2) Cost. The cost performance category weight is zero percent for 
MIPS eligible clinicians who are scored through the APM Performance 
Pathway.
    (3) Improvement activities. The improvement activities performance 
category score is calculated for a MIPS eligible clinician, group, or 
APM Entity group in accordance with Sec.  414.1380(b)(3) based on the 
activities required by the MIPS APM that are included in the MIPS final 
inventory of improvement activities described in Sec.  414.1355(a) 
(excluding any such activities that the MIPS eligible clinician, group, 
or APM Entity group does not perform). MIPS eligible clinicians, 
groups, or APM Entities may report additional improvement activities in 
accordance with Sec.  414.1360.
    (4) Promoting interoperability. The promoting interoperability 
performance category will be scored for the MIPS eligible clinician, 
group, or APM Entity as described in Sec.  414.1375.
    (d) APM Performance Pathway performance category weights--(1) 
Performance category weights. Subject to paragraph (d)(2) of this 
section, the performance category weights used to calculate the final 
score for a MIPS eligible clinician, group, or APM Entity reporting 
through the APM performance Pathway are:
    (i) Quality: 50 percent.
    (ii) Cost: 0 percent.
    (iii) Improvement Activities: 20 percent.
    (iv) Promoting Interoperability: 30 percent.
    (2) Reweighting MIPS performance categories. If CMS determines, in 
accordance with Sec.  414.1380(c)(2), that a different scoring weight 
should be assigned to the quality or promoting interoperability 
performance category, CMS will redistribute the performance category 
weights as follows:
    (i) If CMS reweights the quality performance category to 0 percent: 
Promoting Interoperability performance category is reweighted to 75 
percent, and Improvement Activities performance category is reweighted 
to 25 percent.
    (ii) If CMS reweights the Promoting Interoperability performance 
category to 0 percent: Quality performance category is reweighted to 75 
percent, and Improvement Activities performance category is reweighted 
to 25 percent.
    (e) Final score. The final score is calculated for a MIPS eligible 
clinician, group, or APM Entity in accordance with Sec.  414.1380(c).

0
22. Section 414.1370 is amended by revising paragraph (a) to read as 
follows:


Sec.  414.1370  APM scoring standard under MIPS.

    (a) General. For the 2019 through 2022 MIPS payment years, the APM 
scoring standard is the MIPS scoring methodology applicable for MIPS 
eligible clinicians identified on the Participation List for the 
performance period of an APM Entity participating in a MIPS APM.
* * * * *

0
23. Section 414.1380 is amended--
0
a. By revising paragraph (b)(1)(i) introductory text;
0
b. In paragraph (b)(1)(i)(A)(1) by removing ``for the 2019 through 2022 
MIPS payment years'' and adding in its place ``for the 2019 through 
2023 MIPS payment years'';
0
c. By revising paragraphs (b)(1)(iii);
0
d. In paragraph (b)(1)(v)(A)(1)(ii) by removing ``For the 2019 through 
2022 MIPS payment years'' and adding in its place ``For the 2019 
through 2023 MIPS payments years'';
0
e. In paragraph (b)(1)(v)(B)(1)(i) by removing ``For the 2019 through 
2022 MIPS payment years'' and adding in its place ``For the 2019 
through 2023 MIPS payment years'';
0
f. In paragraph (b)(1)(vi)(C)(4) by removing ``For the 2020 through 
2022 MIPS payment years'' and adding in its place ``For the 2020 
through 2023 MIPS payment years'';
0
g. By revising paragraph (b)(1)(vii)(A);

[[Page 85032]]

0
h. By removing paragraph (b)(1)(viii);
0
i. By revising paragraphs (c)(2)(i)(A)(4) and (5);
0
j. By adding paragraphs (c)(2)(ii)(E) and (F);
0
k. By revising paragraph (c)(3) introductory text and (c)(3)(iii); and
0
l. By adding paragraph (c)(3)(iv).
    The revisions and additions read as follows:


Sec.  414.1380  Scoring.

* * * * *
    (b) * * *
    (1) * * *
    (i) Measure achievement points. For the 2019 through 2023 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 and for each administrative claims-based 
measure that has a benchmark at paragraph (b)(1)(ii) of this section 
and meets the case minimum requirement at paragraph (b)(1)(iii) of this 
section. 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.
* * * * *
    (iii) Minimum case requirements. Except as otherwise specified for 
administrative claims-based measures in the MIPS final list of quality 
measures described in Sec.  414.1330(a)(1), the minimum case 
requirement is 20 cases.
* * * * *
    (vii) * * *
    (A) For each measure that is submitted, if applicable, and impacted 
by significant changes, performance is based on data for 9 consecutive 
months of the applicable CY performance period. If such data are not 
available or may result in patient harm or misleading results, the 
measure is excluded from a MIPS eligible clinician's total measure 
achievement points and total available measure achievement points. For 
purposes of this paragraph (b)(1)(vii)(A), ``significant changes'' 
means changes to a measure that are outside the control of the 
clinician and its agents and that CMS determines may result in patient 
harm or misleading results. Significant changes include, but are not 
limited to, changes to codes (such as ICD-10, CPT, or HCPCS codes), 
clinical guidelines, or measure specifications. CMS will publish on the 
CMS website a list of all measures scored under this paragraph 
(b)(1)(vii)(A) as soon as technically feasible, but by no later than 
the beginning of the data submission period at Sec.  414.1325(e)(1).
* * * * *
    (c) * * *
    (2) * * *
    (i) * * *
    (A) * * *
    (4) For the Promoting Interoperability performance category for the 
2021, 2022 and 2023 MIPS payment years, the MIPS eligible clinician is 
a physical therapist, occupational therapist, clinical psychologist, 
qualified audiologist, qualified speech-language pathologist, or a 
registered dietitian or nutrition professional. 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.
    (5) For the Promoting Interoperability performance category for the 
2019, 2020, 2021, 2022, and 2023 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.
* * * * *
    (ii) * * *
    (E) For the 2023 MIPS payment year:

                                       Table 6 to Paragraph (c)(2)(ii)(E)
----------------------------------------------------------------------------------------------------------------
                                                                                                   Promoting
             Reweighting scenario                Quality (%)      Cost (%)       Improvement    Interoperability
                                                                               activities (%)         (%)
----------------------------------------------------------------------------------------------------------------
No Reweighting Needed:
    Scores for all four performance                        40              20              15                 25
     categories..............................
No Cost......................................              55               0              15                 30
No Promoting Interoperability................              65              20              15                  0
No Quality...................................               0              20              15                 65
No Improvement Activities....................              55              20               0                 25
No Cost and no Promoting Interoperability....              85               0              15                  0
No Cost and no Quality.......................               0               0              15                 85
No Cost and no Improvement Activities........              70               0               0                 30
No Promoting Interoperability and no Quality.               0              50              50                  0
No Promoting Interoperability and no                       80              20               0                  0
 Improvement Activities......................
No Quality and no Improvement Activities.....               0              20               0                 80
----------------------------------------------------------------------------------------------------------------

    (F) For the 2024 MIPS payment year:

[[Page 85033]]



                                       Table 7 to Paragraph (c)(2)(ii)(F)
----------------------------------------------------------------------------------------------------------------
                                                                                                   Promoting
             Reweighting scenario                Quality (%)      Cost (%)       Improvement    Interoperability
                                                                               activities (%)         (%)
----------------------------------------------------------------------------------------------------------------
No Reweighting Needed:
    Scores for all four performance                        30              30              15                 25
     categories..............................
No Cost......................................              55               0              15                 30
No Promoting Interoperability................              55              30              15                  0
No Quality...................................               0              30              15                 55
No Improvement Activities....................              45              30               0                 25
No Cost and no Promoting Interoperability....              85               0              15                  0
No Cost and no Quality.......................               0               0              15                 85
No Cost and no Improvement Activities........              70               0               0                 30
No Promoting Interoperability and no Quality.               0              50              50                  0
No Promoting Interoperability and no                       70              30               0                  0
 Improvement Activities......................
No Quality and no Improvement Activities.....               0              30               0                 70
----------------------------------------------------------------------------------------------------------------

* * * * *
    (3) Complex patient bonus. For the 2020, 2021, 2022, and 2023 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:
* * * * *
    (iii) The complex patient bonus cannot exceed 5.0 except as 
provided in paragraph (c)(3)(iv) of this section.
    (iv) For the 2022 MIPS payment year, the complex patient bonus is 
calculated pursuant to paragraphs (c)(3)(i) and (ii) of this section, 
and the resulting numerical value is then multiplied by 2.0. The 
complex patient bonus cannot exceed 10.0.
* * * * *

0
24. Section 414.1400 is amended--
0
a. By revising paragraphs (a)(2)(i) and (ii) and (a)(4);
0
b. By revising paragraph (b) heading and paragraph (b)(2) introductory 
text;
0
c. By adding paragraphs (b)(2)(iv) and (v);
0
d. By adding paragraphs (b)(3)(v)(C)(1) and (2);
0
e. By revising paragraphs (b)(3)(v)(E) and (b)(3)(vi);
0
f. By removing paragraphs (b)(3)(vii)(H) and (L);
0
g. By redesignating paragraphs (b)(3)(vii)(I), (J), (K), (M), and (N) 
as paragraphs (b)(3)(vii)(H), (I), (J), (K), and (L), respectively;
0
h. By revising paragraph (c) heading;
0
i. By adding paragraphs (c)(2)(iii) and (iv); and
0
j. By revising paragraph (f)(1)(i).
    The additions and revisions read as follows:


Sec.  414.1400  Third party intermediaries.

    (a) * * *
    (2) * * *
    (i) Except as provided under paragraph (a)(2)(ii) of this section, 
QCDRs, qualified registries, and Health IT vendors must be able to 
submit data for all of the following MIPS performance categories:
    (A) Quality, except:
    (1) The CAHPS for MIPS survey; and
    (2) For qualified registries and Health IT vendors, QCDR measures;
    (B) Improvement activities; and
    (C) Promoting Interoperability, if the eligible clinician, group, 
or virtual group is using CEHRT; however, a third party intermediary 
may be excepted from this requirement if its MIPS eligible clinicians, 
groups or virtual groups fall under the reweighting policies at Sec.  
414.1380(c)(2)(i)(A)(4) or (5) or (c)(2)(i)(C)(1) through (7) or 
(c)(2)(i)(C)(9).
    (ii) Health IT vendors that do not support MIPS Value Pathways must 
be able to submit data for at least one of the MIPS performance 
categories described in paragraphs (a)(2)(i)(A) through (C) of this 
section.
* * * * *
    (4) Third party intermediary approval criteria--
    (i) 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:
    (A) A third party intermediary's principle place of business and 
retention of any data must be based in the U.S.
    (B) If the data is derived from CEHRT, a QCDR, qualified registry, 
or health IT vendor must be able to indicate its data source.
    (C) All data must be submitted in the form and manner specified by 
CMS.
    (D) If the clinician chooses to opt-in in accordance with Sec.  
414.1310, the third party intermediary must be able to transmit that 
decision to CMS.
    (E) The third party intermediary must provide services throughout 
the entire performance period and applicable data submission period.
    (F) Prior to discontinuing services to any MIPS eligible clinician, 
group, or virtual group during a performance period, the third party 
intermediary must support the transition of such MIPS eligible 
clinician, group, or virtual group to an alternate third party 
intermediary, submitter type, or, for any measure on which data has 
been collected, collection type according to a CMS approved a 
transition plan.
    (ii) The determination of whether to approve an entity as a third 
party intermediary for a MIPS payment year may take into account:
    (A) Whether the entity failed to comply with the requirements of 
this section for any prior MIPS payment year for which it was approved 
as third party intermediary; and
    (B) Whether the entity provided inaccurate information regarding 
the requirements of this subpart to any eligible clinician.
    (iii) Beginning with the 2023 MIPS payment year, third party 
intermediaries must attend and complete training and support sessions 
in the form and manner, and at the times, specified by CMS.
* * * * *
    (b) QCDRs. * * *
    (2) QCDR conditions for approval. In addition to the other 
requirements in this section, the criteria for an entity to be approved 
as a QCDR include the following:
* * * * *
    (iv) Beginning with the 2023 payment year, the QCDR must conduct 
annual data validation audits in accordance with this paragraph 
(b)(2)(iv).
    (A) The QCDR must conduct data validation for the payment year 
prior to submitting any data for that payment

[[Page 85034]]

year to CMS for purposes of the MIPS program.
    (B) The QCDR must conduct data validation on data for each 
performance category for which it will submit data, including if 
applicable the Quality, Improvement Activities, and Promoting 
Interoperability performance categories.
    (C) The QCDR must conduct data validation on data for each 
submitter type for which it will submit data, including if applicable 
MIPS eligible clinicians, groups, virtual groups, voluntary 
participants, and opt-in participants.
    (D) The QCDR must use clinical documentation (provided by the 
clinicians they are submitting data for) to validate that the action or 
outcome measured actually occurred or was performed.
    (E) The QCDR shall conduct each data validation audit using a 
sampling methodology that meets the following requirements:
    (1) Uses a sample size of at least 3 percent of the TIN/NPIs for 
which the QCDR will submit data to CMS, except that if a 3 percent 
sample size would result in fewer than 10 TIN/NPIs, the QCDR must use a 
sample size of at least 10 TIN/NPIs, and if a 3 percent sample size 
would result in more than 50 TIN/NPIs, the QCDR may use a sample size 
of 50 TIN/NPIs.
    (2) Uses a sample that includes at least 25 percent of the patients 
of each TIN/NPI in the sample, except that the sample for each TIN/NPI 
must include a minimum of 5 patients and does not need to include more 
than 50 patients.
    (F) Each QCDR data validation audit must include the following:
    (1) Verification of the eligibility status of each eligible 
clinician, group, virtual group, opt-in participant, and voluntary 
participant.
    (2) Verification of the accuracy of TINs and NPIs.
    (3) Calculation of reporting and performance rates.
    (4) Verification that only the MIPS quality measures and QCDR 
measures, as applicable, that are relevant to the performance period 
will be used for MIPS submission.
    (G) In a form and manner and by a deadline specified by CMS, the 
QCDR must report the results of each data validation audit, including 
the overall data deficiencies or data error rate, the types of 
deficiencies or data errors discovered, the percentage of clinicians 
impacted by any deficiency or error, and, how and when each deficiency 
or data error type was corrected.
    (v) Beginning with the 2023 MIPS payment year, the QCDR must 
conduct targeted audits in accordance with this this paragraph 
(b)(2)(v).
    (A) If a data validation audit under paragraph (b)(2)(iv) of this 
section identifies one or more deficiency or data error, the QCDR must 
conduct a targeted audit into the impact and root cause of each such 
deficiency or data error for that MIPS payment year.
    (B) The QCDR must conduct any required targeted audits for the MIPS 
payment year and correct any deficiencies or data errors identified 
through such audit prior to the submission of data for that MIPS 
payment year.
    (C) The QCDR must conduct the targeted audit using the sampling 
methodology that meets the requirements described in paragraph 
(b)(2)(iv)(E) of this section. The sample for the targeted audit must 
not include data from the sample used for the data validation audit in 
which the deficiency or data error was identified.
    (D) In a form and manner and by a deadline specified by CMS, the 
QCDR must report the results of each targeted audit, including the 
overall deficiency or data error rate, the types of deficiencies or 
data errors discovered, the percentage of clinicians impacted by each 
deficiency or data error, and how and when each deficiency or data 
error type was corrected.
    (3) * * *
    (v) * * *
    (C) * * *
    (1) To be approved for the 2024 MIPS payment year, a QCDR measure 
must be face valid. To be approved for the 2025 MIPS payment year and 
future years, a QCDR measure must be face valid for the initial MIPS 
payment year for which it is approved and fully tested for any 
subsequent MIPS payment year for which it is approved.
    (2) To be included in an MIPS Value Pathway for the 2024 MIPS 
payment year and future years, a QCDR measure must be fully tested.
* * * * *
    (E) Beginning with the 2022 MIPS payment year, CMS may 
provisionally approve the individual QCDR measures for 1 year with the 
condition that QCDRs address certain areas of duplication with other 
approved QCDR measures or MIPS quality measures in order to be 
considered for the program in subsequent years. If such areas of 
duplication are not addressed, CMS may reject the duplicative QCDR 
measure.
    (vi) Beginning with the 2023 MIPS payment year, QCDR measures may 
be approved for 2 years, at CMS discretion by attaining approval status 
by meeting QCDR measure considerations and requirements. Upon annual 
review, CMS may revoke a QCDR measure's second year approval, if the 
QCDR measure is found to be: Topped out; duplicative of a more robust 
measure; reflects an outdated clinical guideline; or if the QCDR self-
nominating the QCDR measure is no longer in good standing.
* * * * *
    (c) Qualified registries. * * *
    (2) * * *
    (iii) Beginning with the 2023 payment year, the qualified registry 
must conduct annual data validation audits in accordance with this 
paragraph (c)(2)(iii).
    (A) The qualified registry must conduct their data validation 
audits prior to submitting any data to CMS for purposes of the MIPS 
program.
    (B) The qualified registry must conduct data validation on data for 
each performance category for which it will submit data, including if 
applicable the Quality, Improvement Activities, and Promoting 
Interoperability performance categories.
    (C) The qualified registry must conduct data validation on data for 
each submitter type for which it will submit data, including if 
applicable MIPS eligible clinicians, groups, virtual groups, voluntary 
participants, and opt-in participants.
    (D) The qualified registry must use clinical documentation 
(provided by the clinicians they are submitting data for) to validate 
that the action or outcome measured actually occurred or was performed.
    (E) The qualified registry shall conduct each data validation audit 
using a sampling methodology that meets the following:
    (1) Uses a sample size of at least 3 percent of the TIN/NPIs for 
which the qualified registry will submit data to CMS, except that if a 
3 percent sample size would result in fewer than 10 TIN/NPIs, the 
qualified registry must use a sample size of at least 10 TIN/NPIs, and 
if a 3 percent sample size would result in more than 50 TIN/NPIs, the 
qualified registry may use a sample size of 50 TIN/NPIs.
    (2) Uses a sample that includes at least 25 percent of the patients 
of each TIN/NPI in the sample, except that the sample for each TIN/NPI 
must include a minimum of 5 patients and does not need to include more 
than 50 patients.
    (F) Each qualified registry data validation audit must include the 
following:
    (1) Verification of the eligibility status of each eligible 
clinician, group, virtual group, opt-in participant, and voluntary 
participant.

[[Page 85035]]

    (2) Verification of the accuracy of TINs and NPIs.
    (3) Calculation of reporting and performance rates.
    (4) Verification that only MIPS quality measures and qualified 
registry measures that are relevant to the performance period will be 
utilized for MIPS submission.
    (G) In a form and manner and by a deadline specified by CMS, the 
qualified registry must report data validation results, including the 
overall deficiency or data error rate, the types of deficiencies or 
data errors discovered, the percentage of clinicians impacted by any 
deficiency or data error, how and when each deficiency or data error 
type was corrected.
    (iv) Beginning with the 2023 MIPS payment year, the qualified 
registry must conduct targeted audits in accordance with this paragraph 
(c)(2)(iv).
    (A) If a data validation audit under paragraph (c)(2)(iii) of this 
section identifies one or more deficiency or data error, the qualified 
registry must conduct a targeted audit into the impact and root cause 
of each such deficiency or data error for that MIPS payment year.
    (B) The qualified registry must conduct any required targeted 
audits for the MIPS payment year and correct any deficiencies or data 
errors identified through such audit prior to the submission of data 
for that MIPS payment year.
    (C) The qualified registry must conduct the targeted audit using 
the sampling methodology that meets the requirements described in 
paragraphs (c)(2)(iii)(E)(1) and (2) of this section. The sample for 
the targeted audit must not include data from the sample used for the 
data validation audit in which the deficiency or data error was 
identified.
    (D) In a form and manner and by a deadline specified by CMS, the 
qualified registry must report the results of each targeted audit, 
including the overall deficiency or data error rate, the types of 
deficiencies or data errors discovered, the percentage of clinicians 
impacted by each deficiency or data error, how and when each deficiency 
or data error type was corrected.
* * * * *
    (f) * * *
    (1) * * *
    (i) Require the third party intermediary to submit a corrective 
action plan (CAP) by a date specified by CMS. The CAP must address the 
following issues, unless different or additional information is 
specified by CMS:
    (A) The issues that contributed to the non-compliance.
    (B) The impact to individual clinicians, groups, or virtual groups, 
regardless of whether they are participating in the program because 
they are MIPS eligible, voluntary participating, or opting in to 
participating in the MIPS program.
    (C) The corrective actions to be implemented by the third party 
intermediary to ensure that the non-compliance has been resolved and 
will not recur in the future.
    (D) The detailed timeline for achieving compliance with the 
applicable requirements.
* * * * *

0
25. Section 414.1435 is amended by revising paragraph (c)(1) to read as 
follows:


Sec.  414.1435  Qualifying APM participant determination: Medicare 
option.

* * * * *
    (c) * * *
    (1) Attributed beneficiaries are determined from each Advanced APM 
Entity's attributed beneficiary lists generated by each Advanced APM's 
specific attribution methodology except as set forth in this paragraph 
(c)(1).
    (i) Beneficiaries who have been prospectively attributed to an APM 
Entity for a QP Performance Period will be excluded from the 
attribution-eligible beneficiary count for any other APM Entity that is 
participating in an APM where that beneficiary would be ineligible to 
be added to the APM Entity's attributed beneficiary list.
    (ii) [Reserved]
* * * * *

0
26. Section 414.1450 is amended by revising paragraphs (b)(1) and (c) 
to read as follows:


Sec.  414.1450  APM incentive payment.

* * * * *
    (b) * * *
    (1) The amount of the APM Incentive Payment is equal to 5 percent 
of the estimated aggregate payments for covered professional services 
as defined in section 1848(k)(3)(A) of the Act furnished during the 
calendar year immediately preceding the payment year. CMS uses the paid 
amounts on claims for covered professional services to calculate the 
estimated aggregate payments on which CMS will calculate the APM 
Incentive Payment.
* * * * *
    (c) APM Incentive Payment recipient. CMS will pay the APM Incentive 
Payment amount for a payment year to a solvent TIN or TINs associated 
with the QP identified at a specific step in the following hierarchy. 
If no TIN or TINs with which the QP has an association can be 
identified at a step, CMS will move to the next and successive steps 
listed in paragraphs (c)(1) through (8) of this section until CMS 
identifies a TIN or TINs with which the QP is associated, and to which 
CMS will make the APM Incentive Payment.
    (1) Any TIN associated with the QP that, during the QP Performance 
Period, is associated with an APM Entity through which the eligible 
clinician achieved QP status;
    (2) Any TIN associated with the QP that, during the APM Incentive 
Payment base period, is associated with an APM Entity through which the 
eligible clinician achieved QP status;
    (3) Any TIN associated with the QP that, during the APM Incentive 
Payment base period, is associated with an APM Entity participating in 
an Advanced APM through which the eligible clinician had achieved QP 
status;
    (4) Any TIN associated with the QP that, during the APM Incentive 
Payment base period, participated in an APM Entity in an Advanced APM;
    (5) Any TIN associated with the QP that, during the APM Incentive 
Payment base period, participated with an APM Entity in any track of 
the APM through which the eligible clinician achieved QP status;
    (6) Any TIN associated with the QP that, during the APM Incentive 
Payment base period, participated with an APM Entity in an APM other 
than an Advanced APM;
    (7) Any TIN associated with the QP that submitted a claim for 
covered professional services furnished by the QP during the APM 
Incentive Payment base period, even if such TIN has no relationship to 
any APM Entity or APM; then
    (8) If we have not identified any TIN associated with the QP to 
which we can make the APM Incentive Payment, we will attempt to contact 
the QP via a public notice to request their Medicare payment 
information. The QPs identified in the public notice, or any other 
eligible clinicians who believe that they are entitled to an APM 
Incentive Payment must then notify CMS of their claim as directed in 
the public notice by November 1 of the payment year, or 60 days after 
CMS announces that initial payments for the year have been made, 
whichever is later. After that time, any claims by a QP to an APM 
Incentive Payment will be forfeited for such payment year.
* * * * *

0
27. Section 414.1455 is revised to read as follows:

[[Page 85036]]

Sec.  414.1455  Limitation on review.

    (a) There is no right to administrative or judicial review under 
sections 1869, 1878, or otherwise, of the Act of the following:
    (1) The determination that an eligible clinician is a QP or Partial 
QP under Sec.  414.1425.
    (2) The determination of the amount of the APM Incentive Payment 
under Sec.  414.1450, including any estimation as part of such 
determination.
    (b)(1) An eligible clinician or APM Entity may request targeted 
review of a QP or Partial QP determination only if they believe in good 
faith that, due to a CMS clerical error, an eligible clinician was 
omitted from a Participation List.
    (2) If CMS determines that there was such a clerical error, if the 
QP determination for the eligible clinician would have been made at the 
APM Entity level under Sec.  414.1425(b)(1), CMS will assign to the 
eligible clinician the most favorable QP status that was determined at 
the APM Entity level on any snapshot dates for the relevant QP 
Performance Period on which the eligible clinician participated in the 
APM Entity.
    (3) The process for targeted review is as follows:
    (i) An eligible clinician or APM Entity may submit a request for 
targeted review.
    (ii) All requests for targeted review must be submitted during the 
targeted review request submission period, which is a 60-day period 
that begins with the publication of MIPS performance feedback as 
described at Sec.  414.1385(a)(2). The targeted review request 
submission period may be extended as specified by CMS.
    (iii) All requests for targeted review must be submitted in 
accordance with the form and manner specified by CMS.
    (iv) A request for targeted review may be denied if the request is 
duplicative of another request for a targeted review; the request is 
not submitted during the targeted review request submission period; or 
the request is outside the scope of targeted review specified in this 
section. If the targeted review request is denied, CMS will make no 
changes to the QP status of the eligible clinician for whom targeted 
review was requested.
    (v) CMS will respond to each timely submitted request for targeted 
review.
    (vi) A request for targeted review may include additional 
information in support of the request at the time it is submitted. CMS 
may also request additional information from the requestor. If CMS 
requests additional information relating to the eligible clinician or 
the APM Entity group that is the subject of a request for targeted 
review, responsive information must be provided and received by CMS 
within 30 days of the request. If CMS does not receive a timely 
response to a request for additional information, CMS may make a final 
decision on the targeted review request based on the information 
available.
    (vii) If targeted review requests reveal a pattern of CMS error 
with impacts that extend beyond the scope of eligible clinicians or APM 
Entities that submitted such targeted review requests, CMS may adjust 
the QP status of other affected eligible clinicians as provided in 
paragraph (b)(2) of this section.
    (viii) Decisions on a targeted review request are final, and not 
subject to any further administrative or judicial review in accordance 
with paragraph (a) of this section.

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

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

    Authority:  42 U.S.C. 1302 and 1395hh.


0
29. Section 415.172 is amended by revising paragraph (a) introductory 
text, (a)(2), and (b) to read as follows:


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

    (a) General rule. If a resident participates in a service furnished 
in a teaching setting, physician fee schedule payment is made only if a 
teaching physician is present during the key portion of any service or 
procedure for which payment is sought. In residency training sites that 
are located outside a metropolitan statistical area, physician fee 
schedule payment may also be made if a teaching physician is present 
during the key portion of the service, including for Medicare 
telehealth services, through audio/video real-time communications 
technology for any service or procedure for which payment is sought. 
For all teaching settings during the Public Health Emergency, as 
defined in Sec.  400.200 of this chapter, for the COVID-19 pandemic, if 
a resident participates in a service furnished in a teaching setting, 
physician fee schedule payment is made if a teaching physician is 
present during the key portion of the service including for Medicare 
telehealth services, through audio/video real-time communications 
technology for any service or procedure for which payment is sought.
* * * * *
    (2) In the case of evaluation and management services, except as 
otherwise provided in this paragraph (a)(2), the teaching physician 
must be present in person during the portion of the service that 
determines the level of service billed. (However, in the case of 
evaluation and management services furnished in hospital outpatient 
departments and certain other ambulatory settings, the requirements of 
Sec.  415.174 apply.)
    (i) In residency training sites that are located outside of a 
metropolitan statistical area, the teaching physician may be present 
through audio/video real-time communications technology during the 
portion of the service that determines the level of service billed. 
(However, in the case of evaluation and management services furnished 
in hospital outpatient departments and certain other ambulatory 
settings, the requirements of Sec.  415.174 apply.)
    (ii) For all teaching settings during the Public Health Emergency, 
as defined in Sec.  400.200 of this chapter, for the COVID-19 pandemic, 
the teaching physician may be present through audio/video real-time 
communications technology during the portion of the service that 
determines the level of service billed. (However, in the case of 
evaluation and management services furnished in hospital outpatient 
departments and certain other ambulatory settings, the requirements of 
Sec.  415.174 apply.)
    (b) Documentation. Except as otherwise provided in this paragraph 
(b), 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), Sec. Sec.  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 (including a Medicare 
telehealth 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 the 
physician or as provided in Sec.  410.20(e) of this chapter.
    (1) In residency training sites that are located outside of a 
metropolitan statistical area only, except for services furnished as 
set forth in Sec. Sec.  415.174 (concerning an exception for services 
furnished in hospital outpatient and

[[Page 85037]]

certain other ambulatory settings), 415.176 (concerning renal dialysis 
services), and 415.184 (concerning psychiatric services), the medical 
records must document whether the teaching physician was physically 
present or present through audio/video real-time communications 
technology at the time the service (including a Medicare telehealth 
service) is furnished. The medical records must contain a notation 
describing the specific portion(s) of the service for which the 
teaching physician was present through audio/video real-time 
communications technology. 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 the physician 
or as provided in Sec.  410.20(e) of this chapter.
    (2) For all teaching settings during the Public Health Emergency, 
as defined in Sec.  400.200 of this chapter, for the COVID-19 pandemic, 
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 whether the teaching physician was 
physically present or present through audio/video real-time 
communications technology at the time the service (including a Medicare 
telehealth service) is furnished. The medical records must contain a 
notation describing the specific portion(s) of the service for which 
the teaching physician was present through audio/video real-time 
communications technology. 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 the physician 
or as provided in Sec.  410.20(e) of this chapter.
* * * * *

0
30. Section 415.174 is amended by revising paragraph (c) and adding 
paragraph (d) to read as follows:


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

* * * * *
    (c) For all teaching settings during the Public Health Emergency, 
as defined in Sec.  400.200 of this chapter, for the COVID-19 pandemic, 
the requirements in paragraph (a)(3) of this section for a teaching 
physician to direct the care and then to review the services furnished 
by each resident during or immediately after each visit may be met 
through audio/video real-time communications technology.
    (d) In residency training sites that are located outside of a 
metropolitan statistical area only, the requirements in paragraph 
(a)(3) of this section for a teaching physician to direct the care and 
then to review the services furnished by each resident during or 
immediately after each visit may be met through audio/video real-time 
communications technology.

0
31. Section 415.180 is revised to read as follows:


Sec.  415.180  Teaching setting requirements for the interpretation of 
diagnostic radiology and other diagnostic tests.

    (a) General rule. Physician fee schedule payment is made for the 
interpretation of diagnostic radiology and other diagnostic tests if 
the interpretation is performed or reviewed by a physician other than a 
resident.
    (1) In residency training sites that are located outside of a 
metropolitan statistical area only, physician fee schedule payment may 
also be made for the interpretation of diagnostic radiology and other 
diagnostic tests if the interpretation is performed by a resident when 
the teaching physician is present through audio/video real-time 
communications technology. The medical records must document the extent 
of the teaching physician's participation in the interpretation of 
review of the diagnostic radiology test.
    (2) For all teaching settings during the Public Health Emergency, 
as defined in Sec.  400.200 of this chapter, for the COVID-19 pandemic, 
physician fee schedule payment may also be made for the interpretation 
of diagnostic radiology and other diagnostic tests if the 
interpretation is performed by a resident when the teaching physician 
is present through audio/video real-time communications technology. The 
medical records must document the extent of the teaching physician's 
participation in the interpretation or review of the diagnostic 
radiology or diagnostic test.
    (b) [Reserved]

0
32. Section 415.184 is revised to read as follows:


Sec.  415.184  Psychiatric services.

    (a) Physician fee schedule payment is made for psychiatric services 
furnished under an approved GME program if the requirements of 
Sec. Sec.  415.170 and 415.172 are met, including documentation, except 
that the requirement for the presence of the teaching physician during 
the service in which a resident is involved may be met by observation 
of the service by use of a one-way mirror, video equipment, or similar 
device.
    (b) In residency training sites that are located outside of a 
metropolitan statistical area, the requirement for the presence of the 
teaching physician during the service in which a resident is involved 
may be met through audio/video real-time communications technology. The 
medical records must document the extent of the teaching physician's 
participation in the service.
    (c) For all teaching settings during the Public Health Emergency, 
as defined in Sec.  400.200 of this chapter, for the COVID-19 pandemic, 
the requirement for the presence of the teaching physician during the 
service in which a resident is involved may also be met through audio/
video real-time communications technology. The medical records must 
document the extent of the teaching physician's participation in the 
service.

0
33. Section 415.208 is amended by revising paragraph (b) heading and 
paragraph (b)(2) introductory text to read as follows:


Sec.  415.208  Services of moonlighting residents.

* * * * *
    (b) Services in teaching hospitals. * * *
    (2) Services of residents that are not related to their approved 
GME programs and are performed in an outpatient department or emergency 
department of a hospital in which they have their training program are 
covered as physician services and payable under the physician fee 
schedule if criteria in paragraphs (b)(2)(i) through (iii) of this 
section are met. The services of residents that are not related to 
their approved GME programs and are furnished to inpatients of a 
hospital in which they have their training program are covered as 
physician services and payable under the physician fee schedule if 
criteria in paragraphs (b)(2)(i) through (iii) of this section are met. 
The medical record must include documentation to demonstrate in each 
case that these criteria are satisfied.
* * * * *

PART 423--VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT

0
34. The authority citation for part 423 continues to read as follows:

    Authority:  42 U.S.C. 1302, 1306, 1395w-101 through 1395w-152, 
and 1395hh.


0
35. Section 423.160 is amended by adding paragraph (a)(5) to read as 
follows:

[[Page 85038]]

Sec.  423.160  Standards for electronic prescribing.

    (a) * * *
    (5) On January 1, 2021, prescribers must, except in circumstances 
in which the Secretary waives the requirement, conduct all prescribing 
for all Schedule II, III, IV, and V controlled substances 
electronically using the applicable standards in paragraph (b) of this 
section. Compliance actions against those not in compliance with this 
requirement will commence January 1, 2022.
* * * * *

PART 424--CONDITIONS FOR MEDICARE PAYMENT

0
36. The authority citation for part 424 continues to read as follows:

    Authority: 42 U.S.C. 1302 and 1395hh.


0
37. Section 424.67 is amended by--
0
a. Revising paragraphs (b)(1) introductory text, (b)(1)(ii), (b)(2) and 
(3), and (b)(5) introductory text;
0
b. Redesignating paragraphs (c) through (f) as paragraphs (d) through 
(g), respectively;
0
c. Adding new paragraph (c); and
0
d. Revising newly redesignated paragraph (e)(2)(i).
    The revisions and additions read as follows:


Sec.  424.67  Enrollment requirements for opioid treatment programs 
(OTP).

* * * * *
    (b) * * *
    (1) Fully complete and submit, as applicable, the Form CMS-855A or 
Form CMS-855B application (or their successor applications) and any 
applicable supplement or attachment thereto to its applicable Medicare 
contractor. This includes, but is not limited to, the following:
* * * * *
    (ii) Certifying via the Form CMS-855A or Form CMS-855B (as 
applicable) and/or the applicable supplement or attachment thereto that 
the OTP meets and will continue to meet the specific requirements and 
standards for enrollment described in paragraphs (b) and (e) of this 
section.
    (2) Comply with the application fee requirements in Sec.  424.514. 
(This includes OTPs enrolling under the circumstances described in 
paragraph (c)(2) of this section.)
    (3)(i) Except as stated in paragraph (b)(3)(ii) of this section, 
successfully complete the assigned categorical risk level screening 
required under, as applicable, Sec.  424.518(b) and (c).
    (ii) For currently enrolled OTPs that are changing their OTP 
enrollment from a Form CMS-855B enrollment to a Form CMS-855A 
enrollment, or vice versa, successfully complete the limited level of 
categorical screening under Sec.  424.518(a) if the OTP has already 
completed, as applicable, the moderate or high level of categorical 
screening under Sec.  424.518(b) or (c), respectively.
* * * * *
    (5) Report on the Form CMS-855A or Form CMS-855B (as applicable) 
and/or any applicable supplement all OTP staff who meet the definition 
of ``managing employee'' in Sec.  424.502. Such individuals include, 
but are not limited to, the following:
* * * * *
    (c) Clarification of required enrollment forms. (1) An OTP may only 
be enrolled as an OTP via the Form CMS-855A or Form CMS-855B but not 
both.
    (2) If a currently enrolled OTP is changing its OTP enrollment from 
a Form CMS-855B enrollment to a Form CMS-855A enrollment, or vice 
versa, the effective date of billing that was established for the OTP's 
prior enrollment under Sec. Sec.  424.520(d) and 424.521(a) is applied 
to the OTP's new enrollment.
* * * * *
    (e) * * *
    (2) * * *
    (i) The provider does not have a current, valid certification by 
SAMHSA as required under paragraph (b)(4)(i) of this section or fails 
to meet any other applicable requirement or standard in this section, 
including, but not limited to, the OTP standards in paragraphs (b)(6) 
and (e)(1) of this section.
* * * * *

0
38. Section 424.518 is amended by redesignating paragraphs (a)(1)(xii) 
through (xvii) as paragraphs (a)(1)(xiii) through (xviii) and adding a 
new paragraph (a)(1)(xii) to read as follows:


Sec.  424.518  Screening levels for Medicare providers and suppliers.

* * * * *
    (a) * * *
    (1) * * *
    (xii) Opioid treatment programs (if Sec.  424.67(b)(3)(ii) 
applies).
* * * * *

PART 425--MEDICARE SHARED SAVINGS PROGRAM

0
39. The authority citation for part 425 continues to read as follows:

    Authority: 42 U.S.C. 1302, 1306, 1395hh, and 1395jjj.


0
40. Section 425.100 is amended by revising paragraph (b) to read as 
follows:


Sec.  425.100  General.

* * * * *
    (b) An ACO is eligible to receive payments for shared savings under 
subpart G of this part if all of the following conditions are met:
    (1) The ACO meets or exceeds the applicable minimum savings rate 
established under Sec.  425.604, Sec.  425.605, Sec.  425.606, Sec.  
425.609, or Sec.  425.610.
    (2) The ACO meets the minimum quality performance standards 
established under Sec.  425.500 (for performance years or a performance 
period beginning on or before January 1, 2020), or under the quality 
performance standard established under Sec.  425.512 (for performance 
years beginning on or after January 1, 2021).
    (3) The ACO otherwise maintains its eligibility to participate in 
the Shared Savings Program under this part.
* * * * *


Sec.  425.112  [Amended]

0
41. Section 425.112 is amended in paragraph (b)(2)(i) by removing the 
reference ``Sec.  425.500'' and adding in its place the references 
``Sec.  425.500 or Sec.  425.510, as applicable''.


Sec.  425.200  [Amended]

0
42. Section 425.200 is amended in paragraph (d) by removing the 
reference ``Sec.  425.500(c)'' and adding in its place the references 
``Sec.  425.500(c) or Sec.  425.510, as applicable''.

0
43. Section 425.204 is amended by--
0
a. Revising paragraphs (f)(3)(i) through (iv);
0
b. Adding paragraph (f)(3)(v); and
0
c. Revising paragraphs (f)(4)(iv), (f)(5), and (f)(6)(ii) introductory 
text.
    The revisions and addition read as follows:


Sec.  425.204  Content of the application.

* * * * *
    (f) * * *
    (3) * * *
    (i) An ACO participating in Track 2 must demonstrate the adequacy 
of its repayment mechanism prior to any change in the terms and type of 
the repayment mechanism, and at such other times as requested by CMS.
    (ii) An ACO entering an agreement period in Levels C, D, or E of 
the BASIC track or the ENHANCED track must demonstrate the adequacy of 
its repayment mechanism prior to the start of its agreement period, 
prior to any change in the terms and type of the repayment mechanism, 
and at such other times as requested by CMS.
    (iii) An ACO entering an agreement period in Level A or Level B of 
the BASIC track must demonstrate the

[[Page 85039]]

adequacy of its repayment mechanism prior to the start of any 
performance year in which it either elects to participate in, or is 
automatically transitioned to, a two-sided model, Level C, Level D, or 
Level E of the BASIC track, prior to any change in the terms and type 
of the repayment mechanism, and at such other times as requested by 
CMS.
    (iv) An ACO that has submitted a request to renew its participation 
agreement must submit as part of the renewal request documentation 
demonstrating the adequacy of the repayment mechanism that could be 
used to repay any shared losses incurred for performance years in the 
next agreement period. The repayment mechanism applicable to the new 
agreement period may be the same repayment mechanism currently used by 
the ACO, provided that the ACO submits documentation establishing that 
the duration of the existing repayment mechanism has been revised to 
comply with paragraph (f)(6)(ii) of this section, and the amount of the 
repayment mechanism complies with paragraph (f)(4) of this section.
    (v) As part of its application, a re-entering ACO must submit 
documentation demonstrating the adequacy of the repayment mechanism 
that could be used to repay any shared losses incurred for performance 
years in the next agreement period. The repayment mechanism applicable 
to the new agreement period may be the same repayment mechanism 
currently used by the re-entering ACO, provided that the ACO is the 
same legal entity as an ACO that previously participated in the 
program, and the ACO submits documentation establishing that the 
duration of the existing repayment mechanism has been revised to comply 
with paragraph (f)(6)(ii) of this section and the amount of the 
repayment mechanism complies with paragraph (f)(4) of this section.
    (4) * * *
    (iv)(A) In the case of an ACO that has submitted a request to enter 
a new participation agreement for an agreement period starting on or 
after January 1, 2022 and is a renewing ACO or a re-entering ACO that 
is the same legal entity as an ACO that previously participated in the 
program: If the ACO wishes to use its existing repayment mechanism to 
establish its ability to repay any shared losses incurred for 
performance years in the new agreement period, the amount of the 
repayment mechanism must be equal to at least the amount calculated by 
CMS in accordance with paragraph (f)(4)(ii) of this section.
    (B) Under the following circumstances, an ACO that renewed its 
participation agreement for an agreement period beginning on July 1, 
2019, or January 1, 2020, may elect to decrease the amount of its 
repayment mechanism.
    (1) The ACO elected to continue to use its existing repayment 
mechanism for the agreement period beginning on July 1, 2019, or 
January 1, 2020, and the amount of that repayment mechanism was greater 
than the repayment mechanism amount estimated at the time of renewal 
application according to paragraph (f)(4)(ii) of this section.
    (2) The repayment mechanism amount for performance year 2021, as 
recalculated pursuant to paragraph (f)(4)(iii) of this section, is less 
than the existing repayment mechanism amount.
    (3) CMS will notify the ACO in writing if the ACO may elect to 
decrease the amount of its repayment mechanism pursuant to this 
paragraph (f)(4)(iv)(B). The ACO must submit such election, together 
with revised repayment mechanism documentation, in a form and manner 
and by a deadline specified by CMS. CMS will review the revised 
repayment mechanism documentation and may reject the election if the 
repayment mechanism documentation does not comply with the requirements 
of this paragraph (f).
    (5) After the repayment mechanism has been used to repay any 
portion of shared losses owed to CMS, the ACO must replenish the amount 
of funds available through the repayment mechanism within 90 days. The 
resulting amount available through the repayment mechanism must be at 
least the amount specified by CMS in accordance with paragraph (f)(4) 
of this section.
    (6) * * *
    (ii) For a renewing ACO, or a re-entering ACO that is the same 
legal entity as an ACO that previously participated in the program, 
that wishes to use its existing repayment mechanism to establish its 
ability to repay any shared losses incurred for performance years in 
the new agreement period, the existing repayment mechanism must be 
amended to meet one of the following criteria.
* * * * *

0
44. Section 425.224 is amended by revising paragraph (b)(1)(ii)(A) to 
read as follows:


Sec.  425.224  Application procedures for renewing ACOs and re-entering 
ACOs.

* * * * *
    (b) * * *
    (1) * * *
    (ii) * * *
    (A) Whether the ACO demonstrated a pattern of failure to meet the 
quality performance standards or met any of the criteria for 
termination under Sec.  425.316(c)(1)(ii) or (c)(2)(ii).
* * * * *


Sec.  425.302  [Amended]

0
45. Section 425.302 is amended in paragraph (a)(1) by removing the 
reference ``Sec.  425.500'' and adding in its place the references 
``Sec.  425.500 or Sec.  425.510, as applicable''.

0
46. Section 425.316 is amended by revising paragraph (c) to read as 
follows:


Sec.  425.316  Monitoring of ACOs.

* * * * *
    (c) Monitoring ACO compliance with quality performance standards. 
To identify ACOs that are not meeting the quality performance 
standards, CMS will review an ACO's submission of quality measurement 
data under Sec.  425.500 or Sec.  425.512. CMS may request additional 
documentation from an ACO, ACO participants, or ACO providers/
suppliers, as appropriate. If an ACO does not meet quality performance 
standards or fails to report on one or more quality measures, CMS will 
take the following actions:
    (1) For performance years (or a performance period) beginning on or 
before January 1, 2020. (i) The ACO may be given a warning for the 
first time it fails to meet the minimum attainment level on at least 70 
percent of the measures, as determined under Sec.  425.502, in one or 
more domains and may be subject to a CAP. CMS may forgo the issuance of 
the warning letter depending on the nature and severity of the 
noncompliance and instead subject the ACO to actions set forth at Sec.  
425.216 or immediately terminate the ACO's participation agreement 
under Sec.  425.218.
    (ii) The ACO's compliance with the quality performance standards 
will be re-evaluated the following year. If the ACO continues to fail 
to meet the quality performance standard in the following year, the 
agreement will be terminated.
    (iii) An ACO will not qualify to share in savings in any year it 
fails to report accurately, completely, and timely on the quality 
performance measures.
    (2) For performance years beginning on or after January 1, 2021. 
(i) If the ACO fails to meet the quality performance standard, CMS may 
take one or more of the actions prior to termination specified in Sec.  
425.216. Depending on the nature and severity of the noncompliance, CMS 
may forgo pre-termination actions and may

[[Page 85040]]

immediately terminate the ACO's participation agreement under Sec.  
425.218.
    (ii) CMS will terminate an ACO's participation agreement under any 
of the following circumstances:
    (A) The ACO fails to meet the quality performance standard for 2 
consecutive performance years within an agreement period.
    (B) The ACO fails to meet the quality performance standard for any 
3 performance years within an agreement period, regardless of whether 
the years are in consecutive order.
    (C) A renewing ACO or re-entering ACO fails to meet the quality 
performance standard for the last performance year of the ACO's 
previous agreement period and this occurrence was either the second 
consecutive performance year of failed quality performance or the third 
nonconsecutive performance year of failed quality performance during 
the previous agreement period.
    (D) A renewing ACO or re-entering ACO fails to meet the quality 
performance standard for 2 consecutive performance years across 2 
agreement periods, specifically the last performance year of the ACO's 
previous agreement period and the first performance year of the ACO's 
new agreement period.
* * * * *

0
47. Section 425.400 is amended by--
0
a. Revising paragraph (c)(1)(iv) introductory text;
0
b. Adding paragraph (c)(1)(v); and
0
c. Revising paragraph (c)(2).
    The revisions and addition read as follows:


Sec.  425.400  General.

* * * * *
    (c) * * *
    (1) * * *
    (iv) For performance years (or a performance period) during 2019, 
and performance year 2020 as follows:
* * * * *
    (v) For the performance year starting on January 1, 2021, and 
subsequent performance years as follows:
    (A) CPT codes:
    (1) 96160 and 96161 (codes for administration of health risk 
assessment).
    (2) 99201 through 99215 (codes for office or other outpatient visit 
for the evaluation and management of a patient).
    (3) 99304 through 99318 (codes for professional services furnished 
in a nursing facility; professional services or services reported on an 
FQHC or RHC claim identified by these codes are excluded when furnished 
in a SNF).
    (4) 99319 through 99340 (codes for patient domiciliary, rest home, 
or custodial care visit).
    (5) 99341 through 99350 (codes for evaluation and management 
services furnished in a patient's home for claims identified by place 
of service modifier 12).
    (6) 99354 and 99355 (add-on codes, for prolonged evaluation and 
management or psychotherapy services beyond the typical service time of 
the primary procedure; when the base code is also a primary care 
service code under this paragraph (c)(1)(v)).
    (7) 99421, 99422, and 99423 (codes for online digital evaluation 
and management).
    (8) 99439 (code for non-complex chronic care management).
    (9) 99483 (code for assessment of and care planning for patients 
with cognitive impairment).
    (10) 99484, 99492, 99493 and 99494 (codes for behavioral health 
integration services).
    (11) 99487, 99489, 99490 and 99491 (codes for chronic care 
management).
    (12) 99495 and 99496 (codes for transitional care management 
services).
    (13) 99497 and 99498 (codes for advance care planning; services 
identified by these codes furnished in an inpatient setting are 
excluded).
    (B) HCPCS codes:
    (1) G0402 (code for the Welcome to Medicare visit).
    (2) G0438 and G0439 (codes for the annual wellness visits).
    (3) G0442 (code for alcohol misuse screening service).
    (4) G0443 (code for alcohol misuse counseling service).
    (5) G0444 (code for annual depression screening service).
    (6) G0463 (code for services furnished in ETA hospitals).
    (7) G0506 (code for chronic care management).
    (8) G2010 (code for the remote evaluation of patient video/images).
    (9) G2012 (code for virtual check-in).
    (10) G2058 (code for non-complex chronic care management).
    (11) G2064 and G2065 (codes for principal care management 
services).
    (12) G2214 (code for psychiatric collaborative care model).
    (2)(i) When the assignment window (as defined in Sec.  425.20) for 
a benchmark or performance year includes any month(s) during the COVID-
19 Public Health Emergency defined in Sec.  400.200 of this chapter, in 
determining beneficiary assignment, we use the primary care service 
codes identified in paragraph (c)(1) of this section, and additional 
primary care service codes as follows:
    (A) CPT codes:
    (1) 99421, 99422, and 99423 (codes for online digital evaluation 
and management services).
    (2) 99441, 99442, and 99443 (codes for telephone evaluation and 
management services).
    (B) HCPCS codes:
    (1) G2010 (code for the remote evaluation of patient video/images).
    (2) G2012 (code for virtual check-in).
    (ii) The additional primary care service codes specified in 
paragraph (c)(2)(i) of this section are applicable to all months of the 
assignment window (as defined in Sec.  425.20), when the assignment 
window includes any month(s) during the COVID-19 Public Health 
Emergency defined in Sec.  400.200 of this chapter.

0
48. Section 425.500 is amended by revising the section heading and 
paragraph (d) to read as follows:


Sec.  425.500  Measures to assess the quality of care furnished by an 
ACO for performance years (or a performance period) beginning on or 
before January 1, 2020.

* * * * *
    (d) Patient experience of care survey. (1) For performance years 
(or a performance period) beginning in 2014 through 2019, ACOs must 
select a CMS-certified vendor to administer the survey and report the 
results accordingly.
    (2) For performance year 2020, CMS waives the CAHPS for ACOs 
reporting requirement and will assign all ACOs automatic credit for the 
CAHPS for ACOs survey measures.
* * * * *

0
49. Section 425.502 is amended by revising the section heading to read 
as follows:


Sec.  425.502  Calculating the ACO quality performance score for 
performance years (or a performance period) beginning on or before 
January 1, 2020.

* * * * *

0
50. Section 425.508 is amended by revising the paragraph (a) heading 
and adding paragraph (b) to read as follows:


Sec.  425.508  Incorporating quality reporting requirements related to 
the Quality Payment Program.

    (a) For performance years (or a performance period) beginning in 
2017-2020. * * *
    (b) For performance years beginning on or after January 1, 2021. 
ACOs must submit the quality data via the Alternative Payment Model 
Performance Pathway (APP) established under Sec.  414.1367 of this 
chapter, to satisfactorily report on behalf of the

[[Page 85041]]

eligible clinicians who bill under the TIN of an ACO participant for 
purposes of the MIPS Quality performance category of the Quality 
Payment Program.

0
51. Section 425.510 is added to subpart F to read as follows:


Sec.  425.510  Application of the Alternative Payment Model Performance 
Pathway (APP) to Shared Savings Program ACOs for performance years 
beginning on or after January 1, 2021.

    (a) General. (1) CMS establishes quality performance measures to 
assess the quality of care furnished by the ACO. If the ACO 
demonstrates to CMS that it has satisfied the quality performance 
requirements in this subpart, and the ACO meets all other applicable 
requirements, the ACO is eligible to receive shared savings.
    (2) CMS seeks to improve the quality of care furnished by ACOs over 
time by specifying higher standards, new measures, or both.
    (b) Quality reporting. ACOs must report quality data via the APP 
established under Sec.  414.1367 of this chapter, according to the 
method of submission established by CMS.
    (c) Audit and validation of data. CMS retains the right to audit 
and validate quality data reported by an ACO under paragraph (b) of 
this section according to Sec.  414.1390 of this chapter.

0
52. Section 425.512 is added to subpart F to read as follows:


Sec.  425.512  Determining the ACO quality performance standard for 
performance years beginning on or after January 1, 2021.

    (a) Establishing a quality performance standard--(1) Overall 
standard. The quality performance standard is the overall standard the 
ACO must meet in order to be eligible to receive shared savings for a 
performance year. An ACO will not qualify to share in savings in any 
year it fails to meet the quality performance standard.
    (2) For performance year 2022 and subsequent performance years. For 
the first performance year of an ACO's first agreement period under the 
Shared Savings Program, if the ACO meets the data completeness 
requirement at Sec.  414.1340 of this chapter and case minimum 
requirement at Sec.  414.1380 of this chapter on the three measures it 
is actively required to report and fields a CAHPS for MIPS survey via 
the APP, the ACO will meet the quality performance standard.
    (3) For performance years 2021 and 2022--(i) Designation of quality 
performance standard. For all ACOs, except as specified in paragraph 
(a)(2) of this section, CMS designates the quality performance standard 
as the ACO reporting quality data via the APP established under Sec.  
414.1367 of this chapter, according to the method of submission 
established by CMS and achieving a quality performance score that is 
equivalent to or higher than the 30th percentile across all MIPS 
Quality performance category scores, excluding entities/providers 
eligible for facility-based scoring.
    (ii) For performance year 2021. If an ACO does not report any of 
the ten CMS Web Interface measures or any of the three measures it is 
actively required to report and does not field a CAHPS for MIPS survey 
via the APP, the ACO will not meet the quality performance standard.
    (iii) For performance year 2022. If an ACO does not report any of 
the three measures it is actively required to report and does not field 
a CAHPS for MIPS survey via the APP, the ACO will not meet the quality 
performance standard.
    (4) For performance years 2023 and subsequent performance years. 
(i) For all ACOs, except as specified in paragraph (a)(2) of this 
section, CMS designates the quality performance standard as the ACO 
reporting quality data via the APP established under Sec.  414.1367 of 
this chapter, according to the method of submission established by CMS 
and achieving a quality performance score that is equivalent to or 
higher than the 40th percentile across all MIPS Quality performance 
category scores, excluding entities/providers eligible for facility-
based scoring.
    (ii) If an ACO does not report any of the three measures it is 
actively required to report and does not field a CAHPS for MIPS survey 
via the APP, the ACO will not meet the quality performance standard.
    (b) Extreme and uncontrollable circumstances. For performance year 
2021 and subsequent performance years, including the applicable quality 
data reporting period for the performance year, CMS uses an alternative 
approach to calculating the quality score for ACOs affected by extreme 
and uncontrollable circumstances instead of the methodology specified 
in paragraph (a) of this section as follows:
    (1) CMS determines the ACO was affected by an extreme and 
uncontrollable circumstance based on either of the following:
    (i) Twenty percent or more of the ACO's assigned beneficiaries 
reside in an area identified under the Quality Payment Program as being 
affected by an extreme and uncontrollable circumstance.
    (A) Assignment is determined under subpart E of this part.
    (B) In making this determination, CMS uses the quarter four list of 
assigned beneficiaries.
    (ii) The ACO's legal entity is located in an area identified under 
the Quality Payment Program as being affected by an extreme and 
uncontrollable circumstance. An ACO's legal entity location is based on 
the address on file for the ACO in CMS' ACO application and management 
system.
    (2) If CMS determines the ACO meets the requirements of paragraph 
(b)(1) of this section, CMS calculates the ACO's quality score as 
follows:
    (i) For performance years 2021 and 2022, the ACO's minimum quality 
performance score is set to the equivalent of the 30th percentile MIPS 
Quality performance category score for the relevant performance year as 
determined under paragraph (a)(3) of this section.
    (ii) For performance year 2023 and subsequent performance years, 
the ACO's minimum quality performance score is set to the equivalent of 
the 40th percentile MIPS Quality performance category score for the 
relevant performance year as determined under paragraph (a)(4) of this 
section.
    (3) If the ACO reports quality data via the APP and meets data 
completeness and case minimum requirements:
    (i) For performance years 2021 and 2022, CMS will use the higher of 
the ACO's quality performance score or the equivalent of the 30th 
percentile MIPS Quality performance category score for the relevant 
performance year.
    (ii) For performance year 2023 and subsequent performance years, 
CMS will use the higher of the ACO's quality performance score or the 
equivalent of the 40th percentile MIPS Quality performance category 
score for the relevant performance year.
    (4) CMS applies determinations made under the Quality Payment 
Program with respect to--
    (i) Whether an extreme and uncontrollable circumstance has 
occurred; and
    (ii) The affected areas.
    (5) CMS has sole discretion to determine the time period during 
which an extreme and uncontrollable circumstance occurred, the 
percentage of the ACO's assigned beneficiaries residing in the affected 
areas, and the location of the ACO legal entity.

0
53. Section 425.600 is amended by revising paragraph (f)(4)(i) to read 
as follows:


Sec.  425.600  Selection of risk model.

* * * * *
    (f) * * *
    (4) * * *

[[Page 85042]]

    (i) The quality performance standard as described in Sec.  
425.502(a) or Sec.  425.512(a), as applicable.
* * * * *

0
54. Section 425.601 is amended by revising paragraphs (a)(9) and 
(f)(5)(iv) to read as follows:


Sec.  425.601  Establishing, adjusting, and updating the benchmark for 
agreement periods beginning on July 1, 2019, and in subsequent years.

    (a) * * *
    (9) For the second and each subsequent performance year during the 
term of the agreement period, the ACO's benchmark is adjusted for the 
following, as applicable: For the addition and removal of ACO 
participants or ACO providers/suppliers in accordance with Sec.  
425.118(b), for a change to the ACO's beneficiary assignment 
methodology selection under Sec.  425.226(a)(1), and for a change to 
the beneficiary assignment methodology specified in subpart E of this 
part. To adjust the benchmark, CMS does the following:
    (i) Takes into account the expenditures of beneficiaries who would 
have been assigned to the ACO in any of the 3 most recent years prior 
to the start of the agreement period.
    (ii) Redetermines the regional adjustment amount under paragraph 
(a)(8) of this section, according to the ACO's assigned beneficiaries 
for BY3.
* * * * *
    (f) * * *
    (5) * * *
    (iv) If during the term of the agreement period CMS adjusts the 
ACO's benchmark, as specified in paragraph (a)(9) of this section, CMS 
redetermines whether the ACO is considered to have lower spending or 
higher spending compared to the ACO's regional service area for 
purposes of determining the percentage in paragraphs (f)(1) and (2) of 
this section used in calculating the adjustment under either paragraph 
(a)(8) or (e) of this section.
* * * * *

0
55. Section 425.602 is amended by revising paragraph (a)(8) to read as 
follows:


Sec.  425.602  Establishing, adjusting, and updating the benchmark for 
an ACO's first agreement period beginning on or before January 1, 2018.

    (a) * * *
    (8) The ACO's benchmark is adjusted for the addition and removal of 
ACO participants or ACO providers/suppliers in accordance with Sec.  
425.118(b) and for a change to the beneficiary assignment methodology 
specified in subpart E of this part, as applicable, to take into 
account the expenditures for beneficiaries who would have been assigned 
to the ACO in any of the 3 most recent years prior to the start of the 
agreement period.
* * * * *


0
56. Section 425.603 is amended by revising paragraphs (c)(8) and 
(c)(9)(ii)(B)(4)(iv) to read as follows:


Sec.  425.603  Resetting, adjusting, and updating the benchmark for a 
subsequent agreement period beginning on or before January 1, 2019.

* * * * *
    (c) * * *
    (8) The ACO's benchmark is adjusted for the following, as 
applicable: For the addition and removal of ACO participants or ACO 
providers/suppliers in accordance with Sec.  425.118(b), and for a 
change to the beneficiary assignment methodology specified in subpart E 
of this part. To adjust the benchmark, CMS does the following:
    (i) Takes into account the expenditures for beneficiaries who would 
have been assigned to the ACO in any of the 3 most recent years prior 
to the start of the agreement period.
    (ii) Redetermines the regional adjustment amount under paragraph 
(c)(9) of this section, according to the ACO's assigned beneficiaries 
for BY3.
    (9) * * *
    (ii) * * *
    (B) * * *
    (4) * * *
    (iv) If CMS adjusts the ACO's benchmark, as specified in paragraph 
(c)(8) of this section, CMS redetermines whether the ACO is considered 
to have lower spending or higher spending compared to the ACO's 
regional service area for purposes of determining the percentage used 
in calculating the adjustment in paragraphs (c)(9)(ii)(B)(1) and (2) of 
this section.
* * * * *

0
57. Section 425.604 is amended by revising paragraphs (c) and (d) to 
read as follows:


Sec.  425.604  Calculation of savings under the one-sided model.

* * * * *
    (c) Qualification for shared savings payment--(1) For performance 
years (or a performance period) beginning on or before January 1, 2020. 
In order to qualify for shared savings, an ACO must meet or exceed its 
minimum savings rate determined under paragraph (b) of this section, 
meet the minimum quality performance standards established under Sec.  
425.502, and otherwise maintain its eligibility to participate in the 
Shared Savings Program under this part.
    (2) For the performance year beginning on January 1, 2021. To 
qualify for shared savings, an ACO must meet or exceed its minimum 
savings rate determined under paragraph (b) of this section, meet the 
quality performance standard established under Sec.  425.512, and 
otherwise maintain its eligibility to participate in the Shared Savings 
Program under this part.
    (d) Final sharing rate--(1) For performance years (or a performance 
period) beginning on or before January 1, 2020. An ACO that meets all 
the requirements for receiving shared savings payments under the one-
sided model will receive a shared savings payment of up to 50 percent 
of all savings under the updated benchmark, as determined on the basis 
of its quality performance under Sec.  425.502 (up to the performance 
payment limit described in paragraph (e)(2) of this section).
    (2) For the performance year beginning on January 1, 2021. An ACO 
that meets all the requirements for receiving shared savings payments 
under Track 1 will receive a shared savings payment of 50 percent of 
all the savings under the updated benchmark (up to the performance 
payment limit described in paragraph (e)(2) of this section).
* * * * *

0
58. Section 425.605 is amended by revising paragraphs (c), 
(d)(1)(i)(A), (d)(1)(ii)(A), (d)(1)(iii)(A), (d)(1)(iv)(A), and 
(d)(1)(v)(A) to read as follows:


Sec.  425.605  Calculation of shared savings and losses under the BASIC 
track.

* * * * *
    (c) Qualification for shared savings payment--(1) For performance 
years beginning on or before January 1, 2020. To qualify for shared 
savings, an ACO must meet the minimum savings rate requirement 
established under paragraph (b) of this section, meet the minimum 
quality performance standards established under Sec.  425.502, and 
otherwise maintain its eligibility to participate in the Shared Savings 
Program under this part.
    (2) For performance years beginning on or after January 1, 2021. To 
qualify for shared savings, an ACO must meet the minimum savings rate 
requirement established under paragraph (b) of this section, meet the 
quality performance standard established under Sec.  425.512, and 
otherwise maintain its eligibility to participate in the Shared Savings 
Program under this part.
    (d) * * *
    (1) * * *
    (i) * * *
    (A) Final sharing rate--(1) For performance years beginning on or

[[Page 85043]]

before January 1, 2020. An ACO that meets all the requirements for 
receiving shared savings payments under the BASIC track, Level A, 
receives a shared savings payment of up to 40 percent of all the 
savings under the updated benchmark, as determined on the basis of its 
quality performance under Sec.  425.502 (up to the performance payment 
limit described in paragraph (d)(1)(i)(B) of this section).
    (2) For performance years beginning on or after January 1, 2021. An 
ACO that meets all the requirements for receiving shared savings 
payments under the BASIC track, Level A, receives a shared savings 
payment of 40 percent of all the savings under the updated benchmark 
(up to the performance payment limit described in paragraph 
(d)(1)(i)(B) of this section).
* * * * *
    (ii) * * *
    (A) Final sharing rate--(1) For performance years beginning on or 
before January 1, 2020. An ACO that meets all the requirements for 
receiving shared savings payments under the BASIC track, Level B, 
receives a shared savings payment of up to 40 percent of all the 
savings under the updated benchmark, as determined on the basis of its 
quality performance under Sec.  425.502 (up to the performance payment 
limit described in paragraph (d)(1)(ii)(B) of this section).
    (2) For performance years beginning on or after January 1, 2021. An 
ACO that meets all the requirements for receiving shared savings 
payments under the BASIC track, Level B, receives a shared savings 
payment of 40 percent of all the savings under the updated benchmark 
(up to the performance payment limit described in paragraph 
(d)(1)(ii)(B) of this section).
* * * * *
    (iii) * * *
    (A) Final sharing rate--(1) For performance years beginning on or 
before January 1, 2020. An ACO that meets all the requirements for 
receiving shared savings payments under the BASIC track, Level C, 
receives a shared savings payment of up to 50 percent of all the 
savings under the updated benchmark, as determined on the basis of its 
quality performance under Sec.  425.502 (up to the performance payment 
limit described in paragraph (d)(1)(iii)(B) of this section).
    (2) For performance years beginning on or after January 1, 2021. An 
ACO that meets all the requirements for receiving shared savings 
payments under the BASIC track, Level C, receives a shared savings 
payment of 50 percent of all the savings under the updated benchmark 
(up to the performance payment limit described in paragraph 
(d)(1)(iii)(B) of this section).
* * * * *
    (iv) * * *
    (A) Final sharing rate--(1) For performance years beginning on or 
before January 1, 2020. An ACO that meets all the requirements for 
receiving shared savings payments under the BASIC track, Level D, 
receives a shared savings payment of up to 50 percent of all the 
savings under the updated benchmark, as determined on the basis of its 
quality performance under Sec.  425.502 (up to the performance payment 
limit described in paragraph (d)(1)(iv)(B) of this section).
    (2) For performance years beginning on or after January 1, 2021. An 
ACO that meets all the requirements for receiving shared savings 
payments under the BASIC track, Level D, receives a shared savings 
payment of 50 percent of all the savings under the updated benchmark 
(up to the performance payment limit described in paragraph 
(d)(1)(iv)(B) of this section).
* * * * *
    (v) * * *
    (A) Final sharing rate--(1) For performance years beginning on or 
before January 1, 2020. An ACO that meets all the requirements for 
receiving shared savings payments under the BASIC track, Level E, 
receives a shared savings payment of up to 50 percent of all the 
savings under the updated benchmark, as determined on the basis of its 
quality performance under Sec.  425.502 (up to the performance payment 
limit described in paragraph (d)(1)(v)(B) of this section).
    (2) For performance years beginning on or after January 1, 2021. An 
ACO that meets all the requirements for receiving shared savings 
payments under the BASIC track, Level E, receives a shared savings 
payment of 50 percent of all the savings under the updated benchmark 
(up to the performance payment limit described in paragraph 
(d)(1)(v)(B) of this section).
* * * * *

0
59. Section 425.606 is amended by revising paragraphs (c), (d), and (f) 
to read as follows:


Sec.  425.606  Calculation of shared savings and losses under Track 2.

* * * * *
    (c) Qualification for shared savings payment--(1) For performance 
years (or a performance period) beginning on or before January 1, 2020. 
To qualify for shared savings, an ACO must meet the minimum savings 
rate requirement established under paragraph (b) of this section, meet 
the minimum quality performance standards established under Sec.  
425.502, and otherwise maintain its eligibility to participate in the 
Shared Savings Program under this part.
    (2) For the performance year beginning on January 1, 2021. To 
qualify for shared savings, an ACO must meet the minimum savings rate 
requirement established under paragraph (b) of this section, meet the 
quality performance standard established under Sec.  425.512, and 
otherwise maintain its eligibility to participate in the Shared Savings 
Program under this part.
    (d) Final sharing rate--(1) For performance years (or a performance 
period) beginning on or before January 1, 2020. An ACO that meets all 
the requirements for receiving shared savings payments under Track 2 
will receive a shared savings payment of up to 60 percent of all the 
savings under the updated benchmark, as determined on the basis of its 
quality performance under Sec.  425.502 (up to the performance payment 
limit described in paragraph (e)(2) of this section).
    (2) For the performance year beginning on January 1, 2021. An ACO 
that meets all the requirements for receiving shared savings payments 
under Track 2 will receive a shared savings payment of 60 percent of 
all the savings under the updated benchmark (up to the performance 
payment limit described in paragraph (e)(2) of this section).
* * * * *
    (f) Shared loss rate--(1) For performance years (or a performance 
period) beginning on or before January 1, 2020. For an ACO that is 
required to share losses with the Medicare program for expenditures 
over the updated benchmark, the amount of shared losses is determined 
based on the inverse of its final sharing rate described in paragraph 
(d)(1) of this section (that is, 1 minus the final shared savings rate 
determined under paragraph (d)(1) of this section). The shared loss 
rate--
    (i) May not exceed 60 percent; and
    (ii) May not be less than 40 percent.
    (2) For the performance year beginning on January 1, 2021. For an 
ACO that is required to share losses with the Medicare program for 
expenditures over the updated benchmark, the amount of shared losses is 
determined as follows:
    (i) If the ACO meets the quality performance standard established 
in Sec.  425.512, CMS determines the shared loss rate as follows:
    (A) Calculate the quotient of the MIPS Quality performance category 
points

[[Page 85044]]

earned divided by the total MIPS Quality performance category points 
available.
    (B) Calculate the product of the quotient determined in paragraph 
(f)(2)(i)(A) of this section and 60 percent.
    (C) Calculate the shared loss rate as 1 minus the product 
determined in paragraph (f)(2)(i)(B) of this section. The shared loss 
rate--
    (1) May not exceed 60 percent; and
    (2) May not be less than 40 percent.
    (ii) If the ACO fails to meet the quality performance standard 
established in Sec.  425.512, the shared loss rate is 60 percent.
* * * * *


0
60. Section 425.610 is amended by revising paragraphs (c), (d), and (f) 
to read as follows:


Sec.  425.610  Calculation of shared savings and losses under the 
ENHANCED track.

* * * * *
    (c) Qualification for shared savings payment--(1) For performance 
years (or a performance period) beginning on or before January 1, 2020. 
To qualify for shared savings, an ACO must meet the minimum savings 
rate requirement established under paragraph (b) of this section, meet 
the minimum quality performance standards established under Sec.  
425.502, and otherwise maintain its eligibility to participate in the 
Shared Savings Program under this part.
    (2) For performance years beginning on or after January 1, 2021. To 
qualify for shared savings, an ACO must meet the minimum savings rate 
requirement established under paragraph (b) of this section, meet the 
quality performance standard established under Sec.  425.512, and 
otherwise maintain its eligibility to participate in the Shared Savings 
Program under this part.
    (d) Final sharing rate--(1) For performance years (or a performance 
period) beginning on or before January 1, 2020. An ACO that meets all 
the requirements for receiving shared savings payments under the 
ENHANCED track will receive a shared savings payment of up to 75 
percent of all the savings under the updated benchmark, as determined 
on the basis of its quality performance under Sec.  425.502 (up to the 
performance payment limit described in paragraph (e)(2) of this 
section).
    (2) For performance years beginning on or after January 1, 2021. An 
ACO that meets all the requirements for receiving shared savings 
payments under the ENHANCED track will receive a shared savings payment 
of 75 percent of all the savings under the updated benchmark (up to the 
performance payment limit described in paragraph (e)(2) of this 
section).
* * * * *
    (f) Shared loss rate--(1) For performance years (or a performance 
period) beginning on or before January 1, 2020. For an ACO that is 
required to share losses with the Medicare program for expenditures 
over the updated benchmark, the amount of shared losses is determined 
based on the inverse of its final sharing rate described in paragraph 
(d)(1) of this section (that is, 1 minus the final shared savings rate 
determined under paragraph (d)(1) of this section). The shared loss 
rate--
    (i) May not exceed 75 percent; and
    (ii) May not be less than 40 percent.
    (2) For performance years beginning on or after January 1, 2021. 
For an ACO that is required to share losses with the Medicare program 
for expenditures over the updated benchmark, the amount of shared 
losses is determined as follows:
    (i) If the ACO meets the quality performance standard established 
in Sec.  425.512, CMS determines the shared loss rate as follows:
    (A) Calculate the quotient of the MIPS Quality performance category 
points earned divided by the total MIPS Quality performance category 
points available.
    (B) Calculate the product of the quotient determined in paragraph 
(f)(2)(i)(A) of this section, and 75 percent.
    (C) Calculate the shared loss rate as 1 minus the product 
determined in paragraph (f)(2)(i)(B) of this section. The shared loss 
rate--
    (1) May not exceed 75 percent; and
    (2) May not be less than 40 percent.
    (ii) If the ACO fails to meet the quality performance standard 
established in Sec.  425.512, the shared loss rate is 75 percent.
* * * * *

0
61. Section 425.611 is amended by revising paragraph (b)(1)(ii) to read 
as follows:


Sec.  425.611  Adjustments to Shared Savings Program calculations to 
address the COVID-19 pandemic.

* * * * *
    (b) * * *
    (1) * * *
    (ii) Discharges for acute care inpatient services for treatment of 
COVID-19 from facilities that are not paid under the inpatient 
prospective payment system, such as CAHs, when the date of discharge 
occurs within the Public Health Emergency as defined in Sec.  400.200 
of this chapter.
* * * * *


Sec.  425.800  [Amended]

0
62. Section 425.800 is amended--
0
a. In paragraph (a)(1) by removing the references ``Sec.  425.500 and 
Sec.  425.502'' and adding in its place the references ``Sec. Sec.  
425.500, 425.502, 425.510, and 425.512; ''
0
b. In paragraph (a)(2) by removing the reference ``Sec.  425.502'' and 
adding in its place the references ``Sec.  425.502 or Sec.  425.512, as 
applicable''; and
0
c. In paragraph (a)(6) by removing the reference ``Sec.  425.502'' and 
adding in its place the references ``Sec.  425.502 or Sec.  425.512, as 
applicable''.

    Dated: November 18, 2020.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.

    Dated: November 23, 2020.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
BILLING CODE 4120-01-P

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[FR Doc. 2020-26815 Filed 12-2-20; 4:15 pm]
BILLING CODE 4120-01-C