[Federal Register Volume 85, Number 159 (Monday, August 17, 2020)]
[Proposed Rules]
[Pages 50074-50665]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17127]



[[Page 50073]]

Vol. 85

Monday,

No. 159

August 17, 2020

Part II





 Department of Health and Human Services





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





 Centers for Medicare & Medicaid Services





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





42 CFR Parts 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 Under a Prescription Drug Plan or an MA-PD Plan; Payment for 
Office/Outpatient Evaluation and Management Services; Hospital IQR 
Program; Establish New Code Categories; and Medicare Diabetes 
Prevention Program (MDPP) Expanded Model Emergency Policy; Proposed 
Rule

  Federal Register / Vol. 85, No. 159 / Monday, August 17, 2020 / 
Proposed Rules  

[[Page 50074]]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

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

[CMS-1734-P]
RIN 0938-AU10


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 Under a Prescription Drug Plan or an MA-PD 
Plan; Payment for Office/Outpatient Evaluation and Management Services; 
Hospital IQR Program; Establish New Code Categories; and Medicare 
Diabetes Prevention Program (MDPP) Expanded Model Emergency Policy

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

ACTION: Proposed rule.

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

SUMMARY: This major proposed 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.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on October 5, 2020. 
(See the SUPPLEMENTARY INFORMATION section of this proposed rule for a 
list of provisions open for comment.)

ADDRESSES: In commenting, please refer to file code CMS-1734-P.
    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-P, P.O. Box 8016, 
Baltimore, MD 21244-8016.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-1734-P, 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, and specialty-specific impacts 
of PFS proposals.
    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 and 
other services involving communications technology.
    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, 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.
    Pamela West, (410) 786-2302, 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 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, 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, for issues related to the Medicare 
Shared Savings Program (Shared Savings Program) Quality performance 
standard and quality reporting requirements.
    Janae James, (410) 786-0801, or Elizabeth November, (410) 786-4518, 
or [email protected], for issues related to Shared 
Savings Program beneficiary assignment and repayment mechanism 
requirements.
    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
    Irina Akelaitis, (410) 786-4602, for issues related to HCPCS Level 
II codes.

[[Page 50075]]

    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).

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://regulations.gov. Follow the search instructions on that website to view 
public comments.
    Addenda Available Only Through the Internet on the CMS Website: The 
PFS Addenda along with other supporting documents and tables referenced 
in this proposed rule are available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-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 proposed rule, refer to item CMS-1734-P. Readers with 
questions related to accessing any of the Addenda or other supporting 
documents referenced in this proposed rule and posted on the CMS 
website identified above should contact Jamie Hermansen at (410) 786-
2064.
    CPT (Current Procedural Terminology) Copyright Notice: Throughout 
this proposed rule, we use CPT codes and descriptions to refer to a 
variety of services. We note that CPT codes and descriptions are 
copyright 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 proposed rule proposes to revise payment polices under 
the Medicare PFS and makes other policy changes, including proposals to 
implement 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 proposed rule includes provisions related to other 
payment policy changes that are addressed in section III. of this 
proposed rule.
1. Summary of the Major Provisions
    The statute requires us to establish payments under the PFS based 
on national uniform relative value units (RVUs) that account for the 
relative resources used in furnishing a service. The statute requires 
that RVUs be established for three categories of resources: Work; 
practice expense (PE); and malpractice (MP) expense. In addition, the 
statute requires that we establish by regulation each year's payment 
amounts for all physicians' services paid under the PFS, incorporating 
geographic adjustments to reflect the variations in the costs of 
furnishing services in different geographic areas.
    In this major proposed rule, we are proposing to establish RVUs for 
CY 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 proposed rule also includes 
discussions and provisions regarding several other Medicare Part B 
payment policies.
    Specifically, this proposed rule addresses:

 Practice Expense RVUs (section II.B.)
 Potentially Misvalued Services Under the PFS (section II.C.)
 Telehealth and Other Services Involving Communications 
Technology (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 COVID-19 Pandemic 
(section II.F.)
 Scopes of Practice and Related Issues (section II.G.)
 Valuation of Specific Codes (section II.H.)
 Modifications related to Medicare Coverage for Opioid Use 
Disorder (OUD) Services Furnished by Opioid Treatment Programs (OTPs) 
(section II.I.)
 Clinical Laboratory Fee Schedule: Revised Data Reporting 
Period and Phase-in of Payment Reductions, and a Comment Solicitation 
on Payment for Specimen Collection for Covid-19 Tests (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: Proposed 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.)
 Proposal to Remove 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 due 
to the 21st Century Cures Act Final Rule (section III.M.)
 Proposal to Establish New Code Categories (section III.N.)
 Medicare Diabetes Prevention Program (MDPP) expanded model 
Emergency Policy (section III.O.)
 CY 2021 Updates to the Quality Payment Program (section IV.)
 Planned 30-day Delayed Effective Date for the Final Rule 
(section V.)
 Collection of Information Requirements (section VI.)
 Response to Comments (section VII.)
 Regulatory Impact Analysis (section VIII.)

[[Page 50076]]

2. Summary of Costs and Benefits
    We have determined that this proposed rule is economically 
significant. For a detailed discussion of the economic impacts, see 
section VIII. of this proposed rule.
3. Waiver of the 60-Day Delayed 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 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 V. of the preamble of this proposed 
rule, we are hereby waiving the 60-day delay in the effective date of 
the final rule, and replacing it with a 30-day delay in the effective 
date of the final rule.

II. Provisions of the Proposed Rule for the PFS

A. Background

    Since January 1, 1992, Medicare has paid for physicians' services 
under section 1848 of the Act, ``Payment for Physicians' Services.'' 
The PFS relies on national relative values that are established for 
work, practice expense (PE), and malpractice (MP), which are adjusted 
for geographic cost variations. These values are multiplied by a 
conversion factor (CF) to convert the relative value units (RVUs) into 
payment rates. The concepts and methodology underlying the PFS were 
enacted as part of the Omnibus Budget Reconciliation Act of 1989 (Pub. 
L. 101-239, enacted on December 19, 1989) (OBRA '89), and the Omnibus 
Budget Reconciliation Act of 1990 (Pub. L. 101-508, enacted on November 
5, 1990) (OBRA '90). The final rule published 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 proposed rule, unless otherwise noted, 
the term ``practitioner'' is used to describe both physicians and 
nonphysician practitioners (NPPs) who are permitted to bill Medicare 
under the PFS for the services they furnish to Medicare beneficiaries.
1. Development of the 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

[[Page 50077]]

25664) that set forth the criteria for the submission of these 
supplemental PE survey data. The criteria were modified in response to 
comments received, and published in the Federal Register (65 FR 65376) 
as part of a November 1, 2000 final rule. The PFS final rules published 
in 2001 and 2003, respectively, (66 FR 55246 and 68 FR 63196) extended 
the period during which we would accept these supplemental data through 
March 1, 2005.
    In the CY 2007 PFS final rule with comment period (71 FR 69624), we 
revised the methodology for calculating direct PE RVUs from the top-
down to the bottom-up methodology beginning in CY 2007. We adopted a 4-
year transition to the new PE RVUs. This transition was completed for 
CY 2010. In the CY 2010 PFS final rule with comment period, we updated 
the practice expense per hour (PE/HR) data that are used in the 
calculation of PE RVUs for most specialties (74 FR 61749). In CY 2010, 
we began a 4-year transition to the new PE RVUs using the updated PE/HR 
data, which was completed for CY 2013.
c. Malpractice RVUs
    Section 4505(f) of the BBA '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 VII. of this proposed 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 relative value 
units under the PFS and proposed changes to the PE methodology CY 2007 
PFS proposed

[[Page 50078]]

notice (71 FR 37242) and the CY 2007 PFS final rule with comment period 
(71 FR 69629).
b. Indirect Practice Expense per Hour Data
    We use survey data on indirect PEs incurred per hour worked, in 
developing the indirect portion of the PE RVUs. Prior to CY 2010, we 
primarily used the PE/HR by specialty that was obtained from the AMA's 
SMS. The AMA administered a new survey in CY 2007 and CY 2008, the 
Physician Practice Expense Information Survey (PPIS). The PPIS is a 
multispecialty, nationally representative, PE survey of both physicians 
and NPPs paid under the PFS using a survey instrument and methods 
highly consistent with those used for the SMS and the supplemental 
surveys. The PPIS gathered information from 3,656 respondents across 51 
physician specialty and health care professional groups. We believe the 
PPIS is the most comprehensive source of PE survey information 
available. We used the PPIS data to update the PE/HR data for the CY 
2010 PFS for almost all of the Medicare-recognized specialties that 
participated in the survey.
    When we began using the PPIS data in CY 2010, we did not change the 
PE RVU methodology itself or the manner in which the PE/HR data are 
used in that methodology. We only updated the PE/HR data based on the 
new survey. Furthermore, as we explained in the CY 2010 PFS final rule 
with comment period (74 FR 61751), because of the magnitude of payment 
reductions for some specialties resulting from the use of the PPIS 
data, we transitioned its use over a 4-year period from the previous PE 
RVUs to the PE RVUs developed using the new PPIS data. As provided in 
the CY 2010 PFS final rule with comment period (74 FR 61751), the 
transition to the PPIS data was complete for CY 2013. Therefore, PE 
RVUs from CY 2013 forward are developed based entirely on the PPIS 
data, except as noted in this section.
    Section 1848(c)(2)(H)(i) of the Act requires us to use the medical 
oncology supplemental survey data submitted in 2003 for oncology drug 
administration services. Therefore, the PE/HR for medical oncology, 
hematology, and hematology/oncology reflects the continued use of these 
supplemental survey data.
    Supplemental survey data on independent labs from the College of 
American Pathologists were implemented for payments beginning in CY 
2005. Supplemental survey data from the National Coalition of Quality 
Diagnostic Imaging Services (NCQDIS), representing independent 
diagnostic testing facilities (IDTFs), were blended with supplementary 
survey data from the American College of Radiology (ACR) and 
implemented for payments beginning in CY 2007. Neither IDTFs, nor 
independent labs, participated in the PPIS. Therefore, we continue to 
use the PE/HR that was developed from their supplemental survey data.
    Consistent with our past practice, the previous indirect PE/HR 
values from the supplemental surveys for these specialties were updated 
to CY 2006 using the Medicare Economic Index (MEI) to put them on a 
comparable basis with the PPIS data.
    We also do not use the PPIS data for reproductive endocrinology and 
spine surgery since these specialties currently are not separately 
recognized by Medicare, nor do we have a method to blend the PPIS data 
with Medicare-recognized specialty data.
    Previously, we established PE/HR values for various specialties 
without SMS or supplemental survey data by crosswalking them to other 
similar specialties to estimate a proxy PE/HR. For specialties that 
were part of the PPIS for which we previously used a crosswalked PE/HR, 
we instead used the PPIS-based PE/HR. We use crosswalks for specialties 
that did not participate in the PPIS. These crosswalks have been 
generally established through notice and comment rulemaking and are 
available in the file titled ``CY 2021 PFS Proposed Rule PE/HR'' 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.
    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 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 soliciting 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 are seeking 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.
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

[[Page 50079]]

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 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 proposed 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 proposed rule for individual codes.
(a) Setup File
    First, we create a setup file for the PE methodology. The setup 
file contains the direct cost inputs, the utilization for each 
procedure code at the specialty and facility/nonfacility place of 
service level, and the specialty-specific PE/HR data calculated from 
the surveys.
(b) Calculate the Direct Cost PE RVUs
    Sum the costs of each direct input.
    Step 1: Sum the direct costs of the inputs for each service.
    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 
instead use the expected specialty that we identify on a list developed 
based on medical review and input from expert stakeholders. We display 
this list of expected specialty assignments as part of the annual set 
of data files we make available as part of notice and comment 
rulemaking and consider recommendations from the RUC and

[[Page 50080]]

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.
    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 proposed aggregate work RVUs scaled by the ratio of 
current aggregate PE and work RVUs. This adjustment ensures that all PE 
RVUs in the PFS account for the fact that certain specialties are 
excluded from the calculation of PE RVUs but included in maintaining 
overall PFS budget neutrality. (See ``Specialties excluded from 
ratesetting calculation'' later in this proposed 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.
BILLING CODE 4120-01-P

[[Page 50081]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.001

BILLING CODE 4120-01-C
     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 50082]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.002

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

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

Where:

minutes per year = maximum minutes per year if usage were continuous 
(that is, usage = 1); generally 150,000 minutes.
usage = variable, see discussion below in this proposed rule.
price = price of the particular piece of equipment.
life of equipment = useful life of the particular piece of 
equipment.
maintenance = factor for maintenance; 0.05.
interest rate = variable, see discussion below in this proposed 
rule.

    Usage: We currently use an equipment utilization rate assumption of 
50 percent for most equipment, with the exception of expensive 
diagnostic imaging equipment, for which we use a 90 percent assumption 
as required by section 1848(b)(4)(C) of the Act.
    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.
    We note 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 three 
months in one case. We have rarely, if ever, received requests for 
equipment useful life of less than one 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:

[[Page 50083]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.003

    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 note 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 are 
proposing a clarification on how to address these cases.
    We disagree 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 have 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 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 seek to clarify through 
this rulemaking. We also note 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 do 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 proposing 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 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 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 are proposing 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 
proposed rule) portion of the preamble. 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 
welcome 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.
     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 
believe it likely overstates the maintenance costs for other equipment. 
When we solicited comments regarding sources of data containing 
equipment maintenance rates, commenters were unable to identify an 
auditable, robust data source that could be used by CMS on a wide 
scale. We do not believe that voluntary submissions regarding the 
maintenance costs of individual equipment items would be an appropriate 
methodology for determining costs. As a result, in the absence of 
publicly available datasets regarding equipment maintenance costs or 
another systematic data collection methodology for determining a 
different maintenance factor, we are not proposing a variable 
maintenance factor for equipment cost per minute pricing as we do not 
believe that we have sufficient information at present. We continue to 
investigate potential avenues for determining equipment maintenance 
costs across a broad range of equipment items.
     Interest Rate: In the CY 2013 PFS final rule with comment 
period (77 FR 68902), we updated the interest rates used in developing 
an equipment cost per minute calculation (see 77 FR 68902 for a 
thorough discussion of this issue). The interest rate was based on the 
Small Business Administration (SBA) maximum interest rates for 
different categories of loan size (equipment cost) and maturity (useful 
life). The Interest rates are listed in Table 4.

[[Page 50084]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.004

    We are not proposing 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 2020 direct PE input public use files, which are 
available on the CMS website under downloads for the CY 2020 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.
    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

[[Page 50085]]

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 proposed 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 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

[[Page 50086]]

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 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 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:

[[Page 50087]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.005

    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 remain open to the submission of additional invoices to 
establish individual pricing for these scopes, and we continue to 
welcome 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 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 are proposing to update the price the 
ES031 scope video system equipment to $70,673.38. We are not proposing 
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 are soliciting 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 are 
proposing to transition this pricing increase over the remaining two 
years of the pricing update, 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 note 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 are 
proposing to transition the EQ235 pricing increase over the remaining 2 
years of the pricing update, such that the CY 2021 equipment price will 
be $1,981.66 before moving to its destination price of $ $3,195.85 in 
CY 2022. As we stated previously, this

[[Page 50088]]

policy is 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 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 are not 
proposing to further update the prices of these scopes.
    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.
c. Technical Corrections to Direct PE Input Database and Supporting 
Files
    For CY 2021, we are proposing 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 
are proposing 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.
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 are proposing 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 are proposing 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 27: 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

[[Page 50089]]

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-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 6.
[GRAPHIC] [TIFF OMITTED] TP17AU20.006

    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

[[Page 50090]]

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 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 are proposing 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 6. 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 7 contains the list of proposed CY 
2021 market-based supply and equipment pricing updates:
[GRAPHIC] [TIFF OMITTED] TP17AU20.007

    The proposed prices for the supply and equipment items listed in 
Table 7 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 proposed 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

[[Page 50091]]

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 are proposing 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 are not proposing 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 are not proposing 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 two years ago for CY 2019.
    We are also not proposing 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 are not proposing 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 what supply or equipment item this invoice was intended to 
update. As a result, we were unable to use this invoice to make a 
pricing proposal.
(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 proposed 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 are proposing to remove the SA103 supply item from CPT 
codes 37238 and 37239. We are proposing to replace it with a newly 
created ``venous stent system'' (SD340) supply at the same supply 
quantity. We are proposing 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 are proposing the use of the median price due to the 
presence of several invoices that appear to be outliers which are not 
reflective of 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 
welcome additional information from stakeholders regarding the nature 
and pricing of this supply item.
(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

[[Page 50092]]

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 (e.g., 
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 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 are proposing 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 are also proposing 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 are proposing 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 proposed rule. Finally, we 
are removing the ``PET Generator (Rubidium)'' (ER114) equipment from 
our database as requested by the stakeholders. We note 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.
(5) 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 are proposing to continue with the fourth and final 
year of the transition of this adjustment to the standard process for 
allocating indirect PE.
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.

[[Page 50093]]

    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 are thinking through 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 are soliciting comment regarding how we might update the 
clinical labor data. Historically, we have used data from the Bureau of 
Labor Statistics and are seeking comment to determine if this is the 
best data source or if there is an alternative. We are also 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 welcome feedback from all interested parties regarding 
RAND's report and we are not making any proposals based on this report 
at this time. Stakeholders are encouraged to submit feedback as part of 
their public comments or, if outside the public comment process, via 
email at [email protected].

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 RVUs 
established under the PFS. Section 1848(c)(2)(K) of the Act requires 
the Secretary to periodically identify potentially misvalued services 
using certain criteria and to review and make appropriate adjustments 
to the relative values for those services. Section 1848(c)(2)(L) of the 
Act also requires the Secretary to develop a process to validate the 
RVUs of certain potentially misvalued codes under the PFS, using the 
same criteria used to identify potentially misvalued codes, and to make 
appropriate adjustments.
    As discussed in section II.H. of this proposed rule, Valuation of 
Specific Codes, each year we develop appropriate adjustments to the 
RVUs taking into account recommendations provided by the American 
Medical Association Resource-Based Relative Value Scale (RVS) Update 
Committee (RUC), 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

[[Page 50094]]

furnished at the same time as other services.
     Codes with high intraservice work per unit of time.
     Codes with high PE RVUs.
     Codes with high cost supplies.
     Codes as determined appropriate by the Secretary.
    Section 1848(c)(2)(K)(iii) of the Act also specifies that the 
Secretary may use existing processes to receive recommendations on the 
review and appropriate adjustment of potentially misvalued services. In 
addition, the Secretary may conduct surveys, other data collection 
activities, studies, or other analyses, as the Secretary determines to 
be appropriate, to facilitate the review and appropriate adjustment of 
potentially misvalued services. This section also authorizes the use of 
analytic contractors to identify and analyze potentially misvalued 
codes, conduct surveys or collect data, and make recommendations on the 
review and appropriate adjustment of potentially misvalued services. 
Additionally, this section provides that the Secretary may coordinate 
the review and adjustment of any RVU with the periodic review described 
in section 1848(c)(2)(B) of the Act. Section 1848(c)(2)(K)(iii)(V) of 
the Act specifies that the Secretary may make appropriate coding 
revisions (including using existing processes for consideration of 
coding changes) that may include consolidation of individual services 
into bundled codes for payment under the PFS.
2. Progress in Identifying and Reviewing Potentially Misvalued Codes
    To fulfill our statutory mandate, we have identified and reviewed 
numerous potentially misvalued codes as specified in section 
1848(c)(2)(K)(ii) of the Act, and we intend to continue our work 
examining potentially misvalued codes in these areas over the upcoming 
years. As part of our current process, we identify potentially 
misvalued codes for review, and request recommendations from the RUC 
and other public commenters on revised work RVUs and direct PE inputs 
for those codes. The RUC, through its own processes, also identifies 
potentially misvalued codes for review. Through our public nomination 
process for potentially misvalued codes established in the CY 2012 PFS 
final rule with comment period, other individuals and stakeholder 
groups submit nominations for review of potentially misvalued codes as 
well. 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 have 
continued 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.

[[Page 50095]]

     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 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 practice expense related inputs prior to our February 10, 2020 
deadline. We refer readers to section II.B. of this proposed rule, 
Determination of Practice Expense RVUs, for further discussion on the 
PE-related submissions. Our 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], [eg, 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 are 
proposing to nominate CPT code 22867 as potentially misvalued and 
welcome public comment on this code.

D. Telehealth and Other Services Involving Communications Technology

1. Payment for Medicare Telehealth Services Under Section 1834(m) of 
the Act
    As discussed in this proposed rule 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 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. This process provides the public with an 
ongoing opportunity to submit requests for adding services, which are 
then reviewed by us. Under this process, we assign any submitted 
request to add to the 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 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 include any supporting documentation the requester wishes us 
to consider as we review the request. Because we use the annual PFS 
rulemaking process as the vehicle to

[[Page 50096]]

make changes to the Medicare telehealth services list, requesters 
should be advised that any information submitted as part of a request 
is subject to public disclosure for this purpose. For more information 
on submitting a request to add services to the 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 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 PHE for the COVID-19 pandemic, 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), (85 FR 19230, 19234 through 19241, March 31, 2020) 
(hereinafter referred to as the ``March 31st COVID-19 IFC''), on an 
interim final basis for the duration of the PHE for the COVID-19 
pandemic, 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 99468-99473; 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 the COVID-19 pandemic 
changes 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 interaction between professionals 
and patients poses 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 the best means to mitigate 
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 
telecommunication 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 the COVID-19 pandemic, 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. However, 
in the context of the PHE for the COVID-19 pandemic 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.
    In addition to considering public requests and services identified 
through internal review for additions to the Medicare telehealth 
services list, we have also considered which of the services added to 
the Medicare

[[Page 50097]]

telehealth services list on an interim basis should remain on the 
Medicare telehealth services list permanently or on an interim basis 
after the end of the PHE. The following presents a discussion of these 
services and related proposals.
    After reviewing the requests we received, the services we 
identified, and the services we added to the Medicare telehealth 
services list on an interim basis for the duration of the PHE, we 
identified the services we have listed in Table 8 as being sufficiently 
similar to services currently on the Medicare telehealth services list 
to be added on a Category 1 basis. Therefore, we are proposing to add 
the services in Table 8 to the Medicare telehealth services list on a 
Category 1 basis for CY 2021.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TP17AU20.008

BILLING CODE 4120-01-C

[[Page 50098]]

    We believe the services described by the HCPCS codes in Table 8 are 
similar to services currently on the Medicare telehealth services list. 
The add-on codes to the office/outpatient E/M services are, by 
definition, part of the office/outpatient E/M services since they 
cannot be billed with any other codes. 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 office/outpatient 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 or a co-occurring 
mental health disorder, furnished on or after July 1, 2019, to an 
individual with a substance use disorder diagnosis. These domiciliary/
home visits contain the same elements and similar descriptors to the 
office/outpatient 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. Additionally, we believe that, due 
to the vulnerability of this particular patient population, who are 
receiving treatment for a diagnosed substance use disorder or co-
occurring mental health disorder, we should maximize the availability 
of telehealth services for the treatment of substance use disorders and 
co-occurring mental health disorders. We note 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 substance use disorder 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 are proposing 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, as explained below. We are not 
proposing to add the services listed in Table 9 to the Medicare 
telehealth services list.
[GRAPHIC] [TIFF OMITTED] TP17AU20.009

    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 office/outpatient 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 with comment period (76 FR 73096 through 73097), physicians 
and nonphysician practitioners who may independently bill Medicare for 
their services and who are counseling individuals would generally 
report office or other outpatient evaluation and management (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 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; and 
there is no separate payment under the PFS for this category of codes. 
Therefore, we are not proposing to add this service 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
    Recently enacted legislation to address the COVID-19 pandemic 
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

[[Page 50099]]

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 the COVID-19 pandemic. Due to 
the circumstances of the COVID-19 pandemic, particularly the need to 
maintain physical distance to avoid exposure to the virus, we 
anticipate that health care practitioners are developing new approaches 
to providing care using various forms of technology when they are not 
physically present with the patient. We have established several 
flexibilities to accommodate these changes in the delivery of care. 
Through waiver authority under section 1135(b)(8) of the Act, in 
response to the PHE for the COVID-19 pandemic, we have 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 the COVID-19 
pandemic. 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 to the Medicare telehealth 
services list on an interim basis the services identified at the 
beginning of this section. Through the May 1st COVID-19 IFC, on an 
interim basis, we removed the requirement 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 several more 
additional services to the Medicare telehealth services list when we 
issued the May 1st COVID-19 IFC. At the conclusion of the PHE, 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. 
We believe that the experiences of clinicians who are furnishing 
telehealth services during the PHE 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, 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 ends prior to the end of calendar year 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 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 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 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 the COVID-19 
pandemic, we have 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 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 help 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 the COVID-19 pandemic so that we can 
understand 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 are proposing 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 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. 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 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 
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, there 
are increased concerns for patient safety if the service is furnished 
as a telehealth service.
     Whether, outside of the circumstances of the PHE, there 
are concerns about whether the provision of the service via telehealth 
is likely to jeopardize quality of care.
     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 recognize that the circumstances of the PHE 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

[[Page 50100]]

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, 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 the COVID-19 pandemic, we found that the added 
services met the Category 2 criteria on the basis that there is a 
patient population that 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 COVID-19 PHE, 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 is not known at this time. 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 are also proposing 
that the Category 3 criteria and 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 expires.
    We have 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. Therefore we are proposing to continue including these services on 
the Medicare telehealth services list through the calendar year in 
which the PHE ends. These services are listed in Table 10. We invite 
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. While our 
clinical assessment indicated that the services in Table 10 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 are seeking 
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 kinds of information we are seeking 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 office/outpatient 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 note 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 request that commenters 
consider these goals in conjunction with their comments on our 
proposals for the treatment of the telehealth services we added on an 
interim basis during the PHE for the COVID-19 pandemic:
     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, 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

[[Page 50101]]

regional variations in systems of care and the impact of the COVID-19 
pandemic.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TP17AU20.010


[[Page 50102]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.011

BILLING CODE 4120-01-C
d. Comment Solicitation on Medicare Telehealth Services Added on an 
Interim Basis During the PHE for the COVID-19 Pandemic That CMS Is Not 
Proposing To Retain After the PHE Ends
    In the March 31st COVID-19 IFC and the May 1st COVID-19 IFC, we 
finalized on an interim basis during the PHE for the COVID-19 pandemic 
the addition of a number of services to the Medicare telehealth 
services list. While a number of these services were previously 
requested and reviewed for addition by external stakeholders 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 
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. In 
our clinical review of these services, we did not identify sufficient 
information to suggest there is a potential likelihood of clinical 
benefit for these services such that they could meet the Category 1 or 
Category 2 criteria outside the circumstances of the PHE. We 
specifically considered the potential for these services to be 
furnished, outside the circumstances of the PHE, 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. Due to these concerns, we did not find a 
potential likelihood that the services could meet Category 2 criteria 
even with development of additional evidence. However, we are inviting 
public comment on whether any service added to the Medicare telehealth 
services list for the duration of the PHE for the COVID-19 pandemic 
should be added to the Medicare telehealth services list on a 
temporary, Category 3 basis, based on the criteria outlined above. We 
welcome additional information from commenters about these services, as 
outlined in our request for comment for services we are proposing to 
add to the Medicare telehealth services list on a Category 3 basis.
    We are also seeking specific comment on the following 
considerations associated with particular services. Comments on these 
specific concerns will also 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 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 have 
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 and 
therapeutic relationship would be compromised. We believe that 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 are concerned 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 are concerned 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 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

[[Page 50103]]

codes CPT 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 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 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 are concerned 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.
BILLING CODE 4120-01-P

[[Page 50104]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.012


[[Page 50105]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.013


[[Page 50106]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.014


[[Page 50107]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.015


[[Page 50108]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.016


[[Page 50109]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.017

BILLING CODE 4120-01-C
    With regard to the physical therapy, occupational therapy, and 
speech-language pathology services in Table Creceived a number of 
requests that we add therapy services to the Medicare telehealth 
services list. In the CY 2018 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 
this 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. While we continue to believe this is generally the case, 
and we are not proposing to add these services permanently to the 
Medicare telehealth services list, we are seeking 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 are also seeking comment on 
whether all aspects of these services can be fully and effectively 
furnished via two-way, audio/video telecommunications technology. We 
also note 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.
    With regard to the critical care services listed in Table 11, 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. 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 continue to believe 
that the full range of care for critically ill patients cannot be 
performed via two-way, audio/video telecommunications technology for 
the reasons articulated above, we are seeking 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 are seeking comment on the definition, potential coding and 
valuation for this kind of remote service. We are also seeking comment 
on the following concerns:
     How to distinguish the technical component of the remote 
monitoring portion of the service from the 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.
BILLING CODE 4120-01-P

[[Page 50110]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.018

BILLING CODE 4120-01-C
2. 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; 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 are proposing 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,

[[Page 50111]]

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 are also proposing 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 will consider those new codes to be successor codes 
to those that are on the Medicare telehealth services list, and will 
update the Medicare telehealth services list accordingly. At Sec.  
410.78(f), we are proposing 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.
3. 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 
nonphysician practitioner (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. We therefore 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 the COVID-19 pandemic, we waived the requirement 
in 42 CFR 483.30 for physicians and nonphysician practitioners to 
personally perform 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 are seeking public comment on whether it would be appropriate to 
maintain this flexibility on a permanent basis outside of the PHE for 
the COVID-19 pandemic. We invite 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 have also received requests to revise our frequency limitations 
for telehealth subsequent inpatient and nursing facility visits. 
Currently, 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 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 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 are not proposing to modify our 
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 
remove the frequency limitation for subsequent NF care services (83 FR 
59494). We have 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 are persuaded by the comments from these stakeholders, and 
therefore, are proposing to revise the frequency limitation from one 
visit every 30 days to one visit every 3 days. 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 are also seeking 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.

[[Page 50112]]

4. 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 
the COVID-19 pandemic. 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 were also concerned that the reference 
to ``telephones'' in the second sentence of the regulation as 
impermissible technology could cause confusion in instances where an 
otherwise eligible device, 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 are proposing to remove the second sentence of 
the regulation at Sec.  410.78(a)(3) which specifies that 
``[t]elephones, facsimile machines, and electronic mail systems do not 
meet the definition of an interactive telecommunications system.'' As 
we are proposing to adopt this change on a permanent basis, we are also 
proposing to delete the subparagraphs at Sec.  410.78(a)(3)(i) and 
410.78(a)(3)(ii). We believe these amendments to our regulations would 
remove outdated references to specific types of technology and provide 
a clearer statement of our policy.
5. 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 nonphysician practitioners 
(NPPs) consistent with the definition of their respective benefit 
category, although we did not provide specific examples (84 FR 62796).
    We have 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 the COVID-19 pandemic 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. We 
are proposing to adopt that policy on a permanent basis. We note that 
this is not an exhaustive list and we are seeking comment on other 
benefit categories into which these services fall.
    We are also proposing to allow billing of other CTBS by certain 
nonphysician practitioners, 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:
     G20X0 (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.)
     G20X2 (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 are proposing to value these services identically to HCPCS codes 
G2010 and G2012, respectively. We acknowledge 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 do not think that there is a significant differential in 
resource costs to warrant different values, but are seeking 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 therapists, we are 
proposing to designate HCPCS codes G20X0, G20X2, 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.

[[Page 50113]]

    We also note that in section II.K. of this proposed rule we are 
proposing 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 are also making clear 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 do not believe that the timing or manner 
in which beneficiary consent is acquired should interfere with the 
provision of one of these services. We are retaining the requirement 
that, in instances when the brief communication technology-based 
service 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.
6. Comment Solicitation on Continuation of Payment for Audio-Only 
Visits
    In the March 31st COVID-19 IFC, we established separate payment for 
audio-only telephone evaluation and management (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 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 and with the goal of reducing 
exposure risks associated with the COVID-19 pandemic, 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 the COVID-19 pandemic, 
work relative value units (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 
practice expense (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 1st 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, 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 COVID-19 pandemic 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 office/outpatient E/M codes, we established new RVUs for the 
telephone E/M services based on crosswalks to the most analogous 
office/outpatient E/M codes, based on the time requirements for the 
telephone codes and the times assumed for valuation for purposes of the 
office/outpatient 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 COVID-19 PHE, 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 office/outpatient E/M service. We 
noted that to the extent that these extended phone services are taking

[[Page 50114]]

place instead of office/outpatient 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 the COVID-19 pandemic are better captured by the RVUs 
associated with the level 2-4 established patient office/outpatient E/M 
visits. Additionally, we stated that, given our understanding that 
these audio-only services were being furnished as substitutes for 
office/outpatient 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 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.
    We are not proposing to continue to recognize these codes for 
payment under the PFS after conclusion of the PHE for the COVID-19 
pandemic 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 recognize 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 than what is 
described by the virtual check-in. We are seeking 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 are seeking 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 are also seeking 
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 or if it should be PFS payment 
policy permanently.
7. 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, other payers and 
health care providers, we have generally used the term ``Medicare 
telehealth services'' to refer to the subset of services defined in 
section 1834(m) of the Act. Section 1834(m) of the Act defines Medicare 
telehealth services and specifies the payment amounts and circumstances 
under which Medicare makes payment for a discrete set of services, all 
of which must ordinarily be furnished in-person, when they are instead 
furnished using interactive, real time telecommunication technology.
    We believe that the provisions in section 1834(m) of the Act apply 
particularly to the kinds of professional services explicitly 
enumerated in the statutory provisions, like professional 
consultations, office visits, and office psychiatry services. 
Generally, the services we have added to the 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 are seeking 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 are also seeking 
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 are broadly seeking 
comment on any impediments that contribute to healthcare provider 
burden and that may result in practitioners being reluctant to bill for 
CTBS. 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.
8. Proposed Clarification of Existing 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 
the COVID-19 pandemic, 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

[[Page 50115]]

by a physician in private practice. We note 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 note 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 incident to their professional services by 
auxiliary personnel. Under our proposed amendment to the definition of 
direct supervision to permit virtual presence, we acknowledge that 
billing practitioners could more easily meet the direct supervision 
requirements for telehealth services provided incident to their 
services. Consequently, we believe that 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 are proposing to clarify that services that may be billed incident-
to may be provided via telehealth incident to a physicians' service and 
under the direct supervision of the billing professional. This is 
consistent with a policy clarification that we made through the May 1st 
COVID-19 IFC (85 FR 27562).
    We have 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 are clarifying, as we did in the May 1st 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.
9. 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 the COVID-19 pandemic, 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 the COVID-19 
pandemic, 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 are proposing to extend this policy until the later of the end 
of the calendar year in which the PHE 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 note that if we finalize this proposal and the PHE ends 
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 
and our growing understanding of how services may be furnished remotely 
and safely, we now 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 are proposing 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 ends or December 31, 2021. Specifically, we 
propose to continue our current rule that ``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. We propose to add that, until the later of the end of the 
calendar year in which the PHE 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

[[Page 50116]]

supervising physician or (other supervising practitioner). In response 
to questions received since we issued our interim policy for the PHE, 
we are clarifying 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 to ensure beneficiary access to care, 
reduce exposure risk and to increase the capacity of practitioners and 
physicians to respond to COVID-19, we are concerned that direct 
supervision through virtual presence may not be sufficient to support 
PFS payment on a permanent basis, beyond the PHE, 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 are seeking 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 ends or December 31, 
2021, or consider it beyond the time specified. We are also seeking 
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 are seeking comment on potential 
concerns around induced utilization and fraud, waste, and abuse and how 
those concerns might be addressed. We also invite commenters to provide 
data and information about their implementation experience with direct 
supervision using virtual presence during the PHE, 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.
10. 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 
office/outpatient 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 1st 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. We are considering 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 
are soliciting public comments on whether we should continue this 
policy for a period of time, or permanently, after the COVID-19 PHE 
ends.

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

[[Page 50117]]

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 13). In this proposed rule for CY 2021, we 
continue our work to improve payment for care management services 
through proposed code refinements related to remote physiologic 
monitoring (RPM), transitional care management (TCM), and psychiatric 
collaborative care model (CoCM) services.
[GRAPHIC] [TIFF OMITTED] TP17AU20.019

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 medical 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 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 to describe remote monitoring of 
physiologic parameters of a patient's health.
    The RPM process begins with two practice expense (PE) only codes, 
CPT codes 99453 and 99454, finalized in the CY 2019 PFS final rule (83 
FR 39574 through 39576). 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

[[Page 50118]]

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 for purposes of this proposal, and are clarifying that 
the medical device or 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] 2020 Professional 
Codebook (hereafter, CPT Codebook), p. 42) 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 note that CPT 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. 42).
    Other stakeholder inquiries about CPT codes 99453 and 99454 focus 
upon the kinds of medical devices that can be used to collect the 
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). We have found no language 
in the CPT Codebook indicating that a medical device must be FDA 
cleared as some stakeholders have suggested although such clearance may 
be appropriate. Nor have we found information that suggests 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 are clarifying 
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 note also 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, the device must be used to collect and 
transmit reliable and valid physiologic data that allow understanding 
of a patient's health status 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 are clarifying that as E/M codes, 
CPT codes 99453, 99454, 99091, 99457, and 99458, can be ordered and 
billed only by physicians or nonphysician practitioners (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 35771) as services furnished to patients with chronic 
conditions, we are also clarifying 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 30-day data collection period for CPT codes 99453 and 
99454, the physiologic data that are collected and transmitted are 
analyzed and interpreted by the physician or practitioner 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 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 requiring a minimum of 30 
minutes of time, each 30 days) in the CY 2018 PFS final rule (82 FR 
59473). The valuation for CPT code 99091 includes a total time of 40 
minutes of physician or nonphysician practitioner 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 note 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 
healthcare 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 healthcare 
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.'' 
\1\ Accordingly, when referring to a particular service described by a 
CPT code for Medicare purposes, a physician or other qualified 
healthcare 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 clinical staff) ``incident to'' 
the professional services of the billing practitioner. Our regulation 
at Sec.  410.26(a) defines auxiliary personnel (a term that includes 
clinical staff) and delineates the conditions for payment for 
``incident to'' services.
---------------------------------------------------------------------------

    \1\ CPT Codebook, p.xiii.
---------------------------------------------------------------------------

    After analyzing and interpreting a patient's remotely collected 
physiologic data, 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 nonphysician practitioner develops a treatment plan with 
the patient and/or caregiver (that is, patient-centered 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

[[Page 50119]]

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) 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, CPT codes 99457 and 99458 can be furnished by 
clinical staff under the general supervision of the physician or NPP. 
We note 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, nonphysician 
practitioner, 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 see 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 final rule (83 FR 59483 through 59486). Thus, we are clarifying 
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, the interactive communication must total at least 20 minutes of 
interactive 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/
nonphysician practitioner/clinical staff is reported using CPT code 
99458. 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 the ``face-to-
face'' time with the patient or patient's caregiver/medical decision-
maker. See the CPT Codebook, page xvii, as well as pages 10, 13, and 16 
for more information about measuring time. Where, as here, the services 
are not typically furnished in person with the patient, we interpret 
time in the code descriptor to mean the time spent in direct, real-time 
interactive communication with the patient.
    Lastly, we are proposing to establish as permanent policy two of 
the changes we made on an interim basis to the requirements for 
furnishing RPM services in response to the PHE for the COVID-19 
pandemic. (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 the COVID-19 pandemic).
    Our goals during the PHE for the COVID-19 pandemic have been to 
reduce exposure risks to the Novel Coronavirus 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. We also finalized on an interim basis for the duration of the 
PHE for the COVID-19 pandemic policies to allow consent to be obtained 
at the time services are furnished, and by individuals providing RPM 
services under contract with the billing physician or practitioner; and 
to allow 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 are proposing 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 are also proposing 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 the COVID-19 pandemic ends, we again will require 
that RPM services must 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 the COVID-19 pandemic 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.
    Finally, in response to the May 19, 2020 Executive Order 13924, 
``Regulatory Relief To Support Economic Recovery,'' (85 FR 31353 
through 31356), we are seeking comment from the medical community and 
other members of the public on whether the current RPM coding 
accurately and adequately describes the full range of clinical 
scenarios where RPM services may be of benefit to patients. For 
example, CPT codes 99453 and 99454 currently require use of a medical 
device (as defined by the FDA) 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 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 are asking for 
information that would help us to understand whether it would be 
beneficial to consider establishing

[[Page 50120]]

coding and payment rules that would allow practitioners to bill and be 
paid for RPM services with shorter monitoring periods. Specifically, we 
are 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 welcome comments including any 
additional information that the medical community and other members of 
the public believe may 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.
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 7 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 40549 through 40550), 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.
    We are proposing now for CY 2021 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. We 
believe that no overlap exists that would warrant preventing concurrent 
reporting between TCM and the services of these 14 codes. We are also 
proposing to allow the new Chronic Care Management code HCPCS code 
G2058 to be billed concurrently with TCM when reasonable and necessary. 
We note that the minutes counted for TCM services cannot also be 
counted towards other services. See Table 14 for the list of 15 codes 
that we are proposing could be billed concurrently with TCM services 
when reasonable and necessary. We welcome comment on our proposal to 
allow these additional services to billed concurrently with the TCM 
service.
[GRAPHIC] [TIFF OMITTED] TP17AU20.020


[[Page 50121]]


4. Psychiatric Collaborative Care Model (CoCM) Services (HCPCS Code 
GCOL1)
    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, we are proposing 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 of CoCM services, we are proposing 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, the proposed work RVU for the new proposed code is 0.77. 
We are proposing that this code could be used for either the initial 
month or subsequent months. We note that the existing CPT time rules 
for the CoCM services would apply. The proposed code is:
     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 are proposing that the required elements listed for CPT code 
99493 would also be required elements for billing HCPCS cod GCOL1. 
Additionally, we propose 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 are also proposing 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 note 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 propose to add HCPCS code 
GCOL1 to the list of designated care management services for which we 
allow general supervision.
    We welcome comments on the proposal to create this new code, as 
well as the proposed valuation.

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 COVID-19 Pandemic

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 evaluation and management (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).\2\
---------------------------------------------------------------------------

    \2\ 2019 CPT Codebook, Evaluation and Management, pages 6 
through 13.
---------------------------------------------------------------------------

    Currently, there are five levels of office/outpatient 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 office/outpatient 
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 15).
    In total, E/M visits billed using these CPT codes comprise 
approximately 40 percent of allowed charges for PFS services; and 
office/outpatient 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. 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,

[[Page 50122]]

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 
office/outpatient 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 office/
outpatient E/M visits. Instead, an office/outpatient 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.
    As indicated in Table 15, 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 15 provides an overview of how the 
level 1 and level 2 office/outpatient E/M visits are currently 
structured, demonstrating this current overlap.
[GRAPHIC] [TIFF OMITTED] TP17AU20.021

    For levels 2 through 5 office/outpatient 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 office/outpatient 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 office/
outpatient 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).
    Also we finalized separate payment for HCPCS code GPC1X, to provide 
payment for 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 chronic condition.
    The AMA RUC resurveyed and revalued the revised office/outpatient 
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 office/
outpatient 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 16, we provide a summary of the codes and 
work RVUs finalized in the CY 2020 PFS final rule for CY 2021.

[[Page 50123]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.022

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 proposed rule. In the CY 2020 PFS final rule (84 FR 
62859 through 62860), we discussed public comments we received in 
response to our request for comment about whether it would be 
appropriate to revalue certain services, other than the global surgical 
codes which we addressed separately, for which the values are closely 
tied to the values of the office/outpatient E/M visit codes in order to 
improve payment accuracy and maintain relativity within the PFS. We 
responded that we would consider the commenters' recommendations for 
future rulemaking. Since publication of the CY 2020 PFS final rule, we 
have received additional feedback from stakeholders, in the form of 
written requests and in-person meetings, indicating that certain other 
services on which we did not seek comment in the CY 2020 PFS proposed 
rule, but which are similar to the office/outpatient E/M visits, have 
values that were established relative to values for the office/
outpatient E/M visits or contain office/outpatient E/M visits as 
constituent parts of the bundled services included in the code for the 
service. We address many of these requests in the following section, 
and are seeking comment on whether there are additional, similarly 
situated services for which we should consider similar adjustment or 
revaluation through future rulemaking. We have also received questions 
about the definition and utilization assumptions for the HCPCS add on 
code GPC1X.
2. Proposals 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 62568), we sought comment 
on the times associated with the office/outpatient 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 17 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 50124]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.023

    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 are proposing beginning for 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.
b. Revaluing Services That Are Analogous to Office/Outpatient E/M 
Visits
    In the CY 2020 PFS 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 office/outpatient E/M visit codes. We 
specifically identified transitional care management (TCM) services 
(CPT codes 99495, 99496); cognitive impairment assessment and care 
planning (CPT code 99483); certain end-stage renal disease (ESRD) 
services (CPT codes 90951 through 90970); and the annual wellness visit 
(AWV) and initial preventive physical exam (IPPE) (HCPCS codes G0402, 
G0438, G0439). Many of these services were valued via a building block 
methodology and have office/outpatient E/M visits explicitly built into 
their definition or valuation. We stated that we may consider adjusting 
the RVUs for these services in future rulemaking, and we sought public 
input on such a policy. We noted that, unlike the global surgical 
codes, some of these services always include an office/outpatient 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 office/
outpatient 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 office/outpatient E/M visit(s), and for this reason they 
are closely tied to values for office/outpatient E/M visits. Overall, 
we believe that the magnitude of the changes to the values of the 
office/outpatient 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, office/outpatient E/M visits. These proposals take into account 
input from the public and our own internal review.
    We received public comments in support of revaluing certain 
services relative to the new office/outpatient E/M visit values. There 
was particular support for revaluing the ESRD monthly capitation 
payment (MCP) services, TCM services, cognitive impairment assessment 
and care planning services, and the emergency department (ED) visits. 
Based on input provided since publication of the CY 2020 PFS final rule 
by the American College of Obstetricians and Gynecologists (ACOG), we 
have also considered 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 have 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.
(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 2-3 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 are 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

[[Page 50125]]

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, particularly from specialty societies 
representing nephrologists. These commenters pointed out 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 18, we provide a summary of the visits bundled into each ESRD MCP 
service.
[GRAPHIC] [TIFF OMITTED] TP17AU20.024

    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 so over time, the values of the ESRD MCP codes 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 
which 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 believe that the ESRD MCP codes should be updated to 
more accurately account for the associated office/outpatient E/M 
visits. We are proposing 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 19 and 20. By improving payment accuracy for the 
ESRD MCP codes, we would also be supporting broader efforts at 
advancing kidney health.\3\ We believe the majority of the visits 
included in the ESRD MCP bundles are being furnished, but are seeking 
comment on whether there are instances where the number and level of 
visits being furnished are not consistent with the number and level of 
visits built into the valuation of the code.
---------------------------------------------------------------------------

    \3\ 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.
---------------------------------------------------------------------------

3. 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)

[[Page 50126]]

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 
at least 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 are proposing 
to increase the work RVUs associated with the TCM codes commensurate 
with 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 19 and 20 for long descriptors, as well as current 
and proposed work RVUs, physician time, and clinical staff time, for 
the TCM codes.
4. Maternity Services
    In the CY 2002 PFS final rule with comment period (66 FR 55393), we 
finalized separate payment for maternity care services. The maternity 
packages are unlike other services for which payment is made under the 
PFS in that they are the only global codes that provide a single 
payment for almost 12 months of services, including visits, surgical 
services, and imaging (among other services); 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. There are 17 CPT codes that are used for billing delivery, 
antepartum, and postpartum maternity care services, and these codes are 
all designated with a unique global period indicator ``MMM.''
    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. However, 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 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 accounted for.
    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.'' \4\ For this reason, we excluded the maternity codes from 
our recent global surgery data collection.
---------------------------------------------------------------------------

    \4\ 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.
---------------------------------------------------------------------------

    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 practice expense (PE) in the form of clinical staff time between 
the current and 2021 E/M values. We believe that this method accurately 
accounts for the increase in valuation relative to the office/
outpatient E/M visits, and therefore, we are proposing 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 19 
and 20.
    We would also note 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.\5\
---------------------------------------------------------------------------

    \5\ 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.

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

[[Page 50127]]

5. 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 impairment assessment and care planning, 
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 on 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 a cognition-focused 
evaluation including a pertinent history and examination, and medical 
decision making of moderate or high complexity, in addition to many 
functional and other assessments specific to cognitive status. With the 
revaluation we finalized in the CY 2020 PFS final rule for CPT code 
99205 effective beginning in CY 2021, 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, which would create a rank order anomaly between 
the two codes that, given the way the code was valued, we do not 
believe would be appropriate. Rather, because CPT code 99483 was valued 
in relation to a level 5 office/outpatient E/M visit, we believe 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 are proposing 
to adjust the work, time, and PE in the form of clinical staff time for 
CPT code 99483 as shown in Tables 19 and 20.
6. Initial Preventive Physical Examination (IPPE) and Initial and 
Subsequent Annual Wellness (AWV) Visits
    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 73408-73411).
    Because these codes are valued using direct crosswalks to office/
outpatient E/M visits, and based on the principles articulated above, 
we believe 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 are proposing to revise the work, 
physician time, and direct PE inputs for these codes as shown in Tables 
19 and 20.
BILLING CODE 4120-01-P

[[Page 50128]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.025


[[Page 50129]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.026


[[Page 50130]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.027


[[Page 50131]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.028


[[Page 50132]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.029


[[Page 50133]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.030

BILLING CODE 4120-01-C
7. Emergency Department Visits
    The ED visit codes have been revalued under the PFS three times- in 
1997, 2007, and most recently in 2018 as part of the misvalued code 
initiative for CY 2020 rulemaking. Each subsequent revaluation was done 
in part to maintain relativity with the office/outpatient E/M visit 
codes. Specifically, when these services were revalued in prior 
rulemaking, the principle was that levels 1 through 3 of the ED visits 
should have the same value as the level 1 through 3 new patient office/
outpatient E/M visits and that the levels 4 and 5 ED visits should be 
valued higher than the levels 4 and 5 new patient office/outpatient E/M 
visits to reflect higher typical intensity in the ED setting. In the CY 
2018 PFS final rule, we finalized a proposal to nominate the level 1 
through level 5 ED visit codes (CPT codes 99281-99285, see Table 21 for 
long descriptors) 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, 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). The AMA RUC surveyed and reviewed five of these 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, we 
finalized the RUC-recommended 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 direct PE 
inputs for the codes in this family. 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 comment solicitation in CY 2020 PFS rulemaking 
regarding whether certain services should be revalued to maintain 
relativity with office/outpatient E/M visits, the American College of 
Emergency Physicians submitted a public comment stating that relativity 
between the ED visits and office/outpatient E/M visits should be 
maintained, and provided CMS with a specific recommendation for CPT 
codes 99283-99285. The association believed we should continue to 
preserve the same relationship between the ED and office/outpatient E/M 
visit code sets that was established in prior years and would have 
likely been maintained had the office/outpatient E/M visits been 
revalued prior to the ED visits. They have also submitted a subsequent 
letter to this effect. We agree with the society, particularly since 
the justification provided by the AMA RUC recommendations we accepted 
for the CY 2020 revaluation was, in part, to maintain relativity with 
the office/outpatient E/M visits, and that relativity would be 
disrupted if they were to remain unadjusted. The proposed values are 
consistent with the principle that the levels 1-3 ED visits should 
remain the same as the levels 1-3 new patient office visits but the 
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. Therefore, we are proposing the values 
recommended by ACEP as shown in Table 21.
8. 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,

[[Page 50134]]

office/outpatient E/M visits. These 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 are proposing 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 are 
proposing to apply that percentage increase, which we estimate to be 
approximately 28 percent, to the work RVUs for the therapy evaluation 
and psychiatric diagnostic evaluation services codes. 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 recognize that this is not the methodology 
typically used to value services under the PFS and are seeking 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.
9. 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 
21 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 are proposing 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 21 provides a summary of the 
current and proposed RVUs for these services.

[[Page 50135]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.031


[[Page 50136]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.032


[[Page 50137]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.033

10. Ophthalmological Services
    We received a request to revalue the following ophthalmological 
services which we are not proposing 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 are not proposing to revalue these services because they are not 
sufficiently analogous or connected to the office/outpatient E/M visit 
codes. While these ophthalmological services have historically been 
valued relative to office/outpatient E/M visits, they have not been 
reviewed by the RUC 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 are 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 in these 
ophthalmological visits which rely on criteria specific to evaluation, 
examination, specified technical procedures, and treatment of ocular 
conditions for purposes of level selection.\6\ The number of levels 
within the two code sets differs, 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 no longer clear. We are also 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 relying on both of them is 
unclear.
---------------------------------------------------------------------------

    \6\ CPT Codebook pp. 656-7.
---------------------------------------------------------------------------

    In addition, the four ophthalmological evaluation codes are 
reported with modifier -25 (significant, separately identifiable E/M 
service by the same physician on the same day of the procedure or other 
service) approximately 4 to 14 percent of the time (depending on the 
code in question). Similarly, ED visits are reported with modifier -25 
approximately 4 to 12 percent of the time (depending on the code in 
question). In contrast, the office/outpatient E/M visit codes are 
reported with modifier -25 approximately 18 to 35 percent of the time 
(depending on the code in question). We are in the process of analyzing 
these data further to assess how often the accompanying service is a 
minor procedure rather than a visit. 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, and therefore 
should not be revalued commensurate with the increase to stand-alone 
office/outpatient E/M visits for 2021. As we discussed in prior PFS 
rules, 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 continue our analysis, we are seeking 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 note 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. Standalone psychotherapy services cannot 
be billed with office/outpatient E/M visits while ophthalmological 
visits can, as well as with a separate procedure.

[[Page 50138]]

c. Comment Solicitation on the Definition of HCPCS Code GPC1X
    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 GPC1X 
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 GPC1X, 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 are 
soliciting from the public comments providing additional, more specific 
information regarding what aspects of the definition of HCPCS add-on 
code GPC1X 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 GPC1X 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 GPC1X 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 
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 GPC1X 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 GPC1X 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 GPC1X 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 GPC1X 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 GPC1X could 
bolster the efforts of practitioners in rural communities, including 
NPPs, to deliver the comprehensive and longitudinal care that HCPCS 
add-on code GPC1X describes.
d. Prolonged Office/Outpatient E/M Visits (CPT Code 99XXX)
    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 99XXX (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)). CPT code 99XXX is only 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 99XXX 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 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 99XXX

[[Page 50139]]

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 99XXX 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 are proposing that when the time of the 
reporting physician or NPP is used to select office/outpatient E/M 
visit level, CPT code 99XXX 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 22 and 23, we provide 
examples.
[GRAPHIC] [TIFF OMITTED] TP17AU20.034

[GRAPHIC] [TIFF OMITTED] TP17AU20.035

G. Scope of Practice and Related Issues

    We are proposing several policies consistent with the President's 
Executive Order 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, Executive Order 
#13890). In December 2019, we requested feedback in response to part of 
this Executive Order 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 policies 
in this section to address in the PFS proposed rule. 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. These 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.\7\ Some of 
the proposals may also help alleviate the opioid crisis.
---------------------------------------------------------------------------

    \7\ 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/.
---------------------------------------------------------------------------

    We note that the responses to our request for feedback on the 
topics in this section 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 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

[[Page 50140]]

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. Therefore, in this proposed 
rule, we are also seeking 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 are proposing, to help us 
assess the potential impact of, or challenges for, our proposed 
changes. Information about specific services (service-level 
information) would be especially helpful. We are seeking public comment 
on whether applicable state laws, scope of practice, and facility 
policies would permit practitioners to exercise the proposed 
flexibilities if CMS were to adopt the policies proposed in this 
section, and to what extent practitioners would be permitted to 
exercise these proposed flexibilities, such as for all diagnostic tests 
or only a subset.
1. Teaching Physician and Resident Moonlighting Policies
a. Background
    In the March 31st COVID-19 IFC (85 FR 19258 through 19261) and the 
May 1st COVID-19 IFC (85 FR 27550 through 27629), we implemented 
several policies on an interim final basis related to PFS payment for 
the services of teaching physicians involving residents and resident 
moonlighting regulations. The comment periods for both the March 31st 
COVID-19 IFC (85 FR 19230) and the May 1st COVID-19 IFC (85 FR 27550) 
have closed. Therefore, we plan to address the IFC comments for issues 
in which we have proposals in this proposed rule when we publish the 
PFS final rule. We are considering whether these policies 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 are soliciting public comments on whether these policies 
should continue once the PHE ends. We believe public comment will 
assist us in identifying appropriate policy continuation decisions that 
we would consider finalizing in the CY 2021 PFS final rule.
    For teaching physicians, section 1842(b)(7)(A)(i)(I) of the Act 
specifies 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.
b. 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 1st COVID-19 IFC (85 FR 27550 through 27629), we adopted a 
policy on an interim basis during the COVID-19 PHE 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 
COVID-19 PHE 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 COVID-19 PHE to allow PFS payment to 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. 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 COVID-19 PHE 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 are considering whether the flexibilities described above that 
we implemented on an interim basis during PHE 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 are soliciting public 
comments on whether these policies should continue once the PHE ends. 
We believe public comment will assist us in identifying appropriate 
policy continuation decisions that we would consider finalizing in the 
CY 2021 PFS final rule. In addition, we are proposing 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 are concerned that 
continuing to permit teaching physicians to be involved through their 
virtual presence may not be sufficient to warrant PFS payment to the 
teaching

[[Page 50141]]

physician on a temporary or permanent basis. Absent the circumstances 
of the PHE, 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 have some 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 believe 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 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.
    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 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.
    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 have significant concerns about extending our interim 
policy to permit virtual presence of the teaching physician, whether on 
a temporary or permanent basis, we believe public comment 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, we are considering 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 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 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, 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 proposed rule). 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, it may be 
appropriate to continue the virtual presence policy on a temporary or 
permanent basis.
    We note 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

[[Page 50142]]

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 seek comment 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 
invite commenters to provide data and other information on their 
experiences implementing this policy during the PHE.
c. Virtual Teaching Physician Presence During Medicare Telehealth 
Services
    In the March 31st COVID-19 IFC (85 FR 19260), 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 are 
considering whether this policy should be extended on a temporary basis 
(that is, if the PHE 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 are soliciting public 
comments on whether this policy should continue once the PHE ends. We 
believe public comment will 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, 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 to reduce 
exposure risk and to increase the capacity of teaching settings to 
respond to COVID-19, we are concerned 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 on a temporary or permanent basis. We are concerned 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 have 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, we are seeking comment 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 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, 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 are discussed in section II.F. of this 
proposed rule). For such services, it may be appropriate to continue 
the virtual presence policy on a temporary or permanent basis. We seek 
comment 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 invite commenters to provide data and other 
information on their experiences implementing this policy during the 
PHE.
d. 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, 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

[[Page 50143]]

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 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 can be separately identified from those services that are 
required as part of the approved GME program.
    We are considering whether this flexibility that we implemented on 
an interim basis 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 are soliciting public comments on 
whether this policy should continue once the PHE ends. We are concerned 
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, 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 believe public comment will assist us in identifying 
appropriate policy continuation decisions that we would consider 
finalizing in the CY 2021 PFS final rule. We also invite commenters to 
provide data and other information on their experiences implementing 
this policy during the PHE.
e. 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

[[Page 50144]]

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 
1st COVID-19 IFC (85 FR 27550 through 27629), 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 are considering whether these policies 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 are 
soliciting public comments on whether these policies should continue 
once the PHE ends. We believe public comment will assist us in 
identifying appropriate policy continuation decisions that we would 
consider finalizing in the CY 2021 PFS final rule. We are also 
considering whether specific services added under the primary care 
exception should be extended temporarily or made permanent and are 
soliciting public comment on whether these services should continue as 
part of the primary care exception once the PHE 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 
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);
     CPT 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).
    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 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

[[Page 50145]]

after the expiration of the PHE, 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 ends).
    However, we are concerned 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 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. 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 are 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. We are also concerned 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 are considering whether, upon expiration of the PHE, 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 are soliciting 
public comments on whether these services should continue as part of 
the primary care exception after the PHE ends. We also invite 
commenters to provide data and other information on their experiences 
implementing this policy during the PHE.
    We are also considering whether our interim final 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 are soliciting public 
comments on whether this policy should continue once the PHE ends. In 
these cases, outside the circumstances of the PHE, 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, 
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. 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.
f. Conclusion
    In summary, we remind stakeholders that during the PHE 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 through flexibilities afforded to 
providers to safely furnish services to patients. While we anticipate 
reverting to our previous teaching physician policy that was in place 
prior to the PHE for the reasons discussed above, we are considering 
whether the teaching physician and resident moonlighting policies that 
we implemented on an interim basis 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. We are soliciting public comments on whether these policies 
should be continued, and if so, whether they should be made permanent, 
or temporarily extended and the appropriate scope of the extension. As 
discussed above, we are 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. We are also 
concerned 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. We will also 
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 are concerned 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, 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 believe public comment, especially those that focus on the 
variables we identify above regarding the specific services included on 
the primary exception list, clinical scenarios under which residents 
could moonlight or furnish certain types of services under the 
supervision of a teaching physician via virtual presence, will assist 
us in identifying the appropriate policy continuation decisions after 
the end of the PHE, which we will consider finalizing in the CY 2021 
PFS final rule. As part of our review of public comments, we will 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. The benefits of continuation may include 
limiting COVID-19 exposure risk for practitioners and patients, 
increasing workforce capacity of teaching settings

[[Page 50146]]

to respond to continuing effects following the PHE 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, which could 
have the unintended consequence of limiting access to services paid 
under the PFS. The risks may include the potential for duplicative 
payment with Medicare Part A reimbursement for graduate medical 
education 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 risks to patient safety.
2. Supervision of Diagnostic Tests by Certain NPPs
    In response to Executive Order #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 1st COVID-19 IFC (85 FR 27550 through 
27629), we established on an interim basis during the COVID-19 PHE, a 
policy to permit these and certain other NPPs to supervise diagnostic 
tests. We now propose to make those changes permanent by making 
modifications to the regulations at Sec.  410.32. We are planning to 
address comments we receive on our proposals included in this proposed 
rule and comments received on the May 1st COVID-19 IFC (85 FR 27550 
through 27629) simultaneously in the final rule since the comment 
period for the May 1, 2020 COVID-19 IFC (85 FR 27550 through 27629) 
recently closed on July 7, 2020.
    Prior to the COVID-19 PHE, 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 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 note 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 are proposing 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 are proposing 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 are also proposing 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 under Sec.  410.74 
would continue to apply. We are also proposing to make permanent the 
removal of the parenthetical, previously made as part of the May 1, 
2020 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.
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 
1st 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 note 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

[[Page 50147]]

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 note 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 1st 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.
4. Provision of Maintenance Therapy by Therapy Assistants
    In response to our request for feedback on scope of practice (noted 
above), consistent with Executive Order #13890, respondents requested 
that we allow physical therapist assistants (PTAs) and occupational 
therapy assistants (OTAs) to furnish maintenance therapy services 
associated with a maintenance program. The respondents said that our 
Part B therapy policy is not consistent with policies for these 
services when provided to patients in the skilled nursing facility 
(SNF) and home health (HH) settings paid under Part A. Other 
respondents told us that because the therapist is responsible for a 
patient's care over an episode, that this should include assigning 
responsibilities 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 permit therapists and therapy 
providers more flexibility for resource utilization.
    After considering respondents' concerns about the incongruity 
between our Part B and Part A maintenance therapy policy, and to 
provide flexibility to increase the availability of needed health care 
services during the COVID-19 PHE, we amended our policy on an interim 
final basis in the May 1st COVID-19 IFC (85 FR 27550 through 27629) to 
allow the physical therapist (PT) or occupational therapist (OT) who 
established the maintenance program to assign the duties to a PTA or 
OTA, as clinically appropriate, to perform maintenance therapy 
services.
    We explained that making this change could free-up the PT or OT to 
furnish other services, particularly those related to the COVID-19 PHE 
that require a therapist's assessment and evaluation skills, and 
including the CTBS, that is, e-visits, virtual visits, remote 
evaluations, and phone evaluations--that were added as ``sometimes 
therapy'' services in the March 31st COVID-19 IFC for PTs, OTs and 
speech-language pathologists (SLPs). 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, and referred the reader 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 this proposed rule, we are proposing 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. If adopted, our policy would dovetail 
with our amended policy set forth in the May 1st 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. If the PHE is ended prior to 
January 1, 2021, the therapist would need to personally furnish the 
maintenance therapy services until the proposed policy change takes 
effect. We plan to address comments from the May 1st COVID-19 IFC in 
conjunction with the comments from this proposed rule in the final 
rule, given the comment period has only just closed on that IFC.
    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) in cases where rehabilitative services, requiring the 
improvement in the patient's functional status, are no longer or were 
not previously covered. This manual section explains that skilled 
therapy services related to a reasonable and necessary maintenance 
program are available for the establishment or design of the 
maintenance program and the delivery of the maintenance program, that 
is, maintenance therapy, when it needs to be carried out as maintenance 
therapy services. Maintenance programs that can be carried out by the 
patient alone or with the assistance of caregivers, are not covered. 
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 our 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

[[Page 50148]]

pathology services, in addition to 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 believe that it would be appropriate for 
the therapist to use that same judgement in deciding whether to 
delegate to the PTA or OTA the performance of maintenance therapy 
services under the associated plan of care. We believe 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 that are aimed to maintain, slow or prevent further 
decline of a patient's condition. We do not believe that the therapist-
only maintenance therapy requirement is needed in the case of 
outpatient physical or occupational therapy services, and instead 
believe that it would be appropriate for an OT or PT to be permitted to 
use their professional judgement to assign the performance of 
maintenance therapy services to an OTA or PTA when it is clinically 
appropriate to do so.
    As such, we propose 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 now distinguish between 
rehabilitative and maintenance therapy services, we are not proposing 
to amend them. Instead, we propose 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. Therefore, we believe our 
proposal to allow PTs and OTs to delegate maintenance therapy services 
to their supervised assistants is in keeping with Executive Order 
#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 COVID-19 PHE is ended.
    We note 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 by 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)).
5. Medical Record Documentation
    As we established in the CY 2020 PFS final rule (84 FR 62681 
through 62684), and similarly expressed in the May 1st 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 note 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 are clarifying 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. This will 
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 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 also emphasize that information 
entered into the medical record should 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

[[Page 50149]]

new services. For CY 2017, we proposed new values in the CY 2017 PFS 
proposed rule for the vast majority of new, revised, and potentially 
misvalued codes for which we received complete RUC recommendations by 
February 10, 2016. To complete the transition to this new process, for 
codes for which we established interim final values in the CY 2016 PFS 
final rule with comment period (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 evaluation and management (E/M) service, we believe that there is 
overlap between the two services in some of the activities furnished 
during the preservice evaluation and postservice time. Our longstanding 
adjustments have reflected a broad assumption that at least one-third 
of the work time in both the preservice evaluation and postservice 
period is duplicative of work furnished during the E/M visit.
    Accordingly, in cases where we 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.

[[Page 50150]]

    The following paragraphs contain a general discussion of our 
approach to reviewing RUC recommendations and developing proposed 
values for specific codes. When they exist we also include a summary of 
stakeholder reactions to our approach. We note that many commenters and 
stakeholders have expressed concerns over the years with our ongoing 
adjustment of work RVUs based on changes in the best information we had 
regarding the time resources involved in furnishing individual 
services. We have been particularly concerned with the RUC's and 
various specialty societies' objections to our approach given the 
significance of their recommendations to our process for valuing 
services and since much of the information we used to make the 
adjustments is derived from their survey process. We are obligated 
under the statute to consider both time and intensity in establishing 
work RVUs for PFS services. As explained in the CY 2016 PFS final rule 
with comment period (80 FR 70933), we recognize that adjusting work 
RVUs for changes in time is not always a straightforward process, so we 
have applied various methodologies to identify several potential work 
values for individual codes.
    We have observed that for many codes reviewed by the RUC, 
recommended work RVUs have appeared to be incongruous with recommended 
assumptions regarding the resource costs in time. This has been the 
case for a significant portion of codes for which we recently 
established or proposed work RVUs that are based on refinements to the 
RUC-recommended values. When we have adjusted work RVUs to account for 
significant changes in time, we have started by looking at the change 
in the time in the context of the RUC-recommended work RVU. When the 
recommended work RVUs do not appear to account for significant changes 
in time, we have employed the different approaches to identify 
potential values that reconcile the recommended work RVUs with the 
recommended time values. Many of these methodologies, such as survey 
data, building block, crosswalks to key reference or similar codes, and 
magnitude estimation have long been used in developing work RVUs under 
the PFS. In addition to these, we sometimes 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 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 24 contains a list of codes and 
descriptors for which we are proposing work RVUs; this includes all 
codes for which we received RUC recommendations by February 10, 2020. 
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 proposed 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

[[Page 50151]]

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 25 details 
our refinements of the RUC's direct PE recommendations at the code-
specific level. In section II.B. of this proposed rule, Determination 
of Practice Expense Relative Value Units (PE RVUs), we address certain 
refinements that would be common across codes. Refinements to 
particular codes are addressed in the portions of this section that are 
dedicated to particular codes. We note that for each refinement, we 
indicate the impact on direct costs for that service. We note that, on 
average, in any case where the impact on the direct cost for a 
particular refinement is $0.35 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 note that approximately half of the 
refinements listed in Table 25 result in changes under the $0.35 
threshold and are unlikely to result in a change to the RVUs.
    We also note 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 proposed 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.
b. Common Refinements
(1) Changes in Work Time
    Some direct PE inputs are directly affected by revisions in work 
time. Specifically, changes in the intraservice portions of the work 
time and changes in the number or level of postoperative visits 
associated with the global periods result in corresponding changes to 
direct PE inputs. The direct PE input recommendations generally 
correspond to the work time values associated with services. We believe 
that inadvertent discrepancies between work time values and direct PE 
inputs should be refined or adjusted in the establishment of proposed 
direct PE inputs to resolve the discrepancies.
(2) Equipment Time
    Prior to CY 2010, the RUC did not generally provide CMS with 
recommendations regarding equipment time inputs. In CY 2010, in the 
interest of ensuring the greatest possible degree of accuracy in 
allocating equipment minutes, we requested that the RUC provide 
equipment times along with the other direct PE recommendations, and we 
provided the RUC with general guidelines regarding appropriate 
equipment time inputs. We appreciate the RUC's willingness to provide 
us with these additional inputs as part of its PE recommendations.
    In general, the equipment time inputs correspond to the service 
period portion of the clinical labor times. We clarified this principle 
over several years of rulemaking, indicating that we consider equipment 
time as the time within the intraservice period when a clinician is 
using the piece of equipment plus any additional time that the piece of 
equipment is not available for use for another patient due to its use 
during the designated procedure. For those services for which we 
allocate cleaning time to portable equipment items, because the 
portable equipment does not need to be cleaned in the room where the 
service is furnished, we do not include that cleaning time for the 
remaining equipment items, as those items and the room are both 
available for use for other patients during that time. In addition, 
when a piece of equipment is typically used during follow-up 
postoperative visits included in the global period for a service, the 
equipment time would also reflect that use.
    We believe that certain highly technical pieces of equipment and 
equipment rooms are less likely to be used during all of the preservice 
or postservice tasks performed by clinical labor staff on the day of 
the procedure (the clinical labor service period) and are typically 
available for other patients even when one member of the clinical staff 
may be occupied with a preservice or postservice task related to the 
procedure. We also note that we believe these same assumptions would 
apply to inexpensive equipment items that are used in conjunction with 
and located in a room with non-portable highly technical equipment 
items since any items in the room in question would be available if the 
room is not being occupied by a particular patient. For additional 
information, we refer readers to our discussion of these issues in the 
CY 2012 PFS final rule with comment period (76 FR 73182) and the CY 
2015 PFS final rule with comment period (79 FR 67639).
(3) Standard Tasks and Minutes for Clinical Labor Tasks
    In general, the preservice, intraservice, and postservice clinical 
labor minutes associated with clinical labor inputs in the direct PE 
input database reflect the sum of particular tasks described in the 
information that accompanies the RUC-recommended direct PE inputs, 
commonly called the ``PE worksheets.'' For most of these described 
tasks, there is a standardized number of minutes, depending on the type 
of procedure, its typical setting, its global period, and the other 
procedures with which it is typically reported. The RUC sometimes 
recommends a number of minutes either greater than or less than the 
time typically allotted for certain tasks. In those cases, we review 
the deviations from the standards and any rationale provided for the 
deviations. When we do not accept the RUC-recommended exceptions, we 
refine the proposed direct PE inputs to conform to the standard times 
for those tasks. In addition, in cases when a service is typically 
billed with an E/M service, we remove the preservice clinical labor 
tasks to avoid duplicative inputs and to reflect the resource costs of 
furnishing the typical service.
    We refer readers to section II.B. of this proposed rule, 
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

[[Page 50152]]

specialty societies to provide us copies of sales invoices. For CY 2021 
we received invoices for several new supply and equipment items. Tables 
27 and 28 detail the invoices received for new and existing items in 
the direct PE database. As discussed in section II.B. of this proposed 
rule, 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 27 and 28 also include the number of 
invoices received and the number of nonfacility allowed services for 
procedures that use these equipment items. We provide the nonfacility 
allowed services so that stakeholders will note the impact the 
particular price might have on PE relativity, as well as to identify 
items that are used frequently, since we believe that stakeholders are 
more likely to have better pricing information for items used more 
frequently. A single invoice may not be reflective of typical costs and 
we encourage stakeholders to provide additional invoices so that we 
might identify and use accurate prices in the development of PE RVUs.
    In some cases, we do not use the price listed on the invoice that 
accompanies the recommendation because we identify publicly available 
alternative prices or information that suggests a different price is 
more accurate. In these cases, we include this in the discussion of 
these codes. In other cases, we cannot adequately price a newly 
recommended item due to inadequate information. Sometimes, no 
supporting information regarding the price of the item has been 
included in the recommendation. In other cases, the supporting 
information does not demonstrate that the item has been purchased at 
the listed price (for example, vendor price quotes instead of paid 
invoices). In cases where the information provided on the item allows 
us to identify clinically appropriate proxy items, we might use 
existing items as proxies for the newly recommended items. In other 
cases, we included the item in the direct PE input database without any 
associated price. Although including the item without an associated 
price means that the item does not contribute to the calculation of the 
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 address code-specific refinements to clinical labor in the 
individual code sections.
(7) Procedures Subject to the Multiple Procedure Payment Reduction 
(MPPR) and the OPPS Cap
    We note that the public use files for the PFS proposed and final 
rules for each year display 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 proposed 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 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 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 practice expense (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 proposed 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 disagree 
that the utilization crosswalk was erroneous, and we did not make a 
technical correction following the publication of the CY 2019 final 
rule for this reason.
    We also disagree with the RUC that the utilization crosswalk was 
``the

[[Page 50153]]

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 
proposed rule and restated in the CY 2019 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 note 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 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 new information that was not already presented for the 
previous CMS review of these codes. Therefore, we are not proposing 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 welcome the submission of new information regarding 
these services that was not part of the previous CY 2019 review of the 
code family.
(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 to re-review this code at a more granular 
level for the January 2020 RUC meeting.
    We disagree with the RUC-recommended work RVU of 12.40 for CPT code 
11960 (tissue expander other than breast). We are proposing 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 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 are proposing the RUC-recommended direct PE inputs for CPT code 
11960 without refinements.
(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 recommend 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 disagree with the RUC-recommended work RVU of 8.01 for CPT code 
11970 (replacement of tissue expander with permanent implant). We are 
proposing 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 note that our 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 are 
proposing the RUC-recommended direct PE inputs for CPT code 11970.
    We disagree with the RUC-recommended work RVU of 8.64 for CPT code 
19325 (breast augmentation with implant). Although we disagree with the 
RUC-recommended work RVU, we concur 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 are proposing a work 
RVU of 8.12 for CPT code 19325, based on the recommended interval of 
0.63 additional RVUs above our proposed work RVU of 7.49 for CPT code 
11970. 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 are also supporting 
our 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 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 are proposing the RUC-recommended direct PE 
inputs for CPT code 19325.
    We disagree 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 disagree with the RUC-recommended work RVU, we 
concur 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 are proposing 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 are also supporting 
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 are proposing the 
RUC-recommended direct PE inputs for CPT code 19340.
    We disagree 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 disagree with the RUC-recommended work RVU, we 
concur that the relative difference in work

[[Page 50154]]

between CPT codes 19325 and 19342 is equivalent to the RUC-recommended 
interval of 2.36 RVUs. Therefore, we are proposing 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 note 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 are also supporting 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 are proposing the RUC-
recommended direct PE inputs for CPT code 19342.
    We disagree with the RUC-recommended work RVU of 15.36 for CPT code 
19357 (tissue expander placement in breast reconstruction, including 
subsequent expansion). Although we disagree with the RUC-recommended 
work RVU, we concur 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 are proposing 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 are also 
supporting 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 are 
proposing the RUC-recommended direct PE inputs for CPT code 19357.
(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 the October 2019 RUC meeting, they 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 disagree with the RUC-recommended work RVU of 7.02 for CPT code 
11971 (removal of tissue expander w/out insertion of implant). Although 
we disagree with the RUC-recommended work RVU, we concur 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 
are proposing 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 note 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 
families of similarly revised codes. We are also supporting 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 are proposing 
the RUC-recommended direct PE inputs for CPT code 11971.
    We disagree with the RUC-recommended work RVU of 7.44 for CPT code 
19328 (removal of intact breast implant). Although we disagree with the 
RUC-recommended work RVU, we propose increasing the current work RVU 
from 6.48 to 6.92 to account for the increases in total and 
intraservice time. We also concur 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 are proposing 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 are also supporting 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 are proposing 
the RUC-recommended direct PE inputs for CPT code 19328.
    We are proposing the RUC-recommended work RVU of 9.00 for CPT code 
19330 (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 are also proposing the RUC-recommended direct PE 
inputs for this code without refinements.
(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 25th percentile.
    We are proposing the RUC-recommended work RVUs of 17.99 for CPT 
code 19307. We are also proposing 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 are proposing the RUC-recommended work RVU of 11.09 for CPT code 
19316 (mastopexy) and 16.03 for CPT code 19318 (Breast reduction). We 
are proposing the RUC-recommended direct PE inputs for this code family 
without refinements.
(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

[[Page 50155]]

more granular code families but recommended these codes be re-surveyed 
for the January 2020 RUC meeting.
    We disagree 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 are proposing 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 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 are proposing the RUC-recommended 
direct PE inputs for CPT code 19370 without refinements.
    We disagree with the RUC-recommended work RVU of 10.81 for CPT code 
19371 (Peri-implant capsulectomy, breast, complete, including removal 
of all intra-capsular contents). Although we disagree 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 are proposing 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 note 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 are also supporting 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 are 
proposing the RUC-recommended direct PE inputs for CPT code 19371.
    We disagree with the RUC-recommended work RVU of 12.00 for CPT code 
19380 (Revision of reconstructed breast (eg, 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 disagree 
with the RUC-recommended work RVU, we concur 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 are proposing 
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 are also supporting our proposed work RVU of 
11.17 based on a reference code, CPT code 64569 (Revision or 
replacement of cranial nerve (eg, 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 are 
proposing the RUC-recommended direct PE inputs for CPT code 19380.
(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 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 final rule with comment period (79 FR 67632), we 
discussed how in the CY 2014 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 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 are proposing 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 proposing the RUC-recommended direct PE inputs for both codes. 
Additionally, we are seeking 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 are also 
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 are 
interested 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 invite the medical community to continue 
to engage with CMS on this and other topics.

[[Page 50156]]

(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 are proposing them as 000-day global services.
    We disagree with the RUC-recommended work RVU of 4.10 for CPT code 
28820 (Amputation, toe; metatarsophalangeal joint). 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 disagree with the RUC-recommended work RVU of 4.00 for CPT code 
28825 (Amputation, toe; interphalangeal joint). We are proposing a work 
RVU of 3.41 based on the RUC-recommended increment relationship between 
this code and CPT 28820 (a difference of -0.10), which we apply to our 
proposed value for the latter code. 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 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 are proposing 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 are also proposing 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 are also proposing to refine the 
equipment time to conform to these changes in the clinical labor time 
for both codes.
(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 (eg, 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 (eg, 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 are proposing 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 are proposing the RUC recommendations 
CPT codes 29822 and 29823 without refinement.
(11) Absorbable Nasal Implant Repair (CPT Codes 30XX0)
    In September 2019, the CPT Editorial Panel approved the addition of 
CPT code 30XX0 (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 are proposing the RUC-recommended value of 2.80 work RVUs 
without refinement for CPT code 30XX0.
    For the direct PE inputs, were also proposing the RUC-recommended 
values without refinement.
(12) Lung Biopsy-CT Guidance Bundle (CPT Code 324X0)
    CPT codes 32405 (Biopsy, lung or mediastinum, percutaneous needle) 
and 77012 (Computed tomography guidance for needle placement (eg, 
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 324X0 (Core 
needle biopsy, lung or mediastinum, percutaneous, including imaging 
guidance, when performed).
    We are not proposing 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 do not believe a decrease from the current aggregate 
value of 32405 and 77012 is warranted. 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 are proposing a work RVU of 3.18, which is the 
sum of the work RVUs of the two base codes.
    We are proposing the RUC-recommended direct PE inputs without 
refinement.
(13) Atrial Septostomy (CPT Codes 33XX0, 33XX1, 33XX2)
    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

[[Page 50157]]

method, balloon (eg, 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 their 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, so both CPT codes were 
deleted and are now being replaced with the following proposed CPT 
codes.
    CPT code 33XX0 (Transcatheter atrial septostomy (TAS) for 
congenital cardiac anomalies to create effective atrial flow, including 
all imaging guidance by the proceduralist, when performed, any method 
(eg, Rashkind, Sang-Park, balloon, cutting balloon, blade)), is one of 
three codes intending to replace the two deleted Septostomy codes. For 
CPT code 33XX0, the RUC recommends 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 recommends 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 are proposing the RUC recommended work 
RVU of 14.00 and physician times without refinement.
    CPT code 33XX1 (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 (eg, atrial septum, Fontan fenestration, right ventricular 
outflow tract, Mustard/Senning/Warden baffles); initial intracardiac 
shunt) is another proposed new procedure 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 in the old 
atrial septostomy codes utilizing the balloon and blade method. The RUC 
recommends 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 recommends 20.00 work RVUs for CPT 
code 33XX1. We are proposing the RUC recommended work RVUs and their 
recommended physician times.
    CPT code 33XX2, (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 (eg, 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 33XX1, for 60 minutes of physician intraservice time. The RUC 
recommends a work RVU of 10.50 for CPT code 33XX2. 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 33XX1 appears to be unsupportable given the 60 minutes of 
additional physician intraservice time. We are instead proposing a work 
RVU of 8.00 for add-on CPT code 33XX2, which is the 25th percentile 
value from the survey and of similar valuation from reference CPT code 
93592 (Percutaneous 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.
(14) Percutaneous Ventricular Assist Device Insertion (CPT Codes 339X1, 
33990, 33991, 33992, 339X2, 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 are proposing the RUC-recommended work RVUs for all six codes in 
the family. We are proposing 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 339X1 (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 339X2 (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 disagree with the stakeholders and are proposing the RUC-
recommended work RVUs for each code in this family as noted previously. 
We note 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 disagree

[[Page 50158]]

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 are not proposing any direct PE 
inputs for this facility only code family. We are proposing a 000-day 
global period for all six codes as surveyed by the RUC.
(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 are proposing to maintain the current work RVU of 2.39 as 
recommended by the RUC. We are proposing the RUC-recommended direct PE 
inputs for CPT code 43239 without refinement.
(16) Colonoscopy (CPT Code 45385)
    In the CY 2019 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 are proposing to maintain the current work RVU of 4.57 as 
recommended by the RUC. We are proposing the RUC-recommended direct PE 
inputs for CPT code 45385 without refinement.
(17) Transrectal High Intensity Focused US Prostate Ablation (CPT Codes 
558XX)
    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 
558XX, we are not proposing 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 are proposing 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 are proposing the RUC-
recommended PE inputs without refinement.
(18) Computer-Aided Mapping of Cervix Uteri (CPT Code 57XX0)
    In September 2019, the addition of CPT code 57XX0 (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 are proposing the RUC-recommended 
value of 0.81 for CPT code 57XX0. We are also proposing the RUC-
recommended direct PE inputs for this code.
    We are seeking 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 
are proposing to change the name of this new supply item to 
``disposable speculum, medium'' (SD337) to reflect the actual product 
on the invoice submitted. We are seeking clarification as to what 
aspect of the speculum is digital or if a cheaper, non-digital speculum 
would suffice. We note 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 are proposing the new SD337 supply at the $5.80 price as listed on 
the invoice submitted in the RUC materials and are seeking comment as 
to why other disposable speculums at a lower price would not be typical 
for this procedure.
(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 disagree with the RUC-recommended work RVUs for the CPT code 
family of 57282 and 57283. We are proposing a work RVU of 11.63 for CPT 
code 57282, and are also proposing 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

[[Page 50159]]

code 47563 (Laparoscopy, surgical; cholecystectomy with 
cholangiography) which has a work RVU of 11.47 with 238 minutes of 
total time. Although we do not imply that the decrease in time as 
reflected in survey values must equate to a one-to-one or linear 
decrease in the valuation of work RVUs, we believe that since the two 
components of work are time and intensity, significant decreases in 
time should be reflected in decreases to work RVUs. 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 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 note 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 supports 
the RUC's contention that the intensity of this code has increased over 
time.
    For CPT code 57282, we disagree with the RUC-recommended RVU of 
13.48. We note that the significant decrease in total time for code 
57282 suggests an RVU lower than 13.48. Although we disagree with the 
RUC-recommended work RVU, we concur that the relative difference in 
work between CPT codes 57282 and 57283 is equivalent to the RUC-
recommended interval of 0.03 RVUs. 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 are proposing 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 are proposing the RUC-recommended direct PE inputs for the CPT 
code family of 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 disagree with the RUC-recommended work RVU of 18.02 for CPT code 
57425 and propose 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 is 
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 are 
proposing to maintain the current work RVU of 17.03.
    We are proposing the RUC-recommended direct PE inputs for 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 are proposing the RUC-
recommended work RVU of 1.44 for CPT code 67028.
    For the direct PE inputs, we are proposing 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 agree 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 note that we are proposing 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 are also proposing to refine the equipment times to match 
the change in clinical labor time.
(22) Dilation of Eustachian Tube (CPT Codes 697XX and 697X1)
    In September 2019, the CPT Editorial Panel created two new codes 
CPT code 697XX (Nasopharyngoscopy, surgical, with dilation of 
eustachian tube (ie, balloon dilation); unilateral) and CPT code 
697X1(Nasopharyngoscopy, surgical, with dilation of eustachian tube 
(ie, balloon dilation); bilateral)) to describe the dilation of the 
eustachian tube via surgical nasopharyngoscopy, unilateral and 
bilateral. We are proposing the RUC-recommended work RVUs of 3.00 and 
4.27 for CPT codes 697XX and 697X1, respectively. For the direct PE 
inputs, we are proposing the RUC-recommended values without refinement.
(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 are proposing 
the RUC-recommended work RVU of 0.18 for this service. We are proposing 
the RUC-recommended direct PE inputs without refinement.
(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 are proposing the RUC

[[Page 50160]]

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 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 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 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 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 note that 
these codes are relatively consistently valued compared to other codes 
with similar time values and a global period of XXX. We are proposing 
the RUC-recommended direct PE inputs without refinement.
(25) Screening CT of Thorax (CPT Codes 71250, 71260, 71270, and 712X0)
    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 are not proposing 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. We are instead recommending to propose 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 (eg, 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 are not proposing 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 we are instead 
proposing a work RVU of 1.16 based the ratio of current to RUC-
recommended intraservice time. Although we disagree with the RUC-
recommended work RVU, we concur 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 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 note that 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 
are not proposing the RUC recommendation to maintain the current work 
RVU of 1.38 as we believe this does not accurately reflect the 
reduction in physician time, and we are instead proposing 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 support 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 712X0 
(Computed tomography, thorax, low dose for lung cancer screening, 
without contrast material(s)), we are not proposing the RUC-recommended 
work RVU of 1.16, and we are instead proposing 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 are proposing the RUC-recommended direct PE inputs without 
refinement for CPT codes 71250, 71260, and 71270. For the direct PE 
inputs for CPT code 712X0, we are proposing 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 are proposing 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 do 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.
(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 disagree with the RUC-recommended work RVU of 0.32 for CPT code 
74300. We are proposing 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. Our proposal is 
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

[[Page 50161]]

intraservice of 5 minutes and total time of 10 minutes for CPT code 
74300.
    We are proposing 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 disagree 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 are proposing 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 
believe the work involved in the biliary ductal and pancreatic ductal 
systems is similar.
    We disagree 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 are proposing a work RVU of 0.56 based on our 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 are not proposing 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 
recommends 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 are proposing 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 recommends 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 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 recommends 1.48 work RVU and 57 minutes of total 
time for CPT code 75822. We are proposing these RUC recommended values 
for CPT code 75822.
(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 are proposing the work RVU of 0.83 as recommended by 
the RUC. We are proposing the RUC-recommended direct PE inputs for CPT 
code 75984 without refinement.
(29) Medical Physics Dose Evaluation (CPT Code 7615X)
    The CPT Editorial Panel created CPT code 7615X (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 are proposing 
the RUC-recommended direct PE inputs for CPT code 7615X without 
refinement.
(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 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 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 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 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 (eg, barium) study) with identical 
intraservice and total times.
    For the direct PE inputs, we are proposing to make two refinements 
to the clinical labor times of CPT code 76513. We are proposing 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 are also proposing a reduction 
of 1 minute for the clinical labor task CA011: ``Provide education/
obtain consent'' to be consistent with the time for this

[[Page 50162]]

clinical labor task for the services in CPT code 76513's former code 
family.
(31) 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 are proposing 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 are not 
proposing to include the new equipment item ER119 ``Lead Room,'' as we 
do 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 are proposing to maintain the current work RVU of 
0.00.
(32) 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 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 have 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 have 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 systems. We understand 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 do 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 
agree that the provider does need to bear the costs associated with the 
storage of this equipment, this is a form of indirect PE under our 
methodology. We do 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 are proposing to maintain contractor pricing for 
CPT codes 77520, 77522, 77523, and 77525 instead of proposing active 
pricing for these services. 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 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.
    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).
(33) 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 Public Health Emergency 
(PHE) related to the COVID-19 pandemic, 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 cost 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

[[Page 50163]]

vaccine), and G0010 (Administration of hepatitis b vaccine) in the 
interim.
    The RUC has recently re-submitted 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 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 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 agree with the RUC's assertions regarding the importance of 
appropriate resource based valuations for vaccine administration 
services. We also recognize that the importance of these services is 
increased in the context of the current PHE related to the COVID-19 
pandemic, 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 this time, we do 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 
import of these services for Medicare beneficiaries, as well as the 
public health concerns raised by commenters, we believe 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 are proposing 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 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 note that this crosswalk will 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 believe that 
the proposed crosswalk is the most accurate valuation of these services 
and will 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 note 
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 are proposing 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 are proposing 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. 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.
(34) Liver Elastography (CPT Code 91200)
    CPT code 91200 (Liver elastography, mechanically induced shear wave 
(eg, 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 are proposing the RUC-recommended work RVU of 0.21. We are also 
proposing the RUC-recommended direct PE inputs for CPT code 91200 
without refinement.
(35) Remote Retinal Imaging (CPT Codes 92227, 92228, and 9225X)
    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 9225X (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 9225X can be used at a primary care practice site and the 
artificial intelligence technology

[[Page 50164]]

interprets the test instead of a remotely located ophthalmologist. 
Because no physician is involved, this service is PE only. We are 
considering CPT code 9225X to be a diagnostic service under the PFS and 
are creating separate payment for it.
    For CPT code 92228, we are proposing the RUC's recommended work RVU 
of 0.32. CPT codes 92227 and 9225X are PE only codes, and we are 
proposing a work RVU of 0.00 for both codes.
    For both CPT codes 92227 and 92228, we are proposing the AMA RUC's 
recommended direct PE inputs. We are proposing two refinements to the 
direct PE inputs for CPT code 9225X. We are proposing 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 are also not proposing the RUC's recommendation of 
a $25 analysis fee for remote imaging because we consider 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 do 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.
(36) Auditory Evoked Potentials (CPT Codes 92584, 92X51, 92X52, 92X53, 
and 92X54)
    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 are proposing the RUC-recommended work 
RVUs of 1.00 for CPT code 92584, 1.00 for CPT code 92X52 (Auditory 
evoked potentials; for hearing status determination, broadband stimuli, 
with interpretation and report), 1.50 for CPT code 92X53 (Auditory 
evoked potentials; for threshold estimation at multiple frequencies, 
with interpretation and report), and 1.05 for CPT code 92X54 (Auditory 
evoked potentials; neurodiagnostic, with interpretation and report). 
CPT code 92X51 (Auditory evoked potentials; screening of auditory 
potential with broadband stimuli, automated analysis) is a screening 
service and is not payable by Medicare. Therefore, we are not proposing 
a valuation for this code; however, we will display the RUC-recommended 
work RVU of 0.25.
    We are proposing the RUC-recommended direct PE inputs for this code 
family without refinement.
(37) Vestibular Evoked Myogenic Potential Testing (CPT Codes 925X1, 
925X2, and 925X3)
    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 925X1 (Vestibular evoked myogenic potential testing, with 
interpretation and report; cervical (cVEMP)); CPT code 925X2 
(Vestibular evoked myogenic potential testing, with interpretation and 
report; ocular (oVEMP)); and CPT code 925X3 (Vestibular evoked myogenic 
potential testing, with interpretation and report; cervical and 
ocular). The RUC reviewed the three codes at its April 2019 meeting.
    We are proposing the RUC-recommended work RVU of 0.80 for CPT codes 
925X1 and 925X2. For CPT code 925X3, we are proposing the RUC-
recommended work RVU of 1.20. We also are proposing the RUC-recommended 
direct PE inputs without refinement for these three VEMP codes.
(38) 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 93005 (Electrocardiogram, routine ECG with at 
least 12 leads; tracing only, without interpretation and report) is the 
technical component and CPT 93010 is the professional component.
    We are proposing 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 are proposing to 
maintain the current work RVU of 0.00.
    For the direct PE inputs, we are also proposing the RUC-recommended 
values without refinement.
(39) External Extended ECG Monitoring (CPT Codes 93224, 93225, 93226, 
93227, 93XX0, 93XX1, 93XX2, 93XX3, 93XX4, 93XX5, 93XX6, and 93XX7)
    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 are proposing the RUC-recommended work RVU for all 12 codes in 
the family. We are proposing 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 93XX0 (External electrocardiographic recording for more than 48 
hours up to 7 days by

[[Page 50165]]

continuous rhythm recording and storage; includes recording, scanning 
analysis with report, review and interpretation) and 93XX3 (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 93XX4 (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 93XX7 (External 
electrocardiographic recording for more 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 are proposing 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), 93XX1 (External 
electrocardiographic recording for more than 48 hours up to 7 days by 
continuous rhythm recording and storage; recording (includes connection 
and initial recording)), 93XX2 (External electrocardiographic recording 
for more than 48 hours up to 7 days by continuous rhythm recording and 
storage; scanning analysis with report), 93XX5 (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 93XX6 (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 are proposing to refine the clinical 
labor time for the ``Perform procedure/service--NOT directly related to 
physician work time'' (CA021) activity for CPT codes 93XX0, 93XX2, 
93XX4, and 93XX6. We are proposing 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 are proposing to remove 5 
minutes from the clinical labor to reflect these activities which are 
indirect as opposed to direct costs. We are also proposing 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 93XX0 and 93XX4. Both of these codes are the ``global 
component'' for their respective group of codes, such that the direct 
costs for CPT codes 93XX1-93XX3 must sum up to the direct cost of CPT 
code 93XX0 and the direct costs for CPT codes 93XX5 through 93XX7 must 
sum up to the direct cost of CPT code 93XX4. However, CPT codes 93XX0 
and 93XX4 each contained 2 pairs of non-sterile gloves (SB022) whereas 
their constituent technical component codes (93XX1 and 93XX5 
respectively) only contained a single pair of non-sterile gloves. 
Therefore, we are proposing to refine the quantity of the non-sterile 
gloves down to 1 pair for CPT codes 93XX0 and 93XX4 to correct this 
inconsistency. We also considered increasing the quantity of the gloves 
to 2 as in CPT codes 93224 through 93227. However, we believe 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 93XX0 
through 93XX7 as opposed to CPT codes 93224 through 93227 where the 
patient does return for ECG removal.
    We are proposing the RUC-recommended equipment time of 1474 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 1440 minutes (24 hours) of equipment time 
thereafter. We note that an external stakeholder wrote to request that 
the number of minutes of equipment time for the Holter monitor be 
increased from 1440 minutes (24 hours) to 2160 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 
are proposing the RUC-recommended equipment time of 1474 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 appreciate 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 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 provider, we cannot establish supply pricing based 
on an analysis of claims data and in absence of a representative 
invoice.
    Therefore, we are proposing 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 are proposing to use the ``kit, percutaneous neuro test 
stimulation'' (SA022) supply as our proxy item at a price of $413.24.

[[Page 50166]]

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 welcome 
the submission of invoices or other additional information for use in 
pricing the ``extended external ECG patch, medical magnetic tape 
recorder'' supply.
(40) 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 are proposing this value.
    Although we are proposing the RUC's recommended direct PE inputs 
without refinement we note that the RUC's recommendation included both 
25 mL and 50 mL of ultrasound transmission gel. We are proposing a 
supply quantity of 25 mL and seeking clarification on the correct 
amount.
(41) 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 recommends 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 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 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 believe 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 
are proposing 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.
(42) 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.
    The survey resulted in a median intraservice time of 25 minutes, a 
significant shift from the current intraservice time of 55 minutes. The 
RUC recommends a work RVU of 2.53 and 25 minutes of intraservice time 
for add-on CPT code 93662. 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 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. 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 are proposing 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.
(43) 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 (eg, drivelines, alarms, 
power surges), review of device function (eg, 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 (eg, 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

[[Page 50167]]

recommends 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 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, so we are proposing 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 are proposing to accept the RUC-recommended direct PE inputs.
(44) 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 are proposing 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 are proposing the RUC-
recommended direct PE inputs for this code family without refinements.
(45) Exercise Test for Bronchospasm (CPT Codes 946X0, 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 (eg, 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 (eg, 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 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 946X0 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 
946X0, and included a request to reaffirm the values of the rest of the 
codes in the code family.
    For CPT code 946X0, 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 recommends 
the survey's median work RVU of 0.49 for CPT code 946X0.
    We are proposing the RUC's recommendation of a work RVU of 0.49 and 
a total physician time of 24 minutes for CPT code 946X0.
    This CPT family of codes that includes CPT code 946X0, 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 propose to accept them 
without change.
    We are proposing the RUC-recommended PE changes without refinement.
(46) 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 are proposing the RUC-recommended direct PE inputs for the four 
PE only codes. The RUC did not recommend work RVUs and we are proposing 
to maintain the current work RVU of 0.00 for all four codes.
(47) 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 are proposing the direct PE inputs for CPT code 95012 
without refinement. CPT code 95012 is a PE-only code with no work RVU, 
and we are proposing to maintain the current work RVU of 0.00.
(48) 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, 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

[[Page 50168]]

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 are proposing 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 are proposing 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 are 
proposing 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 note 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 
do 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 believe 
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 believe 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 are not proposing 
any changes to the direct PE inputs for CPT codes 97810 through 97814.
(49) Chronic Care Management Services (CPT Code 994XX 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 994XX (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 are proposing the RUC-recommended work RVU of 0.54 
and the RUC-recommended direct PE inputs for CPT code 994XX.
(50) 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 are proposing the RUC-recommended preservice period, service 
period and postservice period with refinements. We propose 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 are proposing 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 note 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 are not proposing to 
change the equipment utilization rate, we are soliciting 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 are not proposing 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 this 
proposed rule, 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 believe that 
applying a multi-year depreciation in these situations would not be 
reflective of market pricing. Although we agree that these costs should 
be reflected in the pricing of HCPCS code G0166, we believe that the 
very frequent replacement of the items in the two equipment packages 
makes them a poor fit under our equipment methodology.
    Therefore, we are proposing to treat the two EECP equipment 
packages as supplies instead of treating them as equipment. We are 
proposing to establish the EECP compression

[[Page 50169]]

equipment package (SD341) as a supply with a cost of $645 based on an 
average of the submitted invoices, and proposing 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 are proposing 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 believe that assigning these two 
items as supplies rather than equipment more accurately captures the 
unusual circumstances associated with providing this service.
(51) 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 are proposing the RUC-recommended work RVU of 0.93 
and the RUC-recommended direct PE inputs for HCPCS code G0452.
(52) 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.
    Additionally, 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 are using a price of $590.02 for the 
supply input that describes 56 mg (supply code SH109) and for HCPCS 
code G2083, we are using 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. We received public comments on this 
policy. The following is a summary of the comments we received and our 
responses.
    Comment: Overall, commenters were supportive of CMS establishing 
coding and payment for E/M, observation and the provision of self-
administered esketamine. However, a few commenters were not in support 
of the proposal, noting that IV ketamine is cheaper and has been proven 
to be more effective than esketamine.
    Response: We appreciate the support for our interim final rule with 
comment period. We continue to believe that it is in the public 
interest to ensure beneficiaries have access to new, potentially life-
saving treatment for treatment-resistant depression (TRD) using 
esketamine. Therefore, we are proposing to maintain HCPCS codes G2082 
and G2083 that describe E/M, observation and the provision of self-
administered esketamine.
    Comment: Several commenters suggested including psychotherapy, CPT 
codes 90833 and 90836, in the valuation of HCPCS codes G2083 and G2083.
    Response: We disagree that psychotherapy should be included in the 
valuation of HCPCS codes G2082 and G2083. HCPCS codes G2082 and G2083 
were created 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. However, practitioners who furnish other allowable, billable 
services, including psychotherapy, on the same day as an E/M, 
observation and provision of self-administered esketamine service can 
bill separately for those services using other codes.
    Comment: Some commenters recommended that esketamine should

[[Page 50170]]

have its own J code in addition to the G codes.
    Response: HCPCS codes G2082 and G2083 are bundled services that 
include, as discussed previously, the E/M, observation and the 
provision of self-administered esketamine. 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.
    Comment: Several commenters disagreed with the use of 99212 to 
establish codes G2082 and G2083. Commenters suggested using 99213, 
99214, and/or 99215 instead of 99212. Some commenters indicated that 
the intraservice work time of 10 minutes is insufficient, and one 
commenter stated a minimum of 20 minutes would be more appropriate. 
Another commenter suggested unbundling the code and, in part, indicated 
that face-to-face visits with the psychiatrist are not required at each 
visit.
    Response: We appreciate the feedback received from the commenters 
regarding the E/M elements of the service. We have considered the wide 
range of recommendations that were received from commenters regarding 
the E/M elements of the service. One commenter indicated that there is 
variability in performance and level of E/M services associated with 
the service (in which self-administered esketamine is provided and 
observed). Another commenter noted that a face-to face visit with the 
psychiatrist is not required at each visit, while other commenters 
recommended using E/M CPT codes up to 99215. We continue to believe 
that the building block methodology we used incorporating CPT code 
99212 is appropriate for valuing this service. Therefore, we are not 
proposing to change the E/M element of the service by incorporating the 
work RVUs, work time and direct PE input associated with a level two 
office/outpatient visit for an established patient, CPT code 99212.
    Comment: Many commenters urged CMS to ensure PFS payment rates are 
sufficient to capture the complexity and time for the provision of 
esketamine.
    A commenter recommended unbundling all the services. The commenter 
stated that the way the bundled payments are currently constructed 
fails to recognize the possible variability of E/M services that may be 
required, the time and effort required of clinical staff to monitor the 
patient during the lengthy observation period, and the amount of pre- 
and post-service work required. The commenter also stated that bundling 
the physician E/M services and the observation services performed by 
clinical staff is problematic and including the medication in the 
bundle is problematic because in many instances the psychiatrist may 
not be incurring the cost of the medication. The commenter stated that 
clinical staff time and effort comprise a significant and separate 
service, including not only the time spent observing and actively 
monitoring the patient's condition for possible adverse side-effects 
(that is, nausea, vomiting, escalation in blood pressure), but also 
extensive pre- and post-service preparation that does not appear to 
have been included as part of the bundled payment and is not described 
by existing CPT codes.
    The commenter recommended increasing the proposed valuation of 
clinical staff time to more appropriately account for the clinical 
staff time and the effort required for pre-, intra-, and post- service 
work. This includes acquisition of the drug, delivery of the medication 
to the patient, and the observation of the self-administration, 
followed by active monitoring of the patient's condition (vitals, etc.) 
for a minimum of 2 hours, the commenter suggested that the more 
appropriate comparison for the clinical staff time related to the 2-
hour observation period is 95076, Ingestion challenge test (sequential 
and incremental ingestion of test items, e.g., food, drug or other 
substance); initial 120 minutes of testing (110 minutes intra service 
time; PE RVU 1.81). Both services, the G2082 and G2083 codes and the 
95076, require a lengthy observation time (minimum of 2 hours) with 
clinical staff monitoring for adverse side-effects. The total PE RVU of 
the 95076 is 1.81 RVUs versus 0.51 RVUs (99415 x 1, 99416 x 2 or 0.27 + 
(0.12 x 2) = 0.51 RVUs) of the combined 99415 and 99416. The associated 
add-on code for 95076 is 95079, Ingestion challenge test (sequential 
and incremental ingestion of test items, e.g., food, drug or other 
substance); each additional 60 minutes of testing (List separately in 
addition to code for primary procedure) (40 minutes intra-service time; 
PE RVU 0.99), which would account for additional time for this service 
when required. Procedurally these services are similar in staff time, 
staff type and effort, and both are reported separately from the E/M 
service. The commenter requested that we use the PE RVUs for the 95076 
and the 95079 in lieu of the 99415 and 99416 in calculating the values 
for the clinical staff component, to more accurately reflect the time 
and effort of the clinical staff in the observation of the patient.
    Response: After consideration of comments requesting that we 
reconsider aspects of our current valuation for these services, 
including at least 2 hours of post-administration observation, we 
believe some of the refinements discussed by stakeholders may be 
appropriate to improve payment accuracy and help ensure that 
beneficiaries who need esketamine for treatment have access to it. 
Based on our review of the Spravato Prescribing Information, Medication 
Guide and REMS requirements, the FDA-approved conditions/requirements 
indicate that the drug is only available as an integral component of a 
physician's service.\8\ \9\ \10\ Spravato is only dispensed and 
administered to patients in a medically supervised healthcare setting 
that monitors these patients.\11\ Therefore, we continue to believe 
this treatment should be paid for as a bundled service. In 
consideration of the comment urging us to account for clinical staff 
time spent observing and actively monitoring the patient for possible 
side-effects, along with pre- and post-service preparation, we are 
proposing 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 the 95079 in lieu of the clinical labor time of CPT codes 99415 and 
99416. We are specifically proposing 150 minutes of observation time 
for HCPCS codes G2082 and G2083 based on the sum of the clinical labor 
for CPT code 95076 (110 minutes) and CPT code 95079 (40 minutes). This 
would replace our previous interim final valuation of 30 minutes of 
observation time based on the sum of the clinical labor for CPT code 
99415 (15 minutes) and two billings of CPT code 99416 (8 minutes). We 
are seeking comment on this proposal. Additionally, under circumstances 
where the health care professional supervising the self-administration 
and observation does not also provide the esketamine product, the 
physician or practitioner cannot report HCPCS codes G2082 or G2083. 
Rather, the visit and the extended observation (by either the billing 
professional or clinical staff) could be reported using the existing E/
M codes that describe the visit and the prolonged

[[Page 50171]]

service of the professional or the clinical staff.
---------------------------------------------------------------------------

    \8\ https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=386.
    \9\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211243s003lbl.pdf.
    \10\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211243s003lbl.pdf#page=38.
    \11\ https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=386.
---------------------------------------------------------------------------

    Comment: One commenter urged CMS to align the HCPCS codes G2082 and 
G2083 for a visit for the provision of esketamine with prescribing 
recommendations from the drug manufacturer that include at least 2 
hours of post-administration observation until a patient is safe to 
leave the facility. Another commenter questioned whether the codes 
should be valued using CPT codes 99213, 99214 and even 99215, with 
99354 (Prolonged evaluation and management or psychotherapy service(s) 
(beyond the typical service time of the primary procedure) in the 
office or other outpatient setting requiring direct patient contact 
beyond the usual service; first hour (List separately in addition to 
code for office or other outpatient Evaluation and Management or 
psychotherapy service)) and 99355 (Prolonged evaluation and management 
or psychotherapy service(s) (beyond the typical service time of the 
primary procedure) in the office or other outpatient setting requiring 
direct patient contact beyond the usual service; each additional 30 
minutes (List separately in addition to code for prolonged service)).
    Response: As previously stated, we are proposing to continue 
valuing HCPCS codes G2082 and G2083, in part, on the basis of a level 2 
established patient office/outpatient E/M visit. However, as previously 
stated, after considering comments regarding the esketamine post-
administration observation time, we are proposing 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 the 95079, specifically 
proposing 150 minutes of observation time. We are seeking comment on 
this proposal.
    Comment: Some commenters indicated that the proposed PE inputs do 
not reflect the costs of, and overall drug cycle management needed to 
safely administer, esketamine. One commenter indicated that, after 
conducting an analysis associated with each patient encounter to 
include: Physician time and technician time, reception time, rent, 
furniture, monitoring, electronic health record (EHR), supplies, waste 
management, etc., their direct overhead cost is $1000 per patient per 
encounter, not including direct cost and management of the drug. 
Therefore, the commenter recommends we revise payment by adding 20 
percent to the direct expense and mandatory overhead costs of $1000 per 
patient encounter. Some commenters indicated that the proposed PE 
inputs do not reflect the costs of initial capital requirements for 
ongoing resources, maintaining the Risk Evaluation and Mitigation 
Strategy (REMS) standards with the FDA and overall drug cycle 
management needed to safely administer esketamine. Specifically, one 
commenter indicated that Spravato will need to be delivered in the 
community setting. A typical community psychiatry practice does not 
have a large enough physical plant to accommodate a 2 hour monitoring 
period, requiring a lease or purchase of additional space. In addition, 
Spravato requires administrative support for medication procurement, 
appropriate storage equipment (for example, Pyxis machine or similar) 
to mitigate abuse and diversion potential, medically appropriate 
staffing (for the required observation of self-administration, multiple 
vital signs checks, completion of REMS monitoring forms and other 
administrative requirements of the REMS, and discharge assessment), and 
equipment and services including a chair that can recline and 
controlled substance waste removal compliance. One commenter indicated 
that the pricing methodology used for esketamine, whether WAC, ASP or 
compendia pricing, does not take into account the costs associated with 
full-management of the drug cycle including ordering, storage, 
inventory tracking, billing, etc. Therefore, the commenter recommends 
valuing the bundled esketamine by adding 20 percent to ASP.
    Response: Under our PE methodology, the costs identified by the 
commenter for reception time, rent, furniture, electronic health 
records (EHRs), and waste management are all types of indirect costs. 
This means that they are not individually allocable to a particular 
patient for a particular service, and therefore they are not summed up 
as separate itemized direct costs for codes such as HCPCS codes G2082 
and G2083. CMS is still paying practitioners for these costs through 
our indirect PE methodology; we note that for a typical HCPCS code, 
indirect costs make up roughly 75 percent of the total PE. If we were 
to itemize administrative costs such as rent and furniture as direct 
costs, we would be double counting them in violation of our standard PE 
methodology. As previously discussed, we are proposing 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 to account for the 
clinical staff time, such that the proposed refinements would increase 
the clinical labor time from 30 minutes to 150 minutes. We believe this 
refinement would account for the clinical staff time and efforts 
including the acquisition and delivery of the medication to the patient 
as required by the REMS.
    Comment: One commenter requested clarification on whether payment 
is fixed for 2020 or whether the payment will be adjusted to reflect 
2020 changes in WAC, for example updated data made available from the 
most recent quarter. The commenter also questioned whether regulatory 
changes made under the PFS to values of the component services would 
also be applied to the G codes, for example, whether changes to values 
of the E/M codes would also be incorporated into the RVU inputs for G 
codes. For instance the outpatient E/M values are set to increase in 
2021, and the commenter asked whether that increase would automatically 
be included in the valuation of the bundle, and whether the payment 
currently ascribed to the bundle for the cost of the medication be 
updated if the input prices for the services change over time.
    Response: Historically, supply input prices are updated on a code-
by-code basis and periodically through annual notice and comment 
rulemaking. The prices, including for a variety of pharmaceutical 
products, are not routinely updated like Part B drugs paid under the 
ASP methodologies. For the supply inputs for the esketamine product 
used in developing rates for HCPCS codes G2082 and G2083, we used the 
most recent available quarter of WAC data for 2020 pricing, but we 
anticipate using either data reported for purposes of determining 
payments under section 1847A of the Act (such as ASP) or compendia 
pricing information (such as WAC) in future years. Since we reviewed 
and are proposing refinements to HCPCS codes G2082 and G2083 for the CY 
2021 rulemaking cycle, we propose to update the payment to reflect the 
most recent available quarter of WAC data for CY 2021 pricing, and 
propose to update the payment to reflect the E/M values (CPT code 
99212) for CY 2021. Therefore, 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 propose to update 
the supply input that describes 56 mg (supply code SH109) from a price 
of $590.02 to $616.93 and for HCPCS code G2083, we propose to update 
the price from $885.02 to $928.38 for the supply input

[[Page 50172]]

describing 84 mg of esketamine (supply code SH110).
    Comment: One commenter indicated that the CMS approach to the E/M 
component of the interim G codes includes inputs associated with an 
established patient for the first visit or any subsequent treatment, 
and requested clarification that, if reasonable and necessary, the 
health care provider could complete an E/M service that is distinct 
from the E/M services necessary for esketamine administration, and in 
such an event, separate E/M service would be eligible to be paid 
separately with E/M codes.
    Response: Given that HCPCS codes G2082 and G2083 already take into 
account E/M services in their valuations, it would be duplicative to 
bill for a separate E/M code along with HCPCS codes G2082 and G2083. 
However, other reasonable and necessary E/M services may be furnished 
and billed for a patient on dates before and after HCPCS code G2082 or 
G2083, for example, when the services are furnished in the course of 
treating and diagnosing treatment-resistant depression.
    After considering the comments we received, we are proposing 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 are 
incorporating 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 are also proposing to include the clinical labor for 
CPT 95076 and 95079 (in lieu of CPT codes 99415 and 99416 as detailed 
earlier); and to account for the cost of the provision of the self-
administered esketamine as a direct PE input, we are proposing to 
incorporate the wholesale acquisition cost (WAC) data from the most 
recent available quarter. We are seeking comment on this updated 
payment proposal and valuation of HCPCS code G2082 and G2083.
(53) 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.
    We have received requests to expand these bundled payments to be 
inclusive of other SUDs, not just OUD. We agree that doing so could 
expand access to needed care. We are proposing to expand these bundled 
payments to be inclusive of all SUDs. To accomplish this, we are 
proposing 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 note 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 proposed 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).
    Additionally, in the CY 2020 PFS final rule we stated that we 
anticipate 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 
nonphysician practitioner (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 
encourage that practitioners consult with specialists in cases where it 
is warranted and refer the patient to specialty care as needed.
    We note 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 do not wish to add any additional burden on practitioners related 
to claims submission, therefore, we are seeking information on whether 
there are sources of data we could explore in order to provide this 
information. We are also seeking 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 note that in some 
instances, the CPT Editorial Panel has created CPT codes to replace G 
codes created by CMS, and that we would welcome such input on these 
services. We look forward to receiving public comments on this proposal 
in order to help evaluate whether more granular coding is needed.
(54) Initiation of Medication Assisted Treatment (MAT) in the Emergency 
Department (HCPCS Code GMAT1)
    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 note 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-

[[Page 50173]]

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.\12\ 
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.\13\ Another study 
found that ED induction of buprenorphine was more cost-effective than 
either brief intervention or referral upon discharge.\14\ 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.
---------------------------------------------------------------------------

    \12\ 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.
    \13\ 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.
    \14\ 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 are 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 are proposing to create one 
add-on G-code to be billed with E/M visit codes used in the ED setting. 
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. The proposed code is:
     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 services (List separately in addition to code for primary 
procedure).
    To price this service, we are proposing 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 
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 note that unlike the requirements for reference code, we are 
not proposing a required number of minutes to bill HCPCS code GMAT1. We 
welcome comment on this proposal and whether we should consider a 
different valuation to account for the resource costs involved with 
these services.
(55) Percutaneous Creation of an Arteriovenous Fistula (AVF) (HCPCS 
Code 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 
that was declared effective January 27, 2020 for the COVID-19 epidemic. 
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 have 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, wen performed) and fistulogram(s), 
angiography, venography, and/or ultrasound, with

[[Page 50174]]

radiologic supervision and interpretation, when performed.)
    We are proposing to maintain contractor pricing for these HCPCS 
codes for CY 2021, however, we are also seeking 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 
note that under the Outpatient Prospective Payment System (OPPS) these 
services are assigned to APC 5193, which for CY 2020 has an assigned 
payment rate of $15,938.20.
(56) 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 are proposing 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 are proposing 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 are also proposing to include one supply and one equipment item 
to the direct PE inputs crosswalked from CPT codes 11981-11983. We are 
adding 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 propose to price at 
$1,500.00, based on information we received from stakeholders. We are 
also proposing to include the smart transmitter associated with the use 
of this implantable interstitial glucose sensor. We propose 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 are 
proposing 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. 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 are not including either the implantable 
interstitial glucose sensor or the EQ392 equipment proxy for Category 
III CPT code 0447T, as it describes only a removal procedure.
    We are seeking comment on the proposed values for these Category 
III CPT codes (0446T, 0447T, and 0448T), and we are seeking comment on 
the appropriateness and accuracy of the proposed work RVUs, work times, 
and direct PE inputs.
BILLING CODE 4120-01-P

[[Page 50175]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.036


[[Page 50176]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.037


[[Page 50177]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.038


[[Page 50178]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.039


[[Page 50179]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.040


[[Page 50180]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.041


[[Page 50181]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.042


[[Page 50182]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.043


[[Page 50183]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.044


[[Page 50184]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.045


[[Page 50185]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.046


[[Page 50186]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.047


[[Page 50187]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.048


[[Page 50188]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.049


[[Page 50189]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.050


[[Page 50190]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.051


[[Page 50191]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.052


[[Page 50192]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.053


[[Page 50193]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.054


[[Page 50194]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.055


[[Page 50195]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.056


[[Page 50196]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.057


[[Page 50197]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.058


[[Page 50198]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.059


[[Page 50199]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.060


[[Page 50200]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.061


[[Page 50201]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.062


[[Page 50202]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.063

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 are proposing several 
refinements and seek to provide clarification on 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

[[Page 50203]]

medications approved by the Food and Drug Administration (FDA) under 
section 505 of the 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. After further 
consideration, we have determined that it is 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.\15\ \16\ 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.\17\
---------------------------------------------------------------------------

    \15\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208411lbl.pdf.
    \16\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/209862lbl.pdf.
    \17\ https://store.samhsa.gov/system/files/sma18-4742.pdf.
---------------------------------------------------------------------------

    Naloxone attaches to opioid receptors and reverses and blocks the 
effects of other opioids.\18\ 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). 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.\19\ Both the nasal 
spray and naloxone auto-injector are packaged in a carton containing 
two doses to allow for repeat dosing if needed.20 21
---------------------------------------------------------------------------

    \18\ https://www.drugabuse.gov/publications/drugfacts/naloxone.
    \19\ https://www.samhsa.gov/medication-assisted-treatment/treatment/naloxone.
    \20\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208411lbl.pdf.
    \21\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/209862lbl.pdf.
    \22\ https://www.hhs.gov/surgeongeneral/priorities/opioids-and-addiction/naloxone-advisory/index.html.
    \23\ http://www.medpac.gov/docs/default-source/reports/mar18_medpac_ch14_sec.pdf.
---------------------------------------------------------------------------

    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.'' \22\
    We are proposing 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 this 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 note 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.\23\ However, we believe allowing beneficiaries 
to access this important emergency treatment at the OTP may help 
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.
    Accordingly, to align with efforts to end the opioid epidemic, 
under the discretionary authority in section 1861(jjj)(1)(F) of the 
Act, we propose 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 are proposing 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. Naloxone is 
not one of the three drugs currently approved by FDA for the treatment 
of opioid dependence (buprenorphine, methadone, and naltrexone); and, 
as a result, we do not believe naloxone fits the criteria of section 
1861(jjj)(1)(A) of the Act. We seek comment on our proposal to expand 
the definition of OUD treatment services.
    Additionally, 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 
welcome comments on whether the definition of OUD treatment services 
should be further revised to include overdose education. Additionally, 
we welcome 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 are specifically seeking 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

[[Page 50204]]

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. Proposed Adjustment Made to the Bundled Payments for OUD Treatment 
Services
    Consistent with our 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 
believe it is appropriate to propose changes to the payment rates for 
the bundled payments to reflect the costs of these medications. 
Therefore, we propose 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 believe that 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 would not expect naloxone to be provided weekly to all 
patients, but only on an as-needed basis. Accordingly, we believe that 
making payment for naloxone through the use of an add-on code is 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 propose 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 are proposing 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 believe it is appropriate 
to use a similar methodology to determine the payment rates for the 
add-on codes for naloxone as we adopted in the CY 2020 PFS final rule 
for purposes of determining the payment rate for the drug component of 
the bundled payments because it provides our 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).
Drug Pricing for Nasal Naloxone
    Consistent with the approach that we adopted for pricing the drug 
component of the weekly bundled payments, we are proposing to price the 
add-on code describing the take home supply of nasal naloxone, HCPCS 
code GOTP1, using the same methodology we previously adopted for 
pricing the drug component of an episode 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. We recognize that nasal naloxone is not an oral, 
implantable or injectable medication; however, ASP data are available. 
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 seek 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.
Drug Pricing for Auto-Injector Naloxone
    We are proposing to price the add-on code describing the take-home 
supply of auto-injector naloxone, HCPCS code GOTP2, 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 propose to use WAC + 0 to determine the 
pricing for the add-on payment for auto-injector naloxone. 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, in the 
future, we believe 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.

[[Page 50205]]

    We note that auto-injector naloxone is available in both a generic 
and brand name version. We 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 is rather new to the 
marketplace,\24\ there are limited utilization data available for the 
generic product. Based on historical information reflecting a trend of 
increased generic utilization uptake,\25\ we believe that in most cases 
where the auto-injector naloxone is prescribed and dispensed by OTPs to 
beneficiaries, it will be the generic formulation of the product. 
Therefore, we believe using the price for the generic formulation is a 
reasonable approach to pricing the proposed add-on code for auto-
injector naloxone and will ensure that beneficiaries who need this drug 
as part of their treatment for OUD have access to it and that OTPs 
receive a reasonable payment for dispensing the drug. Accordingly, we 
are proposing 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 seek 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.
Frequency Limit
    We note that Medicare Part D allows prescription drug plans to 
place quantity limits (QL) on most drugs, including on naloxone. While 
most 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 Part D formularies plan 
to apply a QL to this product (106/564 formularies). However, a review 
of 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. 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.\26\ 
We believe it would be appropriate to apply a similar limit on the 
frequency of the add-on payment for naloxone dispensed by OTPs. We 
believe that applying a frequency limit would assist in enhancing 
patient safety and discourage misuse, waste and abuse. Furthermore, we 
believe such a limitation is 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 do not want to limit access 
to naloxone when it is a medically reasonable and necessary part of the 
treatment for OUD. Therefore, we propose 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 
seek comment on whether this proposed limit is reasonable and whether 
special circumstances may arise under which more frequent payment is 
medically reasonable and necessary and the types of circumstances that 
should qualify for more frequent payment. However, we note 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 propose 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.
---------------------------------------------------------------------------

    \24\ https://kaleo.com/in-the-news/authorized-generic-for-evzio-naloxone-hcl-injection-to-be-available-at-a-reduced-list-price-of-178/.
    \25\ 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.
    \26\ https://www.express-scripts.com/static/formularySearch/2.9.6/#/formularySearch/drugSearch.
---------------------------------------------------------------------------

    We invite public comments on the proposed pricing for nasal 
naloxone and auto-injector naloxone. We also seek comment on our 
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.
    Additionally, we seek comment on whether we should consider 
creating a code and establishing an add-on payment for injectable 
naloxone. We note that all three forms of naloxone (injectable, auto-
injector, and nasal spray) are FDA-approved and may be considered as 
options for community distribution and use by individuals with or 
without medical training to stop or reverse the effects of an opioid 
overdose.\27\ 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).
---------------------------------------------------------------------------

    \27\ https://www.fda.gov/news-events/press-announcements/statement-continued-efforts-increase-availability-all-forms-naloxone-help-reduce-opioid-overdose.
---------------------------------------------------------------------------

    Table 30 details the proposed coding and summarizes the proposed 
payment amounts for nasal naloxone and auto-injector naloxone.

[[Page 50206]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.064

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 Part B or Part D for items and services furnished by an OTP. We 
note that under our proposal, OTPs would be able to provide naloxone to 
Medicare beneficiaries and bill for it as an add-on to the bundled 
payment. Consistent with Sec.  410.67(e), the beneficiary's copayment 
amount would remain zero. We also realize 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 are proposing 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 understand that some OTPs negotiate arrangements 
whereby community pharmacies supply MAT-related medications to OTPs. 
However, as we 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 
Part D plan. We expect that 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 
intend to monitor for duplicative payments, and would take appropriate 
action as needed when and if such duplicative payments are identified.
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 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 when ASP is not available, including WAC and 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 this proposed rule, we 
believe that it is necessary to amend the OTP drug pricing methodology 
in order to limit WAC-based payments to 100 percent of WAC. As 
discussed previously, we are proposing 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 
believe 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 want 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 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.\28\ 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

[[Page 50207]]

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.\29\ 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 are 
proposing that when WAC-based pricing is used, the payment amount shall 
be WAC + 0. We are proposing to amend the provision at Sec.  
410.67(d)(2)(i)(A) to reflect this limitation.
---------------------------------------------------------------------------

    \28\ http://www.medpac.gov/-blog-/requiring-reporting-of-sales-price-data/2019/06/14/payment-for-part-b-drugs.
    \29\ http://medpac.gov/docs/default-source/reports/jun17_ch2.pdf.
---------------------------------------------------------------------------

    We welcome 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.
4. Billing and Payment Policies
a. Institutional Claim Forms
    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 are 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 proposed rule, OTP Provider Enrollment Regulation Updates for 
Institutional Claim Submissions, for a discussion related to OTP 
enrollment as it relates to institutional claims. There would be no 
differences in coverage or payment between services billed on the 
institutional claim form versus the professional claim form. We note 
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 are seeking information on the reasons this flexibility is necessary 
for OTPs, and will address any changes to provider billing policies in 
subsequent 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).
    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 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 are proposing 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 are 
proposing to amend the definition of periodic assessment in Sec.  
410.67(b)(7) to

[[Page 50208]]

provide that the definition is limited to a face-to-face encounter.
    Additionally, we note 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 the COVID-19 pandemic 
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 believe that allowing periodic 
assessments to be furnished via two-way interactive audio-video 
communication technology beyond the conclusion of the PHE for the 
COVID-19 pandemic would help to expand access to care for patients who 
may have a difficult time getting to the OTP in person. Therefore, in 
this proposed rule, we are proposing 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 note that we are currently permitting the use 
of audio-only telephone calls to furnish these services during the PHE 
for the COVID-19 pandemic, 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 do not believe this flexibility will be needed 
in order to ensure access after the PHE ends. Therefore, under this 
proposal, the flexibility to use audio-only telephone services to 
furnish periodic assessments would not be permitted once the PHE for 
the COVID-19 pandemic has ended. We note that we would consider payment 
for any periodic assessment-related services furnished via audio-only 
telephone calls to be included in the bundled payment, but that audio-
only telephone services would not qualify for billing HCPCS code G2077 
after the end of the PHE for the COVID-19 pandemic. We are seeking 
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 the COVID-19 pandemic, and if so, 
whether the payment rate for audio-only services should reflect any 
differences in resource costs.
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.
    We note 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).
d. Coding
    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 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 welcome comments on how we 
might better account for differences in resource costs among patients 
over the course of treatment. We will consider the comments received in 
developing any proposed refinements to our coding policies in 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 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 OTP Proposed Payment Rates 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/PFSFederal-Regulation-Notices.html. Additionally, we 
note that the current 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-

[[Page 50209]]

Payment/Opioid-Treatment-Program/billing-payment.

III. Other Provisions of the Proposed Rule

A. Clinical Laboratory Fee Schedule: Revised Data Reporting Period and 
Phase-in of Payment Reductions, and a Comment Solicitation on Payment 
for Specimen Collection for Covid-19 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 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

[[Page 50210]]

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 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.html.
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 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 does 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 revise our current 
definitions of data collection period and data reporting period, the 
definitions will be incorrect with regard to the data collection period 
that applies to the next data reporting period. Therefore, in section 
III.A.4. of this proposed rule, ``Proposed Conforming Regulatory 
Changes,'' we are proposing 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 amends the provisions in 
section 1834A(b)(3) of the Act regarding the phase-in of payment 
reductions under the CLFS. First, it extends the statutory phase-in of 
payment reductions resulting from private payor rate implementation by 
an additional year, that is, through CY 2024. It further amends 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 amends 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. Proposed Conforming Regulatory Changes
    In accordance with section 105(a) of the FCAA and section 3718 of 
the CARES Act, we are proposing to make certain conforming changes to 
the data reporting and payment requirements at 42 CFR part 414, subpart 
G. Specifically, we are proposing 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 are also proposing 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 are proposing to make conforming changes to our 
requirements for the phase-in of payment reductions to reflect the 
CARES Act amendments. Specifically, we are proposing to revise Sec.  
414.507(d) to indicate that for CY 2021, payment may not be reduced by

[[Page 50211]]

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.
5. Comment Solicitation on Payment for Specimen Collection for COVID-19 
Clinical Diagnostic Tests
    In the ``Medicare and Medicaid Programs; Policy and Regulatory 
Revisions in Response to the COVID-19 Public Health Emergency'' interim 
final with comment period (IFC) (85 FR 19256 through 19258), which 
published in the April 6, 2020 Federal Register, 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. 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 
G2024 (specimen collection for severe acute respiratory syndrome 
coronavirus 2 (SARS-Cov-2) (Coronavirus disease [COVID-19]), 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 COVID-19 PHE.
    We indicated in the April 6, 2020 IFC that this specimen collection 
fee policy was established for the duration of the Public Health 
Emergency (PHE) for the COVID-19 pandemic (85 FR 19256). We are 
requesting comments on whether we should delete HCPCS Codes G2023 and 
G2024 once the COVID-19 PHE ends. Comments received may inform a future 
proposal. Specifically, we are seeking public input on why these codes, 
and their corresponding payment amounts, which are higher than the 
nominal fees for specimen collection for other conditions, would be 
necessary or useful outside of the context of the PHE. We are 
particularly interested in why separate, increased payment for specimen 
collection specifically for COVID-19 tests, in contrast to other tests, 
might be needed following the end of the PHE.

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 vetted; 
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 this 
proposed rule, 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 propose 
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 propose 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 supplement or attachment thereto. We propose 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 
propose 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 the said definition.
    We believe 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.

[[Page 50212]]

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. 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 do 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 propose several changes to Sec.  424.67(b)(3). 
First, we would re-designate existing Sec.  424.67(b)(3) as new Sec.  
424.67(b)(3)(i), though with an exception to its requirements. Second, 
new paragraph (b)(3)(ii) (which would address this exception) would 
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 propose to redesignate existing Sec.  
424.518(a)(1)(xii) through (xvii) as Sec.  424.518(a)(1)(xiii) through 
(xviii). Fourth, 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 propose three additional clarifications related to our 
previously mentioned OTP enrollment provisions. To incorporate these 
into Sec.  424.67, we would 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 propose 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 propose 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).
(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 propose 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

[[Page 50213]]

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. We note, however, 
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 recognize, of course, 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.) 
We define the term ``institutional provider'' 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 non-physician practitioner organizations, which are 
exempt from the fee requirement if they are enrolling as a physician or 
non-physician practitioner organization), Form CMS-855S, Form CMS-
20134, or an associated internet-based PECOS enrollment application.
    We have already noted that 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, as stated 
previously, be enrolling as new providers via the Form CMS-855A or Form 
CMS-855B (as applicable), we believe 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 
propose 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 emphasize 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 should the proposals in section II.I. be finalized.

C. Payment for Principal Care Management (PCM) Services in Rural Health 
Centers (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 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 final rule with comment period (83 FR 59683), 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.

[[Page 50214]]

    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 final rule with comment period, 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. Proposed 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 non-physicians 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 non-physician practitioner 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.
    A national stakeholder organization representing rural health 
clinics has requested that RHCs be allowed to furnish and bill for PCM 
services. We agree 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. 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 are proposing 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 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 propose that 
these 2 new codes be added to the calculation of the G0511 payment 
rate.
3. Other Options Considered
    We also considered creating a separate G code for PCM services. We 
did not choose this approach because PCM and CCM are similar services 
and grouping them together is consistent with an integrated approach to 
care with reduced reporting 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
    If this proposal is finalized as proposed, RHCs and FQHCs that 
furnish qualified 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.

D. Changes to the Federally Qualified Health Center Prospective Payment 
System (FQHC PPS) for CY 2021: Proposed 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 are 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 conversion factor for physician 
service payments. (See the CY 2014 PFS

[[Page 50215]]

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).
    For this CY 2021 PFS/FQHC proposed rule, we propose 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 propose 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 operating and capital portions of the 2017-based FQHC market 
basket, and provide information on the proposed price proxies. We then 
present the CY 2021 market basket update based on the proposed 2017-
based FQHC market basket.
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 (in 
this proposed rule, we propose 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 are inviting public comments on our proposed methodology, 
discussed below, for deriving the proposed 2017-based FQHC market 
basket.
a. Use of Medicare Cost Report Data
    We are proposing 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 note 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 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 note 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).
    Below, we summarize how we 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 propose 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

[[Page 50216]]

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 propose 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 
Medicare cost report. Therefore, we propose to calculate FQHC 
Practitioner Employee Benefits costs using Worksheet S-3, part II data. 
Specifically, we propose 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, we believe 
this 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 
believe is an adequate sample size to enable us to produce a reasonable 
FQHC Practitioner Contract Labor cost weight. Therefore, we propose 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 
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 proposed 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 believe this 
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 propose 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 propose 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 
continue to encourage all providers to report these data on the 
Medicare cost report. Therefore, we propose 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 believe this 
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 propose 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 believe this proposed method of separately 
estimating FQHC clinical staff contract labor is a technical 
improvement over the 2013-based FQHC market basket.

[[Page 50217]]

(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 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 believe this is a 
reasonable estimate of non-health staff employee benefits. We propose 
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 propose to calculate pharmaceuticals costs using the non-salary 
costs for the pharmacy cost center reported on Worksheet A, column 2, 
line 9. We propose 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 believe our proposed 
methodology is a technical improvement as it is more consistent with 
the FQHC PPS reimbursement.
(9) Medical Supplies
    We propose 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 believe the proposed method is a technical improvement to the method 
used in the 2013-based FQHC market basket.
(10) Fixed Capital
    We propose 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 propose 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.
b. Proposed 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 propose to trim the data for outliers. For each of the eleven major 
cost categories, we first are proposing 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 propose 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.
    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 propose 
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 sum the costs for each 
category across all remaining providers. We then are proposing to 
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.
    Finally, we propose 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 refer readers to Table 31 for 
the resulting proposed cost weights for these major cost categories.

[[Page 50218]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.065

    The total compensation cost weight of 71.6 percent (sum of FQHC 
Practitioner Compensation, Clinical Compensation, Non-health Staff 
Compensation) calculated from the Medicare cost reports for the 
proposed 2017-based FQHC market basket is approximately 3.0 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 
Practitioners and Non-Health Staff are each about 2 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 proposed 2017-based Pharmaceuticals cost weight is roughly 1.2 
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-salary costs reported 
in Pharmacy (under general services) (Worksheet A, line 9, column 2 on 
the 2014 Medicare cost report form). 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.
    As we did for the 2013-based FQHC market basket, we propose 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 is 82 percent for FQHC Practitioners 
and 80 percent for clinical staff. Therefore, we propose 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 propose 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. We refer readers to Table 
32 that shows the proposed Wages and Salaries and Employee Benefits 
cost weights after Contract Labor cost weight allocation for the 
proposed 2017-based FQHC market basket.

[[Page 50219]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.066

c. Derivation of the Detailed Operating Cost Weights
    To further divide the ``All Other'' residual cost weight of 15.5 
percent estimated from the 2017 Medicare cost report data into more 
detailed cost categories, we propose 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 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.\30\ 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 propose 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 Medical Equipment cost 
weight represents 7.2 percent of the proposed 2017-based FQHC market 
basket's ``All Other'' cost category (15.5 percent), yielding a Medical 
Equipment cost weight of 1.1 percent in the proposed 2017-based FQHC 
market basket (0.072 x 15.5 percent = 1.1 percent).
---------------------------------------------------------------------------

    \30\ http://www.bea.gov/papers/pdf/IOmanual_092906.pdf.
---------------------------------------------------------------------------

    Using this methodology, we propose 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 proposed 2017-based FQHC 
market basket, we propose 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).
d. Proposed 2017-Based FQHC Market Basket Cost Categories and Weights
    Table 33 shows the proposed cost categories and weights for the 
proposed 2017-based FQHC market basket compared to the 2013-based FQHC 
market basket.

[[Page 50220]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.067

4. Selection of Price Proxies
    After developing the cost weights for the proposed 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 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

[[Page 50221]]

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 34 lists all price proxies that used in the proposed 2017-
based FQHC market basket. Below is a detailed explanation of the price 
proxies we are proposing for each cost category weight, many of which 
are the same as those used for the 2013-based FQHC market basket.
a. Price Proxies for the Proposed 2017-Based FQHC Market Basket
(1) FQHC Practitioner Wages and Salaries
    We propose 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 
propose 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 note 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 propose 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 propose 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 believe that the ECI for health-
related workers is an appropriate proxy to measure wage and salary 
price pressures for these workers. We note 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 propose 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 propose 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 propose 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 propose 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 propose 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 propose 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 
believe FQHCs purchase the types of supplies contained within these 
proxies, including such items as bandages, dressings, catheters, 
intravenous equipment, syringes, and other general disposable medical 
supplies, via wholesale purchase, as well as at the retail level. 
Consequently, we propose 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).

[[Page 50222]]

(10) Miscellaneous Products
    We propose 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 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 propose 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 propose 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 propose 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 propose 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 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 propose 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).
c. Summary of Price Proxies of the Proposed 2017-Based FQHC Market 
Basket
    Table 34 shows the cost categories and associated price proxies for 
the proposed 2017-based FQHC market basket.
[GRAPHIC] [TIFF OMITTED] TP17AU20.068


[[Page 50223]]


5. Proposed CY 2021 Productivity Adjusted Market Basket Update for 
FQHCs
    For CY 2021 (that is, January 1, 2021 through December 31, 2021), 
we are proposing to use the proposed 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 are proposing 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). For the 
proposed rule, we do not have the second quarter of 2020 historical 
data and, therefore, we will use the most recent projection available.
    Based on IGI's first quarter 2020 forecast with historical data 
through the fourth quarter of 2019, the projected proposed 2017-based 
FQHC market basket increase factor for CY 2021 would be 2.5 percent. 
For comparison, the 2013-based FQHC market basket update is also 
projected to be 2.5 percent in CY 2021; this estimate is based on IGI's 
first quarter 2020 forecast (with historical data through the fourth 
quarter of 2019). The proposed 2017-based FQHC market basket and the 
2013-based FQHC market basket are both projected to grow at the same 
rate for CY 2021, the difference in the average update factor over the 
last five historical years (2016-2020) is 0.0 percent.
    Table 35 compares the proposed 2017-based FQHC market basket 
updates and the 2013-based FQHC market basket updates for CY 2016 
through CY 2023.
[GRAPHIC] [TIFF OMITTED] TP17AU20.069

    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 propose to continue 
to include a productivity adjustment to the proposed 2017-based FQHC 
market basket. We propose 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 propose to use the 
most recent historical estimate of annual MFP as published by the BLS. 
Generally, the most recent historical MFP estimate is lagged two years 
from the payment year.
    Therefore, we propose to use the 2019 MFP as published by BLS in 
the CY 2021 FQHC market basket update. We note 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 are proposing 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) is projected to be 0.6 percent. Therefore, the 
proposed CY 2021 productivity-adjusted FQHC Market basket update is 1.9 
percent, based on IGI's first quarter 2020 forecast with historical 
data through the fourth quarter of 2019. This reflects a 2.5-percent 
increase in the proposed 2017-based FQHC market basket and a 0.6-
percent adjustment for productivity. For comparison, if we continue to 
use the 2013-based FQHC market basket, then the CY 2021 productivity-
adjusted FQHC market basket update would also be 1.9 percent (2.5 
percent FQHC market basket update less 0.6 percent MFP adjustment). 
Finally, we are proposing 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.

[[Page 50224]]

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.\31\ In addition to the risk of death from 
overdose, opioids carry a number of other health risks, including 
respiratory depression, drowsiness, confusion, nausea, increased drug 
tolerance, and physical dependence. An estimated 1.7 million people in 
the United States have substance use disorders involving prescription 
opioid pain relievers.\32\
---------------------------------------------------------------------------

    \31\ 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.
    \32\ Substance Abuse and Mental Health Services Administration. 
(2019). Key substance use and mental health indicators in the United 
States: Results from the 2018 National Survey on Drug Use and Health 
(HHS Publication No. PEP19-5068, NSDUH Series H-54). Rockville, MD: 
Center for Behavioral Health Statistics and Quality, Substance Abuse 
and Mental Health Services Administration. Retrieved from https://www.samhsa.gov/data/sites/default/files/cbhsq-reports/NSDUHNationalFindingsReport2018/NSDUHNationalFindingsReport2018.pdf.
---------------------------------------------------------------------------

    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 substance use disorders (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 are proposing 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 this proposed rule, we 
provide background on the IPPE and AWV, discuss how the requirements of 
the SUPPORT Act are related to the IPPE and AWV, and make 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 nonphysician practitioner 
(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

[[Page 50225]]

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 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 initial 
preventive physical examination (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 substance use 
disorders (SUD) as elements of the IPPE and AWV, effective January 1, 
2020.
3. Proposal on Section 2002 of the SUPPORT Act Requirements
    We are proposing to add the requirements of section 2002 of the 
SUPPORT Act to our regulations at 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

[[Page 50226]]

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 substance use disorder 
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 new regulatory elements to add significant burdens 
on physicians and practitioners who furnish these services because 
review of medical and social 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. Proposed Regulatory Text Changes
    We are proposing 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 propose to amend 42 CFR 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''.
(1) ``Screening for Potential Substance Use Disorders''
    We propose to revise Sec. Sec.  410.15 and 410.16 by adding the 
element ``Screening for Potential Substance Use Disorders'' and 
describing the proposed requirement as a review of the individual's 
potential risk factors for substance use disorder and referral for 
treatment as appropriate.
(2) Definition of ``A Review of Any Current Opioid Prescriptions''
    We propose 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.
(3) 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 initial preventive 
physical examination, first and subsequent annual wellness visits are 
meant to represent a beneficiary visit focused on prevention. Among 
other things, the IPPE and AWV encourages 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 are proposing 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 substance use disorders 
including a review of the individual's potential risk factors for 
substance use disorder 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 substance use disorders to include a review of the 
individual's potential risk factors for substance use disorder 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 
nonphysician practitioner, 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
    The initial preventive physical examination, first and subsequent 
annual wellness visits are designed to help prevent disease and 
disability based on the beneficiary's current health and risk factors. 
Increased payment values for the IPPE and AWV in alignment with 
increases to E/M services are being proposed in section II.F. of this 
proposed rule. Our proposals seek to incorporate the new AWV and IPPE 
requirements of section 2002 of the SUPPORT Act in a manner that is 
flexible for clinicians to provide

[[Page 50227]]

the care that is most appropriate for their patients. We look forward 
to receiving public comment on these proposals.

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.
2. eCQM Reporting Requirements for EPs Under the Medicaid Promoting 
Interoperability Program for 2020
    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 this proposed rule, we propose to amend the list of 
available eCQMs for the CY 2021 performance period. To keep eCQM 
specifications current and minimize complexity, we propose 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 propose 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.
    We anticipate that this proposal would reduce burden for Medicaid 
EPs by aligning the requirements for multiple reporting programs, and 
that the system changes required for EPs to implement this change would 
not be significant, particularly in light of our belief that many EPs 
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 expect that this 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 propose 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 
refer 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 propose 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). This 
policy would improve alignment with the MIPS quality performance 
category requirements for eligible clinicians using the eCQM collection 
type. We also propose 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 62899-62900), 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 propose 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

[[Page 50228]]

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 our 
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. As noted above, we propose to use 
the same three methods for identifying high priority eCQMs for the 
Medicaid Promoting Interoperability Program for 2021. We invite 
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).

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 
health care providers to improve the quality of care for Medicare fee-
for-service (FFS) beneficiaries and reduce the rate of growth in 
expenditures under Medicare Parts A and B. (See 42 U.S.C. 1395jjj.) 
Eligible groups of providers and suppliers, including physicians, 
hospitals, and other health care providers, may participate in the 
Shared Savings Program by forming or participating in an Accountable 
Care Organization (ACO). 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

[[Page 50229]]

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 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 public health emergency (PHE) for the COVID-19 pandemic (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 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 COVID-19 PHE 
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).
    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 (MACRA) established the Quality Payment Program (Pub. L. 114-10). 
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. We believe that the 
proposed changes would reduce ACO burden by establishing a smaller 
measure set, out of which ACO 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. Reporting for these measures would begin in January 
2022, for the 2021 performance year. We believe 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.
    As a general summary, in this proposed rule, we are proposing 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.
    ++ Revising the Shared Savings Program Quality Performance 
Standard.
    ++ 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.
    ++ 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 42 CFR 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 policy for determining the amount of repayment 
mechanism arrangements for certain ACOs renewing to continue their 
participation under a two-sided model.
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

[[Page 50230]]

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 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 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).
    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.
    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.
    Although we acknowledge the commenters' concerns, we note 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

[[Page 50231]]

the maturity of the program and consistent with section 1899(b)(3)(C) 
of the Act, 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 value-based care and driving the 
Medicare system to greater value and quality. However, after taking 
into consideration the stakeholder feedback, we 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.
    The Alternative Payment Model Performance Pathway (APP) was 
designed for all MIPS APMs; but, 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 for consumers' key quality performance metrics. The 
measures proposed for inclusion in this set encompass the meaningful 
measure domains of patient voice, wellness and prevention, seamless 
communication, chronic disease management, and behavioral health. For 
these reasons, 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 and the proposed measures 
within it are described in more detail later in this section. A 
detailed discussion of the proposal for use of the APP for MIPS APMs 
more generally is found at section III.C.3.b. of this proposed rule.
(1) APM Performance Pathway for Shared Savings Program ACOs
    In response to 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 are proposing to revise the Shared Savings Program quality 
performance standard effective for performance year 2021 and subsequent 
performance years. This 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 is described in more detail in 
section III.C.3.b. of this proposed rule. At a high level, 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 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 this proposed new approach the quality measures reported for 
purposes of the APP would 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 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 believe 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.
    Under the APP proposed in section III.C.3.b. of this proposed rule, 
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. Eligible clinicians participating in the 
Shared Savings Program are not currently assessed on the MIPS Cost 
performance category as these eligible clinicians are already subject 
to cost and utilization performance assessments as part of the Shared 
Savings Program. Therefore, the cost performance category would 
continue to be weighted at zero percent. The four categories in the 
proposed APP framework would be weighted as follows: Quality: 50 
percent; PI: 30 percent; IA: 20 percent; and Cost: 0 percent.
    Under the APP proposed in section III.C.3.b. of this proposed rule, 
the MIPS Quality performance category score would be calculated for 
ACOs based on MIPS benchmarks, which 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). ACOs 
would be scored on the measures they report and would 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 
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

[[Page 50232]]

Savings Program and awards zero points for quality for ACOs that report 
some but not all of the required measures. We believe that 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 believe 
that alignment with the MIPS scoring methodology would reduce the 
burden on ACOs of tracking to two different scoring methodologies. 
However, 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 losses, if applicable. 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 do 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 this proposal, there would be no quality ``phase 
in.'' 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.
    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 continue to get full credit for 
IA 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, automatic full credit for I.A. 
and zero cost category weight would not be applied).
    Under this proposal, for performance year 2021 and subsequent 
performance years, ACOs would be assessed on a smaller measure set. 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 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). As discussed in section IV.A.3.c.(1) of this proposed rule, we 
are proposing to remove the CMS Web Interface from the MIPS data 
submission types for groups beginning with the 2021 MIPS performance 
year. Medicare Part B claims is not an available submission type for 
ACOs as it is limited to TINs consisting of 15 or fewer eligible 
clinicians. 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 
and section III.C.3.b. of this proposed rule for full details on the 
measures proposed under the APP framework.

[[Page 50233]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.070

    As noted above, the measures proposed for inclusion in the measure 
set for the APP 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 encompass the meaningful 
measure domains of patient voice, wellness and prevention, seamless 
communication, chronic disease management, and behavioral health. We 
also 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 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 note 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 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. 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 our 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 maintains 
the relevance of patient voice. We believe 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 believe this approach strikes 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 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 
recognize the value in the use of primary care-focused measures and in 
developing the proposed measure set for use under the APP, we have 
sought to preserve the measures we believe most reflect high priority 
quality measurement areas while also placing more emphasis on outcome-
based claims measures, which minimize

[[Page 50234]]

reporting burden and reflect greater opportunity for improvement.
    In addition to the measures listed in Table 36, based on 
recommendations from MedPAC in its 2015 Report to Congress: Medicare 
and the Health Care Delivery System,\33\ we are 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. 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.
---------------------------------------------------------------------------

    \33\ http://medpac.gov/docs/default-source/reports/june-2015-report-to-the-congress-medicare-and-the-health-care-delivery-system.pdf.
---------------------------------------------------------------------------

    We welcome public comment on our proposal to apply the APP 
framework to determine the quality performance of Shared Savings 
Program ACOs.
    In addition, we note 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 patients, that the measures ACOs are required to report are not 
always applicable to their patient population. Although we are 
proposing to require ACOs to report via the APP, we are also seeking 
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 seek 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.
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 losses under certain payment tracks, and avoid quality-related 
compliance actions. We are proposing to increase the level of quality 
performance that would be required for all ACOs to meet the Shared 
Savings Program quality performance standard. We believe the proposed 
changes would simplify the Shared Savings Program quality performance 
standard and are 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 are proposing 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 are excluding 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 believe 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, is the next incremental step in increasing the 
quality performance standard. Under the current Shared Savings Program 
quality measurement methodology, 99.6 percent or 546 ACOs participating 
in the program in 2018 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, 425 were ACOs in second or subsequent years of 
participation in the program for which most quality measures were 
scored as pay-for-performance (P4P). We analyzed quality measure data 
from 2018 to simulate how many ACOs would achieve a quality performance 
score that was at or above the 40th percentile of MIPS Quality 
performance category scores. Based on our analysis using 2018 data to 
simulate 2021 MIPS Quality performance category scores, we estimate 95 
percent of ACOs would achieve a quality performance score at or above 
the 40th percentile across all MIPS Quality performance category 
scores, excluding entities/providers eligible for facility-based 
scores. We recognize that this impact could change if the 40th 
percentile across all 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. The impact could range from 98 percent 
of ACOs achieving a quality performance score at or above the 40th 
percentile to 92 percent of ACOs reflecting the respective extreme 
scenarios assumed in the previous sentence.
    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 APP scoring under MIPS. For eligible 
clinicians in an ACO that is participating in a track (or payment model 
within a track) that is an Advanced APM who do not meet the threshold 
to earn QP status but do meet the lower payment and patient count 
threshold to achieve Partial QP status, the ACO can elect to report on 
behalf of the Partial QPs, and the Partial QPs would be subject to a 
MIPS payment adjustment under the APP framework. 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. 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 ACO participant TINs' eligibility to receive Advanced APM incentive 
payments.
    We propose to specify in a new section of the Shared Savings 
Program regulations at Sec.  425.510, policies on the application of 
the APP to Shared Savings Program ACOs for performance years beginning 
on or after January 1, 2021. 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

[[Page 50235]]

requirements, and meets all other applicable requirements, the ACO is 
eligible to receive shared savings. This general provision also 
indicates that CMS seeks to improve the quality of care furnished by 
ACOs over time by specifying higher standards, new measures, or both. 
This new section of the regulations would also specify 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. In 
addition, this new section of the regulation would also specify that 
CMS retains the right to audit and validate quality data reported by an 
ACO according to Sec.  414.1390 of this chapter.
    We also propose 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 propose 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. 
Further, we propose 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 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. In addition, we propose to specify 
that if an ACO does not report any of the three of the measures ACOs 
are actively required to report and does not field a CAHPS survey, the 
ACO would not meet the quality performance standard.
    In addition, we propose to modify the existing Shared Savings 
Program regulation at Sec.  425.508, on incorporating quality reporting 
requirements related to the Quality Payment Program. We propose to add 
a provision applicable to 2021 and subsequent performance years, which 
specifies 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 propose related 
technical and conforming modifications to Sec.  425.508.
    We seek comment on our proposal to revise the Shared Savings 
Program quality performance standard.
d. Use of ACO Quality Performance in Determining Shared Savings and 
Shared Losses
    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 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 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; 
\34\ 60 percent for ACOs participating in Track 2; \35\ 40 percent for 
ACOs participating in Level A or Level B of the BASIC track; \36\ and 
50 percent for ACOs participating in Levels C, D, or E of the BASIC 
track; \37\ and 75 percent for ACOs participating in the ENHANCED 
track.\38\ 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.\39\
---------------------------------------------------------------------------

    \34\ Refer to Sec.  425.604(d).
    \35\ Refer to Sec.  425.606(d).
    \36\ Refer to Sec.  425.605(d)(1)(i)(A), (d)(1)(ii)(A).
    \37\ Refer to Sec.  425.605(d)(1)(iii)(A), (d)(1)(iv)(A), 
(d)(1)(v)(A).
    \38\ Refer to Sec.  425.610(d).
    \39\ 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.\40\ 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

[[Page 50236]]

may not be less than 40 percent for both tracks.\41\ 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.
---------------------------------------------------------------------------

    \40\ 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.
    \41\ 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 addressed elsewhere in section III.G.1. of 
this proposed rule, we also propose 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 propose 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 propose 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 this proposed rule, and otherwise 
maintain its eligibility to participate in the Shared Savings Program 
under part 425. We propose 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 propose revisions to the provisions establishing the final 
sharing rate for all tracks. We propose 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 this 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 
propose that if the ACO fails to meet the proposed quality performance 
standard, the ACO would be ineligible to share in savings. We propose 
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 propose 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 as proposed (see section 
III.G.1.c. of this proposed rule), we would 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.
    Under this 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 propose to revise 
the regulation at Sec.  425.606(f) to expressly state both the minimum 
and maximum shared loss rates for Track 2.
    We propose that if the ACO fails to meet the quality performance 
standard as proposed (see section III.G.1.c. of this proposed rule), 
the shared loss rate would be 60 percent under Track 2 or 75 percent 
under the ENHANCED track. We believe 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 propose 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 propose 
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.
e. Compliance With the Quality Performance Standard
(1) Background
    As discussed in more detail in section III.G.1.c. of this proposed 
rule, 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. 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

[[Page 50237]]

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 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) Proposed Revisions
    We have 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 
propose 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. Sec.  425.500 or 425.512. Under the provision, as 
revised, we would retain the discretion to request additional 
documentation from an ACO, ACO participants, or ACO providers/
suppliers. Further, we believe that in conjunction with our proposed 
changes to the quality performance standard, it is 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 are proposing 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 currently set forth at Sec.  425.316(c)(1) through (3), 
which we propose would be consolidated at Sec.  425.316(c)(1). For 
performance years beginning on or after January 1, 2021, we propose 
that when CMS determines an ACO fails to meet the quality performance 
standard (as described in section III.G.1.c. of this 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 propose 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 propose that ACOs exhibiting a pattern of failure to meet the 
quality performance standard will be terminated from the program. 
Specifically, we propose 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 propose that we will 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 
propose that we will 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 propose to amend Sec.  425.316(c)(2) 
to reflect this new approach.
    Our proposal to terminate an ACO if it fails to meet the quality 
performance standard for 2 consecutive performance years within an 
agreement period is consistent with our current approach. However, we 
also propose 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

[[Page 50238]]

meet the quality performance standard in performance years that are not 
consecutive. Therefore, 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 propose to terminate their participation 
agreement.
    Additionally, we are concerned that a renewing ACO's quality 
performance results for the last performance year of the current 
agreement period will 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 have 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 propose 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. 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 its previous 
agreement period. Therefore, CMS would terminate the ACO's new 
participation agreement during the first performance year of that 
agreement period.
    Furthermore, we are concerned 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 propose to terminate the ACO's 
participation agreement. We would anticipate 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 recognize there is 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. Consistent with 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. Because these 2 
performance years of failed quality performance would be consecutive, 
we would terminate the participation of the new, re-entering ACO.
    Because a significant percentage of the ACO participants in the 
new, re-entering ACO were previously participating in this other ACO, 
we believe it is 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. 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 propose implementing these policies starting with performance 
year 2021 and subsequent years. We acknowledge 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 Sec.  425.512 in 
performance years 2021 and 2023. In this scenario, the ACO will 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, 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.
    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 this proposed rule, we propose 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.
    The termination of an ACO's participation agreement for failure to 
meet the quality performance standard under the proposed approach 
described in this section of 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

[[Page 50239]]

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 propose to revise Sec.  425.316(c) to incorporate this proposed 
approach for monitoring ACO compliance with the quality performance 
standard for performance years beginning on or after January 1, 2021. 
We also propose to make other technical and conforming changes to the 
regulations at Sec.  425.316(c). In particular, we propose 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 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 propose 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 propose to revise Sec.  425.224(b)(1)(ii)(A) to state 
that as part 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. Sec.  425.316(c)(1)(ii) or 
425.316(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 
overall quality score proportional to the ACO's audit match rate, which 
may have implications for the ACO's financial reconciliation.
    Under our proposal to align the quality reporting requirements 
under the Shared Savings Program with quality reporting under the APP 
framework, we believe 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 believe that it would be more appropriate for MIPS 
to validate the data submitted by ACOs for the three measures in the 
APP framework, as ACOs will be able to select the submission method for 
these measures and the MIPS DVA is based on submission method. We 
believe 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 propose to address the audit and validation of data used to 
determine the ACO's quality performance in a new provision we are 
proposing to add to the Shared Savings Program regulations at Sec.  
425.510(c). Specifically, we propose 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.
g. Changes to the Extreme and Uncontrollable Circumstances Policy for 
Performance Year 2021
    As discussed in section III.G.1.c. of this proposed rule, we are 
proposing 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. However, we continue to believe 
it is appropriate to adjust the quality performance scores for ACOs 
affected by extreme and uncontrollable circumstances. Accordingly, we 
propose to update the extreme and uncontrollable circumstances policy 
under the Shared Savings Program consistent with our proposal to align 
the quality reporting requirements for the Shared Savings Program with 
the proposed APP. Specifically, for performance year 2021 and 
subsequent performance years, we would 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 believe this approach is appropriate as it aligns with the 
threshold for meeting the quality performance standard allowing 
impacted ACOs to share in savings at their maximum sharing rate. We 
acknowledge 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. Our simulation of the 2018 MIPS quality data shows that the 
mean MIPS quality performance category score is between the 45th and 
46th percentile, which is lower than the ACO quality mean score under 
the current scoring methodology. However, 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

[[Page 50240]]

extreme and uncontrollable circumstance.
    Under the proposed revisions to the quality reporting requirements, 
we will no longer generate a CMS Web Interface quality reporting sample 
for ACOs because ACOs will no longer be reporting measures via the Web 
Interface; therefore, we propose 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 believe that using the 
quarter four list of assigned beneficiaries is 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. We seek comment on these proposed revisions to the 
extreme and uncontrollable circumstances policy for performance year 
2021 and subsequent performance years.
    In addition, we are soliciting comment on a potential alternative 
extreme and uncontrollable circumstances policy for performance year 
2022 and subsequent years that would continue to incentivize reporting 
but also acknowledge the challenges presented by extreme and 
uncontrollable circumstances. We are 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. To illustrate this potential 
approach, we provide an example of a hypothetical ACO, ACO A, which in 
this example was impacted by an extreme and uncontrollable circumstance 
that lasted for six months of the year and during that time, 50 percent 
of its assigned beneficiaries resided in the impacted area. For this 
example, we assume that ACO A did not quality report and would have 
earned $100,000 in shared savings if it had met the quality performance 
standard. In this example, we would multiply the percentage of the 
total months in the performance year impacted by the extreme and 
uncontrollable circumstance by the percentage of the ACO's assigned 
beneficiaries who resided in the impacted area by the amount of shared 
savings if the ACO had met the quality performance standard; 0.50 * 
0.50 * $100,000 = $25,000. Under this alternative, ACO A's shared 
savings would be $25,000.
    As another example, if ACO B were impacted by an extreme and 
uncontrollable circumstance for nine months of the year, had 50 percent 
of its assigned beneficiaries residing in the impacted area, and did 
report quality data but did not meet the quality performance standard 
of a score equivalent to a MIPS Quality performance category score at 
the 40th percentile, and ACO B would have earned $100,000 in shared 
savings if it had met the quality performance standard; 0.75 * 0.50 * 
$100,000 = $37,500. Under this alternative, ACO B's shared savings 
would be $37,500.
    As illustrated by the above examples, under this potential future 
approach, the amount of shared savings that an ACO impacted by an 
extreme and uncontrollable circumstance would be eligible to receive 
would be greater than the amount an ACO that was not disaster impacted 
would be eligible to receive if it did not report quality or did report 
quality but did not obtain a score equivalent to a MIPS Quality 
performance category score at or above the 40th percentile. An ACO that 
was not disaster impacted and that either did not report quality or did 
report quality but did not obtain a quality performance category score 
equivalent to or higher than a MIPS Quality performance category score 
at or above the 40th percentile would not meet the quality performance 
standard and would not be eligible to receive any shared savings. In 
contrast, an ACO impacted by an extreme and uncontrollable circumstance 
would be eligible to receive an adjusted amount of shared savings, even 
if it did not quality report or did report quality but had a quality 
performance score that was lower than the 40th percentile of MIPS 
Quality performance category scores. The final amount of shared savings 
would be dependent on the degree to which the ACO's assigned 
beneficiaries were disaster impacted during the relevant performance 
year.
    If an ACO impacted by an extreme and uncontrollable circumstance 
does not report quality or 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, then the existing extreme and uncontrollable 
circumstances methodology that applies when calculating the amount of 
shared losses would help to mitigate those losses. We note that 
historically the majority of disaster-impacted ACOs report quality. For 
example, for performance years (or a performance period) starting in 
2019, when all ACOs were determined to be impacted by the PHE for 
COVID-19, which was declared during the quality reporting period, 98.7 
percent of ACOs completely reported via the CMS Web interface. Given 
the historically high rates of quality reporting by ACOs impacted by 
extreme and uncontrollable circumstances and the fact that, under our 
proposed revisions to the quality performance standard, ACOs would 
share in the maximum level of savings available under their track (or 
payment model within a track) if they meet the quality performance 
standard, we believe it is important to consider an extreme and 
uncontrollable circumstances policy that looks at the actual impact of 
an extreme and uncontrollable circumstance on a disaster-impacted ACO, 
and provides for an adjusted amount of shared savings if the ACO does 
not report or does not meet the quality performance standard.
    We seek comment on this potential alternative extreme and 
uncontrollable circumstances policy for future years.
    We propose 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

[[Page 50241]]

Sec.  425.512. In addition, we propose 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 propose 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 an affected by an extreme and uncontrollable circumstance. We 
also propose 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 propose 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.
h. Proposed Technical Changes To Incorporate References to Revised 
Quality Performance Standard
    We propose to make certain technical, conforming changes to the 
following provisions to reflect our 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.
     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 would 
be revised 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 propose 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 proposed 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, would 
be revised to add a reference to Sec.  425.510.
     Under subpart C, which governs application procedures and 
the participation agreement, we would add 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 would add 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 propose to revise the description of program 
requirements that phase-in over multiple agreement periods in Sec.  
425.600(f)(4). Under the proposed revisions to the quality performance 
standard, measurement of an ACO's quality performance would no longer 
phase-in over the course of the ACO's first agreement period from pay-
for-reporting in the first performance year to pay-for-performance in 
all subsequent performance years; rather, all ACOs, regardless of 
performance year and agreement period, would be scored on all the 
measures in the APP. Therefore, we propose to revise Sec.  
425.600(f)(4)(i) to specify that the reference to the quality 
performance standard as described in Sec.  425.502(a) is applicable for 
performance years (or a performance period) beginning on or before 
January 1, 2020.
     Under subpart I, which governs the reconsideration review 
process, we would add references to Sec.  425.510, Sec.  425.512, or 
both to Sec.  425.800(a)(1), (a)(2) and (a)(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 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

[[Page 50242]]

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.  
[thinsp]425.400(c)(1)(iv) for purposes of assigning beneficiaries to 
ACOs under Sec.  [thinsp]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 evaluation and management 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 evaluation and management 
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 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).
    (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 COVID-19 PHE defined in Sec.  
400.200, to include the foregoing codes specified in Sec.  
[thinsp]425.400(c)(1)(iv), as well as specified codes for remote 
evaluations, virtual check-ins, e-visits, and telephone evaluation and 
management services.
(2) Proposed Revisions
    Based on feedback from ACOs and our further review of the HCPCS and 
CPT codes currently recognized for payment under the PFS, we believe 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 propose to revise the definition of primary care services in the 
Shared Savings Program regulations to include the following additions: 
(1) Online digital evaluation and management 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 are proposing 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 evaluation and management (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 COVID-19 PHE 
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 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 COVID-19 PHE.
     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

[[Page 50243]]

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 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.\42\ 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 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.
---------------------------------------------------------------------------

    \42\ 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 elsewhere 
in this proposed rule, we are proposing the 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 are proposing 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

[[Page 50244]]

considered for purposes of assignment under Sec.  425.400 for the 
performance year starting on January 1, 2021, and subsequent 
performance years. 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.
     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 non-physician 
practitioners (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.
    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 relative value units 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 are proposing 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 propose 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).
    Elsewhere in this proposed rule, we are proposing 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 are 
proposing 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 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

[[Page 50245]]

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 this proposed new code 
would be expected to be substantially similar to the services furnished 
under CPT code 99493. Accordingly, contingent upon its finalization, we 
propose 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.
    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 the COVID-19 pandemic, as defined in Sec.  [thinsp]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 
recognize the importance of the flexibility these HCPCS codes provide 
during the PHE, 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 the COVID-19 pandemic, 
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, health care 
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 the COVID-19 pandemic, 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 the COVID-19 pandemic ends, these services 
would likely be replaced by an in-person primary care visit on which 
assignment would be based.
    We seek 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 will consider the comments 
received in developing our policies for the final rule.
    We note 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 evaluation and management 
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 the COVID-19 pandemic, as defined in Sec.  [thinsp]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 propose 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 are no facility setting limitations or 
provider specialty limitations on these codes.\43\ We have since 
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 are 
concerned 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 health care 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. 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

[[Page 50246]]

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 elsewhere in this section of this proposed rule.
---------------------------------------------------------------------------

    \43\ 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 are also seeking comment on an alternative method for 
determining operationally whether advance care planning services are 
provided in an inpatient care setting. Specifically, we seek 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.\44\ Based on initial analysis, we determined that 
this alternative approach would capture slightly fewer claims for 
advance care planning, compared to the proposed approach. We will 
consider any comments received on this alternative approach in 
developing our policies for the final rule.
---------------------------------------------------------------------------

    \44\ 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 propose to specify a revised definition of primary care services 
in a new provision of the Shared Savings Program regulations at Sec.  
[thinsp]425.400(c)(1)(v) to include the list of HCPCS and CPT codes 
specified in Sec.  [thinsp]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.  [thinsp]425.400(c)(1)(v)(A)(12). We also 
propose that the new provision in Sec.  [thinsp]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 
propose the new provision at Sec.  [thinsp]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 propose technical modifications to the 
introductory text in Sec.  [thinsp]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 seek comment on these 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 welcome comments on any 
other existing HCPCS or CPT codes, and new HCPCS or CPT codes proposed 
elsewhere in this proposed rule, that we should consider adding to the 
definition of primary care services for purposes of assignment in 
future rulemaking.
    We note 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, 
if we finalize any of the proposed changes to the definition of primary 
care services discussed in section III.G.2. of this proposed rule for 
purposes of beneficiary assignment applicable for the performance year 
starting on January 1, 2021, and subsequent performance years, we will 
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. We believe it is timely to 
propose 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 42 CFR 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 these proposed changes, we propose to make certain other 
technical changes to Sec. Sec.  425.601, 425.602, and 425.603 for 
clarity and internal consistency.
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 this proposed rule, 
under the Shared Savings Program, we define primary care services in 
Sec.  [thinsp]425.400(c)(1) and Sec.  [thinsp]425.400(c)(2) for 
purposes of assigning beneficiaries to ACOs under Sec.  [thinsp]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

[[Page 50247]]

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) Proposal
    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. We believe it is important 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. 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 propose 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 this proposed rule, we are 
proposing to incorporate the revised definition of primary care 
services in a new provision of the Shared Savings Program regulations 
at Sec.  [thinsp]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 propose to incorporate the proposed revisions to the 
exclusion for CPT codes 99304 through 99318 when services are furnished 
in a SNF at Sec.  [thinsp]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. 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 this proposed rule, we 
adjust the ACO's historical benchmark for changes in the program's 
assignment methodology occurring during the ACO's agreement period. If 
we finalize the proposed exclusion from beneficiary assignment of 
services reported by FQHCs or RHCs on claims that include CPT codes 
99304 through 99318, when

[[Page 50248]]

furnished in a SNF, we will adjust ACOs' historical benchmarks to 
account for these changes.
    Further, 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 solicit 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.
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 repayment mechanism arrangements.\45\ We 
established the repayment mechanism requirements through earlier 
rulemaking,\46\ and most recently modified the repayment mechanism 
requirements in the December 2018 final rule (83 FR 67928 through 
67938).
---------------------------------------------------------------------------

    \45\ 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).
    \46\ 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 only be required to maintain 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 believe it is appropriate 
to revisit the policies requiring renewing ACOs to retain higher 
repayment amounts when these amounts may no longer be needed to support 
their continued participation.
b. Proposed Revisions
    We propose 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

[[Page 50249]]

regulations. The first policy would apply prospectively to any 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. The second 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.
    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, we propose to 
discontinue the policy specified under Sec.  425.204(f)(4)(iv), which 
requires such an ACO to 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 propose to revise the regulations to specify that 
we will determine the repayment mechanism amount for an ACO applying to 
renew its participation for an agreement period only according to the 
methodology currently specified in Sec.  425.204(f)(4)(ii). Under this 
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 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, if finalized, this 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.
    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.
    We believe this 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. This 
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.
    We recognize this 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, 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 42 CFR 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, we are considering 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 if, upon renewal of its participation agreement, it chose to 
use its existing repayment mechanism to demonstrate its ability to pay 
shared losses in the new agreement period, and was required under Sec.  
425.204(f)(4)(iv) to maintain its existing repayment mechanism at the 
amount applicable to the last performance year of the previous 
agreement period instead of the lower amount calculated for the new 
agreement period.
    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. We are considering finalizing 
provisions in the Shared Savings Program regulations specifying the 
conditions under which a re-entering ACO may use an existing

[[Page 50250]]

repayment mechanism arrangement to support its participation in a 
subsequent agreement period in the Shared Savings Program. 
Specifically, we are considering specifying a re-entering ACO 
identified as the same legal entity as an ACO that previously 
participated in the program may use its existing repayment mechanism to 
support its participation in a new agreement period in the Shared 
Savings Program. Since an individual ACO, identified as a legal entity, 
enters into a repayment mechanism arrangement with a financial 
institution, we do not believe this option for continued use of an 
existing repayment mechanism would be feasible for (and therefore would 
not be applicable to) a new legal entity identified as a re-entering 
ACO because 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. Further, we are considering specifying the same requirements 
would apply to both a renewing ACO, and a re-entering ACO identified as 
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), for permitting 
use of an existing repayment mechanism arrangement to support the ACO's 
participation in a new agreement period in the Shared Savings Program.
    We also propose to establish a policy that allows 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 note that this 
proposal would not need to be finalized if we finalize our alternate 
proposal to modify Sec.  425.204(f)(4)(iii) as described above. The 
purpose of this new opportunity is to let any ACO that renewed for an 
agreement period beginning on July 1, 2019, or beginning on January 1, 
2020, decrease its repayment mechanism amount before it seeks to renew 
its agreement under the new proposed policy, which if finalized, would 
be the first 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 
propose 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. 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 propose that CMS would notify the ACO in writing that the ACO 
may elect to decrease the amount of its repayment mechanism. If our 
proposal is finalized, 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 
anticipate we would notify an ACO of its opportunity to reduce its 
repayment mechanism amount after the start of performance year 2021. We 
also propose 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 may require (for example) that an ACO 
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 
of its opportunity 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), as discussed elsewhere in this 
section of this proposed rule. However, we recognize that there may be 
circumstances that necessitate a longer timeframe.
    We propose to amend Sec.  425.204(f)(4)(iv) to specify in paragraph 
(f)(4)(iv)(A) the proposed, 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 propose to add provisions in Sec.  
425.204(f)(4)(iv)(B) establishing policies that would allow eligible 
ACOs with July 1, 2019, or January 1, 2020 start dates to elect to 
lower the amount of their repayment mechanism arrangements.
    We propose to amend Sec.  425.204(f)(5), requiring 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, to specify that the resulting amount available through the 
repayment mechanism 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 this section of this proposed rule. This proposed 
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.

[[Page 50251]]

    We also propose 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 propose 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 propose 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 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 propose 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.
4. Applicability of Policies to Track 1+ Model ACOs
    The Track 1+ Model was established under the Innovation Center's 
authority at section 1115A of the Act, to test innovative payment and 
service delivery models to reduce program expenditures while preserving 
or enhancing the quality of care for Medicare, Medicaid, and Children's 
Health Insurance Program beneficiaries. The Track 1+ Model, which is a 
time-limited model that began on January 1, 2018, is based on Shared 
Savings Program Track 1, but tests a payment design that incorporates 
more limited downside risk, as compared to Track 2 and the ENHANCED 
track. We discontinued all future application cycles for the Track 1+ 
Model, as explained in earlier rulemaking (83 FR 68032 and 68033). As 
of January 1, 2020, there were 20 Track 1+ Model ACOs participating in 
performance year 3 of a 3-year agreement under the model. In the May 
8th COVID-19 IFC (85 FR 27574 and 27575), we explained that we are 
forgoing the application cycle for a January 1, 2021 start date. To 
avoid a gap in participation for ACOs whose agreement period would 
otherwise end on December 31, 2020, we revised Sec.  425.200(b)(3)(ii) 
to allow these ACOs to elect to extend their agreement period for an 
optional fourth performance year. Therefore, Track 1+ Model ACOs, among 
other ACOs whose agreement periods expire December 31, 2020, are 
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.
    ACOs approved to participate in the Track 1+ Model are required to 
agree to the terms and conditions of the model by executing a Track 1+ 
Model Participation Agreement. See https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/track-1plus-model-par-agreement.pdf. Track 1+ Model ACOs are also required to 
have been approved to participate in the Shared Savings Program (Track 
1) and to have executed a Shared Savings Program Participation 
Agreement. As indicated in the Track 1+ Model Participation Agreement, 
in accordance with our authority under section 1115A(d)(1) of the Act, 
we have waived certain requirements of the Shared Savings Program that 
otherwise would be applicable to ACOs participating in Track 1 of the 
Shared Savings Program, as necessary for purposes of testing the Track 
1+ Model, and established alternative requirements for the ACOs 
participating in the Track 1+ Model. Unless stated otherwise in the 
Track 1+ Model Participation Agreement, the requirements of the Shared 
Savings Program under 42 CFR part 425 continue to apply. Consistent 
with Sec.  425.212, Track 1+ Model ACOs generally are subject to all 
applicable regulatory changes, including but not limited to changes to 
the regulatory provisions referenced within the Track 1+ Model 
Participation Agreement that become effective during the term of the 
ACO's Shared Savings Program Participation Agreement and Track 1+ Model 
Participation Agreement, unless otherwise specified through rulemaking 
or amendment to the Track 1+ Model Participation Agreement. We note 
that the terms of the Track 1+ Model Participation Agreement also 
permit the parties (CMS and the ACO) to amend the agreement at any time 
by mutual written agreement.
    Therefore, unless specified otherwise, the proposed changes to the 
Shared Savings Program regulations in this proposed rule that are 
applicable to Shared Savings Program ACOs within a current agreement 
period would 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 proposed changes to those regulations discussed in this proposed 
rule would 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 proposed policies would apply to Track 1+ Model ACOs, if 
finalized:
     The application of the APP framework to determine the 
quality performance of Shared Savings Program ACOs (section III.G.1.c. 
of this proposed rule).
     The revisions to the Shared Savings Program quality 
performance standard. Specifically, under the proposed approach, the 
quality performance standard for Track 1+ Model ACOs would be set at a 
quality score that is equivalent to or higher than the 40th percentile 
across all MIPS Quality performance category scores (section III.G.1.c. 
of this proposed 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 
proposed 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 proposed rule).
     The modifications to Sec.  425.316 to allow CMS to 
identify ACOs that are not meeting the proposed, revised quality 
performance standard, 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 proposed rule).

[[Page 50252]]

     The modifications to the policies governing the audit and 
validation of data used to determine the ACO's quality performance. 
Specifically, under the proposed new provision of the regulations at 
Sec.  425.510(c), CMS would retain 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 proposed rule).
     The proposed new provision of the regulations at Sec.  
425.512(b) to address the effect of extreme and uncontrollable 
circumstances on ACOs' quality performance (section III.G.1.g. of this 
proposed rule).
     The revisions to the definition of primary care services 
used in beneficiary assignment. If finalized, the revised definition 
would be applicable to Track 1+ Model ACOs for the performance year 
starting on January 1, 2021, and we would adjust the Track 1+ ACO's 
historical benchmark to reflect these policies (section III.G.2 of this 
proposed rule).
     The proposed changes to the CAHPS for ACOs reporting 
requirements for performance year 2020 (section III.I.1 of this 
proposed 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, hospital outpatient department) for the furnishing 
of infusion therapy under this part.
    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 are not proposing to create a 
mandatory form nor are we otherwise proposing 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, 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 are 
referring 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.

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 or its participating providers and 
suppliers were 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 
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 equal to the mean quality performance score for all Shared 
Savings Program ACOs for the relevant performance year. However, if the 
ACO 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 Public Health Emergency (PHE) for the COVID-19 pandemic applies 
to all counties in the United States, therefore for performance year 
2020 all ACOs are considered to be affected by an extreme and 
uncontrollable circumstance.
1. Proposed Changes to the CAHPS for ACOs Reporting Requirements for 
Performance Year 2020
    In 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 
COVID-19 pandemic would pose significant

[[Page 50253]]

challenges and safety concerns in successfully completing the CAHPS 
survey. It was 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 in 2020 (85 FR 
19271 and 19272).
    The Shared Savings Program quality measure set for performance year 
2020 includes 10 measures that are collected through the CAHPS for ACOs 
survey. The timeline for the CAHPS for ACOs survey includes: (1) Vendor 
training in late spring, (2) ACO vendor selection in early summer, and 
(3) data collection beginning in late fall. The PHE may affect both the 
PY 2020 CAHPS for ACOs sample frame and the administration of the PY 
2020 survey. The CAHPS for ACO sample frame can include beneficiaries 
who are assigned to an ACO based on having received the plurality of 
their primary care visits from ACO professionals in that ACO or 
voluntary alignment to the ACO. Under our current process, the PY 2020 
CAHPS for ACOs survey sample frame will be constructed based on primary 
care visits of assigned beneficiaries from July 2019 through June 2020.
    We are concerned that the mix of beneficiaries included in the PY 
2020 sample frame may be impacted by the COVID-19 pandemic because the 
time period used to identify eligible beneficiaries based on primary 
care visits overlaps with the PHE for the COVID-19 pandemic. 
Beneficiaries may be assigned to an ACO based on both in person office 
and telehealth primary care visits; however, during the pandemic, many 
beneficiaries may defer or skip primary care visits. As a result, the 
pandemic could reduce the pool of beneficiaries available for 
assignment to the ACO and eligible for the survey sample. The sampling 
methodology requires a beneficiary to have at least two primary care 
service visits, as well as meet other sampling criteria such as a visit 
with a primary care clinician or a specialist that provides primary 
care services used in assignment who delivered the plurality of primary 
care services (that is, the beneficiary's focal provider). In addition, 
the survey is typically administered in late fall of the performance 
year and beneficiaries are asked if they received health care from 
their focal provider in the last 6 months, if they answer no they skip 
over the survey questions evaluating the provider and office staff. 
Given our concerns regarding the decrease in primary care services in 
2020, many beneficiaries could potentially have no office visits with 
their focal provider during this 6-month period and would be unable to 
fully complete the survey. A recent Commonwealth Health Study \47\ 
showed that the number of primary care (in person or telehealth) visits 
were down by about 31 percent in the 2nd quarter of 2020 despite an 
upward trend in telehealth visits. Some ACOs have noted a significant 
decline in primary care service visits in the months used to produce 
the sample. This is supported by preliminary claims data that shows 
primary care services furnished by ACO professionals in Shared Savings 
Program ACOs were down by 26 percent from January-May 2020 and shows a 
greater decrease in visits from January-April, 2020. The decrease was 
observed even following the addition of codes for certain telehealth 
and virtual services to the ACO assignment specifications in the May 
8th COVID-19 IFC (85 FR 27583 through 27586). We continue to monitor 
the impact that the changing mix of in person and telehealth visits has 
on assignment of beneficiaries to ACOs and any subsequent impact on 
sampling both in terms of the impact on the number of beneficiaries and 
composition of the beneficiary population assigned to an ACO.
---------------------------------------------------------------------------

    \47\ https://www.commonwealthfund.org/publications/2020/jun/impact-covid-19-pandemic-outpatient-visits-practices-adapting-new-normal.
---------------------------------------------------------------------------

    Additionally, the atypical pattern of primary care utilization in 
past months potentially introduces non-random differences in the 
patient pool used to assess ACOs in 2020 compared to prior years. The 
current survey instrument may not accurately measure the shifts in care 
caused by the pandemic, such as increased use of telehealth creating 
the potential for under-reporting of experience. Patient experience for 
an atypical period of care may result in patient reports of experiences 
substantially different from previous years making it difficult to 
determine if observed differences are due to changes in the quality of 
care or due to pandemic-related changes in utilization or care 
delivery, compromising the use of the data to measure performance 
improvement over time. For example, 2020 patient reports and ratings of 
care may be more affected by general shortages of personnel and 
capacity rather than by the quality of care delivered by physicians and 
other staff.
    Furthermore, even though the administration of the CAHPS for ACOs 
survey does not occur until late fall of PY 2020, we do not know how 
long the COVID-19 PHE will be in place or the long-term impacts of the 
PHE on the CAHPS for ACOs survey administration. The pandemic may 
negatively impact survey administration procedures and response rates. 
Vendor-specific revisions to the survey protocol may be warranted, such 
as allowing mail-only surveys, which could introduce a lack of 
standardization in survey administration, affecting the comparability 
of data collected by different vendors and could lead to decreased 
response rates affecting performance scores.
    Taken together, the potential negative impacts of the COVID-19 
pandemic detailed above could affect the size and generalizability of 
the survey sample, standardization of survey administration, and the 
utility of the data for purposes of measuring patient experience and 
performance improvement, thus leading to challenges in benchmarking and 
computing quality improvement scores for 2020.
    We note that absent this proposal, all ACOs would be required to 
administer the CAHPS for ACOs survey and pay to contract with a CAHPS 
vendor, regardless of the impact of the PHE. The change in the number 
of visits and the resulting sampling impact will vary for ACOs based on 
their location. If ACOs have sample sizes less than the target sample 
size of 860 beneficiaries, all eligible beneficiaries would be included 
in the survey sample; therefore, ACOs could potentially be paying for a 
vendor and receiving CAHPS for ACOs scores that do not reflect the care 
provided by ACO providers/suppliers. In contrast, the CAHPS for MIPS 
survey is voluntary and MIPS groups and virtual groups may still choose 
to register to field a MIPS for CAHPS survey. MIPS groups that register 
for the CAHPS for MIPS survey and do not meet minimum sample 
requirements are not eligible to administer the survey.
    Accordingly, in an effort to maintain consistency with public 
safety determinations made for the CAHPS survey that is used in Part C 
and Part D Star Ratings Systems in the March 31st COVID-19 IFC and 
address concerns about the negative impacts of COVID-19 on sample size 
and performance scores, we are proposing to modify our regulations to 
remove the requirement that ACOs field a CAHPS for ACOs survey for 
performance year 2020. Instead, we propose that ACOs

[[Page 50254]]

would automatically receive full points for each of the CAHPS survey 
measures within the patient/caregiver experience domain for performance 
year 2020. We acknowledge that this proposal is 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 above, we believe it is in 
the public interest not to require ACOs to field the CAHPS for ACOs 
survey. Accordingly, we propose to amend Sec.  425.500(d) to add 
language stating that for performance year 2020 we waive the CAHPS for 
ACOs reporting requirement and will give all ACOs automatic credit for 
the CAHPS for ACOs survey measures.
    We seek comment on our proposal to waive the CAHPS for ACOs 
reporting requirement and to give ACOs automatic credit for the CAHPS 
for ACOs survey measures for performance year 2020. For instance, we 
would be interested in hearing from ACOs and beneficiaries if there are 
other ways to conduct the survey that would mitigate the concerns 
listed above.
2. Comment Solicitation on Modifications to the Extreme and 
Uncontrollable Circumstances Policy for Performance Year 2020
    Multiple stakeholders have expressed concerns about the potential 
adverse impacts of the PHE for COVID-19 on ACOs, suggesting that we not 
use performance year 2020 data to assess the quality performance of 
ACOs, consider holding clinicians harmless from quality assessment and 
reporting, suspend quality data submission, or make the 2020 
performance year a pay-for-reporting year to allow for an ongoing focus 
on quality while recognizing the unusual circumstances presented this 
year.
    We understand stakeholders' concerns, but we believe that ACOs 
should be in a position to report CMS Web Interface measures for PY 
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. However, 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 believe the 
proposal described above that would give ACOs automatic full credit for 
the CAHPS for ACOs survey measures, in addition to our current extreme 
and uncontrollable circumstances policy, offers relief to ACOs for 
performance year 2020. 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, for ACOs in their second 
or subsequent performance year, there is at least one measure in each 
domain that ACOs could receive full points for, providing they 
completely report quality data, ensuring they 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 2020 quality performance, as noted above. We believe 
it is in the public interest that we strongly 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 that 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.
    However, we are also seeking comment on a potential alternative 
approach to scoring ACOs under the extreme and uncontrollable 
circumstances policy for performance year 2020 that we considered 
proposing. 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. Changes in healthcare utilization during 
2020 may impact sampling and ACO performance on the quality measures 
for reasons that include: (1) Increased healthcare utilization due to 
COVID-19; (2) reduced or delayed non-COVID-19 care due to advice to 
patients to delay routine and/or elective care; and (3) changes in non-
COVID-19 inpatient utilization due to crowd-out. For the reasons 
enumerated above, we believe that the PHE for COVID-19 creates 
uncertainty regarding performance rates on the ACO quality measures for 
performance year 2020. Due to the changes in the healthcare landscape 
and the increased burden they present in providing care for all 
patients during the PHE for COVID-19, we recognize that the mean ACO 
performance rate in 2020 could be lower than it was in previous 
performance years. We therefore considered whether assigning the higher 
of an ACO's own 2020 quality score or the 2020 ACO mean to those ACOs 
that do not completely report quality and those whose quality score 
falls below the mean in 2020, consistent with our current extreme and 
uncontrollable circumstances policy, may disadvantage ACOs. 
Accordingly, below we are seeking comment on a potential change to the 
existing extreme and uncontrollable circumstances policy that we 
considered proposing.
    The potential alternative modification we considered would be 
similar to the current 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 quality data for 2020. For new ACOs 
that completely report quality data, 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). We believe that the 
potential change to use the higher of an ACO's 2020 quality performance 
score or its 2019 quality performance score, for ACOs that do 
completely report quality data for performance year 2020, could help to 
mitigate the impact of the PHE for COVID-19 on ACOs that report, but 
are not able to perform well during 2020. We also believe that 
assigning the 2020 ACO quality mean to ACOs that do not complete 
quality reporting would incentivize reporting by new ACOs that would 
receive 100 percent if they complete reporting, as well as by ACOs in 
their second or subsequent performance years that would have an

[[Page 50255]]

opportunity to receive a score that could be higher than the 2020 mean 
if they complete quality reporting.
    As mentioned above, 98.7 percent of ACOs reported quality data for 
performance year 2019 despite being impacted by the PHE for COVID-19 
during the 2019 CMS Web Interface data submission period. We note that 
preliminary data indicate that the 2019 mean ACO quality score will be 
92 percent, which is comparable to the mean ACO quality scores from 
prior years. For example, the 2018 mean ACO Quality Score was 93 
percent. As a result, we expect that for some ACOs in their second or 
subsequent performance year with consistently above average quality 
scores, assigning their 2019 quality performance score would result in 
a higher quality performance score for 2020 than the 2020 ACO mean 
quality score. However, as noted in section VIII.H.8. of this proposed 
rule, the proposed full credit for the CAHPS for ACOs measures that is 
described above would advantage all ACOs relative to applying only our 
current extreme and uncontrollable circumstances policy to mitigate the 
impact of the PHE for COVID-19.
    We are soliciting 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, as proposed in this section, 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 will 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, as proposed in this 
section.
    (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 believe this potential alternative of modifying the extreme and 
uncontrollable circumstances policy to the higher of an ACO's 2020 
quality performance score or its 2019 quality performance score would 
encourage all ACOs to report quality for performance year 2020, while 
also offering additional protections for ACOs in the event that quality 
performance scores for 2020 are adversely affected by the PHE for 
COVID-19. We believe this approach could help to address concerns about 
the potential for lower quality performance during performance year 
2020 by continuing to benefit ACOs that perform well during 2020, and 
mitigating the impact for those that do not. ACOs that do not 
completely report quality would receive the 2020 mean ACO quality 
score, as provided under the current extreme and uncontrollable 
circumstances policy in Sec.  425.502(f). As noted earlier, 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, and we believe this should also help to 
mitigate concerns regarding quality performance. Nevertheless, we 
recognize that the mean ACO quality performance rate in 2020 could be 
lower than it was in previous performance years. As a result, we 
believe this alternative could provide an incentive to encourage ACOs 
to completely and accurately report quality because they would be 
eligible to receive a score that may be higher than the 2020 ACO mean 
quality score. Accordingly, we seek comment on the potential 
modification to the extreme and uncontrollable circumstances policy for 
performance year 2020, as described above.

J. Proposal To Remove Selected National Coverage Determinations

    In the August 7, 2013 Federal Register notice (78 FR 48164), we 
established the current procedures for requesting a National Coverage 
Determination (NCD) or reconsideration of an existing NCD. We described 
how the public may participate in the NCD process during the indicated 
comment period(s). We also established an expedited administrative 
process, using specific criteria, to remove NCDs older than 10 years, 
thereby allowing the local Medicare Administrative Contractors (MAC) to 
determine coverage.
    We are now proposing to use the rulemaking process to continue to 
use the criterion established in 2013 to regularly identify and remove 
NCDs that no longer contain clinically pertinent and current 
information, in other words those items and services that no longer 
reflect current medical practice, or that involve items or services 
that are used infrequently by beneficiaries. We are proposing this 
change of vehicle because removing a NCD changes a substantive legal 
standard related to Medicare coverage and payment for items and 
services under section 1871(a)(2) of the Act. 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 (42 CFR 
405.1060). Instead, the coverage determinations for those items and 
services will be made by MACs. On the other hand, 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 now be beneficial for some uses. As the 
scientific community continues to conduct research which produces new 
evidence, the evidence base we previously reviewed may have evolved to 
support other policy conclusions.
    Per the guidance issued in the 2013 notice, we may consider an 
older NCD for removal if, among other things, any of the following 
circumstances apply:
     We believe that allowing local contractor discretion to 
make a coverage decision better serves the needs of the Medicare 
program and its beneficiaries.
     The technology is generally acknowledged to be obsolete 
and is no longer marketed.
     In the case of a noncoverage NCD based on the experimental 
status of an item or service, the item or service in the NCD is no 
longer considered experimental.
     The NCD has been superseded by subsequent Medicare policy.
     The national policy does not meet the definition of an 
``NCD'' as defined in sections 1862(l) or 1869(f) of the Act.

[[Page 50256]]

     The benefit category determination is no longer consistent 
with a category in the Act.
    We are interested in public comments that may identify other 
reasons for proposing to remove NCDs. We are also interested in 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.
    The process of removal does not result in an NCD as that term is 
defined in sections 1869(f) and 1862(l) of the Act because there would 
be no uniform national decision about whether or not the particular 
item or service would be covered under Title XVIII of the Act. Rather, 
the initial coverage decision which is normally made for a specific 
beneficiary who has already received an item or service and has 
submitted a Medicare claim would be made by local contractors. For the 
reasons outlined above, we believe that allowing local contractor 
flexibility in these cases better serves the needs of the Medicare 
program and its beneficiaries.
    Since the 2013 notice, we have removed NCDs on two occasions. 
First, in November 2013, we proposed 10 NCDs for expedited removal. 
After reviewing the comments, we issued a final decision memorandum in 
December 2014, removing 7 NCDs and retaining three. We last proposed 
removal of NCDs in March of 2015, proposing to remove 2 NCDs. Based on 
the comments, we removed one NCD and retained one. 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&.
    It has been 5 years since we last evaluated older NCDs for removal. 
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 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 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, we list the NCDs that we propose to remove. In 
addition to conducting an internal review to identify appropriate NCDs 
for removal, we received removal requests from a variety of external 
stakeholders, such as medical specialty societies, device 
manufacturers, beneficiaries, physicians and providers, and other 
interested individuals. Additionally, some of these topics were brought 
to our attention by the MAC medical directors. We solicit comment on 
the nine NCDs discussed in Table 37, as well as comments recommending 
other NCDs for CMS to consider for future removal.
[GRAPHIC] [TIFF OMITTED] TP17AU20.071

    The following outlines each NCD and provides a summary of the 
rationale for removal. Each of the current NCDs below may be found in 
the Medicare National Coverage Determinations Manual located at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/internet-Only-Manuals-IOMs-Items/CMS014961.
1. NCD #20.5 Extracorporeal Immunoadsorption (ECI) Using Protein A 
Columns (01/01/2001)
     Circumstances/criterion: We believe that allowing local 
contractor discretion to make a coverage decision better serves the 
needs of the Medicare program and its beneficiaries.
     Rationale: Extracorporeal immunoadsorption (ECI), using 
Protein A columns, has been developed for the purpose of selectively 
removing circulating immune complexes (CIC) and immunoglobulins (IgG) 
from patients in whom these substances are associated with their 
diseases. The technique involves pumping the patient's anticoagulated 
venous blood through a cell separator from which 1-3 liters of plasma 
are collected and perfused over adsorbent columns, after which the 
plasma rejoins the separated, unprocessed cells and is re-transfused to 
the patient. ECI has been used to treat some diseases of inflammatory 
and autoimmune etiology. External stakeholders suggested this NCD may 
be outdated, with the therapeutic use of ECI constrained by the 
parameters of the NCD as the evidentiary base has continued to evolve. 
Also, the service is a specific type of therapeutic apheresis for the 
treatment of rheumatoid arthritis under certain conditions. The 
stakeholders recommended that this NCD should be removed in conjunction 
with removing NCD #110.14 Apheresis, which is discussed below. Removing 
the outdated CMS NCD for ECI and leaving

[[Page 50257]]

it to contractor discretion would provide flexibility for coverage 
considerations that are more responsive to the evolving evidentiary 
base improving appropriate access for Medicare beneficiaries.
2. NCD #30.4 Electrosleep Therapy
     Circumstances/criterion: The technology is 
generally acknowledged to be obsolete and is no longer marketed.
     Rationale: External stakeholders suggested this 
NCD may be outdated. This NCD predates the current NCD public notice 
standards and has no decision memorandum, no evidence review, and no 
bibliography. Additionally, the term ``Electrosleep therapy'' appears 
to be outdated, superseded by ``cranial electrotherapy stimulators 
(CES).'' In addition to a change in nomenclature, FDA's class level 
assigned to CES has also changed over time for indications of anxiety 
and/or insomnia, although not for depression. Given that the 
therapeutic area has progressed and ``Electrosleep Therapy'' does not 
have the same applicability, we propose to remove this NCD allowing 
local contractor discretion to consider coverage of newer technologies.
3. NCD #100.9 Implantation of Gastroesophageal Reflux Device (06/22/
1987)
     Circumstances/criterion: We believe that 
allowing local contractor discretion to make a coverage decision better 
serves the needs of the Medicare program and its beneficiaries.
     Rationale: External stakeholders suggested this 
NCD may be outdated. The 1987 Noncoverage NCD was determined based on a 
different device, the Angelchik device, which was a device implanted 
around the esophagus (under the diaphragm and above the stomach) that 
was secured by a circumferential tie strap. Implantable treatment for 
GERD initiated with Angelchik prosthetic rings came under scrutiny for 
high dysphagia rates and migration of the implant. It was removed from 
the market in 1990. New FDA market authorized devices for the 
indication of GERD have emerged since that time. However, some devices 
have a limited evidence base with respect to improving long-term 
patient outcomes. Nonetheless, there may be a role for implantable 
devices in the treatment of reflux. We believe that local contractor 
discretion provides an immediate avenue to potential coverage in 
appropriate candidates. Therefore, we believe that allowing local 
contractor discretion to make a coverage decision better serves the 
needs of the Medicare program and its beneficiaries.
4. NCD #110.14 Apheresis (Therapeutic Pheresis) (7/30/1992)
     Circumstances/criterion: We believe that 
allowing local contractor discretion to make a coverage decision better 
serves the needs of the Medicare program and its beneficiaries.
     Rationale: Apheresis (also known as pheresis or 
therapeutic pheresis) is a medical procedure utilizing specialized 
equipment to remove selected blood constituents (plasma, leukocytes, 
platelets, or cells) from whole blood. The remainder is re-transfused 
into the person from whom the blood was taken. The apheresis NCD 
predates the current NCD public notice standards. No evidence review 
was published for this NCD to justify the specific list of conditions 
covered. Since the NCD is silent on non-coverage, the NCD is vague and 
open to interpretation and may not be applied uniformly. Furthermore, 
the scope of indications for apheresis has continued to develop since 
the origin of the NCD. Removing the outdated CMS NCD for apheresis and 
leaving it to contractor discretion will provide flexibility for 
coverage considerations that are more responsive to the evolving 
evidentiary base improving appropriate access for Medicare 
beneficiaries.
5. NCD #110.19 Abarelix for the Treatment of Prostate Cancer (3/15/
2005)
     Circumstances/criterion: The technology is 
generally acknowledged to be obsolete and is no longer marketed.
     Rationale: Abarelix was approved in the Unites 
States in 2003 for restricted use as palliative treatment in men with 
advanced symptomatic prostate cancer and experiencing select 
complications (described in the FDA labeling). However, in response to 
reports of systemic allergic reactions, the GnRH antagonist, Abarelix, 
was voluntarily withdrawn from the U.S. market in 2005. Because 
Abarelix is no longer marketed in the U.S., the NCD no longer contains 
clinically pertinent and current information and should be removed.
6. NCD #190.1 Histocompatability Testing (08/01/1978)
     Circumstances/criterion: We believe that 
allowing local contractor discretion to make a coverage decision better 
serves the needs of the Medicare program and its beneficiaries.
     Rationale: Histocompatibility testing involves matching or 
typing of the human leucocyte antigen (HLA) proteins. External 
stakeholders suggested that the texts within this NCD are now less 
frequently utilized and raised concerns of reducing provider burden as 
adjudication of the claims for certain diagnoses requires submission of 
medical records for each person tested. The techniques have evolved 
from conventional HLA cross-matching to include a range of techniques 
with different levels of matching, including HLA genotyping assays 
(polymerase chain reaction sequence-specific primer [PCR-SSP], 
sequence-specific oligonucleotide probe (SSOP), and sequence-based 
techniques [SBT] including next generation sequencing). Therefore, 
clinicians need to make sophisticated assessments related to the 
indication, their access to histocompatibility testing approaches, and 
appropriate avenues for billing. We propose removing this NCD which 
originated around conventional HLA cross-matching. This would allow 
local contractors discretion to accommodate clinical flexibility to 
better serve the needs of the Medicare program and its beneficiaries 
while streamlining and simplifying the billing and claims processing.
7. NCD #190.3 Cytogenetic Studies (7/16/1998)
     Circumstances/criterion: The NCD has been 
superseded by subsequent Medicare policy.
     Rationale: Cytogenetics involves examining 
stained chromosomes, and distinct chromosomal bands, to help identify 
structural abnormalities in chromosomes that might correspond to poor 
health outcomes. However, direct DNA analyses through DNA sequencing, 
such as Next Generation Sequencing (NGS) (https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=372), allows providers 
to read the exact order of nucleotide molecules that comprise DNA, 
enhancing the sensitivity and specificity in identifying abnormalities 
in the genetic sequence. As a result, the focus of NCDs has generally 
shifted from cytogenetic studies to genetic sequencing when detailed 
genetic information is of interest.
8. NCD #220.2.1 Magnetic Resonance Spectroscopy (09/10/2004)
     Circumstances/criterion: We believe that 
allowing local contractor discretion to make a coverage decision better 
serves the needs of the Medicare program and its beneficiaries.
     Rationale: MRS can determine the relative 
concentrations and physical properties of a variety of biochemicals and 
has the potential to probe a wide

[[Page 50258]]

range of metabolic pathways in different human tissue. Although MRS is 
mostly used in assessing brain tissue, it also offers potential 
applicability to breast, prostate, hepatic, and other cancers. External 
stakeholders suggested this NCD may be outdated, noting the 2004 broad 
noncoverage determination for all indications was based on evidentiary 
review for one limited indication, the diagnosis of brain tumors. As 
the scientific evidence evolves and the clinical utility develops 
across various indications, the restrictive scope of the 2004 NCD may 
prohibit appropriate local coverage determinations.
9. NCD #220.6.16 FDG PET for Inflammation and Infection (03/19/2008)
     Circumstances/criterion: We believe that 
allowing local contractor discretion to make a coverage decision better 
serves the needs of the Medicare program and its beneficiaries.
     Rationale: The decision to use FDG PET for 
inflammation and infection is multifactorial and depends on: Whether 
conventional diagnostics have been unsuccessful, the stage of the 
underlying pathophysiological condition in the affected tissues, and 
the sensitivity and specificity of FDG PET to inform the differential 
diagnosis or course of disease, among other factors. For some 
inflammatory and infectious conditions, there is no overall agreement 
in the current literature about the added value of FDG PET for this 
indication. Conversely, leaving such determinations to local contractor 
discretion builds in flexibility to tailor coverage decisions to the 
pertinent facts of a patient's case and considering any added benefit 
of FDG PET in establishing a diagnosis and treatment plan that might 
link the PET imaging to an improved patient outcome.
    In summary, we solicit comment on the proposal to remove each of 
the nine NCDs, as well as comments recommending other NCDs for CMS to 
consider for future removal. Additionally, we solicit public comments 
that may identify other reasons for proposing to remove NCDs. We 
solicit 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 request commenters include a rationale to support their comments. 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. 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.

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. Background
    Since Part D was signed into law in 2003, electronic prescribing 
(e-prescribing or e-Rx) has been optional for physicians and pharmacies 
for prescriptions made for covered Part D drugs. However, Part D 
sponsors offering drug plans have been required to have the electronic 
capabilities to support electronic prescribing. We understand that 
issuing this regulation would uniquely affect physicians, although it 
may impact other prescribers under Part D. Given the majority of 
affected parties are physicians, we seek to use the CY 2020 PFS 
rulemaking to gain the insight and perspective of providers.
    We track the volume of electronic prescriptions for controlled and 
non-controlled substances through our prescription drug event (PDE) 
processing system for Part D program claims. We have collected data on 
controlled substances and non-controlled substances since the United 
States' Drug Enforcement Administration (DEA) permitted the practice in 
2010.\48\
---------------------------------------------------------------------------

    \48\ See 75 FR 16284, including revisions adopted to 21 CFR 
1304.04.
---------------------------------------------------------------------------

    However, while electronic prescribing has increased, the health 
care system faces a new threat. The United States is currently 
responding to an outbreak of respiratory disease caused by a novel 
(new) coronavirus now detected in 50 States and the District of 
Columbia. 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''). In January 2020, the 
Secretary determined that a Public Health Emergency (PHE) exists for 
the United States to aid the nation's health care community in 
responding to COVID-19 (hereafter referred to as the PHE for the COVID-
19 pandemic) and on April 21, 2020, the Secretary renewed, effective 
April 26, 2020, the determination that a PHE exists. In March, 2020, 
President Trump declared the COVID-19 pandemic a national emergency. 
Certain individuals, including older adults and persons with chronic 
conditions, who comprise a predominance of the Medicare beneficiary 
population, are at elevated risk of more severe illness and potential 
death from COVID-19. As a result of the PHE for the COVID-19 pandemic, 
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 COVID-19 
pandemic. These actions include new flexibilities for telehealth and 
other electronic technologies \49\ 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 the COVID-19 pandemic.\50\ For example, during the PHE 
for the COVID-19 pandemic, 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 the COVID-19 pandemic.
---------------------------------------------------------------------------

    \49\ See https://www.cms.gov/files/document/covid-19-physicians-and-practitioners.pdf.
    \50\ See https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-
023)(DEA075)Decision_Tree_(Final)_33120_2007.pdf.
---------------------------------------------------------------------------

    We believe that social distancing is, in part, responsible for the 
increase in electronic prescribing for controlled substances (EPCS) 
during this PHE for the COVID-19 pandemic. In 2020, EPCS has increased 
to 50 percent of all PDEs being prescribed as compared to 38 percent in 
2019.\51\ With the use of electronic prescribing, a patient and 
provider can conduct a visit via

[[Page 50259]]

telehealth and then have the prescription 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.
---------------------------------------------------------------------------

    \51\ Based on Prescription Drug Event data processed through 
April 30, 2020.
---------------------------------------------------------------------------

    The DEA is also involved in regulating EPCS. In 2010, the DEA 
issued the ``Electronic Prescriptions for Controlled Substances'' 
interim final rule with request for comment (75 FR 16236) (hereinafter 
referred to as the ``2010 DEA EPCS interim final rule'') that provided 
practitioners with the option of writing prescriptions for controlled 
substances electronically. The rule also permitted pharmacies to 
receive, dispense, and archive these electronic prescriptions. Any 
electronic controlled substance prescription issued by a practitioner 
must meet the requirements in the 2010 DEA EPCS interim final rule. We 
note that not all electronic prescribing systems currently meet the 
DEA's requirements.
    Since the issuance of the 2010 DEA EPCS interim final rule, we have 
seen a steady increase in the volume of controlled substance 
prescriptions submitted electronically. States have instituted 
electronic prescribing requirements; some include penalties for not 
using e-prescribing for controlled substances. As of 2020, all states 
in the U.S., and Washington DC allow electronic prescribing of 
controlled substances for schedules II through V.\52\
---------------------------------------------------------------------------

    \52\ Schedule I drugs are not included in EPCS discussions 
because they have no currently accepted medical use. See https://www.deadiversion.usdoj.gov/schedules/#define for additional detail 
on definitions of controlled substances.
---------------------------------------------------------------------------

    EPCS provides multiple advantages over the traditional processing 
of paper prescriptions.53 54 55 56 57 58 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 EPCSs 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.\59\
---------------------------------------------------------------------------

    \53\ 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.
    \54\ 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.
    \55\ 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_content=85955401&_hsenc=p2ANqtz-8xs36u7xTFZ-ieOxJk3309SApbE7to_fnk1SZvz2jqwz0pA3k7TtW9byiOq2zBlheLInMOeajCMCKeQUTzcEDP79HEaeXI52QiadhAYAWU3Px2eZc&_hsmi=85955401 on April 30, 2020.
    \56\ 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.
    \57\ 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.
    \58\ 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.
    \59\ 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.
---------------------------------------------------------------------------

    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 requirement 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.
2. The Current EPCS Environment
    Based on a published report of 2019 data reflecting the majority of 
prescribing activities across the country,\60\ 97 percent of U.S. 
pharmacies were capable of processing EPCSs, yet only 49 percent of 
prescribers were capable of electronically prescribing controlled 
substances. The same report showed that 38 percent of controlled 
substance prescriptions were electronically prescribed, while 85 
percent of non-controlled substances were electronically prescribed. 
Pain management specialists appear to be using electronic prescribing 
more often for opioids than other prescribers, and family practitioners 
are using electronic prescribing for opioids less often. Electronic 
prescribing also varies across practice size and ownership and among 
physicians who practice in groups owned by a health plan, health 
maintenance organizations (HMOs), hospital, or other healthcare entity. 
Use of the technology does not vary

[[Page 50260]]

significantly between rural and urban areas, but it does vary between 
states.\61\ Based on our analysis of the issue and conversations with 
the industry, we believe that this is associated with differences in 
regulations, penalties, waivers, populations, and culture.
---------------------------------------------------------------------------

    \60\ Surescripts. ``National Progress Report 2019.'' March 2020. 
Retrieved from https://surescripts.com/docs/default-source/national-progress-reports/7398_ab-v2_2019-npr-brochure.pdf on April 20, 2020.
    \61\ 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.
---------------------------------------------------------------------------

    The reasons for this disparity between capability and practice are 
varied. There may be challenges associated with clinicians' ability to 
electronically prescribe controlled substances within their normal 
workflow, reluctance to alter workflow habits, or reluctance to use new 
technology, but at this point, as mentioned earlier, most pharmacies 
are capable of processing EPCS. Some prescribers may rely on health 
care groups, clinics, and hospital systems to implement the necessary 
technology. There are also costs associated with the adoption of 
technology, which can disproportionately impact small or rural 
practices or pharmacies. Though EPCS uptake continues to grow in 
physicians and pharmacies,62 63 64 clear gaps remain between 
capacity and adoption of electronic prescribing of controlled 
substances.
---------------------------------------------------------------------------

    \62\ Burger, M. ``Accelerating ePrescribing for Controlled 
Substances.'' HIT Perspectives: Controlled Substances, February 
2014. Retrieved from https://www.pocp.com/hitperspectives-controlled-substances/ on April 30, 2020.
    \63\ Imambaccus N., Glace S., Heath R. Increasing the uptake of 
electronic prescribing in primary care. BMJ Quality Improvement 
Reports 2017;6:u212185. w4870. doi:10.1136/bmjquality.u212185.w4870. 
Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5457970/pdf/bmjqir.u212185.w4870.pdf on April 30, 2020.
    \64\ Monegain, B. ``E-prescribing takes off like a rocket.'' 
Healthcare IT News, June 18, 2015. Retrieved from https://www.healthcareitnews.com/news/e-prescribing-takes-rocket on April 
30, 2020.
---------------------------------------------------------------------------

    Substantial adoption of EPCS has occurred in the thirteen states 
that require it.\65\ Some states have chosen to use penalties to 
increase prescribers' compliance with EPCS requirements. For example, 
New York mandated EPCS with a penalty for non-compliance and 
subsequently experienced an EPCS adoption rate for controlled 
substances of nearly 99 percent for pharmacies and 82 percent for 
prescribers in 2019.\66\ We do not currently impose penalties for 
providers prescribing controlled substances under the Part D program 
who do not use e-prescribing. Rather, Part D plans may reject improper 
transactions or transactions that did not adhere to the CMS transaction 
standards.
---------------------------------------------------------------------------

    \65\ Arizona, Connecticut, Florida, Indiana, Iowa, Maine, 
Minnesota, New York, North Carolina, Oklahoma, Pennsylvania, Rhode 
Island, and Virginia have adopted mandates that will be in effect in 
2020. DrFirst. Mandates Driving EPCS and PDMP Utilization. Accessed 
April 29, 2020. https://drfirst.com/resources/regulatory-mandates/.
    \66\ Surescripts, 2019 National Progress Report. Accessed April 
29, 2020. https://naspa.us/wp-content/uploads/2020/04/7398_2019-NPR-Brochure-Web-Final.pdf.
---------------------------------------------------------------------------

3. E-Prescribing Standards
    CMS adopted the first set of standards for e-prescribing for Part 
D, the National Council for Prescription Drug Programs (NCPDP) SCRIPT 
Standard, Version 5, Release 0 in the Medicare Program; E-Prescribing 
and the Prescription Drug Program, Final Rule, in 2005.\67\ Since then 
CMS has continued to adopt updated e-prescribing standards \68\ with 
the most recent standard described in a final rule published April 16, 
2018 where we finalized an update of the Part D standards to NCPDP 
SCRIPT standard version 2017071 for e-Rx and medication history, 
effective January 1, 2020 (83 FR 16440).
---------------------------------------------------------------------------

    \67\ See 70 FR 67568.
    \68\ CMS regulations adopting updated versions of the NCPDP 
SCRIPT standard: 73 FR 18918 (NCPDP SCRIPT version 8.1); and 77 FR 
688892 (NCPDP SCRIPT version 10.6).
---------------------------------------------------------------------------

    We currently require that Part D plans support the NCPDP SCRIPT 
standard version 2017071 for certain defined e-prescribing transactions 
as finalized in the ``Medicare Program; Contract Year 2019 Policy and 
Technical Changes to the Medicare Advantage, Medicare Cost Plan, 
Medicare Fee-for-Service, the Medicare Prescription Drug Benefit 
Programs, and the PACE Program'' final rule (83 FR 16440). This 
requirement became effective on January 1, 2020. Under CMS regulations, 
prescribers are required to use this standard when conducting e-
prescribing for covered Part D drugs for Part D eligible individuals.
4. 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 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.

[[Page 50261]]

    In the Medicare Program: Electronic Prescribing for Controlled 
Substances; Request for Information, we are requesting 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 on using the important public feedback we 
receive from the Request for Information in future standalone 
rulemaking.
5. Proposed Timeframe for EPCS Adoption
    Section 2003 of the SUPPORT Act mandates that EPCS begin on January 
1, 2021. Due to this statutory mandate coupled with the aforementioned 
advantages provided by EPCS, we encourage all prescribers to conduct 
EPCS as soon as is feasible for them.
    We believe that although EPCS is ultimately more efficient, 
implementing EPCS does take additional time and resources. Prescribers 
must follow all the DEA guidance established by the DEA and summarized 
at https://deadiversion.usdoj.gov/ecomm/e_rx/. The requirements for 
individual practitioners and those enrolled in group practices vary but 
in general, a prescriber will need to make sure that their current 
ePrescribing software can support EPCS and is accredited by the DEA 
accordingly. In addition, before providers are approved for EPCS, their 
identity must be validated, including that they are authorized to 
prescribe controlled substances, and that their DEA number and license 
are in good standing. This step is required even if they are already 
prescribing controlled substances on paper. They must also get two-
factor authentication in place which can be accomplished through 
include a combination of passwords, tokens, mobile phones, smart cards, 
and/or fingerprint biometrics. The providers must often have approved 
software configured to process EPCS which may require another set of 
permissions. Once that's completed, providers can process electronic 
prescriptions of controlled substances using the agreed upon two-factor 
authentication for each transaction. There are software and workflow 
training involved at each step of the process. When writing 
prescriptions, they must talk to their patients about e-prescribing, so 
their patients are aware of the general mechanics of how it is 
conducted.
    We also recognize that the current PHE for the COVID-19 pandemic 
presents additional EPCS challenges for some prescribers. We have seen 
that those prescribers who had already implemented EPCS capabilities 
have been able to increase the number of prescriptions electronically 
prescribed during the PHE. However, other provider groups have 
indicated that they do not anticipate being able to reschedule the EHR 
upgrades necessary to implement EPCS for at least three to four months, 
at which point practice resource limitations could make it difficult to 
deploy the necessary upgrades in a compressed timeframe. Other 
physician practices have indicated that complying with established EPCS 
identify proofing processes may be difficult because key personnel are 
unavailable or working offsite. We are sympathetic to the unique 
challenges faced by prescribers during this PHE for the COVID-19 
pandemic. We also recognize the importance of EPCS and the statutory 
mandate. We believe that requiring EPCS by January 1, 2022 strikes the 
balance between not providing too large of a burden on providers and 
helping ensure that the benefits of EPCS are leveraged expeditiously. 
Furthermore, 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 requirements and penalties. This 
includes 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. 
However, prior to the SUPPORT Act, which modified ePrescribing 
requirements with respect to schedules II through V controlled 
substances, all ePrescribing has been optional for physicians. As 
stated above, the statute provides the Secretary with the authority to 
develop any exceptions to EPCS that might be warranted, and to enforce 
and specify appropriate penalties for non-compliance with the 
requirement. We do not have an existing process for imposing penalties 
on non-compliant prescribers with respect to 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 beneficiary's access to needed drugs. Separate from this rule, 
we intend to conduct future standalone rulemaking that would address 
these topics.
    Based on these considerations, we are proposing to amend Sec.  
423.160(a) by adding the requirement that all prescribers conduct 
electronic prescribing of Schedule II, III, IV, and V controlled 
substances using the NCPDP SCRIPT 2017071 standard by January 1, 2022, 
except in circumstances in which the Secretary waives the requirement. 
We are proposing that prescribers must 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 believe that prescribers should use the same 
standard for their electronic prescribing of controlled substances.
    We understand that the proposal to require electronic prescribing 
for controlled substances for covered Part D drugs under a prescription 
drug plan or MA-PD plan would uniquely affect physicians. As a result, 
we seek to gain the insight and perspective of prescribers and others. 
We welcome comments on this proposal, including the feasibility for 
prescribers to meet the proposed January 1, 2022 deadline. We are also 
soliciting comments regarding the impact of this proposal on overall 
interoperability and the impact on medical record systems. Finally, we 
are interested in receiving comments on whether the proposed change 
would be significant enough for a January 1 implementation date, which 
is required for all significant changes affecting Part D plans.

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

[[Page 50262]]

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_annoucement.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 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 pursuant to section 505(b)(2) (which we refer to as a 
``section 505(b)(2) application'') may 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 ANDA for a generic drug, a 
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 the 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) 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''). 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 sections 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, CMS is 
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.
    CMS has 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 sections 
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/

[[Page 50263]]

Downloads/051807_coding_annoucement.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 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 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. Sections 1847A(c)(6)(E) and (F) of the Act 
establish conditions under which pharmaceutical equivalence and 
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).
    Sections 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 sections 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

[[Page 50264]]

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, and 
frequency. The quantity of a drug (or duration of therapy) and refills 
are also 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 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 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 
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 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) 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) 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. Proposal To Codify Existing Policy for Section 505(b)(2) Drug 
Products
    Our approach (described in section 2) 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 sections 1847A(c)(6)(C) and (D) of the 
Act and authority to assign drug products to billing and payment codes 
in sections 1847A(b)(3) and (6) of the Act as discussed in the sections 
above. 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 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.'' \69\ Our 
approach also encourages competition among products that are 
competitors--that is, when they are described by one billing code and 
share similar labeling.
---------------------------------------------------------------------------

    \69\ https://www.whitehouse.gov/briefings-statements/president-donald-j-trumps-blueprint-lower-drug-prices/.
---------------------------------------------------------------------------

    We are concerned 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

[[Page 50265]]

drug codes. We are also concerned about the effect of high payment 
amounts on individual beneficiaries' cost sharing payments for these 
products.
    We propose to continue 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. As discussed in the previous section, 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 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 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 propose to revise the definition of multiple source 
drug in regulation text at 42 CFR 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. We welcome comments on our 
proposals.

M. Updates to Certified Electronic Health Record Technology Due to the 
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 (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 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 has expanded to 
other government and non-government programs. Since 2019, for the 
Promoting Interoperability Programs and QPP, we have required the use 
of CEHRT as defined at 42 CFR 495.4 and 414.1305, respectively, which 
generally consists of EHR technology (which could include multiple 
technologies) certified under the 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 2015 Edition 
certification criteria for CEHRT with the CY 2019 reporting period/FY 
2021 payment determination (83 FR 41607).
    The 21st Century Cures Act final rule that appeared 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 
these updates to the 2015 Edition will enhance interoperability and 
patients' access to their electronic health information, consistent 
with section 4006(a) of the 21st Century Cures Act. The 21st Century 
Cures Act final rule both revises and adds new certification criteria 
that establish the capabilities and related standards and 
implementation specifications for the certification of health IT, as 
well as removing certain criteria. In this proposed rule, we propose to 
require that technology used to meet the CEHRT definitions must be 
certified in accordance with the updated certification criteria in the 
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 that we 
currently require for the Promoting Interoperability Programs and QPP. 
These changes incorporate certain technical standards, including an e-
prescribing standard required for alignment with other CMS programs, 
and other technical updates to existing 2015 Edition functionality that 
is already being used by many healthcare providers. For instance, 
updates to 2015 Edition certification criteria that referenced the 
Common Clinical Data Set (CCDS) regulatory definition to reference 
instead the United States Core Data for Interoperability (USCDI) 
standard do not require extensive changes to user-facing aspects of 
health IT already certified to these criteria (85 FR 25665).
    For 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 certified under the 
Certification Program that meets the 2015 Edition Base EHR definition 
at Sec.  170.102, and has been 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 for the MIPS advancing 
care information performance category (now known as the Promoting 
Interoperability performance category). These updates finalized by ONC 
in the 21st Century Cures Act final rule impact criteria in the 
different elements of the CEHRT definitions, including certification 
criteria included in the 2015 Edition Base EHR definition for the 
Promoting Interoperability Program and the Quality Payment Program, as 
well as certification criteria necessary to be a meaningful EHR user 
under the Promoting Interoperability Programs, and criteria necessary 
to report on applicable objectives and measures

[[Page 50266]]

specified for the MIPS Promoting Interoperability performance category.
    The 21st Century Cures Act final rule specified a number of 
timelines and compliance dates for health IT developers related to the 
2015 Edition Cures Update. The rule finalized the removal of several 
certification criteria from the 2015 Edition that were also 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 21st Century Cures Act final rule finalized updates to 
existing 2015 Edition criteria, or introduced new 2015 Edition 
criteria, ONC generally finalized that health IT developers will have 
24 months from the publication date of the rule (until May 2, 2022) to 
make technology available that is certified to the updated, or new 
criteria. 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 implementing 
updates, and healthcare providers participating in the Promoting 
Interoperability Programs and QPP may use such technology for the 
purposes of these programs while working with health IT developers to 
implement updates in a manner that best meets their needs.
    On April 21, 2020, in response to the COVID-19 public health 
emergency, ONC announced additional flexibility for health IT 
developers subject to the policies in the 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 will 
exercise enforcement discretion regarding new requirements in the 21st 
Century Cures Act final rule until three months after each initial 
compliance date or timeline. During this period of enforcement 
discretion, healthcare providers participating in the Promoting 
Interoperability Programs and QPP would continue to be able to use 
technology certified to the 2015 Edition criteria that has not been 
updated yet.
    Below, we provide an overview of updates in the ONC 21st Century 
Cures Act final rule that impact certification criteria included in the 
CEHRT definitions, and discuss associated timelines finalized in the 
21st Century Cures Act final rule.
    The 21st Century Cures Act final rule finalized removing the 
following criteria from the 2015 Edition of certification criteria upon 
the effective date of the final rule (June 30, 2020), which included 
removing these criteria from the 2015 Edition Base EHR definition (85 
FR 25657-25660):
     ``Problem list'' at Sec.  170.315(a)(6);
     ``medications'' at Sec.  170.315(a)(7);
     ``medication allergies'' at Sec.  170.315(a)(8); and
     ``smoking status'' at Sec.  170.315(a)(11).
    The final rule noted that 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 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 for 36 months after the publication date of the final 
rule. The 21st Century Cures Act final rule established a new criterion 
``electronic health information export'' at Sec.  170.315(b)(10). This 
new criterion 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 a 
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 
within 36 months after the publication of the 21st Century Cures Act 
final rule (by May 2, 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 MIPS.
    In the 21st Century Cures Act proposed rule, ONC proposed to remove 
several additional certification criteria associated with measures 
under the Promoting Interoperability Programs and MIPS 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).
However, in order to allow participants in the Medicaid Promoting 
Interoperability Program to continue to have access to technology 
meeting 2015 Edition certification criteria for CEHRT required to be 
able to meet the measures for that program, ONC stated in the 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, we note 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 are not proposing any 
changes to these measures, as the final year of the Medicaid Promoting 
Interoperability Program is 2021. Based on the phased approach that ONC 
finalized, Medicaid EPs may keep CEHRT that has been certified to those 
two criteria in 2021, which will enable them to report on these 
measures for the 2021 Medicaid Promoting Interoperability Program EHR 
reporting period. Health IT developers are encouraged to maintain the 
certified functionality for those two criteria through 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 EPs need only meet two of the measures (42 CFR 495.24(d)(6)(i)(B)). 
Even without the secure messaging functionality, an EP 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 e-prescribing 
objective for the Medicare Promoting Interoperability Program and MIPS 
(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 reporting e-prescribing measures for the 
Medicare Promoting Interoperability Program and MIPS, beginning in CY 
2021 (85 FR 25678).
    The 21st Century Cures Act final rule also finalized updates to a 
number of certification criteria which are currently associated with 
objectives and measures

[[Page 50267]]

under the Promoting Interoperability Program, 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). During this 
time, developers are expected to continue supporting technology 
certified to the prior version of certification criteria for use by 
their customers.
    The 21st Century Cures Act final rule updated several criteria to 
include references to the USCDI standard instead of the existing CCDS 
definition (85 FR 25670), and implemented related technical updates (85 
FR 25671). These include the following criteria that may be applicable 
for a healthcare provider's technology to satisfy the CEHRT 
definitions:
     ``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 and is designed to be expanded in an iterative and 
predictable way over time.\70\ In finalizing version 1 of the USCDI, 
the 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).
---------------------------------------------------------------------------

    \70\ 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 APIs, the 21st 
Century Cures Act final rule finalized a new standards-based API 
criterion at Sec.  [thinsp]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 
24 months after the publication of the final rule (by May 2, 2022). 
This criterion replaces the existing ``application access--data 
category request'' certification criterion at Sec.  
[thinsp]170.315(g)(8). However, ONC-ACBs may continue to issue 
certificates for Sec.  [thinsp]170.315(g)(8) for 24 months after the 
publication date of the final rule, permitting certification to both 
criteria during this transition period. The 21st Century Cures Act 
final rule also added the new API criterion at Sec.  
[thinsp]170.315(g)(10) to the 2015 Edition Base EHR definition.
    The 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 24 months after 
publication of the final rule (until May 2, 2022), to make technology 
certified to the updated criterion available to their customers. 
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 for up to 24 months as they 
are updating their products, and healthcare providers may continue to 
use these certified health IT modules for CMS program participation.
    Finally, the 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).
    For further discussion, we refer readers to the 21st Century Cures 
Act final rule at 85 FR 25642 through 25961.
    As noted above, in general, health IT developers have up to 24 
months from May 1, 2020 to make technology certified to the updated 
criteria available to their customers, plus the additional three-month 
period during which ONC will exercise enforcement discretion around 
compliance dates finalized in the 21st Century Cures Act final rule in 
response to the COVID-19 PHE. As a result, where the 21st Century Cures 
Act final rule requires health IT developers to make technology meeting 
new and updated certification criteria available by May 2, 2022, 
developers taking advantage of enforcement discretion would be 
permitted to delay making updated certified technology available until 
August 2, 2022. After this date, technology that has not been updated 
in accordance with the 2015 Edition Cures Update will no longer be 
considered certified.
    ONC expects that developers will introduce these updates into 
certified health IT products in the manner most appropriate for their 
customers, including through the course of normal maintenance, and 
developers are required to notify customers when technology certified 
to the updated criteria is available (85 FR 25642). As discussed in the 
21st Century Cures Act final rule (85 FR 25666), healthcare 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 
will distinguish existing 2015 Edition certification criteria from the 
new or revised criteria adopted in the 21st Century Cures Act final 
rule by referring to the new or revised criteria as the 2015 Edition 
Cures Update, allowing healthcare providers to identify if and when a 
specific Health IT Module has been updated. (https://chpl.healthit.gov/ gov/)
2. Updates to Certified Electronic Health Record Technology 
Requirements in the Promoting Interoperability Program, and Quality 
Payment Program Due to the 21st Century Cures Act Final Rule
    In consideration of the updates made to the certification criteria 
as described in section III.N.1 of this proposed rule, we propose that 
the technology used by healthcare providers to satisfy the definitions 
of CEHRT at Sec. Sec.  495.4 and 414.1305 must be certified under the 
Certification Program in accordance with the updated 2015 Edition of 
health IT certification criteria as finalized in the 21st Century Cures 
Act final rule (85 FR 25642). This would include 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 21st Century Cures Act final rule finalized 
certain compliance dates for health IT developers, as well as 
establishing which versions of certification criteria meet 
certification requirements under the Certification Program for 
healthcare providers, based on those compliance dates. In other words, 
the 21st Century Cures Act final rule established

[[Page 50268]]

timelines for (1) a transition period where technology certified to 
not-yet updated or updated versions of the same certification criteria 
would be considered certified, and (2) the date for which technology 
certified to only the updated version would be considered certified. A 
healthcare provider must use technology that is certified under the ONC 
Health IT Certification Program to meet the CEHRT definitions. 
Therefore, we propose that healthcare providers participating in the 
Promoting Interoperability Programs or QPP would be required to use 
only technology that is considered certified under the ONC Health IT 
Certification Program according to the timelines finalized in the Cures 
Act final rule.
    For updated and new certification criteria included in the CEHRT 
definitions in Sec. Sec.  495.4 and 414.1305, ONC has finalized that 
health IT may be certified to the current 2015 Edition certification 
criteria or the 2015 Edition Cures Update for a period of 24 months, as 
described in timelines finalized in the 21st Century Cures Act final 
rule (85 FR 25670). ONC then announced an additional 3 months during 
which ONC will exercise enforcement discretion in response to the 
COVID-19 PHE and continue to allow health IT certified to either 
version of the criteria to be considered certified. Therefore, under 
our proposal, during that same time period (up to 27 months from May 1, 
2020, or until August 2, 2022), program participants may use technology 
certified to either version and that health IT will be considered 
certified under the ONC Health IT Certification Program.
    While the 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 
could be used by healthcare providers to meet the CEHRT definitions and 
demonstrate meaningful use (for instance, see 82 FR 38490 for a 
discussion of the CY 2018 transition between the 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 
healthcare 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 in 
which health IT certified to either the existing 2015 Edition 
certification criteria or the 2015 Edition Cures Update criteria is 
considered certified, healthcare providers must use technology 
certified to only the updated version of the certification criteria 
finalized in the 21st Century Cures Act final rule to meet the CEHRT 
definitions and demonstrate meaningful use.
    We provide the following discussion to support further 
understanding of how our proposals would impact healthcare providers 
with regard to the CEHRT definitions at Sec. Sec.  495.4 and 414.1305 
and demonstrating meaningful use. If our proposal is finalized, 
healthcare providers would only be able to use CEHRT that has been 
certified to the 2015 Edition Cures Update in order for a measure 
action to count in the numerator during a performance period after 
August 2, 2022 (reflecting the 24-month compliance deadlines finalized 
in the 21st Century Cures Act final rule, and the additional 3-month 
period of enforcement discretion described above). On or prior to 
August 2, 2022, healthcare providers participating in the Medicare 
Promoting Interoperability Program and QPP would be able to continue to 
use technology meeting existing 2015 Edition criteria to meet the CEHRT 
definition and to support program participation. During this period, 
healthcare providers could work with their health IT developers to plan 
for implementing CEHRT that meets the 2015 Edition Cures Update as soon 
as health IT developers make updated technology available. We believe 
this approach to updating the current 2015 Edition would allow 
healthcare providers and health IT developers adequate time to 
implement updates and plan for an effective transition, including 
planning ahead for reporting measure results to CMS for program 
participation.
    For instance, during the CY2022 performance year, if a healthcare 
provider is implementing updates in a phased approach, they could plan 
to use a combination of updated and non-updated certified health IT for 
a 90-day reporting period prior to August 2, 2022, and then complete 
their first reporting period using only updated health IT modules in CY 
2023. Similarly, if a healthcare provider planned to update all of 
their certified technology at one time and to engage in a more 
extensive testing and implementation period during CY 2022, they may 
also wish to complete a 90-day reporting period for CY 2022 prior to 
August 2 using non-updated health IT, and then complete their first 
reporting period using only updated health IT modules in CY 2023. If a 
healthcare provider moved to updated certified health IT prior to 
August 2, including for a reporting period in CY 2020 or CY 2021, they 
would be able to use the updated technology for a 90-day reporting 
period at any point, and would not be required to wait until after 
August 2, 2022.
    Healthcare providers should refer to 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. These ONC Health 
IT Certification Program regulations specify the requirements for what 
health IT developers must make available to customers and associated 
timelines.
    In previous rulemaking, to assist readers in identifying the 
requirements of CEHRT for the Promoting Interoperability Program 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 (for instance, 
see 83 FR 59817 for the MIPS Promoting Interoperability performance 
category). We note two instances in which updates in the 21st Century 
Cures Act final rule will affect information we have provided in past 
rulemaking regarding the certification criteria which support specific 
Promoting Interoperability objectives and measures. First, we note that 
the 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 e-
prescribing objective (80 FR 62882 and 83 FR 59817). ONC has finalized 
that health IT may be certified to this criterion only until January 1, 
2022. (85 FR 25667) We believe the removal of this criterion from the 
Certification Program will have negligible impact on healthcare 
providers. As discussed in prior rulemaking related to the use of these 
functionalities by participants in CMS programs, healthcare providers 
have noted that while formulary checks are a promising approach, 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 healthcare providers who are using the current functionality may 
continue to use the technology for their purposes. Accordingly, we note 
that this certification criterion would no longer

[[Page 50269]]

be associated with the measures under the e-prescribing objective for 
the Promoting Interoperability Programs and MIPS, beginning with the CY 
2021 performance period.
    Second, 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 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. 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). As 
discussed above, health IT meeting either criteria will be considered 
certified during the 24-month period. Table 38 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 healthcare 
providers to complete the actions of the ``Provide Patients Electronic 
Access to Their Health Information'' measure for the Promoting 
Interoperability Programs and MIPS. Allowing healthcare providers the 
flexibility of using EHR technology that is certified to either 
criterion during this 2-year 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 MIPS.
    In light of the changes described above with respect to the ``E-
prescribing'' and ``Provide Patients Electronic Access to Their Health 
Information'' measures and objectives for the Medicare Promoting 
Interoperability Program and the MIPS Promoting Interoperability 
performance category, we are including Table 38, which provides details 
on the measures for the Promoting Interoperability Program for eligible 
hospitals and CAHs and the MIPS Promoting Interoperability performance 
category and the certification criteria that support each measure. We 
also include in Table 38 the certification criteria which support 
reporting of eCQMs. We note that Table 38 is only applicable for the 
measures under the Medicare Promoting Interoperability Program and for 
the Promoting Interoperability performance category of MIPS, and that 
Table 38 does not include all of the updated certification criteria 
included in the CEHRT definition as discussed in this proposed rule. 
For further discussion of changes to criteria under the CEHRT 
definition, we refer readers to the 21st Century Cures Act final rule 
(85 FR 25667).

[[Page 50270]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.072

    Last, we are proposing to revise two definitions of under Sec.  
414.1305. First, under the definitions of CEHRT, we propose 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 propose 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).
    We believe each of these proposals supports our focus on promoting 
interoperability and continued alignment, and would reduce healthcare 
provider burden while providing flexibility to pursue innovative 
applications that improve care delivery. We are seeking public comment 
on all of the proposals discussed above.
3. Proposed Changes to Certification Requirements Under the Hospital 
IQR Program Due to the 21st Century Cures Act
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 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.

[[Page 50271]]

    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 the Department of 
Health and Human Services, 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 new Editions of certified health IT, 
originally requiring hospitals submitting eCQM data to use the 2014 
Edition certification criteria for CEHRT (79 FR 50252) and evolving to 
the current requirement that hospitals use 2015 Edition certification 
criteria for CEHRT 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. Proposed Changes
    Recently, through the 21st Century Cures Act final rule published 
on May 1 2020, ONC updated the 2015 Edition of health IT certification 
criteria (``2015 Edition Cures Update''). Specifically, the 21st 
Century Cures Act final rule finalized updates to existing 2015 Edition 
criteria and introduced new 2015 Edition criteria. As noted above in 
section III.N.1, in general, 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 21st Century 
Cures Act final rule.\71\ As a result, where the 21st Century Cures Act 
final rule requires health IT developers to make technology meeting new 
and updated certification criteria available by May 2, 2022, developers 
taking advantage of enforcement discretion may be permitted to delay 
making updated certified technology available until August 2, 2022. 
After that date, technology that has not been updated in accordance 
with the 2015 Edition Cures Update will no longer be considered 
certified.
---------------------------------------------------------------------------

    \71\ 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).
    In this proposed rule for the Hospital IQR Program beginning with 
the CY 2020 reporting period/FY 2023 payment determination and for 
subsequent years, we are proposing to expand flexibility to allow 
hospitals to use either: (1) Technology certified to the 2015 Edition 
criteria for CEHRT as was previously finalized in the FY 2019 IPPS/LTCH 
final rule (83 FR 41537-41608), or (2) technology certified to the 2015 
Edition Cures Update standards as finalized in the 21st Century Cures 
Act final rule(85 FR 25642 through 25961). We also refer readers to 
sections III.N.1 and III.N.2 for background and more details about the 
2015 Edition Cures Update. We are proposing 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. This 
proposal would allow hospitals that are early adopters of health IT 
certified to the 2015 Edition Cures Update criteria for CEHRT to 
implement those changes while still meeting Hospital IQR Program 
requirements. As mentioned above, in the 21st Century Cures Act final 
rule, ONC finalized that health IT developers will have 24 months from 
the publication date of the rule (that is, until May 2, 2022) to make 
technology available that is certified to the updated, or new criteria. 
We will revisit this topic in future rulemaking as necessitated by 
additional changes by ONC (for example should ONC only allow 
certification under the 2015 Edition Cures Update). We are seeking 
public comment on our proposal.
    We note 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

[[Page 50272]]

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 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 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.

N. Proposal To Establish New Code Categories

1. Background
    Currently, there are four existing HCPCS Level II 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. 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, that is, they are 
not therapeutically equivalent. Therefore, to facilitate more accurate 
coding and more specific reporting of the variety of buprenorphine/
naloxone products on the market, we are proposing an expanded series of 
codes to identify buprenorphine/naloxone products.
    Specifically, we propose 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 
39.
[GRAPHIC] [TIFF OMITTED] TP17AU20.073

    As the existing 4 codes would be replaced with more specific codes 
in the new code series, we also propose to discontinue the existing 
codes in Table 40.
[GRAPHIC] [TIFF OMITTED] TP17AU20.074


[[Page 50273]]


    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 note that these coding 
proposals do 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.

O. Medicare Diabetes Prevention Program (MDPP) Expanded Model Emergency 
Policy

    We propose to amend our regulation at Sec.  410.79(e) to create 
more flexible MDPP policies that will apply during certain emergencies 
(Emergency Policy). In addition, we propose 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. Proposed Changes to Sec.  410.79(b)
    Through this proposed rule, we are proposing 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 COVID-19 Public Health 
Emergency (PHE) 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 propose 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 as defined in 
Sec.  424.205(a), during an 1135 waiver event. We propose 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 propose 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 COVID-19 PHE. 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 pause 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 COVID-
19 PHE and provide MDPP suppliers and MDPP beneficiaries with 
flexibilities to address any future applicable 1135 waiver events.
    The proposed changes herein would preserve the March 31st COVID-19 
IFC MDPP flexibilities and apply them to future 1135 waiver events, 
provide for additional flexibilities that would apply during the COVID-
19 PHE and future 1135 waiver events, clarify certain policies adopted 
in the IFC, and end a flexibility that would become unnecessary in 
light of our other proposals. If finalized, the proposed flexibilities 
would supersede the flexibilities finalized in the March 31st COVID-19 
IFC for the COVID-19 PHE, if the PHE is still in place when the CY 2021 
PFS final rule becomes effective. If finalized, the proposed changes 
would be available to all future applicable 1135 waiver events, 
effective January 1, 2021.
    We are proposing these changes to address MDPP supplier and MDPP 
beneficiary needs in response to the COVID-19 PHE 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 COVID-19 PHE, we propose 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 flexibilities proposed in this rule would be applicable to all 
MDPP beneficiaries and MDPP suppliers (as such terms are defined in 
Sec.  410.79(b)). Although our Emergency Policy will permit MDPP 
services to be furnished entirely on a virtual basis, our Emergency 
Policy does not permit an MDPP supplier to furnish MDPP services 
virtually during the COVID-19 PHE or an applicable 1135 waiver event 
unless the MDPP supplier's preliminary or full CDC 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

[[Page 50274]]

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 when the proposed Emergency Policy is no longer in effect. Given 
the difficulty of predicting when the COVID-19 PHE 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 
services. Permitting virtual-only suppliers to furnish MDPP services 
during the COVID-19 PHE or an applicable 1135 waiver event could 
disrupt the provision of services to MDPP beneficiaries when services 
must resume on an in-person basis.
    We are proposing to amend the MDPP regulations to provide for 
certain changes, including allowing MDPP suppliers to start new cohorts 
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. In addition, these proposed 
changes 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 (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, particularly if they elect to continue to receive 
services virtually. Therefore, we are proposing 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. This proposed policy would ensure that MDPP 
beneficiaries who continue to receive the set of MDPP services 
virtually during in 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 propose 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 either 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 1135 waiver event, would only be 
permitted to resume the set of MDPP services 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 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. This 
proposal would apply prospectively only--that is, under the current 
MDPP regulations, as implemented in the 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 COVID-19 PHE 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 would retain that flexibility for those MDPP beneficiaries who were 
receiving the set of MDPP services as of March 1, 2020, as specified in 
current Sec.  410.79(e)(3)(iii), which we are proposing to revise and 
renumber as Sec.  410.79(e)(vi)(A). Finally, we propose that 
beneficiaries who elect to suspend the set of MDPP services at the 
start of an 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 
1135 waiver event. This proposed policy intends to ensure that MDPP 
beneficiaries may not suspend and re-start the MDPP set of services 
multiple times during the same 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 are proposing 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 COVID-19 PHE 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 propose 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 COVID-19 PHE 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 propose 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 propose 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 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. This proposed rule

[[Page 50275]]

would increase the number of allowable virtual core sessions 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 propose that the 
requirement for in-person attendance at the first core-session would 
not apply. We propose that during the remainder of the COVID-19 PHE 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 propose 
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 propose that the waiver of the minimum 
weight loss requirements for beneficiary eligibility in the ongoing 
maintenance session intervals described in Sec.  410.14(g)(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 COVID-19 PHE 
remains in place as of that date.
    We are proposing to amend our regulation at Sec.  410.79(e). We 
seek comment on these proposals.
2. Proposed Changes 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 propose to amend the definition of ``engagement incentive 
period'' to further qualify when the period ends in the case of the 
COVID-19 PHE or an applicable 1135 waiver event. Specifically, we 
propose to amend paragraph (iii) in the definition 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 solicit comments on when the engagement incentive period should 
end if the MDPP services are not eventually resumed. We are considering 
whether we should deem the incentive engagement period to end if the 
applicable 1135 waiver event or COVID-19 PHE remains in effect for a 
certain period of time, such as one 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 note 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 solicit 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 propose 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 COVID-19 PHE or during an applicable 
1135 waiver event. Specifically, we propose that if the item or service 
is furnished during the COVID-19 PHE or an 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 COVID-19 PHE or the 1135 waiver event, as 
applicable. We propose this requirement to deter abuse and to ensure 
that the incentives furnished during an 1135 waiver event will achieve 
their intended purpose and serve the goals of the MDPP expanded model. 
Some examples of usable beneficiary engagement incentives include 
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; examples of unusable beneficiary engagement 
incentives during an 1135 waiver event include gym memberships during 
lockdowns and stay-at-home orders. We solicit 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 requirement at Sec.  
424.210(b)(9), we propose 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 COVID-
19 pandemic declared by the Secretary on January 27, 2020. Similarly, 
we propose 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. These definitions are consistent with how we propose to 
define the terms for purposes of Sec.  410.79(e).

IV. Quality Payment Program

A. CY 2021 Updates to the Quality Payment Program

1. Executive Summary
a. Overview
    This section of the proposed rule sets forth proposed 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 better focus our measurement efforts and to

[[Page 50276]]

reduce barriers to entry into Advanced APMs.
    Participation in the Quality Payment Program rose in the second 
year. We saw 98 percent of eligible clinicians participate in MIPS in 
2018 with 889,995 eligible clinicians receiving a payment adjustment, 
which exceeded our 2017 participation rates. In addition, 98 percent of 
eligible clinicians participating in MIPS received a positive payment 
adjustment for 2020 based on 2018 performance year results. Regarding 
performance in Advanced APMs, for the 2018 QP Performance Period, 
183,306 eligible clinicians earned Qualifying APM Participant (QP) 
status while another 47 eligible clinicians earned partial QP 
status.\72\ We are still finalizing 2019 numbers given the extended 
time period for 2019 data submission, a flexibility provided due to the 
COVID-19 public health emergency, and will provide updates later this 
year. 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 
being cared for. 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 2019 Novel Coronavirus (COVID-19) pandemic 
public health emergency and resultant need for clinician focus on the 
response, our timeline has changed accordingly such that the proposal 
for initial MVPs will be delayed until at least the 2022 performance 
year. We support clinicians on the front lines by providing burden 
relief via extreme and uncontrollable circumstances policy exceptions 
for 2019 (85 FR 19277 through 19278) and 2020 (84 FR 62568). We are 
proposing to reduce the 2023 MIPS payment year performance threshold in 
section IV.A.3.e.(3) of this proposed rule, and are continuing to 
consider the extraordinary health system stresses resulting from the 
COVID-19 PHE as we propose 2021 performance year/2023 payment year 
policies for the Quality Payment Program.
---------------------------------------------------------------------------

    \72\ 2018 QPP Performance Data Infographic and https://www.cms.gov/blog/2018-quality-payment-program-qpp-performance-results.
---------------------------------------------------------------------------

    As we make long-term improvements, evolve MIPS policies, and plan 
to implement MVPs in the future, we are supporting our objectives 
within the Patients Over Paperwork initiative and the National Quality 
Roadmap.73 74 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.
---------------------------------------------------------------------------

    \73\ https://www.cms.gov/About-CMS/story-page/patients-over-paperwork.
    \74\ https://www.hhs.gov/sites/default/files/national-health-quality-roadmap.pdf.
---------------------------------------------------------------------------

    On May 15, 2020 the National Quality Roadmap was published by the 
Department of Health and Human Services (https://www.hhs.gov/sites/default/files/national-health-quality-roadmap.pdf) as directed by 
Executive Order 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 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.\75\ MVPs will link quality and cost performance 
measurement and help clinicians begin to assess their ability to take 
on risk as in APMs.
---------------------------------------------------------------------------

    \75\ 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.

[[Page 50277]]

b. Summary of Major Proposals
(1) Major MIPS Proposals
    In the CY 2020 PFS final rule (84 FR 62948), we finalized a 
definition of a MIPS Value Pathway (MVP) as a subset of measures and 
activities established through rulemaking. 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.
    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 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 posed a 
set of questions intended to help us to implement this vision as part 
of future rulemaking. We received extensive comments on these issues 
and are using those comments to guide the transition into this new 
framework. We intend to focus the future of MIPS on MVP implementation. 
We have limited our 2021 performance year proposals in light of the 
COVID-19 pandemic to promote program stability and lessen any 
distraction as clinicians focus on responding to this public health 
emergency. We are proposing policies in section IV.A.3. of this 
proposed rule related to:

 Developing MVPs
 Introducing 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
    In this proposed rule, we propose updated MVP framework guiding 
principles in section IV.A.3.a.(1) of this proposed rule and MVP 
development criteria and processes in section IV.A.3.a.(2) of this 
proposed rule as we look towards the 2022 performance period to begin 
MVP implementation. We are also proposing in section IV.A.3.b. of this 
proposed rule an APP to start on January 1, 2021 that aligns with the 
MVP concept. The APP would be a voluntary pathway for reporting and 
scoring under MIPS that would allow APM participants to report a single 
quality measure set with broad applicability, receive an improvement 
activities credit, and have the cost performance category reweighted. 
We propose 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 proposed rule. We are also proposing in section IV.A.3.c.(5)(a) 
of this proposed rule to eliminate the APM scoring standard for the 
2021 performance year beginning January 1, 2021. This would allow APM 
participants to participate in MIPS as individuals, groups, Virtual 
Groups, or APM Entities, and they could report through any MIPS 
reporting and scoring pathway, see section IV.A.3.b.(3) of this 
proposed rule. We are also proposing in section IV.A.3.c.(5)(e) of this 
proposed rule, an extreme and uncontrollable circumstances exception 
policy 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 in sections IV.A.3.a.(2) and 
IV.A.3.a.(3) of this proposed rule when developing the policies 
proposed in this proposed rule. We had stated our intent to begin the 
transition to MVPs in the 2021 performance year by introducing initial 
MVPs, however, due to the 2019 Novel Coronavirus (COVID-19) pandemic 
Public Health Emergency (PHE), our 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 COVID-19 pandemic, 
we have limited our MVP-related proposals in this year's rule to those 
necessary for the collaborative development of MVPs. In section 
IV.A.3.a.(1) of this proposed rule, we propose to update the MVP 
guiding principles to respond to RFI suggestions and to reflect the 
ongoing evolution of MVP policies and further definition of the MVP 
framework.
    We propose in section IV.A.3.a.(2) of this proposed rule, a process 
for collaboration on the development of MVPs, building on our 
discussions with clinician experts to develop a proposed list of MVPs 
for future MIPS rulemaking. We believe that collaboration with 
clinician experts will build a more cohesive and comprehensive set of 
MVPs. We propose a process for MVP candidate submissions in section 
IV.A.3.a.(2)(a)(iii) of this rule.
    We recognize that the transition to MVPs will take time and 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. We seek comment on 
our MVP criteria and MVP development process policies that will be 
considered for the final rule. For instance, we seek comment in section 
IV.A.3.a.(2) of this proposed rule on the proposed MVP co-development 
criteria, patient involvement, and MVP QCDR measures inclusion 
parameters.
(b) Other MIPS and APM Proposals
    Although we look to move MIPS towards the future with the MVP

[[Page 50278]]

framework, in this year's proposed rule we propose to make what we 
believe are necessary Web Interface and quality measure updates, in 
sections IV.A.3.c.(1)(c) and IV.A.3.c.(1)(d) of this proposed rule, 
respectively. Additionally, we propose in section IV.A.3.d.(1)(b) of 
this proposed rule to maintain 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 proposing a 
new optional measure. We are not proposing changes to scoring policies 
for the cost or improvement activities categories. We have heard 
repeatedly in response to each of our proposed rules that clinicians 
value stability in the program so as to not have to learn new program 
requirements each year and seek to limit the number of policy proposals 
for the 2021 MIPS performance year.
    Additionally, we wish to highlight the following proposals for 
changes to MIPS beginning in the 2021 performance period.
     We propose in section IV.A.3.c.(1)(c) of this proposed 
rule to sunset the CMS Web Interface submission method under MIPS for 
groups and virtual groups in 2021 due to low MIPS participant 
utilization and the Medicare Shared Savings Program's discontinuation 
of Web Interface submission method.
     We propose in section IV.A.3.c.(1)(d) of this proposed 
rule 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, and remove 14 quality measures from the MIPS 
program. We are proposing a total of 206 quality measures starting in 
the 2021 performance year.
     We propose in sections IV.A.3.c.(1)(e) and IV.A.3.c.(2)(b) 
of this proposed rule, inclusion of services provided via telehealth in 
quality and cost measurement, respectively, given the recent rise in 
volume of telehealth services.
     We propose in section IV.A.3.c.(2)(a) of this proposed 
rule, 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 would be 40 percent and 30 percent for each of those 
years, respectively (see section IV.A.3.c.(1)(b) of this proposed 
rule). For the 2023 MIPS payment year, we propose performance category 
redistribution policies in section IV.A.3.d.(2)(b)(iii) of this 
proposed rule similar to the redistribution policies as finalized for 
the 2022 MIPS payment year, with the modification that we will not 
redistribute more weight to the cost performance category in the final 
scoring calculation.
     We propose in section IV.A.3.c.(3)(b) of this proposed 
rule, beginning with the CY 2021 performance period and future years, 
we are proposing: (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.
     We propose in section IV.A.3.c.(4) of this proposed rule, 
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, for the 2024 
MIPS payment year and each subsequent MIPS payment year; to update two 
Promoting Interoperability measures; and to continue reweighting the 
Promoting Interoperability performance category for non-physician MIPS 
eligible clinicians for the 2021 performance period. We propose at 
section IV.A.3.c.(4)(c)(ii) of this proposed rule 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.
     We propose in section IV.A.3.d.(1)(b) of this proposed 
rule continuation of quality category scoring and bonus policies, 
adding flexibility for when measure specification or coding changes 
occur during the performance year, and continuing improvement scoring 
of the quality performance category comparing clinicians to a 30 
percent baseline score if clinicians scored 30 percent or less. We 
propose in sections IV.A.3.d.(1)(b)(ii) and IV.A.3.d.(1)(b)(v) of this 
proposed rule benchmark and topped out scoring policy criteria options 
that are responsive to potential low reporting rates for the 2019 
performance year due to the national public health emergency for COVID-
19. We propose in section IV.A.3.d.(1)(b)(iii) of this proposed rule, a 
provision for an exception to the 20-case minimum for all 
administrative claims-based measures to allow scoring of measures that 
meet the specified case minimum.
     We propose in section IV.A.3.d.(2)(a)(iii) of this 
proposed rule to increase the maximum number of points available for 
the complex patient bonus for the 2020 performance period/2022 MIPS 
payment year due to the anticipated increase in patient complexity 
resulting from the national public health emergency for COVID-19.
     We propose in section IV.A.3.e.(3) of this proposed rule 
to reduce the performance threshold for the 2021 MIPS performance 
period/2023 MIPS payment year from 60 points--finalized in the CY 2020 
PFS rule (84 FR 63037)--to 50 points in recognition of the COVID-19 
impact on clinicians.
     We propose in section IV.A.3.g. of this proposed rule to 
modify third party intermediary requirements and remedial action and 
termination.
     We propose in section IV.A.4.b. and IV.A.4.c. of this 
proposed rule to clarify the APM Incentive Payment amount calculation 
basis and propose a hierarchy for recipient TIN affiliation 
identification when making the APM Incentive Payment. We also propose 
policies in section IV.A.4.c. of this proposed rule for MIPS eligible 
clinician scoring and a process for requesting updated APM Incentive 
Payment information in situations where a payee TIN cannot be 
identified, and to address 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.
     We propose in section IV.A.4.e. of this proposed rule a 
change to the methodology for addressing prospectively aligned 
beneficiaries for Threshold Score calculations and QP determinations 
and to establish a targeted review process for QP determinations.
(2) Terms and Definitions
    In addition, in Sec.  414.1305, we are proposing to update the 
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)

[[Page 50279]]

 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 the relevant sections of 
this proposed rule.
3. MIPS Program Details
a. Transforming MIPS: MIPS Value Pathways
(1) Overview
    In this proposed rule, we are proposing updates to the MIPS Value 
Pathways (MVP) guiding principles (here in section IV.A.3.a.(1) of this 
proposed rule) and MVP development criteria and process (section 
IV.A.3.a.(2) of this proposed rule) that would guide MVP implementation 
beginning with the 2022 MIPS performance period/2024 MIPS payment year. 
We finalized in the CY 2020 PFS final rule (84 FR 62946) the definition 
of an MVP at Sec.  414.1305 as ``a subset of measures and activities 
established through rulemaking'' and requested comments in a request 
for information (RFI) on a wide-ranging set of issues related to the 
eventual implementation of this concept within the MIPS program. We 
received RFI comments on many components of the MVP framework including 
the guiding principles, how MVPs and measures/activities are developed, 
and the transition and timeline to MVPs. The RFI comments have helped 
shape the following proposals for MVP implementation.
    In the CY 2020 PFS final rule, we stated our intent to apply the 
MVP framework in the 2021 performance year (84 FR 62946); however, due 
to the COVID-19 pandemic national public health emergency, our timeline 
has changed (see section IV.A.3.a.(3) of this proposed rule). 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, and so have limited our MVP related proposals in this rule to 
guidance necessary for the collaborative development of MVPs. We are 
deferring further MVP implementation to a future year. In particular, 
we now 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, continuous improvement/innovation within 
the practice, and efficient management and transfers of information, 
will help remove barriers to APM participation.
    See infographic at https://qpp.cms.gov/mips/mips-value-pathways 
that provides an overview of our vision for the MIPS path to value 
future state. As shown in the infographic, MIPS is currently comprised 
of four siloed performance categories with many measure and activity 
choices (see left column of infographic), higher reporting burden and 
performance measurement that is not meaningfully aligned. An 
intermediate step (see middle column of infographic) is to move to 
value via building an MVP framework that is cohesive (connects the 
performance categories), lowers reporting burden, and focuses MIPS 
participation around MVPs that are meaningful to clinicians' practices, 
specialty or public health priority. The MVP framework incorporates a 
foundational layer consisting of Promoting Interoperability and 
administrative claims-based quality measures focused on population 
health, provides data and feedback to clinicians, and enhances 
information provided to patients. When MVPs are fully implemented (see 
right column of infographic), we envision a MIPS that is simplified, 
increases the voice of the patient, and facilitates movement into APMs. 
Over time we intend to provide greater amounts of population health 
measurement data using administrative claims information while 
decreasing the amount of clinician reported measurement data used for 
MIPS. To help realize these objectives, we are engaging with clinician 
professional organizations and front-line clinicians to develop the 
MVPs and proposing MVP development criteria and process as described in 
section IV.A.3.a.(2) of this proposed rule.
    We envision 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 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 intend to build a robust inventory of MVPs which are

[[Page 50280]]

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) as 
discussed in section IV.A.3.b. of this rule.
    We listed MVP guiding principles in the CY2020 PFS proposed rule 
(84 FR 40734) to define MVPs. We are proposing updating the guiding 
principles from the CY 2020 PFS proposed rule (84 FR 40734) to 
incorporate RFI comments and the evolution of the MVP framework. In 
response to the RFI, a few commenters specifically voiced their support 
of the stated MVP guiding principles. A few commenters suggested we 
expand the guiding principles to include patient focused wording 
because they believed the guiding principles, as written, may be 
applicable only to clinicians. Other suggestions were to: Include a 
statement supporting physicians and other clinicians to be assessed on 
MVPs that reflect their specialty training, sub-specialization and 
their individual or group priorities; remove ``eliminating burden 
related to selection of measures'' as a principle and instead allow 
some choice; consider the site of service in the comparative data; 
consider evidence-based guidelines as an MVP development resource; have 
comparable reporting burden in all MVPs; use social risk stratification 
and consider social determinants of health; supplement Principle 3 by 
stating explicitly ``high priority areas of morbidity and mortality''; 
and add alignment with other payment programs. One commenter 
acknowledged the benefit of comparative data but opposed any system 
that would come at the expense of physicians having to pay to collect 
and submit data on measures they do not find meaningful.
    We propose changes to the MVP guiding principles as shown below. We 
propose to modify the first guiding principle by adding wording to 
further emphasize that MVP measures and activities are linked 
collectively and they enhance each other to the degree possible by 
adding the words ``connected, complementary'' to describe the MVP 
``sets of measures and activities that are meaningful to clinicians.'' 
In addition, we propose to change ``simplify scoring'' to ``align 
scoring'' in the first guiding principle to acknowledge that as we 
initially transition to MVPs, we will not simplify but rather align 
scoring policies as we continue to have traditional MIPS available. We 
continue to include scoring simplification as part of our long-term 
vision and will consider ways to simplify as MVPs become widely 
available.
    With regard to the commenter suggestion to add in clinician choice 
and to remove wording ``eliminating burden related to selection of 
measures'', the degree of choice of measures and activities within MVPs 
will be limited as we strive for standardization; however, we are 
proposing removing from the first guiding principle the qualification 
for burden reduction, ``related to selection of measures'', as we also 
intend to reduce reporting burden.
    We have provided information about clinicians and groups on 
Physician Compare for a few years, beginning with the CY 2017 final 
rule (81 FR 77390 through 77398). Because so many clinicians 
participate in MIPS as groups, whereby the data received is for the 
overall performance of the group and not any specific individual 
clinicians, Medicare patients are not always able to learn information 
about their individual clinician, which we believe would be valuable in 
selecting a clinician for their care. In the CY 2020 PFS proposed rule 
we discussed our intent to put patients first and provide the 
information they need to be active decision-makers in their care and 
the resultant need for more comprehensive performance data at the 
individual clinician level (84 FR 40734). Whenever feasible, the MIPS 
program should provide meaningful information at the individual 
clinician level. We believe an appropriate step is the collection and 
assessment of more clinician or specific specialty information from 
multispecialty groups.
    Therefore, we are proposing to update the second guiding principle 
to specify allowing the option of subgroup reporting for MVPs, which 
would permit subgroups of clinicians to select relevant MVP(s) to 
report measures and activities that are meaningful to their practices 
and to patients. 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. Though we acknowledge that subgroup reporting is not currently 
an option for groups to use when reporting to MIPS, we believe that it 
is important to recognize and include multispecialty practices in 
guiding principle number 2 as we believe subgroup reporting will be 
crucial to MVP reporting in future years. Subgroup reporting would be a 
step towards individual reporting and would improve the meaning and 
robustness of the performance data used to incentivize high quality and 
cost-effective care and better provide information that patients can 
use to select clinicians.
    As MVPs are intended to promote value and help patients with 
choosing clinicians, we agree with commenters that additional wording 
around the patient focus of MVPs in the guiding principles would 
further the point that engaging patients in their care, beyond informed 
consent, is paramount in the MVP Framework. Therefore, we propose to 
update guiding principle 3 to say that MVP measures should be selected 
to include the patient voice wherever possible. MVPs should support 
proactive communication and partnered decision-making between 
healthcare providers and patients, families, and caregivers and 
reinforce a care relationship that is based on trust and inclusion of 
individual values and beliefs. Along the lines of providing better 
information for patients, as stated above we propose to add wording to 
the guiding principle number 2 to highlight the importance of more 
comprehensive multispecialty reporting from subgroups as a step in 
improving comparative performance data.
    We recognize some of the comments are aimed at ensuring high 
quality measures are used in MVPs. As we agree with commenters 
regarding strengthening the caliber of MVP measures, we are proposing 
to add a reference at guiding principle 3 to the Meaningful Measures 
framework to inform MVP measure selection.
    We propose 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. 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. The new proposed 
guiding principle reads, MVPs should support the transition to digital 
quality measures.
    Regarding the MVP guiding principles commenter suggestion to add 
the idea that MVPs will allow clinicians to be

[[Page 50281]]

assessed according to their specialty and their individual or group 
priorities, we are not adding this wording as an MVP may focus on a 
condition or episode of care rather than a specialty; rather clinicians 
should be electing available MVPs that align with their priorities 
rather than us matching MVPs to individual practice priorities. The 
first guiding principle states MVPs should contain sets of measures and 
activities that are meaningful to clinicians (84 FR 40734). We believe 
this sufficiently addresses the commenter's suggestion. We did not 
include the commenter suggestion to add ``morbidity and mortality'' 
wording as we do not want to restrict what we mean by ``high priority 
measures'' to only morbidity and mortality measures. Regarding the 
equity comment, MVPs will provide comparative performance data that 
measures clinicians fairly and our policies at every level are 
developed and implemented to treat clinicians equitably. We are not 
adding new wording referring to alignment with other payment programs 
as we already refer to our intent that MVPs reduce barriers to APM 
participation in the guiding principles.
    After review and consideration of RFI comments, we are retaining 
guiding principle 4 (84 FR 40734) and proposing to 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.
    In section IV.A.3.a.(2)of this proposed rule, we describe our 
proposed method of creating MVPs. 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 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 look forward to continuing to work with stakeholders to improve the 
program and implement the vision of MVPs.
(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 urged 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 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 had 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 noted 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 refer readers to section 
IV.A.3.c. of this proposed rule for updates to the respective 
performance categories. Therefore, beginning with the 2022 MIPS 
performance period, we propose 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?

[[Page 50282]]

    (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?
    (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 are not prescriptive on the number of quality measures that are 
included in an MVP. In selecting quality measures, we do 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 technologies 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 
believe that the aforementioned criteria will lead to the development 
of MVPs in a manner that is consistent and reliable. We seek comment on 
the MVP development criteria.

[[Page 50283]]

(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 propose that 
stakeholders that are developing MVPs to submit to CMS as candidate 
MVPs should include patients as a part of the MVP development process. 
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 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 
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 seek comments on this 
proposal.
(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 with the 2022 performance 
period, we propose that stakeholders should formally submit their MVP 
candidates formally 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 section IV.A.3.a.(2)(a)(i) of this proposed rule, 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, in continuing 
collaborative efforts, 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 discuss 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 seek comment on the 
proposed process to solicit MVP candidates. In addition, we seek 
comment on how we could make this process more transparent in future 
years, for stakeholders that collaborate to develop MVP candidates and 
other MIPS stakeholders, should we consider the utilization of an 
advisory committee or technical expert panel to review MVP candidates, 
or the review of MVP candidates by an interdisciplinary committee, 
similar to what is used for the MIPS quality measures under the Call 
for Measures or a public process such as the NQF convened Pre-
rulemaking process? We believe that integrating these steps into the 
process could provide greater transparency, however we are concerned 
that integrating these steps could further delay the incorporation of 
MVPs into the MIPS program. We seek feedback on the issue of furthering 
transparency into the MVP development process vs. timeliness of 
introducing MVPs into the MIPS program. Are stakeholders concerned with 
the possibility of delayed MVP implementation if these additional 
methods of review are implemented? If so, what are some strategies CMS 
should consider if we decide to implement additional methods of 
allowing public commentary on potential MVP candidates?
(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

[[Page 50284]]

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 this proposed rule, we are proposing 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 
refer readers to Appendix 1 of this proposed rule for detailed 
discussion of the newly proposed measure.
(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 refer readers to section IV.A.3.g.(2)(b)(iv) of this 
proposed rule for additional discussion of this requirement.
    With regards to 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 propose 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 
propose 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, entities that meet the 
QCDR definition can develop QCDR measures to fulfill the quality 
performance category reporting requirements. 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 this 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, 
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.
(e) 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 proposed rule for additional 
discussion of these 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, if we finalize this policy. We seek 
comments on this proposal.
(6) 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 COVID-19 pandemic, we have decided to 
delay the implementation of MVPs, and revisit

[[Page 50285]]

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 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.
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 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 are proposing at Sec.  414.1367 to establish an APM Performance 
Pathway (APP) under MIPS beginning in the 2021 MIPS performance year, 
designed to provide a predictable and consistent MIPS reporting 
standard to reduce reporting burden and encourage continued APM 
participation.
(2) Applicability
    We propose 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
    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 at IV.A.3.e. of this proposed rule.
    As described further in section III.G.1. of this proposed rule, 
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 section IV.A.3.e. of this proposed rule 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 seek comment on this proposal.
(b) MIPS APMs
    We propose 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 propose to 
codify the following MIPS APM criteria at the new Sec.  414.1367(b). We 
are proposing to maintain two criteria for MIPS APMs that currently are 
included at Sec. 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 are not proposing to continue requiring that MIPS APMs be 
in operation and therefore collecting quality data for the entirety of 
the performance period. We also note 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 are not 
proposing 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 are proposing to expand the 
definition of MIPS APM to include those APMs in which there is only an 
Affiliated Practitioner List and that otherwise meet these proposed 
MIPS APM criteria.
    We seek comment on this proposal.
(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 are proposing 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.
    For PY 2021, we are proposing the measures listed in Table 41 to be 
used for purposes of quality performance category scoring for the APP.

[[Page 50286]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.075

    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 are proposing 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 are proposing to not 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 do not believe it is appropriate to limit the maximum 
quality performance category 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.
    We seek comment on this proposal.
    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 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).\76\ 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.\77\
---------------------------------------------------------------------------

    \76\ 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.
    \77\ 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.'' \78\ We intend to take the revised measure 
through the National Quality Forum (NQF) endorsement process in 2020. 
Because the revisions would make the ACO MCC measure more aligned with 
the MIPS version and given the support received from the MAP, we 
propose 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.
---------------------------------------------------------------------------

    \78\ https://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=91911.
---------------------------------------------------------------------------

(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

[[Page 50287]]

APMs, and at section 1899(f) of the Act for the Medicare Shared Savings 
Program. We are proposing to continue to waive the cost performance 
category under the same authorities because: (1) 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; (2) 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; and (3) 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 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. 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 seek comment on this proposal.
(c) Improvement Activities
    We are proposing 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 are proposing 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, 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 this proposal, the 
MIPS APM participant would not receive credit for the associated 
Improvement Activity.
    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 propose 
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 note 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 seek comment on this proposal.
(d) Promoting Interoperability
    We propose that the Promoting Interoperability performance category 
score would be reported and calculated in the same manner described at 
Sec.  414.1375. We seek comment on this proposal.
(4) APP Performance Category Weights
    We are proposing to continue to waive the requirement to weight 
each MIPS performance category as described in 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 section 
IV.B.3.ii. of this proposed rule, we believe it is necessary to waive 
the cost performance category for MIPS eligible clinicians reporting to 
MIPS through the APP. As a result, 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 are proposing 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 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 propose to codify this proposal at Sec.  414.1367(d)(1). We seek 
comment on these proposals.
(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

[[Page 50288]]

necessary to reweight one or more performance categories.
    In a case where the Promoting Interoperability performance category 
is reweighted to zero percent, we are proposing 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 are proposing to reweight the Promoting 
interoperability performance category to 75 percent and the improvement 
activities performance category to 25 percent.
    We believe that these distributions appropriately value performance 
categories that require reporting on measures and measuring 
improvement, without disproportionately emphasizing one performance 
category over another. Furthermore, these 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 propose to codify this policy at Sec.  414.1367(d)(2). We seek 
comment on these proposals.
(5) Scoring for APM Participants Reporting Through the APP
    We propose 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 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 propose to codify this policy at Sec.  414.1367(e).
(6) Performance Feedback for APM Participants Reporting Through the APP
    We propose 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).
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, we propose to:
     Weigh 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 this proposed rule, 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 beginning with the 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 
five 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 section IV.A.2.c.(2)(a) of this proposed rule, we 
propose 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 are proposing 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 
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 believe that being transparent in how both the quality and cost 
performance category weights would be modified over the next two 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 solicit public comment on our proposals to 
incrementally reduce the weight of the quality performance category as 
we incrementally increase the weight of the cost performance category. 
Particularly, 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.
(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 measures, including at least one outcome measure. The data 
completeness criteria for reporting

[[Page 50289]]

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 section III.G.1.c. of this proposed rule, we discuss our 
proposal to revise the Medicare Shared Savings Program quality 
performance standard and align with the APP framework. With the 
proposed modifications to the Medicare Shared Savings Program quality 
performance standard, which include a proposal to transition to an APP 
for ACOs starting with the 2021 performance period as outlined in 
section III.G.1.b.(1) of this proposed rule, 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 the reporting on a larger set of measures and a higher 
data completeness rate, are more stringent than other collection types 
available under MIPS. Similar to the Medicare Shared Savings Program, 
for purposes of MIPS, we strive to align CMS Web Interface requirements 
across programs, where appropriate and applicable; reduce burden to 
MIPS eligible clinicians; create robust and meaningful quality measure 
sets that promote outcome based measures; and offer quality measures 
that are able to adequately and effectively assess performance such as 
ensuring that topped out measures are removed.
    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, 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 Medicare Shared Savings Program proposal 
to no longer utilize the CMS Web Interface as a means for assessing and 
scoring ACOs, groups, and virtual groups under the CMS Web Interface 
measures. 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 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 believe that groups and virtual groups would be able to select a 
different collection type/submission type, including at least 6 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 CMS Web Interface measures 
having to transition to the utilization of a different collection type/
submission type, we

[[Page 50290]]

recognize 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 6 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 believe 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. We believe 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 believe 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 are proposing at 
Sec.  414.1325(c)(1) et seq. 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 are proposing 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 payment year. We propose 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 and for the 2019 through 2022 MIPS payment years, CMS Web 
Interface measures; the CAHPS for MIPS survey; and administrative 
claims measures. We propose 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 solicit comment on this 
proposal.
(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 measure set as described in Appendix 1 of this proposed rule, 
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 are proposing 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 are found in Table Group A 
of Appendix 1 of this proposed rule. For the 2021 performance year, we 
are proposing 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. Our proposals for modifications to existing 
specialty sets and new specialty sets are outlined in Table Group B of 
Appendix 1 of this proposed rule. 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. Please note that the specialty and subspecialty sets 
are not inclusive of every specialty or subspecialty.
    On January 6, 2020,\79\ 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 that we agree with are 
being proposed in this proposed rule.
---------------------------------------------------------------------------

    \79\ 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).''

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

[[Page 50291]]

    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 this proposed 
rule, we refer readers to Table Group C of Appendix 1 of this proposed 
rule for a list of quality measures and rationales for removal. For the 
2021 performance period, we are proposing 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 have continuously communicated to 
stakeholders our desire to reduce the number of process measures within 
the MIPS quality measure set. We believe our proposal to remove the 
quality measures outlined in Table Group C will 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 this proposed rule. We are 
proposing 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 this proposed 
rule.
(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 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 one 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 this 
proposed rule, we propose to add a new administrative claims measure of 
risk-standardized complication rate following elective primary total 
hip arthroplasty and/or total knee arthroplasty. 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 propose 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 note 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

[[Page 50292]]

claims measures (proposal to add 2 new administrative claims measures 
found in Table Group A of Appendix 1 of this 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 
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 believe that a different 
performance period should be considered on a measure-by-measure level 
for administrative claims measures. We seek public comment on our 
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.
(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 the COVID-19 pandemic and the increased use 
of telehealth care, we propose the following changes to our policies 
related to the CAHPS for MIPS Survey:
     We propose to integrate one telehealth item into the CAHPS 
for MIPS Survey. Specifically, we propose to add a survey-based measure 
on telehealth that assesses patient-reported usage of telehealth 
services (for example, phone or video visit) to the performance year 
2021 CAHPS for MIPS Survey.
     We also propose 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 are considering such changes for the 
performance year 2021 CAHPS for MIPS Survey administration.
    To clarify the instructions in the CAHPS for MIPS Survey, we 
propose 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 are considering such changes for the performance year 2021 
CAHPS for MIPS Survey administration.
    We refer readers to the Collection of Information Requirements 
section VI. of this rule for additional information.
(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 pandemic 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 are proposing 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 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
    ++ Beginning with the 2023 MIPS payment year, 99421, 99422, and 
99423 (codes for online digital evaluation and management services (e-
visit)); 99441, 99442, and 99443 (codes for telephone evaluation and 
management 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 
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 and e-visits. 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 the COVID-19 pandemic 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 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 an effort to address the PHE and use of telehealth, 
and to maintain alignment with the Shared Savings Program, we propose 
to integrate the same telehealth

[[Page 50293]]

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 are proposing 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 aligns 
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 IFC to ensure these codes would be 
included in determining beneficiary assignment for performance year 
2020 and any subsequent performance year that starts during the PHE for 
the COVID-19 pandemic (85 FR 27583). We refer 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 refer 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. 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. 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 the COVID-19 pandemic pertain to the 
telephone E/M services.
    We believe that clinicians are increasingly using communications 
technology-based services as a key component of their ongoing primary 
care. We expect that the utilization of such services will 
substantially increase not only during the PHE for the COVID-19 
pandemic, but also thereafter. Accordingly, we propose to include 
virtual primary care visits and telehealth visits to determine patient 
assignment to groups for purposes of the CAHPS for MIPS Survey for 2021 
and subsequent performance years.
(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 this proposed rule, we are proposing 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 this 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 15 percent increase in the weight from 2023 to 
2024. We considered such option as a result of the

[[Page 50294]]

COVID-19 public health emergency 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 mitigate through the COVID-19 public health emergency.
    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 COVID-19 public health emergency. 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 COVID-19 public health emergency.
    After considering these options, we are proposing 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 solicit public comment on our 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 general, we prefer to consider whole 
numbers for performance category weights, but are 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.
(b) Addition of 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 
propose to add costs associated with telehealth services to the 
previously established cost measures. For each cost measure, the 
telehealth services we propose to add are directly relevant to the 
intent of the measure. We refer 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 propose 
to add are not currently included for a few reasons. First, some codes 
we propose 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 sub-regulatory processes as established in 
the May 8th COVID-19 IFC (85 FR 27550). Second, some codes we propose 
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 public health emergency, we are 
proposing to add them to adapt the measures to this change in practice 
patterns. The codes we propose to add represent service categories 
already captured in the measures (e.g., 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 solicit public comment on this proposal.
(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(b)(2) for the performance period, Sec.  
414.1325 for the data submission requirements, Sec.  414.1355 for the 
inventory and final score, Sec.  414.1360 for the data submission 
criteria, Sec.  414.1365 for the subcategories, Sec.  414.1380 for the 
scoring, Sec.  414.1380(b)(3)(i) through (iii) for weighting, Sec.  
414.1380(b)(3)(iv) and Sec.  414.1380(b)(3)(x) for patient-centered 
medical home, Sec.  414.1380(b)(3)(vii) for exceptions, and Sec.  
414.1380(b)(3)(ix) for APM.
    In this proposed rule, beginning with the CY 2021 performance 
period and future years, we are proposing: (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. These proposals are 
discussed in more detail in this proposed rule.
(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

[[Page 50295]]

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.
(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) Proposed Exception During Public Health Emergencies
    The COVID-19 pandemic was deemed a public health emergency (PHE) by 
the Secretary of the Department of Health and Human Services. 
Information regarding the PHE for the COVID-19 pandemic is available at 
https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx. This unprecedented PHE 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.
    Therefore, beginning with the CY 2021 performance period, we are 
proposing 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 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 still be finalized through a future 
rulemaking. We invite public comments on our proposal.
(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) Proposed New Criteria
    In addition to the aforementioned considerations, when considering

[[Page 50296]]

improvement activities for possible inclusion in MIPS, we propose 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 particular 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 believe that when possible, it is important to establish 
a strong linkage between quality, cost, and improvement activities.
    Therefore, we are proposing 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. If our 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 invite public comment on our proposal.
(ii) HHS-Nominated Improvement Activities
(A) Background
    As stated above in section IV.A.3.c.(3)(b)(i)(A)(bb) of this 
proposed rule titled ``Proposed Exception During Public Health 
Emergencies,'' this unprecedented PHE 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 also believe that we 
should have the flexibility to nominate activities from within HHS. 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 
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 refer 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) Proposed HHS-Nominated Improvement Activities Process
    Beginning with the CY 2021 performance period and future years, we 
propose 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 above 
in section IV.A.3.c.(3)(b)(i)(B) of this proposed rule 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 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 invite public comments on our proposal.
(iii) Proposed 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 X and G 
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 at https://qpp.cms.gov/ for a complete list of 
the most current list of improvement activities. In this proposed rule, 
we are proposing to modify two existing improvement activities for the 
CY 2021 performance period and future years. We refer readers to 
Appendix 2 of this proposed rule for further details. We are not 
proposing to remove any previously adopted improvement activities. We 
invite public comments on our proposals.
(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.

[[Page 50297]]

(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 are proposing 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. This proposal 
aligns with the proposed EHR reporting period in CY 2022 for the 
Medicare Promoting Interoperability Program for eligible hospitals and 
CAHs (85 FR 32853). 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 are requesting comments on this proposal.
(c) Promoting Interoperability Performance Category Measures for MIPS 
Eligible Clinicians
(i) Proposed Changes to the Query of Prescription Drug Monitoring 
Program (PDMP) Measure Under the Electronic Prescribing Objective
    In the CY 2020 PFS final rule (84 FR 62992 through 62994), we 
finalized that the Query of PDMP measure under the Electronic 
Prescribing objective is optional and eligible for 5 bonus points in CY 
2020. However, we have continued to receive substantial feedback from 
health IT developers and clinicians that the flexibility currently 
included in the measure presents unintended challenges such as 
significant burden associated with IT system design and additional 
development needed to accommodate the measure and any future changes to 
it. Since publication of the CY 2020 PFS final rule, stakeholders have 
continued to express concern that it is still too premature to require 
the Query of PDMP measure and score it based on performance in CY 2021.
    We agree with stakeholders that PDMPs are still maturing in their 
development and use. PDMPs vary among the states and are not linked at 
this time to one another or to a larger national system.\80\
---------------------------------------------------------------------------

    \80\ https://namsdl.org/topics/pdmp/ and https://www.pdmpassist.org/content/pdmp-maps-and-tables.
---------------------------------------------------------------------------

    Stakeholders also mentioned the challenge posed by the current lack 
of integration of PDMPs into the EHR workflow. Historically, health 
care providers have had to go outside of the EHR workflow in order to 
separately log in to and access the state PDMP. In addition, 
stakeholders noted the wide variation in whether PDMP data can be 
stored in the EHR. By integrating PDMP data into the health record, 
health care providers can improve clinical decision making by utilizing 
this information to identify potential opioid use disorders, inform the 
development of care plans, and develop effective interventions.
    ONC recently engaged in an assessment to better understand the 
current state of policy and technical factors impacting PDMP 
integration across states. This assessment explored factors like PDMP 
data integration, standards, and hubs used to facilitate interstate 
PMDP data exchange, access permissions, and laws and regulations 
governing PDMP data storage. The assessment revealed ambiguous or non-
existent policies regarding PDMP placement in health IT systems, 
interpretation of PDMP data, and PDMP access roles. In addition, 
variability in standards and hubs used to facilitate interstate PMDP 
data exchange, as well as to store and report PDMP data, contribute to 
the complexity of PDMPs.
    The SUPPORT for Patients and Communities Act, enacted in 2018, is 
an important investment in combating the opioid epidemic. Several of 
the provisions of the SUPPORT for Patients and Communities Act address 
opioid use disorder prevention, recovery, and treatment including 
increased access to evidence-based treatment and follow-up care, 
through legislative changes specific to the Medicare and Medicaid 
programs. Specifically, with respect to PDMPs, the SUPPORT for Patients 
and Communities Act included new requirements and federal funding for 
PDMP enhancement, integration, and interoperability, and established 
mandatory use of PDMPs by certain Medicaid providers, in an effort to 
help reduce opioid misuse and overprescribing, and in an effort to help 
promote the overall effective prevention and treatment of opioid use 
disorder.
    Section 5042(a) of the SUPPORT Act added section 1944 to the Act, 
titled ``Requirements relating to qualified prescription drug 
monitoring programs and prescribing certain controlled substances.'' 
Subsection (f) of section 1944 of the Act increased Medicaid FFP rates 
during FY 2019 and FY 2020 for certain state expenditures to design, 
develop, or implement a qualified PDMP (and to make subsequent 
connections to such program). As a condition of this enhanced FFP, 
states must meet the conditions described in paragraph (f)(2) regarding 
agreements with contiguous states. There are currently a number of 
states that have used or are seeking to use, this enhanced FFP.
    Under section 1944(b)(1) of the Act, to be a qualified PDMP, a PDMP 
must facilitate access by a covered provider to the following 
information (at a minimum) about a covered individual, in as close to 
real-time as possible: Information regarding the prescription drug 
history of a covered individual with respect to controlled substances; 
the number and type of controlled substances prescribed to and filled 
for the covered individual during at least the most recent 12-month 
period; and the name, location, and contact information of each covered 
provider who prescribed a controlled substance to the covered 
individual during at the least the most recent 12-month period. Under 
section 1944(b)(2) of the Act, a qualified PDMP must also facilitate 
the integration of the information described in section 1944(b)(1) of 
the Act into the workflow of a covered provider, which may include the 
electronic system used by the covered provider for prescribing 
controlled substances. CMS issued additional guidance to states about 
the enhanced FFP authorized by the SUPPORT for Patients and Communities 
Act, which is available at https://www.medicaid.gov/sites/default/files/Federal-Policy-Guidance/Downloads/faq051519.pdf.
    Additionally, we note that section 7162 of the SUPPORT for Patients 
and Communities Act supports PDMP integration as part of the CDC's 
grant programs aimed at efficiency and enhancement by states, including 
improvement in the intrastate and interstate interoperability of PDMPs.
    In support of efforts to expand the use of PDMPs, there are 
currently a number of federally supported activities underway aimed at 
developing a more robust and standardized approach to EHR-PDMP 
integration. Partners

[[Page 50298]]

including CMS, CDC, ONC, and private sector stakeholders are focused on 
developing and refining standard-based approaches to enable effective 
integration into clinical workflows, exploring emerging technical 
solutions to enhance access and use of PDMP data, and providing 
technical resources to a variety of stakeholders to advance and scale 
the interoperability of health IT systems and PDMPs. For instance, 
stakeholders are working to map the NCPDP SCRIPT standard version 
2017071 and the 2015 ASAP Prescription Monitoring Program Web Service 
standard version 2.1A to the HL7[supreg] FHIR[supreg] standard version 
R4.\81\ These mapping efforts are currently targeting completion by the 
summer of 2020 after which the standard would be balloted. Moreover, a 
number of enhancements to PDMPs are occurring across the country, 
including enhancements to RxCheck which is a federally supported 
interstate exchange hub for PDMP data.\82\ In addition, the ONC 
Interoperability Standards Advisory (ISA) \83\ includes monitoring of 
current and emerging standards related to PDMP and opioid use disorder 
(OUD) data capture and exchange that would allow a health care provider 
to request a patient's medication history from a state PMDP.\84\ We 
believe these standards and technical approaches are likely to rapidly 
reach maturity and support adoption across health care system 
stakeholders.
---------------------------------------------------------------------------

    \81\ http://hl7.org/fhir/us/meds/pdmp.html.
    \82\ See https://www.pdmpassist.org/RxCheck.
    \83\ https://www.healthit.gov/isa/.
    \84\ See https://www.healthit.gov/isa/allows-a-provider-request-a-patients-medication-history-a-state-prescription-drug-monitoring.
---------------------------------------------------------------------------

    In addition to monitoring activities which can provide a stronger 
technical foundation for a measure focused on PDMP use, we also 
requested comments in the 2020 PFS proposed rule on alternative 
measures designed to advance clinical goals related to the opioid 
crisis (84 FR 40767 through 40769). Specifically, we sought public 
comment on the development of potential measures for consideration for 
the Promoting Interoperability performance category that are based on 
existing efforts to measure clinical and process improvements 
specifically related to the opioid epidemic, including opioid quality 
measures endorsed by the National Quality Forum (NQF) and CDC Quality 
Improvement (QI) opioid measures based on CDC guidelines around 
prescribing practices. The latter of these includes the use of 
electronically specific CDS to support OUD prevention and treatment 
best practices and the integration of a PDMP query as a part of 
specific clinical workflows. We stated that these measures relate to a 
range of activities that hold promise in combatting the opioid epidemic 
as part of OUD prevention and treatment best practices, that they can 
be supported using CEHRT, and that they may include the use of PDMP 
queries as a tool within the broader clinical workflows. We continue to 
evaluate the comments received in response to this request, and will 
explore how measures such as those discussed may help participants to 
better understand the relationship between the measure description and 
the use of health IT to support the actions of the measures related to 
opioid use.
    We understand that there is wide variation across the country in 
how health care providers are implementing and integrating PDMP queries 
into health IT and clinical workflows, and that it could be burdensome 
for health care providers if we were to narrow the measure to specify a 
single approach to EHR-PDMP integration at this time. At the same time, 
we have heard extensive feedback from EHR developers that incorporating 
the ability to count the number of PDMP queries in CEHRT would require 
more robust certification specifications and standards. These 
stakeholders state that health IT developers may face significant cost 
burdens under the current flexibility allowed for health care providers 
if they either fully develop numerator and denominator calculations for 
all the potential use cases and are required to change the 
specification at a later date. Stakeholders have noted that the costs 
of additional development will likely be passed on to health care 
providers without additional benefit as this development would be 
solely for the purpose of calculating the measure rather than 
furthering the clinical goal of the measure.
    Given current efforts to improve the technical foundation for EHR-
PDMP integration, the continued implementation of the SUPPORT for 
Patients and Communities Act (in particular, its provisions specific to 
Medicaid providers and qualified PDMPs), our ongoing review of 
alternative measure approaches, and stakeholder concerns as previously 
discussed about the current readiness across states for implementation 
of the existing measure, we believe that additional time is needed 
prior to requiring a Query of PDMP measure for performance-based 
scoring. While we appreciate the concerns that stakeholders have 
shared, we believe that this measure can play an important role in 
helping to address the opioid crisis. Maintaining it as an optional 
measure eligible for bonus points signals to the clinician and 
developer community that this is an important measure which addresses a 
current gap that can help to spur development and innovation to reduce 
the barriers and challenges reported to CMS.
    Therefore, we are proposing for the performance period in CY 2021 
to maintain the Electronic Prescribing objective's Query of PDMP 
measure as optional. Continuing to include the measure as optional for 
the performance period in CY 2021 would allow time for further progress 
around EHR-PDMP integration efforts minimizing the burden on MIPS 
eligible clinicians while still providing an opportunity for capable 
implementers to report on and earn bonus points for fulfilling the 
optional measure.
    We are also proposing for the performance period in CY 2021 to 
increase 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 
believe that this increase would support the President's National Drug 
Control Strategy \85\ that is trying to increase data sharing and 
integration. As stated in the strategy, a PDMP is a proven means to 
increase accountability in opioid prescribing practices by providing 
information that allows for the coordination of multiple medications, 
as well as to prevent adverse drug interactions. 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 fundamental 
element of this strategy to stop opioid abuse, and ensure the safe, 
legal, and responsible prescribing of opioids for those who need them. 
We believe that improving prescribing practices by use of PDMPs will 
help reduce hospitalizations, Emergency Department visits, and family 
crises associated with the opioid epidemic. The proposed increase in 
bonus points for the Query of PDMP measure reflects our desire to 
increase the use of PDMPs.
---------------------------------------------------------------------------

    \85\ https://www.whitehouse.gov/wp-content/uploads/2020/02/2020-NDCS.pdf.

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

[[Page 50299]]

We invite comments of these proposals.
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. In establishing the new measure, we did not 
change the specifications or actions associated with the two combined 
measures, which address receiving an electronic summary of care record 
and conducting reconciliation of the summary of care record. However, 
the name of the measure includes the word ``incorporating'' which is 
not always required to increment the numerator of the measure. Instead, 
clinical information reconciliation must be completed using CEHRT for 
the following three clinical information sets: (1) Medication; (2) 
Medication Allergy; and (3) Current Problem List. Thus, to better 
reflect specific actions required by the measure's numerator and 
denominator, we are proposing to replace the word ``incorporating'' 
with the word ``reconciling'' in the name of the measure. The new name 
would read: Support Electronic Referral Loops by Receiving and 
Reconciling Health Information measure.
    We invite comment on this proposal.
b. Engagement in Bi-Directional Exchange Through Health Information 
Exchange (HIE)
    In the CY 2020 PFS proposed rule (84 FR 40781), we discussed the 
concept of MIPS eligible clinicians earning credit in the Promoting 
Interoperability performance category by attesting to health IT or 
interoperability activities in lieu of reporting on specific measures. 
In this proposed rule, we are seeking to build on the feedback received 
in prior rulemaking by proposing an alternative measure for 
bidirectional exchange through a HIE under the Health Information 
Exchange objective.
    HIEs allow for the sharing of health information among clinicians, 
hospitals, care coordinators, labs, radiology centers, and other health 
care providers through secure, electronic means so that healthcare 
providers can have the benefit of the most recent information available 
from other health care providers. HIEs allow for broader 
interoperability beyond one health system or point-to-point connections 
among payers, patients, and health care providers. By enabling bi-
directional exchange of information between health care providers and 
aggregating data across providers with disparate systems, HIEs can 
bring together the information needed to create a true longitudinal 
care record and support improved care coordination by facilitating 
timely access to robust health information across care settings. Bi-
directional exchange means that the clinician's EHR is enabled to allow 
for querying and sharing data by sending, receiving, and incorporating 
data via an HIE for every patient. Healthcare quality and public health 
outcomes have been shown in multiple studies to experience a beneficial 
effect from health information exchanges with improved medication 
reconciliation, improved immunization and health record completeness, 
and improved population level immunization rates.\86\ Another study has 
shown that if every clinician who submits claims under Medicare Part B 
\87\ were connected to an HIE, Medicare would have saved $63 million 
annually for each therapeutic procedure performed at a physician's 
office due to the reduction in duplicate procedures,\88\ while other 
research has shown a decrease in emergency department utilization and 
improved care process when using an HIE.\89\
---------------------------------------------------------------------------

    \86\ https://academic.oup.com/jamia/article/25/9/1259/4990601: 
ibid.
    \87\ https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/Downloads/Physician_FAQ.pdf.
    \88\ https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2971503: University of Connecticut School of 
Business Research Paper No. 17-03 ``Do Health Information Exchanges 
Deter Repetition of Medical Services?''
    \89\ https://pubmed.ncbi.nlm.nih.gov/27521368/: Journal of the 
American Medical Informatics Association. 2017 Apr 1;24(e1):e103-
e110. doi: 10.1093/jamia/ocw116. ``Health Information Exchange 
Associated With Improved Emergency Department Care Through Faster 
Accessing of Patient Information From Outside Organizations''.
---------------------------------------------------------------------------

    HIE services are available from many organizations today, which may 
be referred to as HIEs or health information organizations (HIOs). 
State and regional HIEs have a long history of connecting health care 
providers caring for a common patient population across a specified 
geographic area. These HIEs represent a significant public investment, 
with $564 million in federal funding provided as part of the 2009 
HITECH Act, ongoing state funding and support from CMS under both 42 
CFR 495.322 and 42 CFR part 433 subpart C.\90\
---------------------------------------------------------------------------

    \90\ https://protect2.fireeye.com/url?k=d8978709-84c28e1a-d897b636-0cc47adb5650-e634c1ba410d0153&u=https://www.healthit.gov/sites/default/files/reports/finalsummativereportmarch_2016.pdf.
---------------------------------------------------------------------------

    These state and regional HIEs typically obtain not just EHR-
generated data, but a broader array of ADT (admit, discharge, transfer) 
feeds and lab feeds as they build on local relationships and have 
similar but not identical capabilities with several models of data 
storage and a variety of business models. In addition to these 
initiatives, many EHR vendors are participating in the development of 
national-level networks designed to ensure their customers can share 
information with customers of other vendors. Geographically-based 
exchanges have also begun to address national-level exchange, with 
efforts designed to link state and regional networks so that health 
care providers can obtain information on individual patients wherever 
they receive care throughout the United States.
    Recent data indicate that there is wide availability of HIEs across 
the nation, yet gaps remain. Forthcoming analysis of a recent survey of 
HIEs found that 45 states, including DC, were covered by one or more 
operational HIOs that reported a statewide catchment area. Moreover, 81 
percent (or 2,770) of health service areas (HSAs) in the United States 
were in the catchment area of at least one operational HIE effort and 
32 percent of HSAs had more than one operational HIE effort.\91\ 
Despite the widespread availability of HIE services; however, HIE 
participation data suggests there are still significant opportunities 
to increase health care provider engagement with HIEs. For instance, in 
a 2018 survey, 73 percent of hospitals reported participating in either 
a state, regional, or local HIE. When national HIE networks as well as 
state, regional, and local networks, 15 percent of hospitals reported 
not participating in any type of HIE.\92\ While it is more difficult to 
assess individual clinicians' current participation in HIEs, data from 
the forthcoming survey noted above found that, among the HIEs surveyed, 
76 percent reported that independent physician practices or practice 
groups contributed data to the HIE, while 89 percent reported that 
providers viewed data in the HIE, suggesting additional incentives may 
help to spur greater engagement with available HIEs.
---------------------------------------------------------------------------

    \91\ Forthcoming analysis of survey conducted under Contract No. 
HHSP233201700049C, OMB Control No: 0955-0019.
    \92\ ``State of Interoperability among U.S. Non-federal Acute 
Care Hospitals in 2018'' ONC Data Brief No. 51, March 2020. See 
https://www.healthit.gov/sites/default/files/page/2020-03/State-of-Interoperability-among-US-Non-federal-Acute-Care-Hospitals-in-2018.pdf.

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

[[Page 50300]]

    We believe that incentivizing participation in HIEs that support 
bi-directional exchange will contribute to a longitudinal care record 
for the patient and facilitate enhanced care coordination across 
settings. The use of an HIE means that essential health information is 
available for care team members even in the case of referrals the 
clinician may not be aware of, or for instances where the clinician is 
contributing to the patient's record, but may not be the health care 
provider making the referral. In these instances, such transitions may 
or may not be able to be automatically identified by an EHR for 
inclusion in the denominators of the two existing measures associated 
with the HIE objective for the Promoting Interoperability performance 
category. For example, consider a patient who has a hospital emergency 
room visit in January 2020 and receives a prescription, then goes to 
her primary care physician appointment in March 2020 without notifying 
the primary care physician of the hospital visit or the new medication. 
The primary care physician refers the patient to a specialist and the 
specialist receives and reconciles the patient's data from her primary 
care physician records. In this scenario, the hospital may not have had 
access to the patient's health record from the primary care physician, 
and the primary care physician and the specialist may not have access 
to the data from the hospital including essential information like an 
update to current medications. We note that there was a Conditions of 
Participation (CoP) policy related to patient event notifications 
finalized in the Patient Access and Interoperability rule (85 FR 25584 
through 25603). However, the new CoP would not require the hospitals to 
share the clinically relevant information specified in this example. 
The CoP requirement only specifies a minimal set of information for 
inclusion in a notification (patient's name, treating practitioner 
name, and sending institution name) and does not include the 
standardized clinical data that hospitals must share electronically 
using CEHRT in order to participate in the Promoting Interoperability 
program. For instance, the clinical data specified in the ``transitions 
of care'' criterion at 45 CFR 170.315(b)(1), which is currently the 
United States Core Data for Interoperability (USCDI) or Common Clinical 
Data Set (CCDS) (see 85 FR 25670). Moreover, if the patient were to 
have another emergent issue and require emergency room care, the 
situation becomes further compounded. For this scenario, if the 
hospital, primary care physician, and specialist participated in a bi-
directional exchange with a health information network, each health 
care provider from the hospital to the specialist would have access to 
all of the patient's records that may be critical for patient care and 
safety. Under the existing measures for the HIE objective, only the 
known transition of care from primary care physician to specialist 
would be included in the denominator. However, under the proposed 
alternative measure for bi-directional exchange through a HIE, we would 
incentivize the clinician to engage in health information exchange for 
care coordination that includes these additional transitions and 
referrals as well as other potential scenarios: Where the recipient of 
the transition of care may be unknown; Where the eligible clinician may 
not be the referring health care provider; where the transition of care 
may happen outside the scope of the performance period; or where the 
patient was not seen by the eligible clinician during the performance 
period. In this way, the eligible clinician or group's action to engage 
in bi-directional exchange through an HIE would allow each health care 
provider to contribute to the longitudinal care record in a manner that 
supports a wide range of transitions and referrals beyond those 
currently reflected in the measure denominators. This engagement 
supports robust health information exchange without placing burden on 
the clinician or the patient to be individually accountable to 
facilitate exchange via multiple (and potentially unknown) point-to-
point connections.
    The current COVID-19 PHE has further highlighted the need to 
encourage interoperable HIE infrastructure and bi-directional exchange 
across the country that can ensure patients, health care providers, and 
public health authorities have the data they need to support quality 
care. In addition to supporting general care coordination, HIEs can 
specifically support the PHE response by: Enabling enhanced use of 
telehealth and telemedicine for obtaining and aggregating patient 
information including when the patient's health care provider(s) may 
not be known.
    In response to the PHE, CMS has taken steps to significantly expand 
access to services via telehealth, by increasing flexibility around the 
use of telehealth. HIEs can support patient care by ensuring health 
care providers are able to access patient data in support of a 
telehealth encounter or subsequent in-person visit with either an 
established or new health care provider. Particularly for visits with a 
new health care provider, the HIE may provide an option for health care 
providers to access critical health information. In addition, HIEs can 
support telehealth visits for screening, evaluation, and event 
notification for care team members for patients that have been exposed, 
tested, quarantined etc. HIEs, can ensure information about testing 
results is available to support the immediate and longer term health 
and clinical needs of an individual. HIEs offer a rich source of health 
data to support these interactions and can be utilized by health care 
providers who may not have direct exchange capabilities, but operate as 
part of the same care team. HIEs also support these use cases in ways 
that direct exchange cannot, by facilitating aggregation of data from 
multiple sources where `point to point' exchange may be infeasible.
     Proposed New Measure: In order to incentivize 
MIPS eligible clinicians to engage in bi-directional exchange through 
an HIE, we are proposing 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 propose 
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 are proposing that 
clinicians either may report the two existing measures and associated 
exclusions OR may choose to report the new measure. We propose that the 
HIE Bi-Directional Exchange measure would be worth 40 points. In no 
case could more than 40 points be earned for the HIE objective. We are 
proposing the HIE Bi-Directional Exchange measure would be reported by 
attestation and would require a yes/no response. As we believe that 
fulfillment of this measure is an extremely high value action, a 
``yes'' response would enable the clinician to earn the 40 points 
allotted to the HIE objective. We propose 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

[[Page 50301]]

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 believe it is appropriate for the new optional measure to serve 
as an alternative measure of performance on health information exchange 
since, in order to successfully meet the measure, an eligible clinician 
would be required to meet an overall standard of performance on health 
information exchange that is broader than the denominators and 
numerators of the current measures. To successfully attest to the new 
measure the eligible clinician or group must establish the technical 
capacity and workflows to engage in bi-directional exchange via an HIE 
for all patients seen by the eligible clinician and for any patient 
record stored or maintained in their EHR. This includes querying for or 
receiving health information for all new and existing patients seen by 
the eligible clinician, as well as sending or sharing information for 
all new and existing patients seen by the eligible clinician regardless 
of known referral or transition status, or the timing of any potential 
transition or referral. The proposed requirement to query for or 
receive health information for all new and existing patients is broader 
than the current Support Electronic Referral Loops by Receiving and 
Incorporating Health Information measure, which includes only new 
patients and known transitions or referrals received that occur during 
the performance period. Similarly, the proposed requirement to send or 
share information for all new and existing patients represents a 
broader scope than the current Support Electronic Referral Loops by 
Sending Health Information measure which includes only known 
transitions of care or referrals made that occur during the performance 
period. In addition, such bi-directional engagement would facilitate 
exchange of information for patient records stored or maintained in the 
clinician's EHR, even when the patient does not have an encounter or is 
not seen by the eligible clinician during the performance period, and 
for which the clinician has no active transition or referral during the 
performance period. This proposed requirement is likewise more 
expansive than the denominators of either measure.
    Relative to the numerators for the current measures, the new 
optional measure would require that bi-directional engagement occurs 
for all patients and for all patient records without exclusion, 
exception, or allowances made for partial credit. This is similar to 
achieving a score of 100 percent on both the Support Electronic 
Referral Loops by Sending Health Information measure and the Support 
Electronic Referral Loops by Receiving and Incorporating Health 
Information measure, while additionally completing required actions for 
additional exchange cases not included in the existing denominators. 
Finally, while we believe this optional measure would establish a high 
performance standard with respect to information sharing, we also 
believe that availability of this optional measure would reduce current 
reporting burden associated with the program, as eligible clinicians 
choosing to report on the measure would not be required to report on 
the two existing numerator/denominator measures.
    While we believe there are a significant number of HIEs across the 
country that would meet the standards described in the attestation 
statements, some HIE arrangements may not have the capacity to enable 
bi-directional exchange for every patient transition or referral made 
by a clinician, and thus would not meet the standard described in the 
attestation statements required to fulfill the measure. For instance, 
we would exclude exchange networks that only support information 
exchange between affiliated entities, such as health care providers 
that are part of a single health system, or networks that only 
facilitate sharing between health care providers that use the same EHR 
vendor.
    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 the clinical data 
within the CCDS or USCDI. This is consistent with both of the existing 
measures under the Health Information Exchange objective, which require 
the use of CEHRT to create a C-CDA document, which includes the 
clinical data within the CCDS or the USCDI. 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 C-CDAs to the HIE. Participants 
could also utilize API technology certified to either the criterion at 
Sec. Sec.  170.315(g)(8) or (g)(10) as recently finalized in the 21st 
Century Cures Act final rule (85 FR 25742), to enable an HIE to obtain 
data in the CCDS or USCDI from a participant's EHR. As noted in section 
III.M of this proposed rule, the 21st Century Cures Act final rule 
states that these criteria may refer to either the CCDS or USCDI for a 
period of 24 months following the publication of the Cures Act final 
rule (85 FR 25669). After this time, only technology certified to 
criteria referencing the USCDI would be considered certified under the 
ONC Certification Program. We recognize that HIEs are currently 
interacting with health care providers using certified health IT in a 
variety of ways, and believe that we should allow for substantial 
flexibility in how health care providers use certified health IT to 
exchange data using HIE.
    We note that none of the actions required to attest to this measure 
are intended to conflict with a patient's rights or covered entities 
(for example, health care provider's) requirements/responsibilities 
under the HIPAA Privacy Rule, as set out at 45 CFR parts 160 and 164. 
The HIPAA Privacy Rule permits but does not require covered health care 
entities to get patient consent before using or disclosing PHI for 
treatment, payment, and health care operations. Although HIPAA does not 
require the health care entities offer patients a choice about the 
sharing of their PHI, many entities and states have adopted policies or 
laws that require patient consent. HIPAA is designed to work in tandem 
with more privacy protective policies. Moreover, we understand that 
different HIEs that enable exchange in the manner described may have 
different policies related to confidentiality of patient information 
based on local circumstances and requirements. Nothing in the 
attestation statements for this measure are intended to conflict with 
individual HIE policies that may exist in these areas, or prevent 
eligible clinicians from complying with these policies as a condition 
of their participation in the HIE.
    We are not proposing an exclusion for this new measure as this 
measure would be an optional alternative measure to be reported instead 
of the Support Electronic Referral Loops by Sending Health Information 
measure and the Support Electronic Referral Loops by Receiving and 
Incorporating Health Information measure. The exclusions would still be 
available for the Support Electronic Referral Loops by Sending Health 
Information measure and the Support Electronic Referral Loops by 
Receiving and Incorporating Health Information measure.
    We invite comments on these proposals, and whether commenters 
believe such an optional measure would incentivize eligible clinicians 
to participate in HIEs while establishing a high performance standard 
for sharing

[[Page 50302]]

information with other clinicians. We are also seeking comment on the 
proposed attestation statements for the optional measure. For instance:
     Do these statements reflect appropriate expectations about 
information exchange capabilities for eligible clinicians that engage 
with HIEs capable of facilitating widespread exchange with other health 
care providers?
     How should CMS effectively identify those HIEs that can 
support the widespread exchange with other health care providers?
     How are eligible clinicians currently using CEHRT to 
exchange information with HIEs, and do the proposed attestation 
statements allow for different ways health care providers are 
connecting with HIEs utilizing certified health IT capabilities?
(d) Scoring Methodology
(1) Changes to the Scoring Methodology for the 2021 Performance Period
    Table 42 reflects the Promoting Interoperability performance 
category objectives and measures for CY 2021 if the proposed changes 
discussed earlier in this section are adopted as final, including the 
proposed name change to the Support Electronic Referral Loops by 
Receiving and Incorporating Health Information measure and the 
continuation of the optional Query of PDMP measure for CY 2021.
[GRAPHIC] [TIFF OMITTED] TP17AU20.076

(e) Additional Considerations
(1) Nurse Practitioners, Physician Assistants, Clinical Nurse 
Specialists, and Certified Registered Nurse Anesthetists
    In 2018 rulemaking (83 FR 59818 through 59819), we discussed our 
belief that certain types of MIPS eligible clinicians (NPs, PAs, CNSs, 
and CRNAs) may lack experience with the adoption and use of CEHRT. 
Because many of these non-physician clinicians were or are not eligible 
to participate in the Medicare or Medicaid EHR Incentive Program (now 
known as the Promoting Interoperability Program), we stated that we 
have little evidence as to whether there are sufficient measures 
applicable and available to these types of MIPS eligible clinicians 
under the advancing care information (now known as Promoting 
Interoperability) performance category. 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 34percent of MIPS eligible 
clinicians who are NPs, PAs, CRNAs, or CNSs

[[Page 50303]]

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 may result in fewer MIPS eligible clinicians reporting data for 
Promoting Interoperability performance category. Further, due to the 
2019 Novel Coronavirus (COVID-19), we anticipate that many MIPS 
eligible clinicians may not report data for the 2019 performance 
period, although we do not expect to know the full impact on reporting 
for the Promoting Interoperability performance category until fall 
2020.
    Since 2017 we have included a solicitation for new measures for the 
Promoting Interoperability performance category in the annual Call for 
Measures. We have received many suggestions for new measures. We have 
not received any suggestions for new measures for NPs, PAs, CRNAs, CNSs 
or any other non-physician practitioners, which may continue to limit 
their ability to successfully report for the Promoting Interoperability 
performance category.
    For these reasons, we are proposing 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 this proposal. We are 
requesting public comments on this proposal.
(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 non-physician practitioners (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 section IV.A.2.c.4.(b) of this 
proposed rule, for the performance period in 2021, we are proposing 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 to revise Sec.  
414.1380(c)(2)(i)(A)(4) to reflect this proposal. We invite comments on 
this proposal.
(f) Future Direction of the Promoting Interoperability Performance 
Category
    In future years of the Promoting Interoperability performance 
category, we will continue to consider changes which support a variety 
of HHS goals as previously stated (84 FR 62991 through 62992), 
including: Reducing administrative burden; supporting alignment with 
the Medicare Promoting Interoperability Program; supporting alignment 
with the 21st Century Cures Act; advancing interoperability and the 
exchange of health information; and promoting innovative uses of health 
IT. More specifically under the 21st Century Cures Act, we will look at 
and take under consideration potential areas of overlap as we continue 
to align, pending implementation of the statute. This may include, but 
is not limited to, Information Blocking, future growth of PDMP, the use 
of USCDI, FHIR, and updates to 2015 Edition health IT certification 
criteria and the ONC Health IT Certification Program. We believe 
maintaining our focus on promoting interoperability, alignment, and 
simplification will reduce health care provider burden while allowing 
flexibility to pursue innovative applications that improve care 
delivery. For more detailed information, refer to the [21st Century 
Cures Act final rule (85 FR 25642 through 25961)] and Interoperability 
and Patient Access final rule (85FR 25510 through 25640). We also refer 
readers to section III.M. of this proposed rule for discussion of our 
proposal to modify the CEHRT definition as defined for the Quality 
Payment Program under Sec.  414.1305.
(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 are proposing 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 propose in section III.C.3. of this proposed rule, 
effective January 1, 2021, to establish a MIPS APM Performance Pathway 
and scoring rules that would be available for MIPS reporting for MIPS 
eligible clinicians in MIPS APMs.
    We seek comment on this proposal.
(b) APM Entity Groups
    We are proposing to terminate the APM scoring standard effective 
January 1, 2021, however, beginning with the 2021 performance period, 
we propose to retain certain APM Entity group reporting policies that 
were established and finalized for reporting and scoring under MIPS 
beginning with the 2021 performance period. Therefore, we are proposing 
to redesignate in part the regulation that describes APM Entity group 
determinations, from

[[Page 50304]]

Sec.  414.1370(e) to Sec.  414.1317, and to title that section ``APM 
Entity Groups.''
    In addition, because we are proposing 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 are proposing 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 propose 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 these proposals would eliminate the need for the term ``full 
TIN APM,'' we also propose to delete the defined term ``full TIN APM'' 
from Sec.  414.1305.
    We seek comment on this proposal.
(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 propose 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. APM 
Entity reporting, in and of itself, would not confer MIPS eligibility 
to an eligible clinician who would otherwise be excluded from MIPS.
(d) APM Entity Group Scoring
    Consistent with our past approach under APM scoring standard at 
Sec.  414.1370(f), we are proposing 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 are proposing 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 CMS calculates 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 are proposing at Sec.  414.1317(b)(2) that 
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 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 would 
apply to any performance category.
    We seek comment on these proposals.
(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 are proposing 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. 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 are proposing 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 believe it 
is

[[Page 50305]]

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 are proposing 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 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 believe that 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 propose 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 are 
proposing 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 
eligible clinician who is in the APM Entity. We also recognize 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 section II.G. of this 
proposed rule, 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 note that under this proposal and the proposed changes to the 
MIPS scoring hierarchy, described in section IV.A.3.e. of this proposed 
rule, 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.
    Finally, to the extent that these 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 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 COVID-19 PHE. 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 COVID-19 PHE, such as the changes being 
proposed for participants in the Shared Savings Program in section 
III.I.1. of this proposed rule, would make obtaining reweighting under 
MIPS based on extreme and uncontrollable circumstances unusually 
burdensome absent these proposed changes. For instance, the Shared 
Savings Program 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 this 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.
    We seek comment on our proposals discussed above.
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, we are 
proposing 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 public health emergency (PHE) for 
the COVID-19 pandemic.
     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 are not proposing 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)(a) of this proposed rule for the 
discussion of our proposal to remove the APM scoring standard and 
section IV.A.3.b of this proposed rule

[[Page 50306]]

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 refer 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 
are proposing 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)(b) of this proposed 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 starting with the 2021 performance period. If 
the proposal is finalized, scoring policies proposed for the 2021 
performance period will not be applicable to CMS Web Interface as a 
collection type.
(i) Scoring Flexibility for Changes That Impact Quality Measures During 
the Performance Period
    We are proposing 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) or the complete suppression of the 
measure if 9 months of data are not available. We have 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 that 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 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-month assessment period 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 propose 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 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.

[[Page 50307]]

    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 performance 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, 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, we propose 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. Under this proposal we would 
maintain the flexibility to assess the measure on 9 months of data when 
available. Under the proposal we would suppress the measure if 9 
consecutive months of data are not available. We propose that we would 
publish a list of measures requiring a 9-month assessment period 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 propose 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 Sec.  414.1380(b)(1)(vii)(A), ``significant changes'' 
means changes to codes (including ICD-10, CPT, and HCPCS), clinical 
guidelines, or measure specifications. We will publish a list of all 
measures scored under this paragraph Sec.  414.1380(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).
(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 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 performance period (see 85 FR 
19277 through 19278), we may not have as representative of a sample of 
data as we would have had without the national PHE for COVID-19. 
Therefore, we want to revisit our benchmarking policy for the 2021 
performance period. We anticipate 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 believe 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 intend to use performance period benchmarks for the CY 2021 
performance period in accordance with Sec.  414.1380(b)(1)(ii). 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 
believe 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 recognize 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 are seeking feedback on the criteria for using data from the 
2019 MIPS performance period to calculate CY 2021 benchmarks. We also, 
as an alternative to performance period benchmarks, considered, and 
request 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 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 
remain concerned that utilizing outdated data could also potentially 
result in distributions of scores used for benchmarks that no longer 
reflect the standard of care.

[[Page 50308]]

(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 all-cause hospital 
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 complication measure, a case 
minimum of 25 is proposed and is applicable for individuals and groups. 
We propose to amend Sec.  414.1380(b)(1)(i) to clarify how 
administrative claims measures are scored. We propose 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.
(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 propose 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 in section 
IV.A.3.a.(1) of this proposed rule, we anticipate 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 will wait until there is further 
policy development under the MVP framework before proposing to remove 
the 3-point floor. Accordingly, we propose 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.
(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 are not proposing to modify how we score these measures within 
MIPS, as we consider policies for transitioning to MVPs described in 
section IV.A.3.a.(3) of this proposed rule. For class 2 measures, for 
the 2023 MIPS payment year, we propose 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, we propose 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.
    A summary of the proposed policies for the CY 2021 MIPS performance 
period is provided in Table 43.

[[Page 50309]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.077

(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).
    As noted in section IV.A.3.d.(1)(b)(ii) of this proposed rule, we 
are using performance period benchmarks for the 2021 MIPS performance 
period, which will mean we would not be able to publish measures that 
are topped out prior to the 2021 MIPS performance period. That 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 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 appreciate 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 propose 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 historic 
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 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 two years as 
published in the 2020 MIPS performance period historic benchmarks.
(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

[[Page 50310]]

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 will 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.
    In this proposed rule, we propose to maintain the cap on measure 
points for reporting high priority measures for the 2023 MIPS payment 
year. Accordingly, we propose 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.
(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 with the framework for transforming MIPS through 
MVPs discussed in the CY 2020 PFS proposed rule (84 FR 40739) and in 
section IV.A.3.a.(1) of this proposed rule, we will find ways to 
incorporate digital measures without needing to incentivize end-to-end 
reporting with 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 will 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.
    In this proposed rule, we propose 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 propose 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.
(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.
    In this proposed rule, we propose 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.
(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 
this rule, we propose to continue the complex patient bonus for the 
2023 MIPS payment year, and we also propose to modify the complex 
patient bonus for the 2022 MIPS payment year as established in prior 
rulemaking due to the national public health emergency for COVID-19. In 
addition, we propose performance category redistribution policies for 
the 2023, 2024, and future MIPS payment years. These proposals are 
discussed in more detail in this section of the proposed rule.
(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

[[Page 50311]]

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 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 with dual eligible status (82 FR 53771 through 53776).
(ii) Complex Patient Bonus for the 2023 MIPS Payment Year
    We intended the complex patient bonus as a short-term solution to 
address the impact patient complexity may have on MIPS scoring. 
However, 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 in this proposed rule 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 proposed 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 providers 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 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. As we continue 
to review the analyses and findings of 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 propose to continue the 
complex patient bonus as finalized for the 2020 MIPS performance 
period/2022 MIPS payment year and to revise Sec.  414.1380(c)(3) 
accordingly. 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 will propose 
modifications to the complex patient bonus in future rulemaking as 
appropriate.
(iii) Complex Patient Bonus for the 2022 MIPS Payment Year
    In this section of the proposed rule, we discuss our proposal to 
modify the complex patient bonus for the 2022 MIPS payment year in 
response to the national public health emergency for COVID-19. 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.\93\ 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.\94\ However, due to the national public health 
emergency for COVID-19 during performance period 2020, we believe we 
need to re-evaluate the previously established policy for the complex 
patient bonus for the 2022 MIPS payment year. We acknowledge 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 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 Center for Disease Control 
and Prevention guidance on ``Groups at Higher Risk for Severe 
Illness'', indicate that COVID-19 patients who are already

[[Page 50312]]

high-risk due to pre-existing medical conditions are at further risks 
of increased COVID-19 related hospitalizations and mortality.\95\ 
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.\96\
---------------------------------------------------------------------------

    \93\ 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.
    \94\ CMS, ``Report to Congress: Risk Adjustment in Medicare 
Advantage'': https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads/RTC-Dec2018.pdf.
    \95\ CDC, ``Groups at Higher Risk for Severe Illness'': https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/groups-at-higher-risk.html.
    \96\ 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.\97\ 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,\98\ this only 
partially filled the gap in services from the reduction in delivery of 
care, as not all specialties can utilize telehealth. We recognize the 
increased challenges of providing care to complex patients in the 
context of the national public health emergency 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-19.99 100 101 More specifically, 
findings from our recently released data reinforces previous findings 
by the Centers for Disease Control and Prevention 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 dual eligible populations.\102\ Additionally, 
in light of the care delivery changes, we believe 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.103 104 105 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 pandemic.
---------------------------------------------------------------------------

    \97\ 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.
    \98\ CMS, ``Medicare Telemedicine Healthcare Provider Fact 
Sheet'': https://www.cms.gov/newsroom/fact-sheets/medicare-telemedicine-health-care-provider-fact-sheet.
    \99\ 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.
    \100\ 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-March28, 2020'': https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7119513/pdf/mm6913e2.pdf.
    \101\ 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.
    \102\ CMS, ``Medicare COVID-19 Data Release Blog'': https://www.cms.gov/blog/medicare-covid-19-data-release-blog.
    \103\ 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/.
    \104\ 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.
    \105\ U.S. 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/.
---------------------------------------------------------------------------

    Currently, the complex patient bonus is worth up to 5 points. 
However, given the anticipated increase in complexity due to the 
national public health emergency for COVID-19, we propose 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. 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 propose 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). Under this proposal, 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 
this 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 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 public health emergency 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, 
currently we are unable to measure the magnitude of the direct and 
indirect effects of the COVID-19 pandemic on MIPS scores, and we remain 
concerned about potentially misidentifying poor performance with regard 
to the care delivered in CY 2020 due to the national PHE. Hence, we 
believe this approach of doubling the complex patient bonus recognizes 
the difficulty of managing complex patients during the pandemic 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 pandemic, it is 
difficult to gauge whether our 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 assume clinicians may 
be facing, we believe 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 decided 
not to propose those options as we were concerned that an approach of 
tripling the bonus could artificially increase final scores and 
maintaining the current

[[Page 50313]]

bonus (up to 5 points) may not be sufficient to account for the 
increased patient complexity during the CY 2020 performance period. 
Additionally, 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 pandemic 
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 were concerned about this alternative 
approach for two reasons. First, we do not believe the effects of 
COVID-19 are limited to those patients who are experiencing the 
illness. Second, we are 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.
    We request comments on our proposal, the alternatives we 
considered, and any other approaches to account for patient complexity 
during the public health emergency that commenters believe we should 
consider, as well as alternative data sources for patient complexity.
(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 this proposed rule, 
we propose 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 this proposed rule, we 
propose 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. Table 44 summarizes the proposed weights for each 
performance category.
[GRAPHIC] [TIFF OMITTED] TP17AU20.078

(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

[[Page 50314]]

Coordinator for Health IT (ONC) on implementation of the 
interoperability provisions of the 21st Century Cures Act (the Cures 
Act) (Pub. L. 115-233, 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 section IV.A.3.c.(2)(a) of this proposed rule, we are proposing 
a weight for the cost performance category of 20 percent for the 2023 
MIPS payment year. For the 2023 MIPS payment year, we propose similar 
redistribution policies as finalized for the 2022 MIPS payment year, 
with minor modifications to account for the cost performance category 
being 20 percent. Under this proposal, 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 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 propose to codify at Sec.  
414.1380(c)(2)(ii)(E), are included in Table 45.
[GRAPHIC] [TIFF OMITTED] TP17AU20.079

    In section IV.A.3.c.(2)(a) of this proposed rule, we are proposing 
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 do 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 continue to believe 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 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 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 propose to codify at Sec.  414.1380(c)(2)(ii)(F), are 
included in Table 46.

[[Page 50315]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.080

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). We are proposing 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 section IV.A.2.b.(5) of this proposed rule; (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 47 
when more than one final score is associated with a TIN/NPI.
[GRAPHIC] [TIFF OMITTED] TP17AU20.081

    With the proposed discontinuation of the APM scoring standard and 
addition of the APP in section IV.A.2.b.(5) of this proposed rule, we 
are proposing 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

[[Page 50316]]

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 are proposing to terminate the APM scoring 
standard in section IV.A.2.b.(5) of this proposed rule, and while we 
believe it is important to still encourage movement to APMs, 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 propose 
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 propose to use the highest available final score 
associated with the TIN/NPI to determine the MIPS payment adjustment. 
This proposal is 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 
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 48 illustrates the proposed modified final score hierarchy.
    [GRAPHIC] [TIFF OMITTED] TP17AU20.082
    
(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 includes a special rule for 
the initial 2 years of MIPS, which requires the Secretary, prior to the 
performance period for such years, to establish a performance threshold 
for purposes of determining the MIPS payment adjustment factors under 
section 1848(q)(6)(A) of the Act and an additional performance 
threshold for purposes of determining the additional MIPS payment 
adjustment factors under section 1848(q)(6)(C) of the Act, each of 
which shall be based on a period prior to the performance period and 
take into account data available for performance on measures and 
activities that may be used under the performance categories and other 
factors determined appropriate by the Secretary. Section 51003(a)(1)(D) 
of the Bipartisan Budget Act of 2018 amended section 1848(q)(6)(D)(iii) 
of the Act to extend the special rule to apply for the initial 5 years 
of MIPS instead of only the initial 2 years of MIPS.
    In addition, section 51003(a)(1)(D) of the Bipartisan Budget Act of 
2018 added a new clause (iv) to section 1848(q)(6)(D) of the Act, which 
includes an additional special rule for the third, fourth, and fifth 
years of MIPS (the 2021 through 2023 MIPS payment years). This 
additional special rule provides, for purposes of determining the MIPS 
payment adjustment factors under section 1848(q)(6)(A) of the Act, in 
addition to the requirements specified in section 1848(q)(6)(D)(iii) of 
the Act, the Secretary shall increase the performance threshold for 
each of the third, fourth, and fifth years to ensure a gradual and 
incremental transition to the performance threshold described in 
section 1848(q)(6)(D)(i) of the Act (as estimated by the Secretary) 
with respect to the sixth year (the 2024 MIPS payment year) to which 
the MIPS applies.
    In the CY 2020 PFS final rule (84 FR 63031 through 63037) at Sec.  
414.1405(b)(7) and Sec.  414.1405(b)(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 49. 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 50317]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.083

    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 COVID-19 Public Health Emergency (PHE). We 
anticipate 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 on clinicians, 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.
    Clinicians who are unable to participate in the fourth year of MIPS 
due to the COVID-19 PHE, 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, especially 
those with small practices. Preliminary analysis has shown that when 
applying a performance threshold of 50 points to the data we received 
from the 2021 regulatory impact analysis described in section 
VIII.F.16. of this proposed rule, 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, analysis shows 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 (analysis detailed in section VIII.F.16.b. of this 
proposed rule), 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 are not revisiting the 
additional performance threshold, which is set at 85 points for year 5. 
We are proposing 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 are open 
to considering alternatives for the performance threshold for the 2023 
MIPS payment year. We request 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 50 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 50318]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.084

    At the time of publication of this proposed rule, we do not have 
actual performance scores and other data for year 3 (2019 performance 
period/2021 MIPS payment year). In the event this information becomes 
available with sufficient time to inform our policy decisions for the 
final rule, we propose 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 anticipate 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 COVID-19 
PHE occurred during the data submission period. We also expect that the 
2019 performance period data may be unusual due to the PHE occurring 
during the submission period. We request comments on our proposal to 
revisit and potentially revise our prior estimate of the performance 
threshold for year 6. In particular, we seek comment on what indicators 
(for example, if the distribution of scores is skewed due to the PHE), 
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 propose to consider the revised 
estimate when we decide on an appropriate numerical value for the 
performance threshold for the 2023 MIPS payment year. As an example, 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 believe that we should take into account the 
revised estimate when determining the performance threshold for the 
2023 MIPS payment year. We request comments on our proposal to consider 
the revised estimate for the 2024 MIPS payment year when we select a 
performance threshold for the 2023 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 proposed policies for the 2023 MIPS 
payment year. In Figure A, the performance threshold is set at 50 
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 12.5 points based on the proposed performance threshold of 50 
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 50 
points (which is the proposed performance threshold) would receive a 
neutral MIPS payment adjustment. Because the performance threshold is 
50 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

[[Page 50319]]

score of 100 points would be less than 9 percent.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TP17AU20.000

    Table 51 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 and the changes 
potentially modifying the performance threshold for the 2023 MIPS 
payment year discussed in this proposed rule, as well as the applicable 
percent required by section 1848(q)(6)(B) of the Act.

[[Page 50320]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.085


[[Page 50321]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.086

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 Public Health 
Emergency (PHE) and COVID-19, we wish to inform stakeholders that we 
may provide performance feedback after July 1, 2020 (that is, 
performance feedback based on data submitted for the performance period 
in 2019). 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. At this time, we 
estimate that we will provide performance feedback in late July or 
early August, although this timeframe may be subject to change. Please 
refer to qpp.cms.gov for more information.
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-2 
(85 FR 27594 through 27595) for our previously established policies 
regarding third party intermediaries.
    In this proposed rule, we propose 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 third party 
intermediaries may submit. Through this proposed rule, we intend on 
clarifying 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 propose 
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;

[[Page 50322]]

     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 Sec.  
414.1380(c)(2)(i)(C)(1) through (7) or Sec.  414.1380(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 
request comments on these proposals.
(i) Reporting MVPs Through Third Party Intermediaries
    We refer readers to section IV.A.3.a. of this proposed rule where 
we discuss reporting MVPs through third party intermediaries and 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 proposed rule where 
we discuss 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) are 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-2 (85 FR 27594 
through 27595) for previously finalized policies related to the 
approval criteria for third party intermediaries.
(ii) Proposed 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 encourage the selection of misrepresentative 
data, commonly referred to as ``cherry-picking,'' to maximize scores.
    In preparation for future years of the program, we believe it is 
important to 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. 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 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 are proposing to amend the current Sec.  
414.1400(a)(4) to propose a new paragraph at Sec.  414.1400(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 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 regards 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 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 request 
comments on our proposals; specifically, we request comments on whether 
there are other factors that should inform our considerations when 
approving third party intermediaries.
(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 
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 the COVID-19 pandemic and consistent with the goal 
of infection control, we have 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 believe virtual 
meetings would be sufficient when in-person meetings are not possible.
    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

[[Page 50323]]

IV.A.3.g.(1)(iv) of this proposed 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 are 
proposing for the requirement that third party intermediaries 
participate in an annual meeting and training calls as deemed necessary 
by CMS include those third party intermediaries that are health IT 
vendors. We are soliciting comments on the best method to reach health 
IT vendors so that we can invite them to required meetings and share 
additional information. 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. 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 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 propose 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 affirm that, in addition to the obligations under this 
proposal, CMS-approved survey vendors must also continue to meet the 
requirements at Sec.  414.1400(e)(3).
(iv) Future Safeguards for All Third Party Intermediaries
    We understand our obligation to ensure the integrity of the MIPS 
program and we 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). As 
discussed in this proposed rule, we are proposing additional program 
safeguards in regard to data validation audit and targeted audit 
requirements that would apply specifically to QCDRs and qualified 
registries, respectively found in section IV.A.3.g.(2)(a) and section 
IV.A.3.g.(3) of this proposed rule. These 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 have 
limited these proposals to QCDRs and qualified registries at this time, 
but as described further below we solicit feedback on expanding these 
requirements to all third party intermediaries through future 
rulemaking.
    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 has adopted a definition of certified electronic health 
record technology (CEHRT) at Sec.  414.1305.
    For discussion of proposed revisions to the CEHRT definition 
adopted for the Quality Payment Program we refer readers to section 
III.M. of this proposed 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 a 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 are not proposing to add data validation requirements 
for health IT vendors at this time, we are considering ways to impose 
such requirements in the future. We are soliciting 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 proposed for QCDRs and Qualified Registries. 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 seek 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

[[Page 50324]]

such a policy. For instance, we are seeking to further understand where 
data quality issues may arise in data submitted by health IT vendors on 
behalf of MIPS eligible clinicians. We are also seeking comment 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 are proposing for QCDRs and Qualified 
Registries. We are also seeking comment regarding 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. We also would welcome input 
as to whether alternative requirements for health IT vendors would 
impose a less burden on these third parties' intermediaries while still 
ensuring that the data submitted is accurate and complete. Finally, we 
are interested in 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 
are also not proposing any new data validation requirements at this 
time. 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 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 solicit 
feedback on whether the audit requirements in this proposal should be 
expanded to include survey 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 Qualified Clinical Data Registry (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-2 (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 this proposed rule, 
we propose 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 are proposing 
policies related to QCDR: (1) Data validation audits and targeted 
audits; and (2) measure requirements. These are discussed in detail 
below.
(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 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 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, in this proposed rule, we propose 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 
propose specific obligations for those audits as discussed below.
     We propose 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). 
In this proposed rule, we are proposing 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 propose 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 be 
done 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 propose 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. Therefore, we propose to require that

[[Page 50325]]

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 note 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 believe all data the QCDR submits, 
regardless of its use for payment or public reporting, should be true, 
accurate, and complete.
     We propose 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 believe meaningful validation of such 
data requires the QCDR to use clinical documentation to confirm that 
the activity occurred or was performed.
     We propose 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 propose 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 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 propose 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 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 emphasize 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 propose 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 believe targeted audits are 
important to further evaluate the impact of deficiencies or data errors 
to the cohort of clinicians and groups that the QCDR intends to submit 
data for, and for QCDRs to determine the

[[Page 50326]]

reason the deficiency or data error occurred.
     We propose 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 propose 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 believe the sampling methodology we are proposing 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 propose 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 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 request comments on the aforementioned proposals, including 
whether stakeholders are concerned with implementing these policies for 
the 2023 MIPS payment year, and if so, what barriers do they believe 
they would face in implementing these requirements.
(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-2 (85 FR 27594 
through 27595) for where we previously finalized standards and criteria 
for QCDR measures. In this proposed rule, we are proposing 
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 believe our 
proposals in this proposed rule will help to refocus measures to those 
most meaningful to a clinician's scope of practice.
    In this proposed rule, we are proposing to modify a few QCDR 
measure requirements: Measures in MVPs; measure testing; duplicative 
QCDR measures; and collection of data. These proposals are discussed in 
detail below.
(A) QCDR Measures in MVPs
    We refer readers to section IV.A.3.a. of this proposed rule, where 
we discuss the inclusion of QCDR measures in MVPs, at CMS discretion, 
beginning with the 2024 MIPS payment year. While we acknowledge and 
appreciate the level of innovation that QCDRs have put forward as they 
have developed and implemented QCDR measures, we note 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,\106\ 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.
---------------------------------------------------------------------------

    \106\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Blueprint.pdf.
---------------------------------------------------------------------------

    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). Subsequently, 
due to the

[[Page 50327]]

PHE for the COVID-19 pandemic, we delayed this requirement by 1 year in 
the May 8th COVID-19 IFC-2 (85 FR 27594 through 27595). In the May 8th 
COVID-19 IFC-2 (85 FR 27594 through 27595), we finalized at Sec.  
414.1400(b)(3)(v)(C) beginning with the CY 2024 MIPS payment year, 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, based on subsequent 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, we are proposing 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.
    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 want to balance those interests with 
stakeholders' concerns. Therefore, we propose a gradual approach to 
have fully tested QCDR measures within the MIPS program. We want to 
emphasize 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 described in section IV.A.3.a and below of this proposed rule. We 
propose 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 propose to revise Sec.  
414.1400(b)(3)(v)(C) to account for an incremental approach to require 
fully tested QCDR measures. We discuss requirements for QCDR measures 
considered for inclusion in an MVP separately. This is discussed in 
more detail below.
(i) Proposed Requirements for Existing Measures
    We propose 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 \107\ 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).
---------------------------------------------------------------------------

    \107\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Blueprint.pdf.
---------------------------------------------------------------------------

    In addition, we propose 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 are clarifying in this 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 \108\ 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 refer 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.
---------------------------------------------------------------------------

    \108\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Blueprint.pdf.
---------------------------------------------------------------------------

(ii) Proposed Requirements for New QCDR Measures
    We propose 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 recognize that not all QCDR measures currently approved would 
continue in the program due to business decisions by each QCDR. We 
acknowledge that there is a cost involved with full testing of quality 
measures (see 84 FR 63173); however, we believe it is important that 
all measures used within the MIPS program are fully tested and 
reliable. 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 do encourage 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.

[[Page 50328]]

(iii) Proposed Requirements for QCDR Measures Considered for MVP
    As an additional layer, we are also proposing 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 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.
    We request comments on our proposals.
(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 to mean measures for 
which previously identified areas of duplication with other approved 
QCDR measures or MIPS quality measures have been addressed. To be clear 
with our intent, we are proposing to revise previously codified 
policies that refer to measure harmonization with this updated 
terminology.
    Therefore, we propose 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 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 propose 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 propose to remove two previously codified policies 
that we have identified as areas of redundancy. We propose 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 
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, as stated in the above paragraph, we are proposing technical 
updates to re-number the regulation text to reflect these removals. 
Therefore, in Sec.  414.1400(b)(3)(vii), we propose to redesignate 
paragraphs (I), (J), (K), (M), and (N) as paragraphs (H), (I), (J), (K) 
and (L), respectively.
(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. For 
reasons discussed in the May 8th COVID-19 IFC-2 (85 FR 27594 through 
27595), we delayed implementation of this policy by 1 year, as 
described at Sec.  414.1400(b)(3)(v)(D), beginning with the CY 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. We are 
not proposing any changes in this proposed rule.
(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 this proposed rule, we propose 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, in this proposed rule, we propose 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, in this proposed rule, we propose at Sec.  
414.1400(c)(2)(iii)

[[Page 50329]]

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 propose specific obligations for those audits as discussed below.
     We propose 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 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). 
In this proposed rule, we are proposing 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 propose 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 propose to codify at Sec.  414.1400(c)(2)(iii)(C), that 
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. 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 
propose 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 note 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 
believe all data the qualified registry submits, regardless of its use 
for payment or public reporting, should be true, accurate, and 
complete.
     We propose 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 believe 
meaningful validation of such data requires the qualified registry to 
use clinical documentation to confirm that the activity occurred or was 
performed.
     We propose 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 propose 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

[[Page 50330]]

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 propose 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 emphasize 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 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 propose 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 propose 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 propose 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 are proposing 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 propose 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 request comments on the aforementioned proposals, including 
whether stakeholders are concerned with implementing these policies for 
the 2023 MIPS payment year, and if so, what barriers do they believe 
they would face in implementing these requirements.
(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 including 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 are proposing to revise and elaborate 
on the obligations for a CAP. Specifically, we propose 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

[[Page 50331]]

recur in the future and (4) the detailed timeline for achieving 
compliance with the applicable requirements.
    We believe these 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 propose 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 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 propose 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 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 propose 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 propose at Sec.  
414.1400(f)(1)(i)(D) that each CAP must include the detailed timeline 
for achieving compliance with the applicable requirements. We invite 
public comments on these proposed revisions to our requirements for 
correction action plans.
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 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 on the CMS (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 propose 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 seek comment on this proposal. For ease of 
reference, we will use the term ``Physician Compare'' in this proposed 
rule.
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 2 percent of the estimated 
aggregate amount of 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 
NPI's CMS-588 Electronic Funds Transfer (EFT).
    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

[[Page 50332]]

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 this proposed rule, 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 are 
proposing 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 note 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 seek comment on this proposal.
(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 these 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 are proposing 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. 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 believe that this 
revised approach will enable CMS to more accurately identify TINs with 
which QPs are currently receiving other Medicare payments, and through 
which they would likely anticipate receiving their APM Incentive 
Payment. 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 are also proposing 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. 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

[[Page 50333]]

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. 
In order 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.
    In order 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 more timely 
and efficient manner, we propose to sequentially apply the hierarchy in 
the following paragraph and to amend Sec.  414.1450(c) of our 
regulations to reflect such hierarchy. We propose 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 propose 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 propose 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 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 seek comment on these proposals.
(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 CMS attempts 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 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 remind 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 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. 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 would 
categorically assign these QPs to the list of QPs that will be given 
public notice requesting updated payment information within 90 days, as 
described in the proposed regulation at Sec.  414.1450(c)(8). We 
believe that in many if not most of these cases, such individuals have 
retired or otherwise ceased participation in Medicare; however, we 
recognize that there may be scenarios under which such individuals 
remain active, and our proposal is 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 seek comment on this proposal.
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 this proposed rule, we are proposing 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 are clarifying our policies on Advanced APM

[[Page 50334]]

determinations and QP determinations in light of questions that may 
arise based on the effects of the COVID-19 PHE.
    Finally, we are soliciting 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 prospectively 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 also 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 with retrospective 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 propose to amend Sec.  414.1435(c)(1) of our 
regulations and add a new paragraph Sec.  414.1435(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. The effect of 
this 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.
    We seek comment on these proposals.
(3) Targeted Review of QP Determinations
(i) Overview
    We are proposing at Sec.  414.1455(b) to establish a targeted 
review process for limited circumstances surrounding QP determinations. 
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 propose 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 note 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 propose 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. If we determine that we 
made such a clerical error, we believe that it would be appropriate, 
and we are proposing to assign to the erroneously omitted 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. 
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

[[Page 50335]]

through an Advanced APM for an APM Entity with which they were 
associated.
    Alternatively, if we were to instead 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 CMS's notification of their 
prior QP determination, and 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 are proposing to not conduct targeted review of potential 
omissions from Affiliated Practitioner Lists, as QP determinations for 
eligible clinicians on an Affiliated Practitioner List are 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 note that we are not proposing 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 propose to align this targeted review process with 
the MIPS targeted review process as codified at Sec.  414.1385. We 
believe that this general alignment is appropriate and will reduce the 
likelihood of confusion and burden on eligible clinicians and APM 
Entities. We propose to revise Sec.  414.1455 of our regulations by 
redesignating the current 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 propose to specify at Sec.  414.1455(b) that either an eligible 
clinician or APM Entity may submit a request for targeted review. We 
also propose 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 propose 
that all requests for targeted review must be submitted in accordance 
with the form and manner specified by CMS.
    We propose 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). If the targeted 
review request is denied, there will be no change to either the QP or 
Partial QP determination. If the targeted review request is approved, 
we would assign the most favorable Threshold Score and corresponding QP 
status of the APM Entity in which such eligible clinician participates.
    We propose that we will respond to each request for targeted review 
timely submitted and determine whether a targeted review is warranted.
    We propose that a request for targeted review may include 
additional information in support of the request at the time it is 
submitted. If CMS requests additional information from requests 
additional information from the eligible clinician or the APM Entity 
group that is the subject of a request for targeted review, it must be 
provided and received by CMS within 30 days of CMS's request. Non-
responsiveness to 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 propose 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 propose that decisions based on the targeted review are final, 
and there is no further administrative review or appeal or judicial 
review.
    We seek comment on these proposals.
(4) COVID-19 Public Health Emergency (PHE) Advanced APM determination 
and QP Determinations
(i) Advanced APM Determinations
    We anticipate that the COVID-19 PHE, as defined in 42 CFR 400.200, 
may result in CMS making changes to aspects of some APMs. For example, 
CMS may publish regulations or amend APM Participation Agreements to 
address issues that arise as a result of the COVID-19 PHE.
    Due to the COVID-19 PHE and the urgent need to address changes to 
certain APMs during CY 2020 to respond to the extreme shifts in the 
healthcare delivery system, CMS is exercising its enforcement 
discretion in connection with Advanced APM determinations. 
Specifically, CMS will not reconsider the Advanced APM determinations 
of APMs which have already been evaluated and determined to meet the 
Advanced APM criteria for 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 COVID-19 
PHE will not be considered to the extent they would prevent the APM 
from meeting the Advanced APM criteria for a year.
    We note 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);

[[Page 50336]]

     Vermont All-Payer ACO Model (Vermont Medicare ACO 
Initiative).
(ii) QP Determinations
    We also understand that the COVID-19 PHE may lead 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 COVID-19 PHE, 
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 are aware that circumstances resulting from the COVID-19 PHE 
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 COVID-19 PHE.
    However, after considering whether changes in our methodology to 
address the PHE 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 note that with the 
duration, scope, and severity of the PHE 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 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 across 
the board. We also 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 also believe Advanced APM participants benefit from timely and 
predictable QP determinations. With all of these considerations in 
mind, we are clarifying that, apart from the exercise of enforcement 
discretion explained above, we will 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 COVID-19 PHE.
(5) Partial QP Election To Report MIPS
    We anticipate there may be an increase in the number of eligible 
clinicians who are determined to be Partial QPs in the 2021 QP 
Performance Period in comparison to the 2020 QP Performance Period, due 
to the increase in the QP thresholds. Beginning in the CY 2021 QP 
Performance Period, as provided at Sec.  414.1430(a) of our regulations 
for the Medicare option, the QP payment amount threshold increases from 
50 percent to 75 percent, while the QP patient count threshold 
increases from 35 percent to 50 percent. While the Partial QP 
thresholds for the Medicare option also increase, based on historical 
performance we expect a greater number of Partial QPs based on 
performance in the CY 2021 QP Performance Period than for the prior QP 
Performance Period. As provided in Sec.  414.1310(b)(2), Partial QPs 
who do not elect to participate in MIPS as a MIPS eligible clinician 
are excluded from MIPS, and thus, not subject to the MIPS reporting 
requirements or payment adjustments. To date our method of contacting 
Partial QPs has been to send a letter to the APM Entity's contact 
listed with the APM. As such, we are considering options to make the 
Partial QP election process less burdensome.
    We are requesting comment on whether to allow an APM Entity to make 
the Partial QP election on behalf of all of the individual eligible 
clinicians associated with such APM Entity. We believe that allowing an 
APM Entity to make a single election on behalf of all of its eligible 
clinicians may help to simplify such elections, particularly for those 
eligible clinicians who will be Partial QPs for the first time because 
of the increasing QP thresholds in 2021. We also believe that allowing 
an APM Entity to make the Partial QP election for its eligible 
clinicians could reduce burden for individual eligible clinicians and 
allow APM Entities to have a centralized source of feedback as to the 
statuses of their individual eligible clinician participants.
    However, we acknowledge that allowing APM Entities to make 
elections on behalf of eligible clinicians would create the possibility 
that we could receive conflicting election responses from different 
parties. Specifically, we are interested in receiving comments, 
feedback, and recommendations for how to address: (1) Conflicting 
responses either from an APM Entity and an individual or from two or 
more different APM Entities (eligible clinicians often participate with 
more than one APM Entity); and (2) situations where the eligible 
clinician is participating in more than one APM Entity and we do not 
receive elections from all parties.
    In the case where an APM Entity election conflicts with that of an 
individual eligible clinician, we believe it would be most appropriate 
to follow the individual eligible clinician's election, as that 
election would apply at the NPI level across all of their TIN/NPI 
combinations, and in recognition that the eligible clinician has taken 
the opportunity to express their preference. Similarly, if we were to 
receive an election for an eligible clinician from one APM Entity in 
which the eligible clinician participates but not all such APM 
Entities, and the individual clinician does not make an election, we 
believe it would be appropriate to apply the election we received for 
the eligible clinician across all their TIN/NPI combinations. However, 
if multiple APM Entities make elections that are not in agreement, and 
the individual eligible clinician does not make an election, there is 
no clearly appropriate course of action as to which election to follow, 
and therefore we solicit comments detailing how we might go about 
applying conflicting Partial QP elections for an eligible clinician 
made by more than one APM Entity.
    We seek public comment on whether to allow Partial QP elections to 
be made by APM Entities on behalf of all eligible clinicians within the 
APM Entity, and how to handle potentially conflicting elections.

V. Planned 30-Day Delayed Effective Date for the Final Rule

    We are committed to ensuring that we fulfill our statutory 
obligation to update the PFS as required by law and are working 
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 accord 
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 procedure are impracticable, unnecessary, or contrary 
to the public interest, the rule shall take effect at such time as the 
agency determines.
    The United States is responding to an outbreak of respiratory 
disease caused by a novel (new) coronavirus that has

[[Page 50337]]

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.
    Due to CMS prioritizing efforts in support of containing and 
combatting the COVID-19 PHE, and devoting significant resources to that 
end, the work needed on the PFS payment rule will 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 fiscal 
year to which it applies. Up to an additional 30 days may be needed to 
complete the work needed on this payment rule. 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 fiscal year to which they are 
intended to apply.
    Therefore, due to CMS prioritizing efforts in support of containing 
and combatting the COVID-19 PHE, and devoting significant resources to 
that end, we expect that we will determine, pursuant to 5 U.S.C. 
808(2), that the PFS final rule will be effective 30 days after 
publication; it would be impracticable and contrary to the public 
interest for CMS to do otherwise. Accordingly, we also do expect to 
provide 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.

VI. 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:
     The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
     The accuracy of our burden estimates.
     The quality, utility, and clarity of the information to be 
collected.
     Our effort to minimize the information collection burden 
on the affected public, including the use of automated collection 
techniques.
    We are soliciting public comment on each of the 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 52 presents the mean hourly wage, 
the cost of fringe benefits and overhead (calculated at 100 percent of 
salary), and the adjusted hourly wage.

[[Page 50338]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.087

    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. Proposed Information Collection Requirements (ICRs)

1. ICRs Regarding Modifications to OTP Enrollment Process (Sec.  
424.67)
    The following proposed 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 proposed rule to help stakeholders better understand the 
burdens associated with our proposed 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 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).

[[Page 50339]]

b. Proposed Revisions to Sec.  424.67
(1) Completion of Form CMS-855A
    We foresee three main implications associated with our proposed 
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 proposed/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 proposed 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: (1) Completion of a Form CMS-855A or 
Form CMS-855B application as a new enrollment; and (2) reporting the 
voluntary termination of its existing Form CMS-855 enrollment via the 
latter form (i.e., if the OTP is ceasing its Form CMS-855B enrollment, 
it would report this via a Form CMS-855B voluntary termination 
submission).
(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)). Regarding voluntary terminations (and consistent with previous 
ICR estimates for reporting this type of Form CMS-855B transaction), 
the typical burden is 15 minutes. Of this time period, a medical 
secretary spends 12 minutes completing the relevant sections of the 
Form CMS-855 while a health diagnosing and treating practitioner takes 
3 minutes to review and sign the form. This would result in a total 
burden of 75 hours (300 OTPs x 0.25 hr) at a cost of $3,675 (300 OTPs x 
((0.2 hr x $36.62/hr) + (0.05 hr x $98.52/hr)).
    We believe that the burden described in the previous paragraph 
would be incurred exclusively in the first year following our proposed 
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. 
Accordingly, the average annual burden in the first 3 years would be as 
follows:
     Form CMS-855A--400 hours (1,200 hr/3) at a cost of $17,743 
($53,229/3).
     Form CMS-855B--25 hours (75 hr/3) at a cost of $1,225 
($3,675/3).
(ii) Transition to Form CMS-855B Enrollment
    In line with our hour and wage estimates previously referenced in 
this section IV.B.1, 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)). Concerning Form CMS-855A voluntary terminations (and using the 
time burdens identified earlier), we estimate a total burden of 2.5 
hours (10 OTPs x 0.25 hr) at a cost of $123 (10 OTPs x ((0.2 hr x 
$36.62/hr) + (0.05 hr x $98.52/hr)).
    We anticipate that changes to a Form CMS-855B 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 two 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 as follows:
     Form CMS-855B--10 hours (30 hr/3) at a cost of $469 
($1,408/3).
     Form CMS-855A--0.8 hours (2.5 hr/3) at a cost of $41 
($123/3).
    (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 
533 hours (132 hr + 400 hr + 0.8 hr) at a cost of $23,639 ($5,855 + 
$17,743 + $41).
     Form CMS-855B--We project a reduction in annual burden of 
-64 hours (-99 hr-25 hr-10 hr) and $2,866 (-$4,560-$1,225-$469).
(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

[[Page 50340]]

preamble, the cost is included under the Regulatory Impact Analysis 
section.
(4) Fingerprinting
    We discussed in section III.B. of this proposed 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 proposed revisions to Sec.  424.67 would 
involve any additional or reduced fingerprinting burden for two 
reasons. First, we are proposing 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.
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 of 
the 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. and VIII.H.8. of this proposed rule for a discussion of the 
impacts associated with this rule's proposed changes to the Shared 
Savings Program's quality reporting requirements.
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)
    The following requirements and burden will be submitted to OMB for 
approval under control number 0938-0763 (CMS-R-262).
    We are proposing to implement 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 proposing that prescribers be required to 
use the NCPDP SCRIPT 2017071 standard for Electronic Prescription for 
Controlled Substances (EPCS) prescription transmissions.
    Based on internal 2019 CMS data, the transaction costs for the 
current process is approximately $2,855,390.85 [560,430 authorizations 
* 0.5 (accounting for one transaction since manual authorization takes 
2 transactions) * $10.19 per manual authorization]) per year. Should we 
finalize this requirement after reviewing comments received in response 
to this proposed rule and the Request for Information entitled 
``Medicare Program: Electronic Prescribing for Controlled Substances; 
Request for Information,'' the total annual cost for conducting the 
process electronically using the standard that we propose is 
$526,804.20($1.88 * 0.5 * 560,430 authorizations). This amounts to an 
annual savings of $2,328,586.65 ($2,855,390.85 - $526,804.20).
    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 the industry, 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. 
However, we seek comment on this assumption.
    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 and the benefits of e-prescribing, in light of the 
current social distancing guidelines, we estimate that by January 1 
2022, 65 percent of Part D prescribers will have electronic prescribing 
capabilities absent the requirement. Therefore, the one-time burden to 
implement this provision is 743,750 hours (148,750 prescribers * 5 hr) 
at a cost of $27,236,125 (743,750 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. However, we seek comment on this assumption and all other 
assumption in this burden estimate.
    Therefore, the total costs of the existing ePA activity is 
$2,855,390.85 per year as compared to $526,804.20 for using the 
standard. This amounts to an annual savings of $2,328,586.65 in 
prescriber expenses with the first year resulting in an added cost of 
$24,907,538.35 ($27,236,125-$2,328,586.65)
4. ICRs Regarding the Medicare Diabetes Prevention Program (MDPP) 
Expanded Model
    In section III.P. of this proposed rule, we propose policies 
necessary to allow certain flexibilities for Medicare enrolled MDPP 
suppliers and eligible beneficiaries in the MDPP Expanded Model during 
a public health emergency. 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 
Proposed Rule)
    The following QPP-specific ICRs reflect this rule's proposed 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 VI.B.5.b of this proposed 
rule); QCDR self-nomination applications and other requirements (see 
section VI.B.5.c.(2) of this proposed rule); qualified registry self-
nomination applications and other

[[Page 50341]]

requirements (see section VI.B.5.c.(3) of this proposed rule); CAHPS 
survey vendor applications (see section VI.B.5.c.(4) of this proposed 
rule); Open Authorization credentialing and token request process (see 
section VI.B.5.d of this proposed rule); Quality Payment Program 
Identity Management Application Process (see section VI.B.5.e.(3) of 
this proposed rule); quality performance category data submission by 
Medicare Part B claims collection type (see section VI.B.5.e.(4) of 
this proposed rule), QCDR and MIPS CQM collection type (see section 
VI.B.5.e.(5) of this proposed rule), and eCQM collection type (see 
section VI.B.5.e.(6) of this proposed rule); CAHPS for MIPS survey 
beneficiary participation (see section VI.B.5.e.(7) of this proposed 
rule); group registration for CAHPS for MIPS survey (see section 
VI.B.5.e.(8) of this proposed rule); call for quality measures (see 
section VI.B.5.f of this proposed rule); reweighting applications for 
Promoting Interoperability and other performance categories (see 
section VI.B.5.g.(2) of this proposed rule); Promoting Interoperability 
performance category data submission (see section VI.B.5.g.(3) of this 
proposed rule); call for Promoting Interoperability measures (see 
section VI.B.5.h of this proposed rule); improvement activities 
performance category data submission (see section VI.B.5.i of this 
proposed rule); nomination of improvement activities (see section 
VI.B.5.j of this proposed rule); nomination of MVPs (see section 
VI.B.5.k of this proposed rule); and opt-out of Physician Compare for 
voluntary participants (see section VI.B.5.o of this proposed rule).
    The ICRs for Advanced APMs consist of: Partial Qualifying APM 
Participant (QP) election (section VI.B.5.m of this proposed rule); 
Other Payer Advanced APM identification: Payer Initiated and Eligible 
Clinician Initiated Processes (sections VI.B.5.n.(1) and (2) of this 
proposed rule); and submission of data for QP determinations under the 
All-Payer Combination Option (section VI.B.5.n.(3) of this proposed 
rule).
(2) Summary of Quality Payment Program Changes: MIPS
    Two of our currently approved MIPS ICRs [(1) quality performance 
category data submission by CMS Web Interface collection type and (2) 
group registration for the CMS Web Interface] are being removed while 
five MIPS ICRs [(1) quality performance category data submission by 
QCDR and MIPS CQM collection type, (2) quality performance category 
data submission by eCQM collection type, (3) CAHPS for MIPS survey 
beneficiary participation, (4) nomination of improvement activities, 
and (5) reweighting applications for Promoting Interoperability and 
other performance categories] show changes in burden due to proposed 
policies. In aggregate, we estimate the proposed policies will result 
in a net decrease in burden of -5,488 hours and -$488,115. The proposal 
discussed in section IV.A.3.c.(1)(c) of this proposed rule to sunset 
the CMS Web Interface measures as a collection type/submission type 
starting with the 2021 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. 
The same proposal will increase the number of respondents for both the 
MIPS CQM and QCDR and eCQM collection types for the quality performance 
category 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. The proposal discussed in 
section IV.A.3.c.(1)(e)(i) of this proposed 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 proposal discussed in section 
IV.A.3.c.(3)(b)(i)(B)(bb) of this proposed 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 proposal 
discussed in section IV.A.3.c.(5)(e) of this proposed 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 
proposed rule.
    We have also added two new ICRs (Open Authorization (OAuth) 
Credentialing and Token Request Process (see section VI.B.5.d, below) 
and the Nomination of MVPs (see section VI.B.5.k, below). 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 VI.B.5. 
of this proposed 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 2018 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.

[[Page 50342]]

(4) Framework for Understanding the Burden of MIPS Data Submission
    Because of the wide range of information collection requirements 
under MIPS, Table 53 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 53, 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 53.
    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 proposed 
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 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 50343]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.088

BILLING CODE 4120-01-C

[[Page 50344]]

    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 proposed rule create some additional data collection 
requirements not listed in Table 53. 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 
VI.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).
     Open Authorization Credentialing and Token Request Process 
(New) (OMB 0938-1314) (see section VI.B.5.d).
Additional ICRs Related to the Data Submission and the Quality 
Performance Category (See Section VI.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 VI.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 VI.B.5.f, VI.B.5.h, VI.B.5.j. and VI.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 VI.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 VI.B.5.m and VI.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 proposing 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 proposed multiple changes to 
the third party intermediary regulations at Sec.  414.1400. 
Specifically, we are proposing to: (1) Amend 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) require attendance by 
all third party intermediaries for training and support sessions; (3) 
require 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 increase 
requirements for QCDR measure testing and clarify what is meant by full 
testing; and (5) require 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.\109\ 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.
---------------------------------------------------------------------------

    \109\ 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
    This rule is not proposing any new or revised collection of 
information requirements or burden related solely to QCDRs. For 
simplicity and due to limitations in data available, the changes in 
burden associated with QCDRs due to this rule's proposals have been 
incorporated into the discussion of burden for qualified registries. We 
assume no additional changes in burden due to other proposals discussed 
in this section. The requirements and burden for QCDRs are currently 
approved by OMB under control number 0938-1314 (CMS-10652). 
Consequently, we are not making any changes under that control number 
other than those discussed in the context of 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

[[Page 50345]]

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-
nomination of QCDRs and nomination of QCDR measures. In sections 
VI.A.3.g.(2)(a) of this rule, we are proposing to codify that beginning 
with the 2023 payment year as a condition of approval each QCDR must 
conduct an annual data validation audit that conforms 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 propose 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. In addition, we propose to codify 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 proposal to codify that QCDRs must 
conduct particular data validation audits and report data validation 
results because we believe the burdens of the proposed 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 proposal to require QCDRs to conduct 
targeted audits if one or more data errors are identified during data 
validation audits, we are unable to estimate the number of targeted 
audits which may occur or the time and costs associated with submitting 
results which could vary substantially depending on the nature of the 
data error and the amount of data to be audited. We seek comment on the 
burdens associated with the proposed 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 
proposal. We also discuss additional impacts of this proposal in 
section VIII.F.16.d.(4)(d) of the Regulatory Impact Analysis.
    In sections VI.A.3.g.(1)(b)(iii) of this rule, we are proposing to 
codify 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 
proposed 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 proposals. 
However, we refer readers to section VIII.F.16.d.(4)(d) of this 
proposed rule for discussion of our estimates of overall impact.
    In section VI.A.3.g.(1)(b)(ii) of this rule, we are proposing 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 proposal 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 proposal 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 proposal. We are soliciting public 
feedback to help us determine if there are any burden implications.
(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 VI.A.3.g.(2)(b)(i)(A)(aa) of this rule, we 
are proposing an incremental approach to require fully tested QCDR 
measures. Specifically, we propose at Sec.  414.1400(b)(3)(v)(C)(1) 
that, generally, QCDR measures that were previously approved for the CY 
2020 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 proposals are not modifying the final testing 
requirements for QCDR measures but are instead proposing 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.F.16.d.(4)(d) of this proposed rule for discussion of impacts 
associated with this proposal. Such burden estimates and requirements 
are currently approved by OMB under control number 0938-1314 (CMS-
10621). We seek comment on our burden estimates and assumptions

[[Page 50346]]

associated with these proposals regarding the testing of QCDR measures 
including those which will be included in an MVP.
(3) Qualified Registry Self-Nomination Process and Other Requirements
    The requirements and burden associated with this rule's proposed 
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 sections IV.A.3.g.(3)(a) of this rule, we are proposing to 
codify that beginning with the 2023 payment year as a condition of 
approval each qualified registry must conduct an annual data validation 
audit that conforms 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 propose 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. In addition, we propose 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. We are not revising our 
burden estimates as a result of the proposal to codify that qualified 
registries must conduct particular data validation audits and report 
data validation results because we believe the burdens of the proposed 
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 proposal to require qualified 
registries conduct targeted audits if one or more data errors are 
identified during data validation audits, we are unable to estimate the 
number of targeted audits which may occur or the time and costs 
associated with submitting results which could vary substantially 
depending on the nature of the data error and the amount of data to be 
audited. We seek comment on the burdens associated with the proposed 
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 proposal. We also discuss additional impacts of 
this proposal in section VIII.F.16.d.(4)(d) of the Regulatory Impact 
Analysis.
    In sections VI.A.3.g.(1)(b)(iii) of this rule, we are proposing to 
codify 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 
proposed 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 proposals. 
However, we do refer readers to section VIII.F.16.d.(4)(d) of this 
proposed rule for discussion of our estimates of the overall impact of 
this proposal for all third party intermediaries.
    In section VI.A.3.g.(1)(b)(ii) of this rule, we are proposing 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 proposal 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. We also do not anticipate this proposal 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 proposal. We are 
soliciting public feedback to help us determine if there are any burden 
implications.
    In section VI.A.3.g.(4) of this proposed rule, we are proposing to 
modify 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 proposed rule. In 
addition, to clarify expectations and create consistency in the content 
of the CAPs provide by third party intermediaries, we are proposing to 
revise and elaborate on the obligations for a CAP in this proposed 
rule. Specifically, we propose 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

[[Page 50347]]

recur in the future and (4) the detailed timeline for achieving 
compliance with the applicable requirements. Specifically, we propose 
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. We also propose 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. In addition, we propose 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. Furthermore, we propose at Sec.  414.1400(f)(1)(i)(D) that 
each CAP must include 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 proposed 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.
    In the CY 2020 PFS final rule, we estimated 153 qualified 
registries would self-nominate (84 FR 63116). Using updated wage rates, 
the currently approved burden associated with these qualified 
registries is 459 hours (153 respondents x 3 hr/respondent) at a cost 
of $42,439 (459 hr x $92.46/hr). 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 a total of 489 hours (459 
hr + 30 hr) at a cost of $45,213 ($42,439 + $2,774).
(4) Survey Vendor Requirements
    This rule is not proposing 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 proposing 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 
proposals promulgated in this proposed 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 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 
proposed burden associated with the OAuth

[[Page 50348]]

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 
VI.B.5.e.(5), VI.B.5.e.(6), VI.B.5.g, and VI.B.5.i of this proposed 
rule individual clinicians or groups may submit their quality measures 
using the direct submission type via the MIPS CQM and QCDR or eCQM 
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 54, 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] TP17AU20.089

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 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 QP 
List for the 2019 third snapshot that contains participation in 
Advanced APMs as of August 31, 2019, 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). As in the CY 2020 PFS final rule, we are using 
2018 MIPS performance period data to estimate the number of 
respondents, so we use the same methodology for this proposed rule; 
however, because of changes in the number of QPs and APM participation, 
the application of this methodology results in a slightly different 
adjustment to our estimates of respondents. In the CY 2020 PFS final 
rule, this approach resulted in a 103,103 decrease in the estimated 
number of clinicians who will submit quality data via Medicare Part B 
claims and a 12,931 increase in the number of clinicians who will 
submit via the QCDR/MIPS CQM collection type (84 FR 63122). For this 
rule, our assumptions result in a 101,390 decrease (from 195,977 to 
94,587 in the estimated number of clinicians who will

[[Page 50349]]

submit quality data via Medicare Part B claims and a 12,496 increase 
(from 92,340 to 104,836 in the number of clinicians who will submit via 
the MIPS CQM and QCDR collection type.
    In section IV.A.3.c.(1)(c) of this rule, we are proposing to sunset 
the CMS Web Interface measures as a collection type/submission type 
starting with the 2021 performance period. If this proposal is 
finalized, it will result in groups of 25 or more clinicians that 
previously submitted quality performance data via the CMS Web Interface 
being required to use an alternate collection type, 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 
2018 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 1,335 TINs 
with a practice size of 25 to 49 clinicians which submitted data for 
the 2018 MIPS performance period, 974 (73 percent) submitted data via 
the MIPS CQM and QCDR collection type and 361 (27 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 2018 MIPS 
performance period to estimate that 8 (11 TINs x 0.73) would elect to 
submit data via the MIPS CQM and QCDR collection type and the remaining 
3 (11 TINs x 0.27) would elect to submit data via the eCQM collection 
type. In total, we estimate that 50 of the 111 groups that submitted 
data via the CMS Web Interface collection type for the 2018 MIPS 
performance period will now submit quality data via the MIPS CQM and 
QCDR collection type and 61 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. In total, 
of the estimated 39,318 individual clinicians affected by this 
proposal, we estimate that 11,448 would submit quality data as part of 
a group via the MIPS CQM and QCDR collection type and 27,870 would 
submit quality data as part of a group via the eCQM collection type. 
These estimates are reflected in Tables 55 and 57 and the associated 
changes in burden are reflected in Tables 61, 63, and 85. In aggregate, 
as discussed in sections VI.B.5.e.(5), (6), and (9) of this proposed 
rule, we estimate the proposal 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.F.16.d.(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 VI.4.a.(4) of this 
proposed 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 third snapshot 
data of the 2019 QP performance period and supplemented with clinicians 
who are in an APM in 2018 but not in the 2019 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. If a 
MIPS eligible clinician is determined to not be scored as a MIPS APM, 
then their reporting assumption is based on their reporting for the CY 
2018 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.\110\ Tables 55, 56 and 
57 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.
---------------------------------------------------------------------------

    \110\ 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 55 provides our estimated counts of clinicians that will 
submit quality performance category data as MIPS individual clinicians 
or groups in the 2021 MIPS performance period based on data from the 
2018 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. We estimate the 
burden for collecting data via collection type: Claims, QCDR and MIPS 
CQMs, and eCQMs. 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 55, using participation data from the 2018 MIPS 
performance period combined with the estimate of QPs for the 2021 
performance period, we estimate a total of 792,061 clinicians will 
submit quality data as individuals or groups in the 2021 MIPS 
performance period, an increase of 11,456 clinicians when compared to 
our estimate of 780,605 clinicians in the CY 2020 PFS final rule (84 FR 
63122). We estimate 94,587 clinicians will submit data as individuals 
for the Medicare Part B claims collection type; 410,518 clinicians will 
submit data as individuals or as part of groups for the MIPS CQM and 
QCDR collection type; and 286,956 clinicians will submit data as 
individuals or as part of groups via eCQM collection types.
    Table 55 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

[[Page 50350]]

expected number of clinicians to submit as individuals or part of 
groups.
[GRAPHIC] [TIFF OMITTED] TP17AU20.090

    In the CY 2018 Quality Payment Program final rule (82 FR 53625 
through 53626), beginning with the 2019 MIPS performance period, we 
allowed MIPS eligible clinicians to submit data for multiple collection 
types for a single performance category. Therefore, with the exception 
of clinicians not in small practices who previously submitted quality 
data via Medicare Part B claims, 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. Hence, the estimated numbers of individual clinicians 
and groups to collect via the various collection types are not mutually 
exclusive and reflect the occurrence of individual clinicians or groups 
that collected data via multiple collection types during the 2018 MIPS 
performance period.
    Table 56 uses methods similar to those described to estimate the 
number of clinicians that will submit data as individual clinicians via 
each collection type in the 2021 MIPS performance period. We estimate 
that approximately 94,587 clinicians will submit data as individuals 
using the Medicare Part B claims collection type; approximately 104,836 
clinicians will submit data as individuals using MIPS CQM and QCDR 
collection type; and approximately 41,477 clinicians will submit data 
as individuals using eCQMs collection type.
[GRAPHIC] [TIFF OMITTED] TP17AU20.091

    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 56 are not mutually exclusive.
    Table 57 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 MIPS performance period. We assume that 
groups that submitted quality data as groups in the 2018 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 MIPS performance 
period. Specifically, we estimate that 11,071 groups and virtual groups 
will submit data for the MIPS CQM and QCDR collection type on behalf of 
305,682 clinicians; and 4,474 groups and virtual groups will submit for 
eCQM collection types on behalf of 245,479 eligible clinicians. In 
section IV.A.3.(b) of this rule, we are proposing the APM Performance 
Pathway for clinicians in APM Entities. The APM Performance Pathway is 
available for both ACO and non ACOs. However, due to data limitations 
and our inability to determine who would use the APM Performance 
Pathway versus the traditional MIPS submission mechanism, we assume 
non-ACO APM Entities would participate through traditional MIPS and 
base our estimates on submissions received in the 2018 MIPS performance 
period.

[[Page 50351]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.092

    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 
206. The new MIPS quality measures proposed 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 proposed substantive 
changes can be found in Table Group D of Appendix 1; and MIPS quality 
measures proposed for removal can be found in Table Group C of Appendix 
1. These measures are stratified by collection type in Table 58 as well 
as counts of new, removed, and substantively changed measures.
[GRAPHIC] [TIFF OMITTED] TP17AU20.093

    For the 2021 MIPS performance period, there is a net reduction of 
12 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 proposing 
to add 2 new administrative claims outcome measures, remove 14 quality 
measures, and make substantive updates to 92 quality measures where the 
changes will require the removal of an existing benchmark. We do not 
anticipate that removing these measures will increase or decrease the 
reporting burden on clinicians and groups as respondents are still 
required to submit quality data for 6 measures.
(3) Quality Payment Program Identity Management Application Process
    This rule is not proposing 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 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 proposing 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 proposed burden

[[Page 50352]]

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 55, based on 2018 MIPS performance period data, 
we assume that 94,587 individual clinicians will collect and submit 
quality data via the Medicare Part B claims collection type. This rule 
is proposing to adjust the number of Medicare Part B claims respondents 
from 94,846 to 94,587 (a decrease of 259) based on more recent data and 
our methodology of accounting only for clinicians in small practices 
who submitted such claims data in the 2018 MIPS performance period 
rather than all clinicians who submitted quality data codes to us for 
the Medicare Part B claims collection type.
    As shown in Table 59, 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 676,297 hours (7.15 hr x 
94,587 clinicians) to 1,343,135 hours (14.2 hr x 94,587 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 $69,713,362 (94,587 
clinicians x $737.03) to a maximum of $131,369,236 (94,587 clinicians x 
$1,388.87).
    Table 59 summarizes the range of total annual burden associated 
with clinicians submitting quality data via Medicare Part B claims.
[GRAPHIC] [TIFF OMITTED] TP17AU20.094


[[Page 50353]]


    As shown in Table 60, 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 94,587 results in a 
total adjustment of between -1,852 hours (-259 respondents x 7.15 hr/
respondent) at a cost of -$190,891 (-259 respondents x $737.03/
respondent) and -3,678 hours (-259 respondents x 14.2 hr/respondent) at 
a cost of -$359,718 (-259 respondents x $1,388.87/respondent). For 
purposes of calculating total burden associated with the proposed rule 
as shown in Table 60, only the maximum burden is used.

[GRAPHIC] [TIFF OMITTED] TP17AU20.095

(5) Quality Data Submission by Individuals and Groups Using MIPS CQM 
and QCDR Collection Types
    The following proposed 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.
    As discussed in section IV.A.3.c.(1)(c) of this rule, we are 
proposing to sunset the CMS Web Interface measures as a collection type 
and submission type starting with the 2021 performance period. Using 
the methodology discussed in section VI.B.5.e.(1) of this proposed 
rule, we estimate 50 groups which previously submitted quality data via 
the CMS Web Interface collection type will now submit quality data via 
the MIPS CQM and QCDR collection type.
    As noted in Tables 55, 56, and 57, and based on 2018 MIPS 
performance period data, we assume that 410,518 clinicians will submit 
quality data as individuals or groups using MIPS CQM or QCDR collection 
types; 104,836 clinicians will submit as individuals and the remaining 
305,682 clinicians will submit as members of 11,071 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 an annual burden of 1,052,783 hours 
[9.083 hr/response x (104,836 clinicians submitting as individuals + 
11,071 groups submitting via QCDR or MIPS CQM on behalf of individual 
clinicians or 115,907 responses)] at a cost of $ 104,023,540 (115,907 
responses x $897.47/response). Based on these assumptions, we have 
estimated in Table 61 the burden for these submissions.

[[Page 50354]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.096

    As shown in Table 62, using the unchanged currently approved per 
respondent burden estimate, the increase of 4,689 respondents from 
111,218 to 115,907 results in an increase of 42,590 hours (4,689 
respondents x 9.083 hr/respondent) and $4,208,256 (4,689 respondents x 
$897.47/respondent).

[GRAPHIC] [TIFF OMITTED] TP17AU20.097


[[Page 50355]]


(6) Quality Data Submission by Clinicians and Groups: eCQM Collection 
Type
    The following proposed 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 section IV.A.3.c.(1)(c) of this rule, we are proposing to sunset 
the CMS Web Interface measures as a collection type and submission type 
starting with the 2021 performance period. Using the methodology 
discussed in section VI.B.5.e.(1) of this proposed rule, we estimate 61 
groups which previously submitted quality data via the CMS Web 
Interface collection type will now submit quality data via the eCQM 
collection type.
    Based on 2018 MIPS performance period data, we assume that 286,956 
clinicians will elect to use the eCQM collection type; 41,477 
clinicians are expected to submit eCQMs as individuals; and 4,474 
groups and virtual groups are expected to submit eCQMs on behalf of the 
remaining 245,479 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. For this collection 
of information request, we estimate 45,951 respondents (41,477 
clinicians who are expected to submit eCQMs as individuals + 4,474 
groups and virtual groups who are expected to submit eCQMs) an increase 
of 2,618 respondents (45,951 proposed respondents-43,333 active 
respondents).
    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 we estimate an annual burden of 367,608 hours (8 hr x 
45,951 groups and clinicians submitting as individuals) at a cost of 
$36,638,570 (45,951 responses x $797.34/response). Based on these 
assumptions, we have estimated in Table 63 the burden for these 
submissions.

[[Page 50356]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.098

    As shown in Table 64, using the unchanged currently approved per 
respondent burden estimate, the increase of 2,618 respondents from 
43,333 to 45,951 results in a total difference of 20,944 hours (2,618 
respondents x 8 hr/respondent) at a cost of $2,087,436 (2,618 
respondents x $797.34/respondent).
[GRAPHIC] [TIFF OMITTED] TP17AU20.099

(7) Beneficiary Responses to CAHPS for MIPS Survey
    In this proposed rule, we are proposing changes to requirements for 
the CAHPS for MIPS survey which, if finalized, 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)(e)(ii), we are proposing to (1) revise and 
codify at

[[Page 50357]]

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) revise the CAHPS for MIPS 
Survey cover page to include a reference to care received in telehealth 
settings. We do not believe any of these proposals 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, we are also proposing in IV.A.2.c.(1)(e)(i) to add 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 proposal 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 29,915 beneficiaries will respond to the survey during the 2021 
MIPS performance period. This is a decrease of 9,124 from our currently 
approved estimate of 39,039 beneficiaries. Using this updated number of 
respondents and our revised estimate of burden per respondent, we 
estimate an annual burden of 6,531 hours (29,915 respondents x 0.2183 
hr/respondent) at a cost of $167,989 (6,531 hr x $25.72/hr). Table 66 
shows the estimated annual burden for beneficiaries to participate in 
the CAHPS for MIPS Survey.
[GRAPHIC] [TIFF OMITTED] TP17AU20.100

    Independent of the change in burden per respondent, the decrease of 
-9,124 respondents from 39,039 to 29,915 results in a difference of -
1,962 hours (-9,124 respondents x 0.215 hr/respondent) at a cost of -
$50,454 (-9,124 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 (29,915 
respondents x 0.0033 hr/respondent) at a cost of $2,565 (100 hrs x 
$25.72/hr). As shown in Table 66, the aggregate change in burden is -
1,862 hours (100 hours-1,962 hours) at a cost of -$47,889 ($2,565-
$50,454).
[GRAPHIC] [TIFF OMITTED] TP17AU20.101

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.
(8) Group Registration for CAHPS for MIPS Survey
    This rule is not proposing 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.
(9) Removal of Quality Data Submission by Clinicians and Groups: CMS 
Web Interface Collection Type and Group Registration for CMS Web 
Interface ICRs
    The following proposed changes will be submitted to OMB for 
approval under control number 0938-1314 (CMS-10621).

[[Page 50358]]

    As discussed in section IV.A.3.c.(1)(c) we are proposing to sunset 
the CMS Web Interface measures as a collection type/submission type 
starting with the 2021 performance period. If this proposal is 
finalized, it will result in removal of the CMS Web Interface 
collection type and group registration for CMS Web Interface ICRs as 
they will no longer be necessary. In the CY 2020 PFS final rule, we 
estimated the time associated with quality data submissions via the CMS 
Web Interface to be 6,414 hours (104 responses x 61.67 hr per response) 
(84 FR 63130). Using more recent BLS wage estimates, we estimate a cost 
of $593,038 (6,414 hr x $92.46/hr). We had also estimated the time 
associated with group registration for the CMS Web Interface to be 
17.25 hours (69 responses x 0.25 hr per response) (84 FR 63131). Using 
more recent BLS wage estimates, we estimate a cost of $1,595 (17.25 hr 
x $92.46/hr). In this regard, this rule proposes a reduction of 6,431 
hours (6,414 hr + 17.25 hr) and $594,633 ($593,038 + $1,595) (see Table 
85).
f. ICRs Regarding the Call for MIPS Quality Measures
    This rule is not proposing 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 proposed 
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 67 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 2019 Coronavirus 
Disease (COVID-19) pandemic, 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 are proposing 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 VI.B.5.a.(4), 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,

[[Page 50359]]

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 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 67, 
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] TP17AU20.102

    As shown in Table 68, 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] TP17AU20.103

(3) Submitting Promoting Interoperability Data
    This rule is not proposing 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 proposed 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 proposed rule, we are not proposing any changes to our 
current criteria for automatic reweighting of the

[[Page 50360]]

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 proposing 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. 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)(2)(b) we are proposing 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 proposal 
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 proposal 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 proposal in section IV.A.3.(b) of this 
proposed rule to establish an APM Performance Pathway, our reporting 
assumptions for clinician in MIPS APMs remains unchanged.
    As shown in Table 69, based on data from the 2018 MIPS performance 
period, we estimate that a total of 77,499 respondents consisting of 
62,746 individual MIPS eligible clinicians and 14,753 groups and 
virtual groups will submit Promoting Interoperability data. Since our 
CY 2020 final rule estimated 74,281 respondents, this represents an 
increase of 3,218 respondents (77,499 proposed respondents-74,281 
active respondents).
    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 proposed 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] TP17AU20.104

    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 70, the total burden estimate for submitting data on the 
specified Promoting Interoperability objectives and measures is 
estimated to be 206,664 hours (77,499 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 $19,108,153 (206,664 hr x $92.46/
hr)).

[[Page 50361]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.105

    As shown in Table 71, using our unchanged currently approved per 
respondent burden estimate, the decrease in number of respondents 
results in a total adjustment of +8,581 hours (3,218 respondents x 2.67 
hr/respondent) at a cost of +$793,430 (8,581 hr x $92.46/hr).
[GRAPHIC] [TIFF OMITTED] TP17AU20.106

h. ICRs Regarding the Nomination of Promoting Interoperability (PI) 
Measures
    This rule is not proposing 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 proposed 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 proposed rule, we are not proposing 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 
proposing for the CY 2021 performance period and future years to modify 
2 existing improvement activities. We refer readers to Appendix 2 of 
this proposed 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 proposals to affect our currently approved information 
collection burden estimates.
    In section IV.A.3.(b).(3)(c) of this rule, we propose how we would 
assign a score for the Improvement Activities performance category for 
MIPS APMs. We would 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 
would 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 proposal, 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 
propose 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 50362]]

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. 
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 72, based on 2018 MIPS performance period 
data, we estimate that a total of 102,474 respondents consisting of 
85,760 individual clinicians and 16,714 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 -1,339 respondents (102,474 proposed respondents-103,813 
active respondents).
    As discussed in sections VI.B.5.e.(2) and VI.B.5.g.(3) of this 
proposed 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 2018 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] TP17AU20.107

    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 73, we estimate an annual burden of 8,540 hours 
(102,474 responses x 5 minutes/60) and $789,562 (8,540 hr x $92.46/
hr)).
[GRAPHIC] [TIFF OMITTED] TP17AU20.108

    As shown in Table 74, using our unchanged currently approved per 
respondent burden estimate, the decrease in the number of respondents 
results in an adjustment of -111 hours (-1,339 responses x 5 minutes/
60) at a cost of -$10,317 (-111 hr x $92.46/hr).

[[Page 50363]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.109

j. ICRs Regarding the Nomination of Improvement Activities (Sec.  
414.1360)
    The requirements and burden associated with this rule's proposed 
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 
proposing to require 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 proposing 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. 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 proposal, 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 proposal. Additionally, in section 
IV.A.3.c.(3)(b)(ii)(B), we are proposing, beginning with the CY 2021 
performance period and future years, to 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 
section VIII.F.16.d.(4)(c) where we discuss our impact analysis.
    The 2020 Annual Call for Activities will end on July 1, 2020. 
Therefore, 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 shown in Table 75, 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)]).

[[Page 50364]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.110

    As shown in Table 76, 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] TP17AU20.111

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 proposed 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 proposing at 
that stakeholders should formally submit their MVP candidates utilizing 
a standardized template, which will be published in the QPP resource 
library four 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 section 
IV.A.3.a.(2)(a)(i) of this proposed 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 seek comment on our estimate 
of the 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 77, 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 50365]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.112

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 proposed 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)(ii) and 
414.1430)
    This rule is not proposing 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 proposed burden 
will be submitted to OMB for approval under control number 0938-1314 
(CMS-10621).
    As shown in Table 78, 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] TP17AU20.113

    As shown in Table 79, 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 50366]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.114

n. ICRs Regarding Other Payer Advanced APM Determinations: Payer-
Initiated Process (Sec.  414.1445) and Eligible Clinician Initiated 
Process (Sec.  414.1445)
    The following proposed 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 proposing 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 80, 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] TP17AU20.115

    As shown in Table 81, 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] TP17AU20.116


[[Page 50367]]


(2) Eligible Clinician Initiated Process (Sec.  414.1445)
    This rule is not proposing 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 proposing 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 proposing 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 2018 MIPS performance period. The proposed 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 9,904 (0.10 x 99,042 
voluntary MIPS participants) clinicians and groups, a decrease of 138 
from the currently approved estimate of 10,042. 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 82 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 2,476 hours (9,904 requests x 0.25 hr/request) and $228,931 (2,476 
hr x $92.46/hr).
[GRAPHIC] [TIFF OMITTED] TP17AU20.117

    As shown in Table 83, using our unchanged currently approved per 
respondent burden estimate, the decrease of -138 opt outs by voluntary 
participants results in an adjustment of -34.5 hours (-138 requests x 
0.25 hr) from our currently approved burden of 2,510.5 hours at a cost 
of -$3,190 (-34.5 hr x $92.46/hr) (84 FR 63145).

[[Page 50368]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.118

p. Summary of Annual Quality Payment Program Burden Estimates
    Table 85 summarizes this proposed rule's burden estimates for the 
Quality Payment Program. 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 burden 
of continuing policies and information set forth in the CY 2020 PFS 
final rule into the 2021 MIPS performance period is 2,937,520 hours at 
a cost of $287,160,638; an increase of 4,871 hours and $7,610,148. To 
understand the burden implications of the policies proposed 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 MIPS performance period. This burden 
estimate of 3,008,022 hours at a cost of $293,717,313 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 70,502 hours and $7,044,791. This burden 
estimate is higher 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 proposed in this rule or 
finalized in any previous final rule, but rather an operational 
improvement. The difference of -5,488 hours (70,502 hours-66,876 hours 
+ 1,862 hours) and -$488,115 ($7,044,791-$6,604,565 + $47,889) between 
this estimate and the total burden shown in Table 87 is the reduction 
in burden associated with impacts of the proposed 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 proposed policy to add a survey-
based measure on telehealth that assesses patient-reported usage of 
telehealth services to the CAHPS for MIPS Survey, the proposal to allow 
APM Entities to submit an extreme and uncontrollable circumstances 
exception application, and the proposed 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 84 to 
assist in understanding these differences.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TP17AU20.119


[[Page 50369]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.120

    Table 86 provides the reasons for changes in the estimated burden 
for information collections in the Quality Payment Program segment of 
this proposed 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 50370]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.121


[[Page 50371]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.122

C. Summary of Annual Burden Estimates for Proposed Requirements
[GRAPHIC] [TIFF OMITTED] TP17AU20.123

BILLING CODE 4120-01-C

D. Submission of Comments

    We have submitted a copy of this rule to OMB for its review of the 
rule's proposed information collection requirements and burden. The 
requirements are not effective until they have been approved by OMB.
    To obtain copies of the supporting statement and any related forms 
for the proposed collections previously discussed, please visit CMS's 
website at https://www.cms.gov/Regulations-andGuidance/Legislation/PaperworkReductionActof1995/PRAListing.html, or call the Reports 
Clearance Office at (410) 786-1326.
    We invite public comments on the proposed information collection 
requirements and burden. If you wish to comment, please submit your 
comments electronically as specified in the DATES and ADDRESSES 
sections of this proposed rule and identify the rule (CMS-1734-P) and 
where applicable the ICR's CFR citation, CMS ID number, and OMB control 
number.

VII. Response to Comments

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

[[Page 50372]]

VIII. Regulatory Impact Analysis

A. Statement of Need

    This proposed 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 proposed rule would also 
make changes to payment policy and other related policies for Medicare 
Part B.
    This proposed 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 proposed rule 
would redistribute more than $100 million in 1 year. Therefore, we 
estimate that this rulemaking is ``economically significant'' as 
measured by the $100 million threshold, and hence also a major rule 
under the Congressional Review Act. Accordingly, we prepared an RIA 
that, to the best of our ability, presents the costs and benefits of 
the rulemaking. The RFA requires agencies to analyze options for 
regulatory relief of small entities. For purposes of the RFA, small 
entities include small businesses, nonprofit organizations, and small 
governmental jurisdictions. Most hospitals, practitioners and most 
other providers and suppliers are small entities, either by nonprofit 
status or by having annual revenues that qualify for small business 
status under the Small Business Administration standards. (For details, 
see the SBA's website at 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 
proposed 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 603 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 
nonphysician practitioners (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 
proposed 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 proposed rule will impose 
no mandates on state, local, or tribal governments or on the private 
sector.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it issues a proposed rule (and subsequent final 
rule) that imposes substantial direct requirement costs on state and 
local governments, preempts state law, or otherwise has Federalism 
implications. Since this regulation does not impose any costs on state 
or local governments, the requirements of Executive Order 13132 are not 
applicable.
    Executive Order 13771, entitled ``Reducing Regulation and 
Controlling Regulatory Costs,'' was issued on January 30, 2017. This 
proposed rule, if finalized, is expected to be an E.O. 13771 regulatory 
action. We estimate the rule generates $1.34 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 proposed rule; details the costs and benefits of the rule; 
analyzes alternatives; and presents the measures we would use to 
minimize the burden on small entities. As indicated elsewhere in this 
proposed rule, we proposed a variety of changes to our regulations, 
payments, or payment policies to ensure that our payment systems 
reflect changes in medical practice and the relative value of services, 
and implementing statutory provisions. We provide information for each 
of the policy changes in the relevant sections of this proposed rule.

[[Page 50373]]

We are unaware of any relevant federal rules that duplicate, overlap, 
or conflict with this proposed rule. The relevant sections of this 
proposed rule contain a description of significant alternatives if 
applicable.

C. Changes in Relative Value Unit (RVU) Impacts

1. Resource-Based Work, PE, and MP RVUs
    Section 1848(c)(2)(B)(ii)(II) of the Act requires that increases or 
decreases in RVUs may not cause the amount of expenditures for the year 
to differ by more than $20 million from what expenditures would have 
been in the absence of these changes. If this threshold is exceeded, we 
make adjustments to preserve budget neutrality.
    Our estimates of changes in Medicare expenditures for PFS services 
compared payment rates for CY 2020 with payment rates for CY 2021 using 
CY 2019 Medicare utilization. The payment impacts in this proposed rule 
reflect averages by specialty based on Medicare utilization. The 
payment impact for an individual practitioner could vary from the 
average and would depend on the mix of services he or she furnishes. 
The average percentage change in total revenues 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 annual update to the PFS conversion factor (CF) was previously 
calculated based on a statutory formula; for details about this 
formula, we refer readers to the CY 2015 PFS final rule with comment 
period (79 FR 67741 through 67742). Section 101(a) of the MACRA 
repealed the previous statutory update formula and amended section 
1848(d) of the Act to specify the update adjustment factors for CY 2015 
and beyond. The 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 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 32.2605 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 
19.9631 which reflects the same overall PFS adjustments with the 
addition of anesthesia-specific PE and MP adjustments.
[GRAPHIC] [TIFF OMITTED] TP17AU20.124

    Table 90 shows the payment impact on PFS services of the policies 
contained proposed rule. To the extent that there are year-to-year 
changes in the volume and mix of services provided by practitioners, 
the actual impact on total Medicare revenues will be different from 
those shown in Table 90 (CY 2021 PFS Estimated Impact on Total Allowed 
Charges by Specialty). The following is an explanation of the 
information represented in Table 90.
     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

[[Page 50374]]

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.
BILLING CODE 4120-01-P

[[Page 50375]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.125


[[Page 50376]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.126

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 proposed 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, our proposal to increase 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 
+5 percent. For clinical social workers and clinical psychologists, our 
proposals to increase the valuations for certain behavioral health 
services that are analogous to office/outpatient E/M visits result in 
estimated impacts of 0 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 -8 percent reflect proposed 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 3 percent gain as a result of proposed 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 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 90), including comments received 
in response to the proposed rates. We remind stakeholders that although 
the estimated impacts are displayed at the specialty level, typically 
the changes are driven by the valuation of a relatively small number of 
new and/or potentially misvalued codes. The percentages in Table 90 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 90 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 proposed 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/.

D. Effect of Changes Related to Telehealth Services

    As discussed in section II.F. of this proposed rule, we are 
proposing to add eight new codes, HCPCS code GPC1X and CPT codes 99XXX, 
96121, 99483, 99334, 99335, 99347, and 99348, to the list of Medicare 
telehealth services list for CY 2021. We are also proposing to add the 
following services provisionally on a category 3 basis: CPT codes 
96130,

[[Page 50377]]

96131, 96132, 96133, 96136, 96137, 96138, 96139, 99281, 99282, 99283, 
99315, 99316, 99336, 99337, 99349, and 99350. 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 are furnished via 
telehealth, on average, less than 0.1 percent of the time they are 
reported overall. The restrictions placed on Medicare telehealth 
services by section 1834(m) of the statute limit increases in 
utilization; however, we believe there is value in allowing physicians 
to furnish these additional services via Medicare 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, 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 would 
not anticipate any significant uptick in utilization.

E. Effect of Proposed Changes Related to Scopes of Practice

    As discussed in section II.G. Scopes of Practice for PFS Services, 
of this proposed rule, we proposed to allow certain nonphysician 
practitioners to supervise diagnostic tests, which would authorize NPs, 
CNSs, PAs, and CNMs 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. However, 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.
    An alternative in the case of this proposal concerning supervision 
of diagnostic tests is 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.
    Also, we are proposing 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 based on respondents 
feedback on scope of practice following the President's Executive Order 
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. Our proposal would 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 do 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 Executive Order 
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 our proposal would 
permit this to occur in all settings when therapy is paid under Part B.
    In summary, we expect that these proposed policies regarding scope 
of practice would result in increased administrative and clinical 
flexibility for the specified professionals, but we cannot determine 
the specific impact our proposed policies would have on practice 
business plans and demand for certain types of clinicians. This is 
especially true due to the wide variation in diagnostic tests as well 
as variation in state law and facility policies.

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

    As discussed in section II.H. Valuation of Specific Codes, of this 
proposed rule, we are proposing to expand 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 
proposed 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 approach to billing in cases where all of the services 
described in the code descriptors are furnished. In our

[[Page 50378]]

previous response, we sought to clarify 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, just an E/M visit code.

G. Effect of Proposed 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 proposing to create two new add-on codes, one 
add-on code for nasal naloxone and another add-on code for auto-
injector naloxone. We are proposing to price nasal naloxone based upon 
the methodology set forth in section 1847A of the Act, except that the 
payment amount shall be ASP + 0. We are proposing to price the auto-
injector using the lowest pricing available (the lower of ASP + 0, WAC 
+ 0, or NADAC). Under this methodology, the proposed price for nasal 
naloxone would be $89.63 per 2-pack and the proposed price for the 
naloxone auto-injector would be $178 per 2-pack. We are proposing 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 estimate the cost impact of the recommended naloxone add-on 
codes will be approximately $2.28 million in CY 2021. This estimate is 
based on a maximum impact of approximately $23 million, scaled down 
using the percentage of beneficiaries on MAT who received naloxone 
under Medicare Part D in 2018 (9.91 percent). The maximum total annual 
cost was calculated using the proposed payment rate for the more 
expensive of the two codes, and we assumed every Medicare beneficiary 
receiving treatment at an OTP would receive the maximum allowed number 
of doses ($178 x 12 months) under the proposed frequency limit. 
However, we note that some patients would receive the less expensive 
nasal formulation and we believe that many patients would not require 
doses each month, if no need arises for opioid overdose reversal. This 
estimate uses the assumption from CY 2020 rulemaking that roughly 
10,600 beneficiaries would utilize the OTP benefit in the first year. 
This estimate also assumes that there is no beneficiary cost-sharing 
and makes no assumptions for ramp-up.
    We believe that the benefits associated with establishing payment 
for naloxone in the OTP setting justify the cost of this proposal. As 
noted in section II.I. of this proposed 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. 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.'' \111\ We are proposing 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 this proposal, beneficiaries 
receiving OUD treatment services from the OTP would be able to receive 
two doses of naloxone from the OTP every 30 days under the OUD 
treatment services benefit, to the extent it is medically reasonable 
and necessary as part of their OUD treatment. 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 would not need to 
visit a separate provider to access naloxone.
---------------------------------------------------------------------------

    \111\ https://www.hhs.gov/surgeongeneral/priorities/opioids-and-addiction/naloxone-advisory/index.html.
---------------------------------------------------------------------------

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 proposed 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 proposing to make certain conforming 
changes to the data reporting and payment requirements in our 
regulations at 42 CFR 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 rate-based 
CLFS update will be effective January 1, 2023 instead of January 1, 
2021. In addition, we are proposing to make conforming changes to our 
requirements for the phase-in of payment reductions to reflect the 
CARES Act amendments. Specifically, we are proposing 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 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 proposed 
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

[[Page 50379]]

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 III.B. of this proposed 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.
     10 OTPs that enroll using the Form CMS-855A would later 
change their enrollment to a Form CMS-855B.
    These 310 OTPs would be required to pay an application fee because 
said change to a Form CMS-855A 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. Although we cannot 
predict future changes to the CPI, the fee amounts between 2018 and 
2020 increased by an average of $13 per year. We believe this is a 
reasonable barometer with which to estimate (strictly for purposes of 
this proposed rule) the fee amount in CY 2021, the year in which we 
believe all of the above-referenced 310 OTPs would change their 
enrollments. Accordingly, we project a fee amount of $608 in 2021, 
resulting in a total application fee cost of $188,480 (310 x $608).
3. Payment for Principal Care Management (PCM) Services in Rural Health 
Centers (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: Proposed Rebasing and Revising of the 
FQHC Market Basket
    Since the proposed FQHC market basket and multi-factor productivity 
adjustment are the same under the current 2013-based market basket and 
the proposed 2017-based market basket (1.9 percent), we estimate no 
economic impact from rebasing and revising of the FQHC market basket 
for CY 2021.
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 proposing to implement 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 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 propose to align 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 
would reduce burden for Medicaid EPs by aligning the requirements for 
multiple reporting programs, and that the system changes required for 
EPs to implement this change would not be significant, as many EPs are 
expected to report eCQMs to meet the quality performance category of 
MIPS and therefore should be prepared to report on those eCQMs for 
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 proposed policy would 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 this proposal would be 
approximately $100,000 per state. State expenditures to make any 
systems changes that would be required as a result of this proposal 
would most likely be eligible for 90 percent Federal financial 
participation.
    For 2021, we propose to require 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 proposal 
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 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 proposal would be a continuation of our policy for 2020 
and we believe it will not create new burden for EPs or states.

[[Page 50380]]

7. Medicare Shared Savings Program
    In section III.G.1.c. of this proposed rule, we propose changes to 
the 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 losses under 
certain payment tracks, and avoid quality-related compliance actions. 
We are proposing 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. Please refer to section III.G.1.c. of this proposed rule for a 
detailed discussion of the data simulation used to inform the impacts 
for the proposed change to the quality performance standard.
    Our analysis of quality performance data reported by ACOs for 
performance year 2018 indicates that the proposed methodological 
changes in ACO quality scoring will reduce the mean ACO quality score 
by roughly 10 to 15 percentage points 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 an increase in the fraction of ACOs failing to achieve the 
minimum threshold for qualifying for potential shared savings, the 
proposal is estimated to marginally increase overall shared savings 
payments to ACOs because under the proposed approach we would no longer 
prorate the savings sharing rate for ACOs that do meet or exceed the 
threshold. Our best estimate is that shared savings payments to ACOs 
would increase by $38 million for the 2021 performance year because of 
these proposed changes, representing an increase in shared savings 
payments of only about 2 percent of projected total gross measured 
savings for ACOs earning shared savings that year. We also recognize 
that this impact could differ if the 40th percentile across all 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. Taking into account such possibilities indicates the 
impact of the proposed changes to the quality performance standard 
could range from $15 million in lower total shared savings payments to 
ACOs to $154 million in additional shared savings payments to ACOs 
(reflecting the respective extreme scenarios assumed above). However, 
it is important to note that under all scenarios, the program continues 
to achieve significant net savings after sharing savings with ACOs.
    We do not anticipate a material aggregate impact for the other 
proposed changes related to the Shared Savings Program, specifically 
the changes related to repayment mechanism requirements (section 
III.G.3. of this proposed rule) and the assignment methodology (section 
III.G.2. of this proposed rule); however, the latter proposal may have 
differing effects on a subset of participating ACOs, for example by 
changing which competing ACO ultimately achieves the assignment for a 
small subset of beneficiaries.
8. Modifications to Medicare Shared Savings Program Quality Reporting 
Requirements for Performance Year 2020
    We are proposing 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 CAHPS measures, we estimate moving to a 100 percent 
score for the CAHPS measures would 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.
9. Proposal To Remove Selected National Coverage Determinations
    We are proposing 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. Generally, 
proactively removing obsolete or unnecessary NCDs removes barriers to 
innovation and reduces burden for stakeholders and CMS. The nine 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 
national coverage determination 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 six NCDs where we are proposing to go 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 2019. For 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. 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. 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. 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.
    For the three non-covered NCDs proposed to be eliminated, we would 
not expect to find historical claims data. CMS broadly noncovers both 
Electrosleep Therapy (NCD 30.4) and Magnetic Resonance Imaging (NCD 
220.2.1) for all indications. CMS noncovers FDG PET (NCD 220.6.16) for 
three specific conditions. The FDG PET NCD as written is silent on 
covered conditions, thereby allowing MACs to determine coverage for all 
other conditions not specifically noncovered. 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

[[Page 50381]]

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 
proposed rule, including cost to Medicare.
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
    We believe that if finalized, our proposal to continue assigning 
certain section 505(b)(2) drug products to existing multiple source 
drug codes, as described in section III.L. of this proposed rule, would 
result in continued savings by preventing excessive payments for some 
drug products that are labeled and used in a manner that is similar to 
generic versions of existing products that are paid under multiple 
source drug codes. Finalizing this proposal would result in the 
continuation of what we have characterized as longstanding policy. We 
believe that savings would continue based on differences in Medicare 
payment allowances between codes that contain only section 505(b)(2) 
drug products (with labeling and uses that are similar to multiple 
source drug codes) and multiple source drug codes that include generic 
drugs with the same active ingredient(s). In these cases, recent 
payment limits determined under section 1847A of the Act for the 
505(b)(2) drugs were roughly 10 times higher than the payments for 
multiple source drug codes that included the generic drug products. The 
multiple source drug code payment limits used in the comparisons 
consisted of a weighted average of generic and branded drug products.
    We are not able to provide a detailed estimate of the potential 
continued savings for the following reasons. First, we cannot estimate 
how many section 505(b)(2) drug products will be approved over the next 
few years. Second, we cannot estimate how many of these drug products 
will be paid under Part B. Third, we cannot estimate what share of Part 
B drug claims relative to similar (and potentially lower priced) 
multiple source drug codes the section 505(b)(2) drug products will 
capture. Fourth, we cannot estimate the price or payment difference 
between the yet to be approved section 505(b)(2) drug products and 
items priced in multiple source drug codes. We also note that the 
proposed approach will not prevent the separate payment of all section 
505(b)(2) drug products. If an approved section 505(b)(2) drug product 
does not meet the definition of a multiple source drug as discussed in 
section III.L. of this proposed rule and is separately payable under 
Part B, that section 505(b)(2) drug product would be paid separately, 
for example it would be assigned to a single source drug code.
    However, we can provide a very rough estimate of the effect on 
spending that this policy has. Based on 2018 data on the Part B Drug 
Spending Dashboard (https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Information-on-Prescription-Drugs/MedicarePartB), a 50 percent uptake of two recently approved 
section 505(b)(2) drug products relative to the corresponding multiple 
source drug code, and payment allowance estimates derived from the July 
2020 ASP Drug Pricing files (or WAC from pricing compendia if ASP was 
not yet available), we estimate that payment under separate single 
source drug codes could result in $15 million to $33 million more 
spending per code each year for each section 505(b)(2) drug product 
that is assigned to a separate code. Even if a small number of section 
505(b)(2) drug products were paid under separate codes, for example 5 
to 10 each year, this could result in $75 million to $330 million in 
additional spending per year (just for each year's 5 to 10 new section 
505(b)(2) drug products). Over 10 years, the combined total for paying 
for 5 to 10 more additional section 505(b)(2) drug products each year 
using separate codes could result in over $1 billion in additional Part 
B spending if this proposal is not finalized and these section 
505(b)(2) drug products are treated as single source drugs.
    We also note that as discussed in section III.L. of this rule, the 
proposed approach will not prevent the separate payment of all section 
505(b)(2) drug products.
12. Updates To Certified Electronic Health Record Technology Due to the 
21st Century Cures Act
    In section III.M. of this proposed rule, we propose to update the 
definitions of CEHRT for the Promoting Interoperability Programs and 
for MIPS. Under this proposal, the technology must be certified under 
the Certification Program to the current 2015 Edition certification 
criteria or the certification criteria in the 2015 Edition Cures 
Update, for the period of 24 months, as described in timelines 
finalized in the 21st Century Cures Act final rule (85 FR 25670). After 
that time, when ONC only allows certification under the 2015 Edition 
Cures Update, the technology must be certified to the 2015 Edition 
Cures Update. We also propose 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.
    If these proposals are finalized, eligible hospitals and clinicians 
would 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 accounts 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 and health care providers that would be impacted by their 
regulatory action on the number of hospitals and health care providers 
that have historically participated in the CMS EHR Incentive Programs 
(now Promoting Interoperability (PI) Programs (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 
upgraded technology has been accounted for under the ONC 21st Century 
Cures Act. However, we acknowledge ambiguity in attributing impacts 
across that earlier rule and this proposal, and request comment that 
would help with identification of effects that are dependent on these 
new regulatory provisions. (We further note that if the ambiguity is 
ultimately resolved such that all the costs are attributed to the ONC 
21st Century Cure Rule, leaving no costs associated with this proposed 
rule's certified EHR provisions, then these provisions would also yield 
no benefits.)
13. Proposal To Establish New Code Categories
    In section III.N. of this proposed rule, we are proposing to create 
15 new Level

[[Page 50382]]

II HCPCS codes to identify the current array of buprenorphine/naloxone 
products available on the U.S. market. This code series is intended to 
replace and more specifically identify the series of four existing 
codes (J0572 through and including J0575). Even though this would 
result in a greater number of codes than previously available, the net 
result of this modification is simply a more complete set of codes, 
updated to reflect the current market, available for health care 
providers and coders to identify and report on claims. Therefore these 
changes place no additional burden on coders, health care providers.
14. Medicare Diabetes Prevention Program Expanded Model Emergency 
Policy
a. Effects on Beneficiaries
    In section III.O. of this proposed rule, we are proposing 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 proposed changes would apply during the COVID-19 Public 
Health Emergency (PHE) and any future PHE, 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.
    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 COVID-19 PHE have led CMS to make 
changes to the MDPP expanded model, and now to propose 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 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 COVID-19 PHE 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 COVID-19 PHE. 
Given the extended duration of the COVID-19 PHE, we are proposing to 
finalize the regulations in the March 31st COVID-19 IFC, amend the MDPP 
expanded model to revise certain MDPP policies during the COVID-19 PHE 
and any future 1135 waiver event where such 1135 waiver event may cause 
a disruption to in-person MDPP services. These proposed 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 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.
    Beneficiaries who are eligible to restart the set of MDPP services, 
as proposed in Sec.  410.79(e)(4)(vi), would be currently enrolled in 
the first 12 months of the set of MDPP services, as demonstrated by the 
effective date of the first core session.
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 250 
organizations nationally are enrolled as MDPP suppliers, representing 
938 locations across the US and its territories.
    For the current COVID-19 PHE, 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 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 propose to update our 
assumptions, based on subsequent data from the CDC regarding DPRP 
organizations' plans for managing their existing cohorts during the 
PHE, 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 COVID-19 PHE. 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. 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

[[Page 50383]]

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] TP17AU20.127

15. Changes Due to Updates to the Quality Payment Program
    In section IV.A. of this proposed rule, we included our policies 
for the Quality Payment Program. In this section of the proposed 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 
proposed policies to modify the MIPS final score and the performance 
threshold proposed in section IV.A.3.e.(3) of this rule and additional 
performance threshold finalized in the CY 2020 PFS final rule (84 FR 
63040).
    The measure submissions for the 2019 MIPS performance period were 
not available in time to incorporate into this CY 2021 PFS proposed 
rule regulatory impact analysis. As a result, this analysis uses the 
2018 MIPS performance period submissions that were used for the CY 2020 
PFS final rule (84 FR 63164), with some updates of supplementary 2019 
datasets used to better reflect trends in APM participation and QP 
status since the 2018 MIPS performance period. Furthermore, due to the 
application of the extreme and uncontrollable circumstances policy for 
the 2019 MIPS performance period, not all clinicians submitted measure 
data for the 2019 performance period. We will evaluate for the final 
rule as to whether it will be appropriate to use the 2019 performance 
period data.
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 analysis covers only the fifth payment 
year (2023 payment year) of the Quality Payment Program.

[[Page 50384]]

    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 
$14,012 million and $18,015 million in total for the 2021 performance 
year. The analysis for this proposed rule used the 2019 third snapshot 
participation file. We based APM Incentive Payment Amounts on paid 
amounts with service states 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 proposed 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, and the Radiation Oncology Model as proposed, have been included 
in our analysis as we anticipate that they 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;
     Radiation Oncology Model (RO), if finalized; 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 proposed rule, we proposed to 
double the total points available for the complex patient bonus to up 
to 10 points. If this proposal is finalized, we expect 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 COVID-19 PHE 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. 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 proposed rule, our scoring model used a 
combination of the first determination period from the 2019 MIPS 
performance period (from October 1, 2017 to September 30, 2018) and 
data from the end of calendar year 2018 (from October 1, 2018 to 
December 31, 2018). The first determination period from the 2019 MIPS 
performance period eligibility file was selected as it includes the 
several eligibility file changes that affect the Quality Payment 
Program moving forward. The rationale for including the data from the 
end of CY 2018 was to create a 15-month window for assigning MIPS 
eligible clinicians, as finalized in the CY 2019 PFS final rule (83 FR 
59727 through 59730). We included 1.6 million clinicians (see Table 92) 
who had PFS claims from October 1, 2017 to December 31, 2018. We 
excluded from our analysis individual clinicians who were affected by 
the automatic extreme and uncontrollable policy finalized for the 2018 
MIPS performance period/2020 MIPS payment year in the CY 2019 PFS final 
rule (83 FR 59876) 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, 
submitters with one or more categories identified as being suppressed 
as a result of bad data were also excluded.
    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

[[Page 50385]]

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 final snapshot date for the 2019 QP 
performance period, supplemented by the most recent 2018 performance 
period APM participation data for those clinicians not on the 2019 
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 115,936. 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 2018 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 92 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 2018 MIPS performance period data and applying the 
proposed 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 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 proposed rule model, we estimate approximately 230,000 
clinicians \112\ would be MIPS eligible because they exceed the low 
volume threshold as individuals and are not otherwise excluded. In 
Table 92, we identify these clinicians as having ``required 
eligibility.''
---------------------------------------------------------------------------

    \112\ The count of 230,738 MIPS eligible clinicians for required 
eligibility includes those who participated in MIPS (212,973 MIPS 
eligible clinicians), as well as those who did not participate 
(17,765 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 
2018 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 2018 performance period as well as the additional 
clinicians in the final snapshot date of the 2019 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 2018 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 680,253 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 92, 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 assumed that 33 percent of the clinicians who exceed 
at least one but not all low-volume threshold criteria and submitted 
data to CY 2018 MIPS performance period would elect to opt-in to MIPS. 
We selected a random sample of 33 percent of clinicians without 
accounting for performance. We believe this 33 percent opt-in 
participation assumption is reasonable because some clinicians may 
choose not to submit data due to performance, practice size, or 
resources or alternatively, some may submit data, but elect to be a 
voluntary reporter and not be subject to a MIPS payment adjustment 
based on their performance. This 33 percent participation assumption is 
identified in Table 92 as ``Opt-In eligibility''. In this proposed rule 
analysis, we estimate an additional 20,059 clinicians would be eligible 
through this ``opt-in'' policy for a total MIPS eligible clinician 
population of approximately 930,000. The leads to an associated $72 
billion allowed PFS charges estimated to be included in the 2021 MIPS 
performance period.
BILLING CODE 4120-01-P

[[Page 50386]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.128

BILLING CODE 4120-01-C
    There are an estimated 368,961 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 the low-volume threshold 
on all three criteria (approximately 80,000) or because they are 
excluded for other reasons (approximately 220,000).
    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

[[Page 50387]]

submission period for the 2021 MIPS performance period is closed. For 
this impact analysis, we used the estimated population of 931,050 MIPS 
eligible clinicians described above.
d. 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 proposed 
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.c.(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 proposed policies for the 2021 performance 
period. Our impact analysis looks at the total effect of the previously 
finalized and newly proposed 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.c.(2) of this proposed rule, we generally used the most 
recently available data from the Quality Payment Program which is data 
submitted for the 2018 MIPS performance period.
    The estimated payment impacts presented in this proposed rule 
reflect averages by practice size based on Medicare utilization. The 
payment impact for a MIPS eligible clinician could vary from the 
average and would depend on the combination of services that the MIPS 
eligible clinician furnishes. The average percentage change in total 
revenues 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 proposed rule, we generally used 2018 MIPS performance 
period data. Our scoring model included the 931,050 estimated MIPS 
eligible clinicians as described in section VIII.H.15.b.(1)(b) of this 
RIA.
    To estimate the impact of MIPS policies on MIPS eligible 
clinicians, we generally used the 2018 MIPS performance period data, 
including data submitted for the quality, improvement activities, and 
Promoting Interoperability performance categories, CAHPS for MIPS and 
CAHPS for ACOs, the total per capita cost measure, Medicare Spending 
Per Beneficiary (MSPB) clinician measure and other data sets.\113\ 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.
---------------------------------------------------------------------------

    \113\ Data submitted to MIPS for the 2017 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 
proposed policies for the 2021 MIPS performance period. As discussed in 
section IV.A.3.c.(1)(c) of this proposed rule, we 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 proposed rule, we 
proposed to use a performance period benchmark as opposed to a 
historical benchmark. Because the performance data for this analysis 
came primarily from the 2018 MIPS performance period, we elected to 
continue using the 2018 MIPS performance period benchmarks. We did not 
believe using performance period benchmarks for 2018 performance period 
submissions would appropriately simulate the data issues that might 
occur with historic benchmarks for the 2019 MIPS performance period. 
The one exception to using the 2018 MIPS performance benchmarks is 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)(b) of this proposed rule, we 
proposed the removal of Web Interface as a collection type for the 2021 
MIPS performance period. As discussed in section IV.A.3.c.(1) of this 
proposed rule, we proposed a quality performance category weight of 40 
percent for the 2021 MIPS performance period.
    To estimate a quality performance category score for clinicians in 
groups who previously used Web Interface as a collection type in 2018, 
we assumed these groups would use the other two other collection types 
(MIPS CQMs and eCQMs) available in the 2021 MIPS performance period. To 
estimate the effect of this change, we used the measures submitted 
through Web Interface in 2018 and estimated a 2021 quality performance 
category score by multiplying their computed 2021 quality performance 
category score using Web Interface by an adjustment factor. The 
assumption is that the adjustment factor would reflect how clinicians 
who previously used Web Interface in the 2018 MIPS performance period 
would perform in the 2021 MIPS performance period in the absence of Web 
Interface when using the other two collection types available in the 
2021 MIPS performance period. The computed adjustment factor accounts 
for the distribution of clinicians using MIPS CQMs and eCQMs in 2018 
and the associated average quality performance category score by 
practice size categories (25-49 clinicians, 50-99 clinicians, 100-199 
clinicians, 200-499 clinicians, 500-999 clinicians, and 1000 or more 
clinicians). The adjustment factor was calculated in two steps within 
each practice size category: In

[[Page 50388]]

step one, the average quality performance category score for each 
collection type was weighted by the proportion of MIPS eligible 
clinicians using each collection type. In step two, the weighted 
average quality performance category score for the other collection 
types was divided by the average quality performance score for Web 
Interface, which yields the adjustment factor for each practice size 
category.
    Finally, our model applied the APM Performance Pathway policies 
proposed in section IV.A.3.b. of this proposed rule for clinicians in 
APM Entities. The APM Performance Pathway is available for both ACO and 
non ACOs. However, due to data limitations, our analysis only applied 
the APM Performance Pathway scoring policies to ACO APM Entities. For 
ACOs, quality performance under the proposed APM performance pathway 
was modeled using data from the 2018 Shared Savings Program and Next 
Generation ACO Model public use files.\114\ We simulated scores for the 
Hospital Wide Readmission measure proposed in section IV.A.3.c.(1)(c). 
Data does not exist for APM performance pathway or MIPS quality 
measures for non-ACO APM Entities, so we assumed these non-ACO APM 
entities would not participate in the APP. 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.
---------------------------------------------------------------------------

    \114\ The public use files for the 2018 Medicare Shared Savings 
Program can be accessed here: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/program-data.
---------------------------------------------------------------------------

(b) Methodology To Estimate the Cost Performance Category Score
    In section IV.A.3.c.(2) of this proposed rule, we 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 CY2019 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
    We estimated the Promoting Interoperability performance category 
score using the methodology described in the CY 2020 PFS final rule (84 
FR 63169 through 84 FR 63170)).
    In section IV.2.c.(4)(c)(ii)(B) we are proposing 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 proposal 
provides clinicians the option of either reporting the new measure or 
the two existing measures. Because we lack data on who would adopt 
these new measures and how they would score, we have used past 
reporting on existing measures to estimate future PI performance, and 
do not otherwise model the impact of these HIE measures.
    In our model, for the APM participants that we modeled as 
participating in APP (that is, those in ACO entities), we simulated 
MIPS APM Entity scores by using submitted Promoting Interoperability 
data by groups or individuals that we identified as being in a MIPS APM 
to calculate an APM Entity score.
(e) Methodology To Estimate the Improvement Activities Performance 
Category Score
    We modeled the improvement activities performance category score 
based on CY 2018 MIPS performance period data and APM participation 
identified in section VIII.H.15.b.(1)(b) of this proposed 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 proposed 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 proposed rule, we 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 2018 
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 proposed 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 proposed 
rule.
(h) Methodology To Estimate the MIPS Payment Adjustment
    As described in section IV.A.3.e.(2) of this proposed rule we 
applied the proposed 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 50 points which was proposed in section IV.A.3.e.(3) of 
this rule 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 60 as finalized in the 
CY 2020 PFS final rule (84 FR 63037). We used these resulting 
parameters to estimate the positive or negative MIPS

[[Page 50389]]

payment adjustment based on the estimated final score and the paid 
amount for covered professional services furnished by the MIPS eligible 
clinician.
(3) Impact of Payments by Practice Size
    Using the assumptions provided above, our model estimates that $442 
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 
76.75 and the median is 81.32.
    The model further estimates that the maximum positive payment 
adjustments are 6.9 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 60, which had been finalized in 
the 2020 PFS final rule. In this alternate model, $520 million would be 
redistributed through budget neutrality and the maximum positive 
payment adjustments would be 7.4 percent.
    Table 93 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 93 also shows that 90.7 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 
2018 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 or clinicians changing behavior because 
of the performance thresholds increased for the 2021 MIPS performance 
period to avoid a negative payment adjustment.
    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, 89 percent are in small practices (15,748 out of 17,780 
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. We also note 
this participation data is generally based off participation for the 
2018 performance period, which is associated with the 2020 MIPS payment 
year and had a performance threshold of 15 points, and that 
participation may change for the 2021 performance period when the 
performance threshold is proposed at 50 points.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TP17AU20.129

BILLING CODE 4120-01-C

[[Page 50390]]

(4) Additional Impacts From Outside Payment Adjustments
(a) Burden Overall
    In addition to the payment adjustments, we propose several policies 
that have an impact on burden. In section VI.B.4 of this proposed 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 proposal included in this regulation which impacts our estimate of 
collection burden, the incremental burden for each is summarized in 
Table 94. We also provide additional burden discussions that we are not 
able to quantify.
[GRAPHIC] [TIFF OMITTED] TP17AU20.130

(b) Additional Impacts to Clinicians
(i) Web Interface
    As discussed in section IV.A.3.c.(1)(b) of this proposed rule, we 
are proposing 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 2021 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 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. Given that the Medicare Part B claims collection type 
is limited to small practices, the alternatives for these groups and 
virtual groups would 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 2,932 TINs 
comprised of 25 or more clinicians who submitted MIPS data via a 
collection type other than the CMS Web Interface, 62 percent reported 
via the MIP CQM and QCDR collection type and 38 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 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 would 
also be reducing reporting requirements. Groups and virtual groups 
would no longer have to completely report on all pre-determined CMS Web 
Interface measures and would 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 CMS Web Interface) decreased by 
approximately 45 percent. Similarly, the number of groups utilizing the 
CMS

[[Page 50391]]

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)(c), we are proposing 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)(ii) of this rule, we are 
proposing for the CY 2021 performance period and future years to modify 
two existing improvement activities. We refer readers to Appendix 2 of 
this proposed rule for further details. We do not believe these 
proposals would 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 this proposal 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, would continue to perform the 
same activities under the policies established in this proposed 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)(aa) of this rule, we are proposing 
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 proposal, 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.2.c.(3)(b)(ii)(B) of this 
rule, we are proposing, 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 VI.B.5.i. of this proposed 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.
(d) Impact on Third Party Intermediaries
    In section IV.A.3.g. of this rule, we proposed multiple changes to 
the third party intermediary regulations at Sec.  414.1400. 
Specifically, we are proposing to: (1) Amend 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) require attendance by 
all third party intermediaries for training and support sessions; (3) 
require 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 increase 
requirements for QCDR measure testing and clarify what is meant by full 
testing; and (5) require 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 proposal to amend current requirements for 
approval of third party intermediaries, we do not anticipate this to 
require any additional effort for affected entities as the proposal is 
to allow CMS to utilize already available information to make approval 
decisions.
    The proposed 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 
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.\115\ 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

[[Page 50392]]

estimate a total burden of $20,852 ($212.78/hr x 98 hours).
---------------------------------------------------------------------------

    \115\ 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 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 
proposed 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 proposed 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 are unable to estimate the 
number of audits which may occur or the time and costs associated with 
their conduct which could vary substantially depending on the nature of 
the data error and the amount of data to be audited. We seek comment on 
the expected frequency of targeted audits and the anticipated scope of 
effort.
    Because the proposal to incrementally increase requirements for 
QCDR measure testing is not changing the requirements for fully testing 
measures, but is instead proposing an incremental approach to achieve 
previously finalized requirements, we do not anticipate any additional 
impact as a result of the proposal.
    As discussed in section VI.B.5.c.(2) of this rule, we estimate the 
total burden impact associated with the proposal 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, 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. We 
based our analyses on the data prepared to support the 2019 performance 
period initial determination of clinician and special status 
eligibility (available via the NPI lookup on qpp.cms.gov),\116\ APM 
Participant List for the final snapshot date for the 2019 QP 
performance period, CY 2018 Quality Payment Program Year 2 data, 2018 
ACO Public Use File for MSSP and Next Gen and CAHPS for ACOs. The 
scoring model results presented in this proposed rule assume that CY 
2018 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 performance 
period using CY 2018 Quality Payment Program data may be underestimated 
because the performance threshold to avoid a negative payment 
adjustment for the 2018 MIPS performance period/2020 MIPS payment year 
was significantly lower (15 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.
---------------------------------------------------------------------------

    \116\ The time period for this eligibility file (September 1, 
2017 to August 31, 2018) maximizes the overlap with the performance 
data in our model.
---------------------------------------------------------------------------

    In our MIPS eligible clinician assumptions, we assumed that 33 
percent of the opt-in eligible clinicians that participated in the CY 
2018 Quality Payment Program would elect to opt-in to the MIPS program. 
It is difficult to predict whether clinicians will elect to opt-in to 
participate in MIPS with the proposed 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 93; and (2) our cost data does not overlap with CY 2018 
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 proposed rule contains a range of policies, including some 
provisions related to specific statutory provisions. The preceding 
preamble provides descriptions of the statutory provisions that are 
addressed, identifies those policies when discretion has been 
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 proposed 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 60 which was previously finalized in the CY 
2020 final rule (84 FR 63037) as an alternative to the proposed 
performance threshold of 50. For reference, our model of proposed 
policies has a mean final score of 76.75 and median final score of 
81.32. The model with a performance threshold of 60, has a mean final 
score of 76.75 and a median final score of 81.32. We estimate that $520 
million would be redistributed through budget neutrality. There would 
be a maximum payment adjustment of 7.36 percent after considering the 
MIPS payment adjustment and the additional MIPS payment adjustment for 
exceptional performance. In addition, 10.4 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 proposed 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.

[[Page 50393]]

The model with a cost performance category weight of 15 has a mean 
score of 82.14 and a median score of 77.31. The model with a cost 
performance category weight of 30 has a mean score of 75.85 and a 
median score 80.06. We refer readers to section IV.A.2.c.(2)(a) for 
additional rationale on the selection of the cost performance category 
weight.
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 proposal 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.

J. Impact on Beneficiaries

    We do not believe our proposals 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, the proposed Emergency Policy allows 
beneficiaries to restart their set of MDPP services, maximizing 
beneficiary options and access to MDPP both during the PHE 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 assume 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 last year's rule in detail, and it is also possible 
that some reviewers chose not to comment on the rule. For these reasons 
we thought that the number of past commenters would be a fair estimate 
of the number of reviewers of this rule. We welcomed any comments on 
the approach in estimating the number of entities which will review 
this rule.
    We also recognize that different types of entities are in many 
cases affected by mutually exclusive sections of this rule, and 
therefore for the purposes of our estimate we assume that each reviewer 
reads approximately 50 percent of the rule. We sought comments on this 
assumption.
    Using the wage information from the BLS for medical and health 
service managers (Code 11-9111), we estimate that the cost of reviewing 
this rule is $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 $38,477,277.44 ($885.92 x 43,432 reviewers on last 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 95 and 96 
(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.

[[Page 50394]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.131

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 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, Drugs, Health 
facilities, Health professions, Diseases, 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 proposes to amend 42 CFR chapter IV as set forth 
below:

PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS

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

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

0
2. 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.

[[Page 50395]]

    (xi) Any other element determined appropriate through the national 
coverage determination process.
* * * * *
0
2. 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;
0
b. In the definition of ``Initial preventive physical examination'' by 
revising paragraphs (6) and (7) and adding paragraphs (8) and (9).
    The addition 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
3. 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 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, 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
4. Section 410.33 is amended by adding paragraph (j) to read as 
follows:


Sec.  410.33  Independent diagnostic testing facility.

* * * * *
    (j) Exception for IDTFs with no beneficiary interaction. An IDTF 
supplier that has no beneficiary interaction, treatment, or testing at 
its practice location must not be subject to the requirements at:
    (1) Paragraph (c) of this section.
    (2) Paragraph (e)(1)(i) of this section.
    (i) The requirement that the IDTF maintain documentation that its 
technicians are licensed and certified in each of the States in which 
the IDTF operates does not apply to IDTFs that are excepted in this 
paragraph (j). The requirement that the IDTF maintain documentation 
that its supervising physicians are licensed and certified in each of 
the States in which the IDTF operates does apply to IDTFs that are 
excepted in this paragraph.
    (ii) [Reserved]
    (3) Paragraph (e)(1)(ii) of this section.
    (4) Paragraph (g)(1) of this section.
    (5) Paragraph (g)(6) of this section.
    (6) Paragraph (g)(8) of this section.
    (7) Paragraph (g)(9) of this section.
    (8) Paragraph (g)(11) of this section.
    (9) Paragraph (g)(12) of this section.
* * * * *
0
5. Section 410.67 is amended--
0
a. 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.
* * * * *

[[Page 50396]]

    (d) * * *
    (2) * * *
    (i) * * *
    (A) 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 an adjustment will be made when 
these medications are dispensed. This adjustment will be limited to 
once every 30 days to the extent that it is medically reasonable and 
necessary. The amount of the adjustment will be determined using the 
methodology in paragraph (d)(2)(i) of this section, except the payment 
for auto-injector naloxone will be determined using the lowest pricing 
available (the lower of 100 percent of the ASP, 100 percent of WAC, or 
the National Average Drug Acquisition Cost).
* * * * *
0
6. 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
7. 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 of 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), during an 1135 waiver 
event.
    (ii) If CMS determines that an 1135 event may disrupt in-person 
MDPP services, CMS will communicate such determination for policies 
described in this paragraph (e), to all impacted 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)(4)(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 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.
    (iv) The virtual session limits described in paragraphs (d)(2), 
(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 so long as the 
provision of virtual services complies with all of the following 
requirements:
    (A) The curriculum furnished during the virtual session must 
address the

[[Page 50397]]

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;
    (C) The MDPP supplier furnishes to the MDPP beneficiary a maximum 
of one virtual make-up session per week;
    (D) Virtual sessions must be furnished in a manner consistent with 
the DPRP standards for virtual sessions;
    (E) An MDPP supplier can offer virtual sessions only upon an 
individual MDPP beneficiary's request or agreement to receive services 
virtually;
    (F) An MDPP supplier can offer 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 1135 waiver event, and 
subsequently resume services either upon the effective end date of the 
1135 waiver event or upon an effective date specified by CMS. Upon 
resumption of the set of MDPP services, the MDPP services must be 
furnished in compliance with the requirements in accordance with the 
following paragraphs (the once per lifetime requirement as described in 
paragraph (c)(1)(i)(B) of this section does not apply):
    (A) Beneficiaries who were receiving MDPP services as of March 1, 
2020 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 and who are in the first 12 months of the set of MDPP 
services as of the start of an applicable 1135 waiver event, and whose 
sessions are suspended due to the applicable 1135 waiver event, 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 and who are in the second year of the set of MDPP 
services as of the start of an applicable 1135 waiver event are 
eligible to 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 who elected to continue with MDPP services 
virtually, as described in paragraph (c)(iii) of this section, are not 
eligible to restart or resume the set of MDPP services at a later date.
    (E) Beneficiaries who elect to suspend the set of MDPP services at 
the start of an applicable 1135 waiver event may choose to restart the 
set of MDPP services at the beginning, or may resume with the most 
recent attendance session of record, only one time per 1135 waiver 
event.

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

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

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

0
9. 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
10. 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
11. 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.
* * * * *
0
12. Section 414.902 is amended by revising the definition of ``Multiple 
source drug'' to read as follows:


Sec.  414.902  Definitions.

* * * * *
    Multiple source drug means a drug described by section 
1847A(c)(6)(C) of the Act, including drug products approved through the 
pathway established under section 505(b)(2) of the Federal Food, Drug, 
and Cosmetic Act that are described in Sec.  414.904(k).
* * * * *
0
13. Section 414.904 is amended by adding paragraph (k) to read as 
follows:


Sec.  414.904  Average sales price as the basis for payment.

* * * * *
    (k) Assigning drug products approved through the pathway 
established under section 505(b)(2) of the Federal Food, Drug, and 
Cosmetic Act to a multiple source drug code. (1) Drug products approved 
through the pathway established under section 505(b)(2) of the Federal 
Food, Drug, and Cosmetic Act are assigned to multiple source drug 
billing and payment codes based on--
    (i) The existence of a multiple source drug billing code described 
by section 1847A(c)(6)(C) of the Act.
    (ii) A determination of whether an existing multiple source drug 
code's descriptor describes the drug product approved through the 
pathway established under section 505(b)(2) of the Federal Food, Drug, 
and Cosmetic Act based on factors including--
    (A) The active ingredient(s), drug name, and the drug description.
    (B) Information in drug labeling.
    (C) Prescribing and clinical use of the drug.
    (2) [Reserved]
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

[[Page 50398]]

(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 definitions for ``Physician Compare'' and ``Primary care 
services'' in alphabetical order; and
0
g. By revising the definitions of ``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 2022 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 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, 99442, and 99443 (codes for telephone evaluation and 
management services); and 96160 and 96161 (codes for administration of 
health risk assessment).

[[Page 50399]]

    (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 2022 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 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) 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).
    (3) 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 Sec.  
414.1380(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-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:

[[Page 50400]]

    (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 2022 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) and (b)(1)(iv)(B);
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);
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:

[[Page 50401]]

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.
    (iv) * * *
    (B) Except as provided in paragraph (b)(1)(iv)(B)(1) of this 
section, beginning with the 2021 MIPS payment year, each measure 
(except for measures in the CMS Web Interface) for which the benchmark 
for the applicable collection type is identified as topped out for 2 or 
more consecutive years receives no more than 7 measure achievement 
points in the second consecutive year it is identified as topped out, 
and beyond.
    (1) For the 2023 MIPS payment year, a measure is topped out if it 
is identified as such in the baseline period benchmarks for the 2020 
MIPS performance period and in the performance period benchmarks for 
the 2021 MIPS performance period.
    (2) [Reserved]
* * * * *
    (vii) * * *
    (A) For each submitted measure that is impacted by significant 
changes that CMS determines may result in patient harm or misleading 
results, performance is based on data for 9 consecutive months of the 
applicable CY performance period. If such data are not available, 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 codes (including, but not limited to, ICD-10, CPT, and 
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:

[[Page 50402]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.132

    (F) For the 2024 MIPS payment year:
    [GRAPHIC] [TIFF OMITTED] TP17AU20.133
    
* * * * *
    (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), 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 the paragraph (b) subject 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 the paragraph (c) subject 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:

[[Page 50403]]

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 Sec.  414.1380(c)(2)(i)(C)(1) through 
(7) or Sec.  414.1380(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 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 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.
    (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) * * *

[[Page 50404]]

    (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.
    (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 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.
    (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 
paragraph (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 414.1405 is amended by revising paragraph (b)(8) to read as 
follows:


Sec.  414.1405  Payment.

* * * * *
    (b) * * *
    (8) The performance threshold for the 2023 MIPS payment year is 50 
points.
* * * * *
0
26. Section 414.1435 is amended by revising paragraph (c)(1) to read as 
follows:


Sec.  414.1435  Qualifying APM Participant determination: Medicare 
option.

* * * * *
    (c) * * *

[[Page 50405]]

    (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 below.
    (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
27. 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 the 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 below 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
28. Section 414.1455 is revised to read as follows:


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) Targeted review. (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.
    (iv) CMS will respond to each timely submitted request for targeted 
review.
    (v) 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.
    (vi) 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.
    (vi) 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.

[[Page 50406]]

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

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

    Authority:  42 U.S.C. 1302 and 1395hh.

0
30. Section 415.184 is revised to read as follows:


Sec.  415.184  Psychiatric services.

    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. 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 be met by audio/video real-time communications 
technology.

PART 423--VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT

0
31. The authority citation for part 423 continues to read as follows:

    Authority:  42 U.S.C. 1302, 1395w-01 through 1395w-152, and 
1395hh.

0
32. Section 423.160 is amended by adding paragraph (a)(5) to read as 
follows:


Sec.  423.160  Standards for electronic prescribing.

    (a) * * *
    (5) On or after January 1, 2022, 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.
* * * * *

PART 424--CONDITIONS FOR MEDICARE PAYMENT

0
33. The authority citation for part 424 continues to read as follows:

    Authority:  42 U.S.C. 1302 and 1395hh.

0
34. 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) of this 
chapter 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
35. Section 424.210 is amended by revising paragraph (a) and adding 
paragraph (b)(9) to read as follows:


Sec.  424.210   Beneficiary engagement incentives under the Medicare 
Diabetes Prevention Program expanded model.

    (a) Definitions. In addition to the definitions specified at Sec.  
410.79(b) and Sec.  424.205(a) of this chapter, the following 
definitions apply to this section:
    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 waivers under section 1135 of the Act.
    COVID-19 Public Health Emergency means the emergency period and 
emergency area, as such terms are defined in section 1135(g) of the 
Social Security Act, related to the COVID-19 pandemic and declared by 
the Secretary on January 27, 2020.
    Engagement incentive period means the period of time during which 
an MDPP supplier may furnish in-kind beneficiary engagement incentives 
to a given MDPP beneficiary to whom the MDPP supplier is furnishing 
MDPP services. This period begins when an MDPP supplier furnishes any 
MDPP service to an MDPP eligible beneficiary, and ends when one of the 
following occurs, whichever occurs first:
    (i) The MDPP beneficiary's MDPP services period ends as described 
in Sec.  410.79(c)(3) of this chapter.
    (ii) The MDPP supplier knows that the MDPP beneficiary will no 
longer be receiving MDPP services from the MDPP supplier.
    (iii) 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

[[Page 50407]]

Sec.  410.79(e) of this chapter and the MDPP services are eventually 
resumed or restarted in accordance with Sec.  410.79(e) of this 
chapter.
    (b) * * *
    (9) If the item or service is furnished during the COVID-19 Public 
Health Emergency or an 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 COVID-19 Public Health Emergency or the section 1135 waiver event, 
as applicable.
* * * * *
0
36. Section 424.518 is amended by redesignating paragraphs (a)(1)(xii) 
through (xvi) as paragraphs (a)(1)(xiii) through (xvii) 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
37. The authority citation for part 425 continues to read as follows:

    Authority:  42 U.S.C. 1302, 1306, 1395hh, and 1395jjj.

0
38. 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
39. 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. Sec.  425.500 or 425.510, as applicable''.


Sec.  425.200  [Amended]

0
40. Section 425.200 is amended in paragraph (d) by removing the 
reference ``Sec.  425.500(c)'' and adding in its place the references 
``Sec. Sec.  425.500(c) or 425.510, as applicable''.
0
41. Section 425.204 is amended by revising paragraphs (f)(3)(i) through 
(iv), (f)(4)(iv), and (f)(5) to 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 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.
    (4) * * *
    (iv)(A) In the case of an ACO that has submitted a request to renew 
its participation agreement for an agreement period starting on or 
after January 1, 2022 and 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 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.
* * * * *
0
42. 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) * * *

[[Page 50408]]

    (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. Sec.  425.316(c)(1)(ii) or 425.316(c)(2)(ii).
* * * * *


Sec.  425.302  [Amended]

0
43. Section 425.302 is amended in paragraph (a)(1) by removing the 
reference ``Sec.  425.500'' and adding in its place the references 
``Sec. Sec.  425.500 or 425.510, as applicable''.
0
44. 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. Sec.  425.500 or 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 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 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
45. Section 425.400 is amended by revising paragraph (c)(1)(iv) 
introductory text and adding paragraph (c)(1)(v) to 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) 99483 (code for assessment of and care planning for patients 
with cognitive impairment).
    (9) 99484, 99492, 99493 and 99494 (codes for behavioral health 
integration services).
    (10) 99487, 99489, 99490 and 99491 (codes for chronic care 
management).
    (11) 99495 and 99496 (codes for transitional care management 
services).
    (12) 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) G2058 (code for non-complex chronic care management).
    (9) G2064 and G2065 (codes for principal care management services).
    (10) GCOL1 (code for psychiatric collaborative care model).
* * * * *
0
46. 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

[[Page 50409]]

requirement and will assign all ACOs automatic credit for the CAHPS for 
ACOs survey measures.
* * * * *
0
47. 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
48. Section 425.508 is amended by revising the paragraph (a) subject 
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 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
49. 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
50. 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) 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 all ACOs, 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.
    (3) 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 would 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) 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.
    (ii) If the ACO reports quality data via the APP framework and 
meets data completeness and case minimum requirements, CMS will use the 
higher of the ACO's quality performance score or the equivalent of the 
40th percentile MIPS Quality performance category score.
    (3) 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.
    (4) 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
51. Section 425.600 is amended by revising paragraph (f)(4)(i) to read 
as follows:


Sec.  425.600  Selection of risk model.

* * * * *
    (f) * * *
    (4) * * *
    (i) The quality performance standard as described in Sec.  
425.502(a), for performance years (or a performance period) beginning 
on or before January 1, 2020.
* * * * *
0
52. 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

[[Page 50410]]

(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
53. 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
54. 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
55. 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
56. 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 
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

[[Page 50411]]

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
57. 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 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
58. 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

[[Page 50412]]

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.
* * * * *


Sec.  425.800  [Amended]

0
59. 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. Sec.  425.502 or 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. Sec.  425.502 or 425.512, as 
applicable''.

    Dated: July 16, 2020.
Seema Verma
Administrator, Centers for Medicare & Medicaid Services.

    Dated: July 31, 2020.
Alex M. Azar II,
Secretary, Department of Health and Human Services.

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

Appendix 1: MIPS Quality Measures

    NOTE: Except as otherwise noted in this proposed rule, 
previously finalized measures and specialty measure sets will 
continue to apply for the 2023 MIPS payment year and future years. 
In addition, electronic Clinical Quality Measures (eCQMs) that are 
National Quality Forum (NQF) endorsed are shown in Table A as 
follows: NQF #/eCQM NQF #.
BILLING CODE 4120-01-P

[[Page 50413]]

[GRAPHIC] [TIFF OMITTED] TP17AU20.134


[[Page 50414]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.135


[[Page 50415]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.136


[[Page 50416]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.137


[[Page 50417]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.138


[[Page 50418]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.139


[[Page 50419]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.140


[[Page 50420]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.141


[[Page 50421]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.142


[[Page 50422]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.143


[[Page 50423]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.144


[[Page 50424]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.145


[[Page 50425]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.146


[[Page 50426]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.147


[[Page 50427]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.148


[[Page 50428]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.149

[GRAPHIC] [TIFF OMITTED] TP17AU20.150


[[Page 50429]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.151


[[Page 50430]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.152


[[Page 50431]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.153


[[Page 50432]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.154


[[Page 50433]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.155


[[Page 50434]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.156


[[Page 50435]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.157

[GRAPHIC] [TIFF OMITTED] TP17AU20.158


[[Page 50436]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.159


[[Page 50437]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.160


[[Page 50438]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.161


[[Page 50439]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.162


[[Page 50440]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.163


[[Page 50441]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.164


[[Page 50442]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.165


[[Page 50443]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.166

[GRAPHIC] [TIFF OMITTED] TP17AU20.167


[[Page 50444]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.168


[[Page 50445]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.169


[[Page 50446]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.170


[[Page 50447]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.171


[[Page 50448]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.172


[[Page 50449]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.173


[[Page 50450]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.174


[[Page 50451]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.175


[[Page 50452]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.176


[[Page 50453]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.177


[[Page 50454]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.178


[[Page 50455]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.179


[[Page 50456]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.180


[[Page 50457]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.181


[[Page 50458]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.182


[[Page 50459]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.183


[[Page 50460]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.184


[[Page 50461]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.185


[[Page 50462]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.186


[[Page 50463]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.187


[[Page 50464]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.188


[[Page 50465]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.189


[[Page 50466]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.190


[[Page 50467]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.191


[[Page 50468]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.192


[[Page 50469]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.193


[[Page 50470]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.194


[[Page 50471]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.195


[[Page 50472]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.196


[[Page 50473]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.197


[[Page 50474]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.198


[[Page 50475]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.199


[[Page 50476]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.200


[[Page 50477]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.201


[[Page 50478]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.202


[[Page 50479]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.203


[[Page 50480]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.204


[[Page 50481]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.205


[[Page 50482]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.206


[[Page 50483]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.207


[[Page 50484]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.208


[[Page 50485]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.209


[[Page 50486]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.210


[[Page 50487]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.211


[[Page 50488]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.212


[[Page 50489]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.213


[[Page 50490]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.214


[[Page 50491]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.215


[[Page 50492]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.216


[[Page 50493]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.217


[[Page 50494]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.218


[[Page 50495]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.219


[[Page 50496]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.220


[[Page 50497]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.221


[[Page 50498]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.222


[[Page 50499]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.223


[[Page 50500]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.224

[GRAPHIC] [TIFF OMITTED] TP17AU20.225


[[Page 50501]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.226


[[Page 50502]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.227


[[Page 50503]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.228


[[Page 50504]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.229

[GRAPHIC] [TIFF OMITTED] TP17AU20.230


[[Page 50505]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.231


[[Page 50506]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.232


[[Page 50507]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.233


[[Page 50508]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.234


[[Page 50509]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.235


[[Page 50510]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.236


[[Page 50511]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.237

[GRAPHIC] [TIFF OMITTED] TP17AU20.238


[[Page 50512]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.239


[[Page 50513]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.240


[[Page 50514]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.241


[[Page 50515]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.242

[GRAPHIC] [TIFF OMITTED] TP17AU20.243


[[Page 50516]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.244


[[Page 50517]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.245


[[Page 50518]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.246


[[Page 50519]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.247


[[Page 50520]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.248


[[Page 50521]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.249


[[Page 50522]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.250


[[Page 50523]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.251


[[Page 50524]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.252


[[Page 50525]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.253


[[Page 50526]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.254


[[Page 50527]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.255


[[Page 50528]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.256


[[Page 50529]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.257


[[Page 50530]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.258


[[Page 50531]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.259


[[Page 50532]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.260


[[Page 50533]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.261

[GRAPHIC] [TIFF OMITTED] TP17AU20.262


[[Page 50534]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.263


[[Page 50535]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.264


[[Page 50536]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.265


[[Page 50537]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.266


[[Page 50538]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.267

[GRAPHIC] [TIFF OMITTED] TP17AU20.268


[[Page 50539]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.269


[[Page 50540]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.270


[[Page 50541]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.271


[[Page 50542]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.272


[[Page 50543]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.273


[[Page 50544]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.274


[[Page 50545]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.275


[[Page 50546]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.276

[GRAPHIC] [TIFF OMITTED] TP17AU20.277


[[Page 50547]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.278


[[Page 50548]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.279


[[Page 50549]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.280


[[Page 50550]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.281


[[Page 50551]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.282


[[Page 50552]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.283


[[Page 50553]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.284


[[Page 50554]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.285


[[Page 50555]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.286


[[Page 50556]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.287

[GRAPHIC] [TIFF OMITTED] TP17AU20.288


[[Page 50557]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.289


[[Page 50558]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.290


[[Page 50559]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.291


[[Page 50560]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.292


[[Page 50561]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.293


[[Page 50562]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.294

[GRAPHIC] [TIFF OMITTED] TP17AU20.295


[[Page 50563]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.296


[[Page 50564]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.297


[[Page 50565]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.298


[[Page 50566]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.299


[[Page 50567]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.300


[[Page 50568]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.301


[[Page 50569]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.302


[[Page 50570]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.303

[GRAPHIC] [TIFF OMITTED] TP17AU20.304


[[Page 50571]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.305


[[Page 50572]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.306

[GRAPHIC] [TIFF OMITTED] TP17AU20.307


[[Page 50573]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.308


[[Page 50574]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.309


[[Page 50575]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.310


[[Page 50576]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.311

[GRAPHIC] [TIFF OMITTED] TP17AU20.312


[[Page 50577]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.313


[[Page 50578]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.314


[[Page 50579]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.315


[[Page 50580]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.316

[GRAPHIC] [TIFF OMITTED] TP17AU20.317


[[Page 50581]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.318


[[Page 50582]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.319


[[Page 50583]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.320


[[Page 50584]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.321


[[Page 50585]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.322


[[Page 50586]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.323


[[Page 50587]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.324

[GRAPHIC] [TIFF OMITTED] TP17AU20.325

[GRAPHIC] [TIFF OMITTED] TP17AU20.326


[[Page 50588]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.327


[[Page 50589]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.328

[GRAPHIC] [TIFF OMITTED] TP17AU20.329


[[Page 50590]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.330

[GRAPHIC] [TIFF OMITTED] TP17AU20.331


[[Page 50591]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.332

[GRAPHIC] [TIFF OMITTED] TP17AU20.333


[[Page 50592]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.334


[[Page 50593]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.335


[[Page 50594]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.336


[[Page 50595]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.337

[GRAPHIC] [TIFF OMITTED] TP17AU20.338

[GRAPHIC] [TIFF OMITTED] TP17AU20.339


[[Page 50596]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.340


[[Page 50597]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.341


[[Page 50598]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.342


[[Page 50599]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.343


[[Page 50600]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.344


[[Page 50601]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.345

[GRAPHIC] [TIFF OMITTED] TP17AU20.346


[[Page 50602]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.347

[GRAPHIC] [TIFF OMITTED] TP17AU20.348


[[Page 50603]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.349


[[Page 50604]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.350


[[Page 50605]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.351


[[Page 50606]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.352


[[Page 50607]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.353


[[Page 50608]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.354

[GRAPHIC] [TIFF OMITTED] TP17AU20.355


[[Page 50609]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.356


[[Page 50610]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.357


[[Page 50611]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.358


[[Page 50612]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.359

[GRAPHIC] [TIFF OMITTED] TP17AU20.360


[[Page 50613]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.361


[[Page 50614]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.362

[GRAPHIC] [TIFF OMITTED] TP17AU20.363

[GRAPHIC] [TIFF OMITTED] TP17AU20.364


[[Page 50615]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.365

[GRAPHIC] [TIFF OMITTED] TP17AU20.366


[[Page 50616]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.367


[[Page 50617]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.368


[[Page 50618]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.369


[[Page 50619]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.370


[[Page 50620]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.371

[GRAPHIC] [TIFF OMITTED] TP17AU20.372


[[Page 50621]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.373


[[Page 50622]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.374


[[Page 50623]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.375


[[Page 50624]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.376


[[Page 50625]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.377


[[Page 50626]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.378

[GRAPHIC] [TIFF OMITTED] TP17AU20.379

[GRAPHIC] [TIFF OMITTED] TP17AU20.380


[[Page 50627]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.381

[GRAPHIC] [TIFF OMITTED] TP17AU20.382

[GRAPHIC] [TIFF OMITTED] TP17AU20.383


[[Page 50628]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.384


[[Page 50629]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.385

[GRAPHIC] [TIFF OMITTED] TP17AU20.386


[[Page 50630]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.387

[GRAPHIC] [TIFF OMITTED] TP17AU20.388

[GRAPHIC] [TIFF OMITTED] TP17AU20.389


[[Page 50631]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.390

[GRAPHIC] [TIFF OMITTED] TP17AU20.391


[[Page 50632]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.392


[[Page 50633]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.393


[[Page 50634]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.394

[GRAPHIC] [TIFF OMITTED] TP17AU20.395


[[Page 50635]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.396

[GRAPHIC] [TIFF OMITTED] TP17AU20.397


[[Page 50636]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.398

[GRAPHIC] [TIFF OMITTED] TP17AU20.399


[[Page 50637]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.400

[GRAPHIC] [TIFF OMITTED] TP17AU20.401


[[Page 50638]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.402

[GRAPHIC] [TIFF OMITTED] TP17AU20.403


[[Page 50639]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.404

[GRAPHIC] [TIFF OMITTED] TP17AU20.405


[[Page 50640]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.406

[GRAPHIC] [TIFF OMITTED] TP17AU20.407


[[Page 50641]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.408

[GRAPHIC] [TIFF OMITTED] TP17AU20.409


[[Page 50642]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.410

[GRAPHIC] [TIFF OMITTED] TP17AU20.411

[GRAPHIC] [TIFF OMITTED] TP17AU20.412


[[Page 50643]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.413

[GRAPHIC] [TIFF OMITTED] TP17AU20.414


[[Page 50644]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.415


[[Page 50645]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.416


[[Page 50646]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.417


[[Page 50647]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.418


[[Page 50648]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.419


[[Page 50649]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.420


[[Page 50650]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.421


[[Page 50651]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.422


[[Page 50652]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.423


[[Page 50653]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.424

[GRAPHIC] [TIFF OMITTED] TP17AU20.425


[[Page 50654]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.426


[[Page 50655]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.427

[GRAPHIC] [TIFF OMITTED] TP17AU20.428

[GRAPHIC] [TIFF OMITTED] TP17AU20.429


[[Page 50656]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.430

[GRAPHIC] [TIFF OMITTED] TP17AU20.431

[GRAPHIC] [TIFF OMITTED] TP17AU20.432


[[Page 50657]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.433

[GRAPHIC] [TIFF OMITTED] TP17AU20.434

[GRAPHIC] [TIFF OMITTED] TP17AU20.435


[[Page 50658]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.436

[GRAPHIC] [TIFF OMITTED] TP17AU20.437


[[Page 50659]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.438


[[Page 50660]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.439


[[Page 50661]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.440

[GRAPHIC] [TIFF OMITTED] TP17AU20.441

[GRAPHIC] [TIFF OMITTED] TP17AU20.442


[[Page 50662]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.443


[[Page 50663]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.444


[[Page 50664]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.445


[[Page 50665]]


[GRAPHIC] [TIFF OMITTED] TP17AU20.446

[FR Doc. 2020-17127 Filed 8-4-20; 8:45 am]
BILLING CODE 4120-01-C